COVID-19 Updates

For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

A version of this article originally appeared on Medscape.com.

For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

A version of this article originally appeared on Medscape.com.

For mid-career oncologist Tanya Wildes, MD, the pandemic was the last straw. In late September, she tweeted: “I have done the academically unfathomable: I am resigning my faculty position without another job lined up.”

She wasn’t burned out, she insisted. She loved her patients and her research. But she was also “100% confident” in her decision and “also 100% sad. This did not have to happen,” she lamented, asking not to disclose her workplace for fear of retribution.

Being a woman in medicine “is a hard life to start with,” Dr. Wildes said in an interview. “We all have that tenuous balance going on and the pandemic made everything just a little bit harder.”

She describes her prepandemic work-life balance as a “Jenga tower, with everything only just in place.” But she realized that the balance had tipped, when after a difficult clinic she felt emotionally wrung out. Her 11-year-old son had asked her to help him fly his model airplane. “I told him, ‘Honey, I can’t do it because if it crashes or gets stuck in a tree ... you’re going to be devastated and I have nothing left for you.’ “

This was a eureka moment, as “I realized, this is not who I want to be,” she said, holding back tears. “Seventy years from now my son is going to tell his grandchildren about the pandemic and I don’t want his memory of his mom to be that she couldn’t be there for him because she was too spent.”

When Dr. Wildes shared her story on Twitter, other female oncologists and physicians responded that they too have felt they’re under increased pressure this year, with the extra stress of the pandemic leading others to quit as well.

The trend of doctors leaving medicine has been noticeable. A July survey from the Physicians Foundation found that roughly 16,000 medical practices had already closed during the pandemic, with another 8,000 predicted to close within the next year.

“Similar patterns” were evident in another analysis by the Larry A. Green Center and the Primary Care Collaborative, as reported in The New York Times. In that survey, nearly one-fifth of primary care clinicians said “someone in their practice plans to retire early or has already retired because of COVID-19,” and 15% say “someone has left or plans to leave the practice.” About half said their mental exhaustion was at an all-time high, the survey found.

“COVID-19 is a burden, and that added burden has tipped people over the edge of many things,” said Monica Bertagnolli, MD, chief of the division of surgical oncology at Brigham and Women’s Hospital, Boston, and former president of the American Society of Clinical Oncology.

“It has illustrated that we do have a lot of people who are working kind of on the edge of not being able to handle everything,” she said.

While many in medicine are struggling, the pandemic seems to be pushing more women to leave, highlighting longtime gender disparities and increased caregiving burdens. And their absence may be felt for years to come.

Firm numbers are hard to come by, said Julie Silver, MD, associate professor, associate chair, and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston, and an expert in gender equity in medicine. But she sees some troubling trends.

“There are many indications that women are leaving medicine in disproportionately high numbers,” Dr. Silver said in an interview. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

A survey of 1,809 women conducted in mid-April with the Physician Moms Facebook Group and accepted for online publication by the American Journal of Psychiatry found that 41% scored over the cutoff points for moderate or severe anxiety, with 46% meeting these criteria among front-line workers.

“It’s really important for society to recognize the extraordinary impact this pandemic is having on physician mothers, as there will be profound ripple effects on the ability of this key segment of the health care workforce to serve others if we do not address this problem urgently,” co-senior author Reshma Jagsi, MD, DPhil, a radiation oncologist at the University of Michigan, Ann Arbor, said in an interview.

Women weighed in on Twitter, in response to Dr. Silver’s tweet to #WomenInMedicine: “If you are thinking of leaving #medicine & need a reason to stay: we value you & need you.”

In reply, Emmy Betz, MD, MPH, associate professor of emergency medicine at the University of Colorado at Denver, Aurora, said via Twitter, “I’ve had lots of conversations with women considering leaving medicine.”

“I have thought about leaving many times. I love what I do, but medicine can be an unkind world at times,” responded Valerie Fitzhugh MD, associate professor and pathologist at New Jersey Medical School, Newark.

“Too late. Left at the end of July and it was the best decision ever,” wrote Michelle Gordon, DO, who was previously a board-certified general surgeon at Northern Westchester Surgical Associates in Putnam Valley, N.Y.


 

Prepandemic disparities accentuated

The pandemic “has merely accentuated – or made more apparent – some of the longstanding issues and struggles of women in oncology, women in medicine, women in academia,” said Sarah Holstein, MD, PhD, another mid-career oncologist and associate professor at the University of Nebraska Medical Center, Omaha.

“There are disparities in first-author/last-author publications, disparities in being asked to give speaking engagements, disparities in leadership,” Dr. Holstein said in an interview. “And then ... put on top of that the various surges with the pandemic where you are being asked to do clinical responsibilities you don’t normally do, perhaps some things you haven’t done since your training 10 or 20 years ago.”

This is backed up with data: There is already a “robust” body of prepandemic literature demonstrating pay gaps for female physicians and scientists, noted Dr. Silver, who founded the Her Time Is Now campaign for gender equity in medicine and runs a women’s leadership course at Harvard.

In addition, female physicians are more likely to be involved in “nonpromotable” work, group projects and educator roles that are often underappreciated and undercompensated, she said.

Writing recently in a blog post for the BMJ, Dr. Silver and colleagues predict that as a result of the pandemic, female physicians will “face disadvantages from unconscious bias in decisions about whose pay should be cut, whose operating schedules should take priority when resources are limited, and whose contributions merit retention ... The ground that women lose now will likely have a profound effect for many years to come, perhaps putting them at a disadvantage for the rest of their careers.”

There is already evidence of reduced publishing by female scientists during the pandemic, something that “could undermine the careers of an entire generation of women scholars,” noted Caitlyn Collins, PhD, assistant professor of sociology at Washington University in St. Louis.

“Science needs to address the culture of overwork,” Dr. Collins said in an interview. “Parents and other caregivers deserve support. The stress and ‘overwhelm’ they feel is not inevitable. A more fair, just, and humane approach to combining work and family is possible – what we need is the political will to pass better policies and a massive shift in our cultural understandings about how work should fit into family life, not the other way around.”

Lack of support for “vulnerable scientists,” particularly “junior scientists who are parents, women, or minorities” could lead to “severe attrition in cancer research in the coming years,” Cullen Taniguchi, MD, PhD, a radiation oncologist and associate professor at the University of Texas MD Anderson Cancer Center, Houston, and colleagues, warned in a recent letter to the journal Cancer Cell.

“The biggest worries of attrition will come from young faculty who started just before or after the pandemic,” Dr. Taniguchi said in an interview. “The first year in an academic setting is incredibly challenging but also important for establishing research efforts and building networks of colleagues to collaborate with. While completely necessary, the restrictions put in place during the pandemic made doing these things even more difficult.”
 

Another stressor: Caregiving at home

Another reason female physicians may be marginalized during the pandemic is that they are more often the primary caregivers at home.

“Anyone who is a caregiver, be it to kids, parents, or spouses, can relate to the challenges brought [on] by the pandemic,” said Ishwaria Subbiah, MD, a palliative care physician and medical oncologist at MD Anderson.

“Most of us work toward meeting our responsibilities by engaging a network of support, whether it’s home care workers, center-based or at-home child care, schools, or activities outside of school. The pandemic led to a level of disruption that brought most (if not all) of those responsibilities onto the caregivers themselves,” she said in an interview.

As the mother of an adult son with severe epilepsy, Dr. Bertagnolli has certainly experienced the challenges of parenting during the pandemic. “Our son is now 24 but he is handicapped, and lives with us. The care issues we have to deal with as professionals have been enormously magnified by COVID,” she said.

But she cautions against making gender distinctions when it comes to caregiving. “Has it fallen on the women? Well, this kind of stuff generally falls on the women, but I am certain it has fallen on an awful lot of men as well, because I think the world is changing that way, so it’s fallen on all of us.”

There is no question that female oncologists are bearing the brunt, both at work and at home, contended Dr. Taniguchi. “Absolutely. I have seen this first-hand,” he said.

“If it was difficult for women, underrepresented minorities, and junior faculty to find a voice in the room prepandemic, I think it can be harder in the times of virtual meetings when it is difficult to engage audiences,” he said. 

Dr. Holstein said she is lucky to be well-supported at her institution, with both a female chief of hematology/oncology and a female chair of internal medicine, but still, she worries about the long-term consequences of the pandemic on the gender landscape of medicine.

“If you’re having to put aside research projects because you have extra responsibilities – again because women just tend to have a lot of other things going on – that might not be a big deal for 3 months, 6 months, but this is going to be a year or 2 years before ‘normal’ comes back,” she says. “One to two years of underpublishing or not getting the grants could be career killers for women in academic oncology.”
 

Cancer COVID-19 combo

As Dr. Wildes completed her final weeks of seeing cancer patients, she received an outpouring of support, which she says convinced her of the shared experience of all doctors, and especially female doctors, during the pandemic. But even more specifically, she feels that she has tapped into the unique burden shouldered by oncologists during this time.

“It’s intimidating being an oncologist; we are literally giving people poison for a living. Then throw into it a pandemic where early in March we had so little data. I was helping my patients make decisions about their cancer care based on a case series of four patients in China. The burden of those conversations is something I never want to have to live through again,” she said.

“Oncology is a particularly intense subspecialty within medicine,” agreed Dr. Subbiah. “The people we care for have received a life-altering and potentially life-limiting diagnosis. Coupled with that, the COVID-19 pandemic has brought an unprecedented cloud of uncertainty ... Whether the patients can see it overtly or not, oncologists carry the weight of this worry with them for not just one but all of their patients.”

Dr. Wildes said she plans to return to academic medicine and clinical care “in time,” but for now, the gap that she and others like her leave is troubling to those who have stayed on.

“We need these women in medicine,” said Dr. Holstein. “We have data suggesting that women take more time with their patients than men, that patient outcomes are better if they have a female physician. But also for the generations coming up, we need the mid-career and senior women to be in place to mentor and guide and make sure we continue to increase women in leadership.”

A version of this article originally appeared on Medscape.com.

The numbers tell the story:

110,066 veterans diagnosed with COVID-19 as of November 30;

879,457 veterans and employees tested for COVID-19 as of November 6;

14,168 veterans admitted to a US Department of Veterans Affairs (VA) medical center for COVID-19 care;

1,525% increase in telehealth visits;

59,095 new staff hired to meet surge in demand for COVID-19 care;

75 completed Fourth Mission assignments; and

> 2,000 VA employees helping to support nonveteran patients and non-VA health care systems.

But those numbers are just some of the data in the COVID-19 Response Report, which the VA recently released. The report offers “an extensive look at VA’s complex COVID-19 response,” including how it prepared for the pandemic, the initial response, and key COVID-19 policies and directives.

The report was compiled from more than 90 interviews with health care leaders and stakeholders, along with documents and data pertaining to the Veterans Integrated Service Networks. The interviews were designed to “keep discussion at a strategic level.”

Meeting the crisis mandated that the Veterans Health Administration (VHA) act “with unity of effort and agility,” the authors note, across 18 networks with 170 medical centers. Not only is the VA called on to serve veterans, but its “Fourth Mission” explicitly calls on the VA to “improve the Nation’s preparedness for response to war, terrorism, national emergencies, and natural disasters.” But the VHA possessed some major assets, they add, including a nationwide capacity for inpatient health care, “considerable experience” generating and managing response to regional and local public health emergencies, and strong clinical processes focused on evidence-based guidelines. However, “[w]ithout national analytics of data from outbreaks in other nations, and without a national plan addressing the VHA role, forecasting demand for VHA inpatient services under the Fourth Mission required assumptions with a high degree of uncertainty.”

VHA planners adapted the existing High Consequence Infections Base Plan to COVID-19 and then developed the COVID-19 Response Plan as an annex to that. They released their plan to the public in the interest of a coordinated national response—although not all states were aware of VHA’s important safety-net capabilities. Despite that, the report says, during the pandemic, the mission assignments under the VA’s Fourth Mission have grown to the greatest scale and scope in the VA’s history.

“[H]ealth care in the United States will never be the same,” said Richard Stone, MD, VHA Executive in Charge, in his foreword to the report. Much of what we now consider routine, he said, such as parking lot screenings, digital questionnaires and rapid testing “were revolutionary and challenging to implement” when the pandemic began. “While we are certainly not perfect, we are a learning organization and seek to always find ways to improve.”

Identifying root causes for complex process problems is essential to improvement, the report authors say, and require “new knowledge.” To that end, the VA also has played a critical role in COVID-19–related research, participating in more than 90 and leading 28 multiple-site COVID-19 research studies, including research on 3D-printed respirator masks and convalescent plasma treatment.

The VA’s pandemic response has been “robust and far-reaching,” said VA Secretary Robert Wilkie. The report, he adds, “reflects VA’s agility throughout the pandemic to adapt based on lessons learned.”

The numbers tell the story:

110,066 veterans diagnosed with COVID-19 as of November 30;

879,457 veterans and employees tested for COVID-19 as of November 6;

14,168 veterans admitted to a US Department of Veterans Affairs (VA) medical center for COVID-19 care;

1,525% increase in telehealth visits;

59,095 new staff hired to meet surge in demand for COVID-19 care;

75 completed Fourth Mission assignments; and

> 2,000 VA employees helping to support nonveteran patients and non-VA health care systems.

But those numbers are just some of the data in the COVID-19 Response Report, which the VA recently released. The report offers “an extensive look at VA’s complex COVID-19 response,” including how it prepared for the pandemic, the initial response, and key COVID-19 policies and directives.

The report was compiled from more than 90 interviews with health care leaders and stakeholders, along with documents and data pertaining to the Veterans Integrated Service Networks. The interviews were designed to “keep discussion at a strategic level.”

Meeting the crisis mandated that the Veterans Health Administration (VHA) act “with unity of effort and agility,” the authors note, across 18 networks with 170 medical centers. Not only is the VA called on to serve veterans, but its “Fourth Mission” explicitly calls on the VA to “improve the Nation’s preparedness for response to war, terrorism, national emergencies, and natural disasters.” But the VHA possessed some major assets, they add, including a nationwide capacity for inpatient health care, “considerable experience” generating and managing response to regional and local public health emergencies, and strong clinical processes focused on evidence-based guidelines. However, “[w]ithout national analytics of data from outbreaks in other nations, and without a national plan addressing the VHA role, forecasting demand for VHA inpatient services under the Fourth Mission required assumptions with a high degree of uncertainty.”

VHA planners adapted the existing High Consequence Infections Base Plan to COVID-19 and then developed the COVID-19 Response Plan as an annex to that. They released their plan to the public in the interest of a coordinated national response—although not all states were aware of VHA’s important safety-net capabilities. Despite that, the report says, during the pandemic, the mission assignments under the VA’s Fourth Mission have grown to the greatest scale and scope in the VA’s history.

“[H]ealth care in the United States will never be the same,” said Richard Stone, MD, VHA Executive in Charge, in his foreword to the report. Much of what we now consider routine, he said, such as parking lot screenings, digital questionnaires and rapid testing “were revolutionary and challenging to implement” when the pandemic began. “While we are certainly not perfect, we are a learning organization and seek to always find ways to improve.”

Identifying root causes for complex process problems is essential to improvement, the report authors say, and require “new knowledge.” To that end, the VA also has played a critical role in COVID-19–related research, participating in more than 90 and leading 28 multiple-site COVID-19 research studies, including research on 3D-printed respirator masks and convalescent plasma treatment.

The VA’s pandemic response has been “robust and far-reaching,” said VA Secretary Robert Wilkie. The report, he adds, “reflects VA’s agility throughout the pandemic to adapt based on lessons learned.”

The numbers tell the story:

110,066 veterans diagnosed with COVID-19 as of November 30;

879,457 veterans and employees tested for COVID-19 as of November 6;

14,168 veterans admitted to a US Department of Veterans Affairs (VA) medical center for COVID-19 care;

1,525% increase in telehealth visits;

59,095 new staff hired to meet surge in demand for COVID-19 care;

75 completed Fourth Mission assignments; and

> 2,000 VA employees helping to support nonveteran patients and non-VA health care systems.

But those numbers are just some of the data in the COVID-19 Response Report, which the VA recently released. The report offers “an extensive look at VA’s complex COVID-19 response,” including how it prepared for the pandemic, the initial response, and key COVID-19 policies and directives.

The report was compiled from more than 90 interviews with health care leaders and stakeholders, along with documents and data pertaining to the Veterans Integrated Service Networks. The interviews were designed to “keep discussion at a strategic level.”

Meeting the crisis mandated that the Veterans Health Administration (VHA) act “with unity of effort and agility,” the authors note, across 18 networks with 170 medical centers. Not only is the VA called on to serve veterans, but its “Fourth Mission” explicitly calls on the VA to “improve the Nation’s preparedness for response to war, terrorism, national emergencies, and natural disasters.” But the VHA possessed some major assets, they add, including a nationwide capacity for inpatient health care, “considerable experience” generating and managing response to regional and local public health emergencies, and strong clinical processes focused on evidence-based guidelines. However, “[w]ithout national analytics of data from outbreaks in other nations, and without a national plan addressing the VHA role, forecasting demand for VHA inpatient services under the Fourth Mission required assumptions with a high degree of uncertainty.”

VHA planners adapted the existing High Consequence Infections Base Plan to COVID-19 and then developed the COVID-19 Response Plan as an annex to that. They released their plan to the public in the interest of a coordinated national response—although not all states were aware of VHA’s important safety-net capabilities. Despite that, the report says, during the pandemic, the mission assignments under the VA’s Fourth Mission have grown to the greatest scale and scope in the VA’s history.

“[H]ealth care in the United States will never be the same,” said Richard Stone, MD, VHA Executive in Charge, in his foreword to the report. Much of what we now consider routine, he said, such as parking lot screenings, digital questionnaires and rapid testing “were revolutionary and challenging to implement” when the pandemic began. “While we are certainly not perfect, we are a learning organization and seek to always find ways to improve.”

Identifying root causes for complex process problems is essential to improvement, the report authors say, and require “new knowledge.” To that end, the VA also has played a critical role in COVID-19–related research, participating in more than 90 and leading 28 multiple-site COVID-19 research studies, including research on 3D-printed respirator masks and convalescent plasma treatment.

The VA’s pandemic response has been “robust and far-reaching,” said VA Secretary Robert Wilkie. The report, he adds, “reflects VA’s agility throughout the pandemic to adapt based on lessons learned.”

As a result of the coronavirus disease 2019 (COVID-19) pandemic, the content of outpatient psychotherapy and psychopharmacology sessions has seen significant change, with many patients focusing on how the pandemic has altered their daily lives and emotional well-being. Most patients were suddenly limited in both the amount of time they spent, and in their interactions with people, outside of their homes. Additionally, employment-related stressors such as working from home and the potential loss of a job and/or income added to pandemic stress.¹ Patients simultaneously processed their experiences of the COVID-19 pandemic while often striving to adapt to new virtual modes of mental health care delivery via phone or video conferencing.

The clinic staff at our large, multidisciplinary, urban outpatient mental health practice conducts weekly case consultation meetings. In meetings held during the early stages of the COVID-19 pandemic, we noted 4 dominant clinical themes emerging across our patients’ experiences:

• isolation
• uncertainty
• household stress
• grief.

These themes occurred across many diagnostic categories, suggesting they reflect a dramatic shift brought on by the pandemic. Our group compared clinical experiences from the beginning of the pandemic through the end of May 2020. For this article, we considered several patients who expressed these 4 themes and created a “composite patient.” In the following sections, we describe the typical presentation of, and recommended interventions for, a composite patient for each of these 4 themes.

Isolation

Mr. J, a 60-year-old, single, African American man diagnosed with bipolar disorder with psychotic features, lives alone in an apartment in a densely populated area. Before COVID-19, he had been attending a day treatment program. His daily walks for coffee and cigarettes provided the scaffolding to his emotional stability and gave him a sense of belonging to a world outside of his home. Mr. J also had been able to engage in informal social activities in the common areas of his apartment complex.

The start of the COVID-19 pandemic ends his interpersonal interactions, from the passive and superficial conversations he had with strangers in coffee shops to the more intimate engagement with his peers in his treatment program. The common areas of Mr. J’s apartment building are closed, and his routine cigarette breaks with neighbors have become solitary events, with the added stress of having to schedule his use of the building’s designated smoking area. Before COVID-19, Mr. J had been regularly meeting his brother for coffee to talk about the recent death of their father, but these meetings end due to infection concerns by Mr. J and his brother, who cares for their ailing mother who is at high risk for COVID-19 infection.

Mr. J begins to report self-referential ideation when walking in public, citing his inability to see peoples’ facial expressions because they are wearing masks. As a result of the pandemic restrictions, he becomes depressed and develops increased paranoid ideation. Fortunately, Mr. J begins to participate in a virtual partial hospitalization program to address his paranoid ideation through intensive and clinically-based social interactions. He is unfamiliar with the technology used for virtual visits, but is given the necessary technical support. He is also able to begin virtual visits with his brother and mother. Mr. J soon reports his symptoms are reduced and his mood is more stable.

Engaging in interpersonal interactions can have a positive impact on mental health. Social isolation has demonstrated negative effects that are amplified in individuals with psychiatric disorders.² Interpersonal interactions can provide a shared experience, promote positive feelings of social connection, and aid in the development of social skills.^3,4 Among our patients, we have begun to see the effects of isolation manifest as loneliness and demoralization.

Continue to: Interventions

Interventions. Due to restrictions imposed to limit the spread of COVID-19, evidence-based interventions such as meeting a friend for a meal or participating in in-person support groups typically are not options, thus forcing clinicians to accommodate, adapt, and use technology to develop parallel interventions to provide the same therapeutic effects.^5,6 These solutions need to be individualized to accommodate each patient’s unique social and clinical situation (Table 1). Engaging through technology can be problematic for patients with psychosis and paranoid ideation, or those with depressive symptoms. Psychopharmacology or therapy visit time has to be dedicated to helping patients become comfortable and confident when using technology to access their clinicians. Patients can use this same technology to establish virtual social connections. Providing patients with accurate, factual information about infection control during clinical visits ultimately supports their mental health. Delivering clinical care during COVID-19 has required creativity and flexibility to optimize available resources and capitalize on patients’ social supports. These strategies help decrease isolation, loneliness, and exacerbation of psychiatric symptoms.

Uncertainty

Ms. L, age 42, has a history of posttraumatic stress disorder and obstructive sleep apnea, for which she uses a continuous airway positive pressure (CPAP) device. She had been working as a part-time nanny when her employer furloughed her early in the COVID-19 pandemic. Her anxiety has gotten worse throughout the quarantine; she fears her unemployment benefits will run out and she will lose her job. Her anxiety manifests as somatic “pit-of-stomach” sensations. Her sleep has been disrupted; she reports more frequent nightmares, and her partner says that Ms. L has had apneic episodes and bruxism. The parameters of Ms. L’s CPAP device need to be adjusted, but a previously scheduled overnight polysomnography test is deemed a nonessential procedure and canceled. Ms. L has been reluctant to go to a food pantry because she is afraid of being exposed to COVID-19. In virtual sessions, Ms. L says she is uncertain if she will be able to pay her rent, buy food, or access medical care, and expresses overriding helplessness.

During COVID-19, anxiety and insomnia are driven by the sudden manifestation of uncertainty regarding being able to work, pay rent or mortgage, buy food and other provisions, or visit family and friends, including those who are hospitalized or live in nursing homes. Additional uncertainties include how long the quarantine will last, who will become ill, and when, or if, life will return to normal. Taken together, these uncertainties impart a pervasive dread to daily experience.

Interventions. Clinicians can facilitate access to services (eg, social services, benefits specialists) and help patients parse out what they should and can address practically, and which challenges are outside of their personal or communal control (Table 2). Patients can be encouraged to identify paralytic rumination and shift their mental focus to engage in constructive projects. They can be advised to limit their intake of media that increases their anxiety and replace it with phone calls or e-mails to family and friends. Scheduled practice of mindfulness meditation and diaphragmatic breathing can help reduce anxiety.^7,8 Pharmacotherapeutic interventions should be low-risk to minimize burdening emergency departments saturated with patients who have COVID-19 and serve to reduce symptoms that interfere with behavioral activation. While the research on benzodiazepines and non-benzodiazepine receptor agonists (“Z-drugs” such as zolpidem and eszopiclone) in the setting of obstructive sleep apnea is complex, and there is some evidence that the latter may not exacerbate apnea,⁹ benzodiazepines and Z-drugs are associated with an array of risks, including tolerance, withdrawal, and traumatic falls, particularly in older adults.¹⁰ Sleep hygiene and cognitive-behavioral therapy are first-line therapies for insomnia.¹¹

Household stress

Ms. M, a 45-year-old single mother with a history of generalized anxiety disorder, is suddenly thrust into homeschooling her 2 children, ages 10 and 8, while trying to remain productive at her job as a software engineer. She no longer has time for herself, and spends much of her day helping her children with schoolwork or planning activities to keep them engaged rather than arguing with each other. She feels intense pressure, heightened stress, and increased anxiety as she tries to navigate this new daily routine.

Continue to: New household dynamics...

New household dynamics abound when people are suddenly forced into atypical routines. In the context of COVID-19, working parents may be forced to balance the demands of their jobs with homeschooling their children. Couples may find themselves arguing more frequently. Adult children may find themselves needing to care for their ill parents. Limited space, a lack of leisure activities, and uncertainty about the future coalesce to increase conflict and stress. Research suggests that how people cope with a stressor is a more reliable determinant of health and well-being than the stressor itself.¹²

Interventions. Mental health clinicians can offer several recommendations to help patients cope with increased household stress (Table 3). We can encourage patients to have clear communication with their loved ones regarding new expectations, roles, and their feelings. Demarcating specific areas within living spaces to each person in the household can help each member feel a sense of autonomy, regardless of how small their area may be. Clinicians can help patients learn to take the time as a family to work on establishing new household routines. Telepsychiatry offers clinicians a unique window into patients’ lives and family dynamics, and we can use this perspective to deepen our understanding of the patient’s context and household relationships and help them navigate the situation thrust upon them.

Grief

Following a psychiatric hospitalization for an acute exacerbation of psychosis, Ms. S, age 79, is transferred to a rehabilitation facility, where she contracts COVID-19. Because Ms. S did not have a history of chronic medical illness, her family anticipates a full recovery. Early in the course of Ms. S’s admission, the rehabilitation facility restricts visitations, and her family is unable to see her. Ms. S dies in this facility without her family’s presence and without her family having the opportunity to say goodbye. Ms. S’s psychiatrist offers her family a virtual session to provide support. During the virtual session, the psychiatrist notes signs of complicated bereavement among Ms. S’s family members, including nonacceptance of the death, rumination about the circumstances of the death, and describing life as having no purpose.

The COVID-19 pandemic has complicated the natural process of loss and grief across multiple dimensions. Studies have shown that an inability to say goodbye before death, a lack of social support,¹³ and a lack of preparation for loss¹⁴ are associated with complicated bereavement and depression. Many people are experiencing the loss of loved ones without having a chance to appropriately mourn. Forbidding visits to family members who are hospitalized also prevents the practice of religious and spiritual rituals that typically occur at the end of life. This is worsened by truncated or absent funeral services. Support for those who are grieving may be offered from a distance, if at all. When surviving family members have been with the deceased prior to hospitalization, they may be required to self-quarantine, potentially exacerbating their grief and other symptoms associated with loss.

Interventions. Because social support is a protective factor against complicated grief,¹⁴ there are several recommendations for survivors as they work through the process of grief (Table 4). These include preparing families for a potential death; discussing desired spiritual and memorial services¹⁵; connecting families to resources such as community grief support programs, counseling/therapy, funeral services, video conferencing, and other communication tools; and planning for additional support for surviving family and friends, both immediately after the death and in the long term. It is also important to provide appropriate counseling and support for surviving family members to focus on their own well-being by exercising, eating nutritious meals, getting enough sleep, and abstaining from alcohol and drugs of abuse.¹⁶

Continue to: An ongoing challenge

 

 

An ongoing challenge

Our clinical team recommends further investigation to define additional psycho­therapeutic themes arising from the COVID-19 pandemic and provide evidence-based interventions to address these categories, which we expect will increase in clinical salience in the months and years ahead. Close monitoring, follow-up by clinical and research staff, and evidence-based interventions will help address these dominant themes, with the goal of alleviating patient suffering.

Bottom Line

Our team identified 4 dominant clinical themes emerging across our patients’ experiences during the coronavirus disease 2019 pandemic: isolation, uncertainty, household stress, and grief. Clinicians can implement specific interventions to reduce the impact of these themes, which we expect to remain clinically relevant in the upcoming months and years.

Related Resources

• Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-32,39.
• Carr D, Boerner K, Moorman S. Bereavement in the time of coronavirus: unprecedented challenges demand novel interventions. J Aging Soc Policy. 2020;32(4-5):425-431.

Drug Brand Names

Eszopiclone • Lunesta
Zolpidem • Ambien

As a result of the coronavirus disease 2019 (COVID-19) pandemic, the content of outpatient psychotherapy and psychopharmacology sessions has seen significant change, with many patients focusing on how the pandemic has altered their daily lives and emotional well-being. Most patients were suddenly limited in both the amount of time they spent, and in their interactions with people, outside of their homes. Additionally, employment-related stressors such as working from home and the potential loss of a job and/or income added to pandemic stress.¹ Patients simultaneously processed their experiences of the COVID-19 pandemic while often striving to adapt to new virtual modes of mental health care delivery via phone or video conferencing.

The clinic staff at our large, multidisciplinary, urban outpatient mental health practice conducts weekly case consultation meetings. In meetings held during the early stages of the COVID-19 pandemic, we noted 4 dominant clinical themes emerging across our patients’ experiences:

• isolation
• uncertainty
• household stress
• grief.

These themes occurred across many diagnostic categories, suggesting they reflect a dramatic shift brought on by the pandemic. Our group compared clinical experiences from the beginning of the pandemic through the end of May 2020. For this article, we considered several patients who expressed these 4 themes and created a “composite patient.” In the following sections, we describe the typical presentation of, and recommended interventions for, a composite patient for each of these 4 themes.

Isolation

Mr. J, a 60-year-old, single, African American man diagnosed with bipolar disorder with psychotic features, lives alone in an apartment in a densely populated area. Before COVID-19, he had been attending a day treatment program. His daily walks for coffee and cigarettes provided the scaffolding to his emotional stability and gave him a sense of belonging to a world outside of his home. Mr. J also had been able to engage in informal social activities in the common areas of his apartment complex.

The start of the COVID-19 pandemic ends his interpersonal interactions, from the passive and superficial conversations he had with strangers in coffee shops to the more intimate engagement with his peers in his treatment program. The common areas of Mr. J’s apartment building are closed, and his routine cigarette breaks with neighbors have become solitary events, with the added stress of having to schedule his use of the building’s designated smoking area. Before COVID-19, Mr. J had been regularly meeting his brother for coffee to talk about the recent death of their father, but these meetings end due to infection concerns by Mr. J and his brother, who cares for their ailing mother who is at high risk for COVID-19 infection.

Mr. J begins to report self-referential ideation when walking in public, citing his inability to see peoples’ facial expressions because they are wearing masks. As a result of the pandemic restrictions, he becomes depressed and develops increased paranoid ideation. Fortunately, Mr. J begins to participate in a virtual partial hospitalization program to address his paranoid ideation through intensive and clinically-based social interactions. He is unfamiliar with the technology used for virtual visits, but is given the necessary technical support. He is also able to begin virtual visits with his brother and mother. Mr. J soon reports his symptoms are reduced and his mood is more stable.

Engaging in interpersonal interactions can have a positive impact on mental health. Social isolation has demonstrated negative effects that are amplified in individuals with psychiatric disorders.² Interpersonal interactions can provide a shared experience, promote positive feelings of social connection, and aid in the development of social skills.^3,4 Among our patients, we have begun to see the effects of isolation manifest as loneliness and demoralization.

Continue to: Interventions

Interventions. Due to restrictions imposed to limit the spread of COVID-19, evidence-based interventions such as meeting a friend for a meal or participating in in-person support groups typically are not options, thus forcing clinicians to accommodate, adapt, and use technology to develop parallel interventions to provide the same therapeutic effects.^5,6 These solutions need to be individualized to accommodate each patient’s unique social and clinical situation (Table 1). Engaging through technology can be problematic for patients with psychosis and paranoid ideation, or those with depressive symptoms. Psychopharmacology or therapy visit time has to be dedicated to helping patients become comfortable and confident when using technology to access their clinicians. Patients can use this same technology to establish virtual social connections. Providing patients with accurate, factual information about infection control during clinical visits ultimately supports their mental health. Delivering clinical care during COVID-19 has required creativity and flexibility to optimize available resources and capitalize on patients’ social supports. These strategies help decrease isolation, loneliness, and exacerbation of psychiatric symptoms.

Uncertainty

Ms. L, age 42, has a history of posttraumatic stress disorder and obstructive sleep apnea, for which she uses a continuous airway positive pressure (CPAP) device. She had been working as a part-time nanny when her employer furloughed her early in the COVID-19 pandemic. Her anxiety has gotten worse throughout the quarantine; she fears her unemployment benefits will run out and she will lose her job. Her anxiety manifests as somatic “pit-of-stomach” sensations. Her sleep has been disrupted; she reports more frequent nightmares, and her partner says that Ms. L has had apneic episodes and bruxism. The parameters of Ms. L’s CPAP device need to be adjusted, but a previously scheduled overnight polysomnography test is deemed a nonessential procedure and canceled. Ms. L has been reluctant to go to a food pantry because she is afraid of being exposed to COVID-19. In virtual sessions, Ms. L says she is uncertain if she will be able to pay her rent, buy food, or access medical care, and expresses overriding helplessness.

During COVID-19, anxiety and insomnia are driven by the sudden manifestation of uncertainty regarding being able to work, pay rent or mortgage, buy food and other provisions, or visit family and friends, including those who are hospitalized or live in nursing homes. Additional uncertainties include how long the quarantine will last, who will become ill, and when, or if, life will return to normal. Taken together, these uncertainties impart a pervasive dread to daily experience.

Interventions. Clinicians can facilitate access to services (eg, social services, benefits specialists) and help patients parse out what they should and can address practically, and which challenges are outside of their personal or communal control (Table 2). Patients can be encouraged to identify paralytic rumination and shift their mental focus to engage in constructive projects. They can be advised to limit their intake of media that increases their anxiety and replace it with phone calls or e-mails to family and friends. Scheduled practice of mindfulness meditation and diaphragmatic breathing can help reduce anxiety.^7,8 Pharmacotherapeutic interventions should be low-risk to minimize burdening emergency departments saturated with patients who have COVID-19 and serve to reduce symptoms that interfere with behavioral activation. While the research on benzodiazepines and non-benzodiazepine receptor agonists (“Z-drugs” such as zolpidem and eszopiclone) in the setting of obstructive sleep apnea is complex, and there is some evidence that the latter may not exacerbate apnea,⁹ benzodiazepines and Z-drugs are associated with an array of risks, including tolerance, withdrawal, and traumatic falls, particularly in older adults.¹⁰ Sleep hygiene and cognitive-behavioral therapy are first-line therapies for insomnia.¹¹

Household stress

Ms. M, a 45-year-old single mother with a history of generalized anxiety disorder, is suddenly thrust into homeschooling her 2 children, ages 10 and 8, while trying to remain productive at her job as a software engineer. She no longer has time for herself, and spends much of her day helping her children with schoolwork or planning activities to keep them engaged rather than arguing with each other. She feels intense pressure, heightened stress, and increased anxiety as she tries to navigate this new daily routine.

Continue to: New household dynamics...

New household dynamics abound when people are suddenly forced into atypical routines. In the context of COVID-19, working parents may be forced to balance the demands of their jobs with homeschooling their children. Couples may find themselves arguing more frequently. Adult children may find themselves needing to care for their ill parents. Limited space, a lack of leisure activities, and uncertainty about the future coalesce to increase conflict and stress. Research suggests that how people cope with a stressor is a more reliable determinant of health and well-being than the stressor itself.¹²

Interventions. Mental health clinicians can offer several recommendations to help patients cope with increased household stress (Table 3). We can encourage patients to have clear communication with their loved ones regarding new expectations, roles, and their feelings. Demarcating specific areas within living spaces to each person in the household can help each member feel a sense of autonomy, regardless of how small their area may be. Clinicians can help patients learn to take the time as a family to work on establishing new household routines. Telepsychiatry offers clinicians a unique window into patients’ lives and family dynamics, and we can use this perspective to deepen our understanding of the patient’s context and household relationships and help them navigate the situation thrust upon them.

Grief

Following a psychiatric hospitalization for an acute exacerbation of psychosis, Ms. S, age 79, is transferred to a rehabilitation facility, where she contracts COVID-19. Because Ms. S did not have a history of chronic medical illness, her family anticipates a full recovery. Early in the course of Ms. S’s admission, the rehabilitation facility restricts visitations, and her family is unable to see her. Ms. S dies in this facility without her family’s presence and without her family having the opportunity to say goodbye. Ms. S’s psychiatrist offers her family a virtual session to provide support. During the virtual session, the psychiatrist notes signs of complicated bereavement among Ms. S’s family members, including nonacceptance of the death, rumination about the circumstances of the death, and describing life as having no purpose.

The COVID-19 pandemic has complicated the natural process of loss and grief across multiple dimensions. Studies have shown that an inability to say goodbye before death, a lack of social support,¹³ and a lack of preparation for loss¹⁴ are associated with complicated bereavement and depression. Many people are experiencing the loss of loved ones without having a chance to appropriately mourn. Forbidding visits to family members who are hospitalized also prevents the practice of religious and spiritual rituals that typically occur at the end of life. This is worsened by truncated or absent funeral services. Support for those who are grieving may be offered from a distance, if at all. When surviving family members have been with the deceased prior to hospitalization, they may be required to self-quarantine, potentially exacerbating their grief and other symptoms associated with loss.

Interventions. Because social support is a protective factor against complicated grief,¹⁴ there are several recommendations for survivors as they work through the process of grief (Table 4). These include preparing families for a potential death; discussing desired spiritual and memorial services¹⁵; connecting families to resources such as community grief support programs, counseling/therapy, funeral services, video conferencing, and other communication tools; and planning for additional support for surviving family and friends, both immediately after the death and in the long term. It is also important to provide appropriate counseling and support for surviving family members to focus on their own well-being by exercising, eating nutritious meals, getting enough sleep, and abstaining from alcohol and drugs of abuse.¹⁶

Continue to: An ongoing challenge

 

 

An ongoing challenge

Our clinical team recommends further investigation to define additional psycho­therapeutic themes arising from the COVID-19 pandemic and provide evidence-based interventions to address these categories, which we expect will increase in clinical salience in the months and years ahead. Close monitoring, follow-up by clinical and research staff, and evidence-based interventions will help address these dominant themes, with the goal of alleviating patient suffering.

Bottom Line

Our team identified 4 dominant clinical themes emerging across our patients’ experiences during the coronavirus disease 2019 pandemic: isolation, uncertainty, household stress, and grief. Clinicians can implement specific interventions to reduce the impact of these themes, which we expect to remain clinically relevant in the upcoming months and years.

Related Resources

• Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-32,39.
• Carr D, Boerner K, Moorman S. Bereavement in the time of coronavirus: unprecedented challenges demand novel interventions. J Aging Soc Policy. 2020;32(4-5):425-431.

Drug Brand Names

Eszopiclone • Lunesta
Zolpidem • Ambien

As a result of the coronavirus disease 2019 (COVID-19) pandemic, the content of outpatient psychotherapy and psychopharmacology sessions has seen significant change, with many patients focusing on how the pandemic has altered their daily lives and emotional well-being. Most patients were suddenly limited in both the amount of time they spent, and in their interactions with people, outside of their homes. Additionally, employment-related stressors such as working from home and the potential loss of a job and/or income added to pandemic stress.¹ Patients simultaneously processed their experiences of the COVID-19 pandemic while often striving to adapt to new virtual modes of mental health care delivery via phone or video conferencing.

The clinic staff at our large, multidisciplinary, urban outpatient mental health practice conducts weekly case consultation meetings. In meetings held during the early stages of the COVID-19 pandemic, we noted 4 dominant clinical themes emerging across our patients’ experiences:

• isolation
• uncertainty
• household stress
• grief.

These themes occurred across many diagnostic categories, suggesting they reflect a dramatic shift brought on by the pandemic. Our group compared clinical experiences from the beginning of the pandemic through the end of May 2020. For this article, we considered several patients who expressed these 4 themes and created a “composite patient.” In the following sections, we describe the typical presentation of, and recommended interventions for, a composite patient for each of these 4 themes.

Isolation

Mr. J, a 60-year-old, single, African American man diagnosed with bipolar disorder with psychotic features, lives alone in an apartment in a densely populated area. Before COVID-19, he had been attending a day treatment program. His daily walks for coffee and cigarettes provided the scaffolding to his emotional stability and gave him a sense of belonging to a world outside of his home. Mr. J also had been able to engage in informal social activities in the common areas of his apartment complex.

The start of the COVID-19 pandemic ends his interpersonal interactions, from the passive and superficial conversations he had with strangers in coffee shops to the more intimate engagement with his peers in his treatment program. The common areas of Mr. J’s apartment building are closed, and his routine cigarette breaks with neighbors have become solitary events, with the added stress of having to schedule his use of the building’s designated smoking area. Before COVID-19, Mr. J had been regularly meeting his brother for coffee to talk about the recent death of their father, but these meetings end due to infection concerns by Mr. J and his brother, who cares for their ailing mother who is at high risk for COVID-19 infection.

Mr. J begins to report self-referential ideation when walking in public, citing his inability to see peoples’ facial expressions because they are wearing masks. As a result of the pandemic restrictions, he becomes depressed and develops increased paranoid ideation. Fortunately, Mr. J begins to participate in a virtual partial hospitalization program to address his paranoid ideation through intensive and clinically-based social interactions. He is unfamiliar with the technology used for virtual visits, but is given the necessary technical support. He is also able to begin virtual visits with his brother and mother. Mr. J soon reports his symptoms are reduced and his mood is more stable.

Engaging in interpersonal interactions can have a positive impact on mental health. Social isolation has demonstrated negative effects that are amplified in individuals with psychiatric disorders.² Interpersonal interactions can provide a shared experience, promote positive feelings of social connection, and aid in the development of social skills.^3,4 Among our patients, we have begun to see the effects of isolation manifest as loneliness and demoralization.

Continue to: Interventions

Interventions. Due to restrictions imposed to limit the spread of COVID-19, evidence-based interventions such as meeting a friend for a meal or participating in in-person support groups typically are not options, thus forcing clinicians to accommodate, adapt, and use technology to develop parallel interventions to provide the same therapeutic effects.^5,6 These solutions need to be individualized to accommodate each patient’s unique social and clinical situation (Table 1). Engaging through technology can be problematic for patients with psychosis and paranoid ideation, or those with depressive symptoms. Psychopharmacology or therapy visit time has to be dedicated to helping patients become comfortable and confident when using technology to access their clinicians. Patients can use this same technology to establish virtual social connections. Providing patients with accurate, factual information about infection control during clinical visits ultimately supports their mental health. Delivering clinical care during COVID-19 has required creativity and flexibility to optimize available resources and capitalize on patients’ social supports. These strategies help decrease isolation, loneliness, and exacerbation of psychiatric symptoms.

Uncertainty

Ms. L, age 42, has a history of posttraumatic stress disorder and obstructive sleep apnea, for which she uses a continuous airway positive pressure (CPAP) device. She had been working as a part-time nanny when her employer furloughed her early in the COVID-19 pandemic. Her anxiety has gotten worse throughout the quarantine; she fears her unemployment benefits will run out and she will lose her job. Her anxiety manifests as somatic “pit-of-stomach” sensations. Her sleep has been disrupted; she reports more frequent nightmares, and her partner says that Ms. L has had apneic episodes and bruxism. The parameters of Ms. L’s CPAP device need to be adjusted, but a previously scheduled overnight polysomnography test is deemed a nonessential procedure and canceled. Ms. L has been reluctant to go to a food pantry because she is afraid of being exposed to COVID-19. In virtual sessions, Ms. L says she is uncertain if she will be able to pay her rent, buy food, or access medical care, and expresses overriding helplessness.

During COVID-19, anxiety and insomnia are driven by the sudden manifestation of uncertainty regarding being able to work, pay rent or mortgage, buy food and other provisions, or visit family and friends, including those who are hospitalized or live in nursing homes. Additional uncertainties include how long the quarantine will last, who will become ill, and when, or if, life will return to normal. Taken together, these uncertainties impart a pervasive dread to daily experience.

Interventions. Clinicians can facilitate access to services (eg, social services, benefits specialists) and help patients parse out what they should and can address practically, and which challenges are outside of their personal or communal control (Table 2). Patients can be encouraged to identify paralytic rumination and shift their mental focus to engage in constructive projects. They can be advised to limit their intake of media that increases their anxiety and replace it with phone calls or e-mails to family and friends. Scheduled practice of mindfulness meditation and diaphragmatic breathing can help reduce anxiety.^7,8 Pharmacotherapeutic interventions should be low-risk to minimize burdening emergency departments saturated with patients who have COVID-19 and serve to reduce symptoms that interfere with behavioral activation. While the research on benzodiazepines and non-benzodiazepine receptor agonists (“Z-drugs” such as zolpidem and eszopiclone) in the setting of obstructive sleep apnea is complex, and there is some evidence that the latter may not exacerbate apnea,⁹ benzodiazepines and Z-drugs are associated with an array of risks, including tolerance, withdrawal, and traumatic falls, particularly in older adults.¹⁰ Sleep hygiene and cognitive-behavioral therapy are first-line therapies for insomnia.¹¹

Household stress

Ms. M, a 45-year-old single mother with a history of generalized anxiety disorder, is suddenly thrust into homeschooling her 2 children, ages 10 and 8, while trying to remain productive at her job as a software engineer. She no longer has time for herself, and spends much of her day helping her children with schoolwork or planning activities to keep them engaged rather than arguing with each other. She feels intense pressure, heightened stress, and increased anxiety as she tries to navigate this new daily routine.

Continue to: New household dynamics...

New household dynamics abound when people are suddenly forced into atypical routines. In the context of COVID-19, working parents may be forced to balance the demands of their jobs with homeschooling their children. Couples may find themselves arguing more frequently. Adult children may find themselves needing to care for their ill parents. Limited space, a lack of leisure activities, and uncertainty about the future coalesce to increase conflict and stress. Research suggests that how people cope with a stressor is a more reliable determinant of health and well-being than the stressor itself.¹²

Interventions. Mental health clinicians can offer several recommendations to help patients cope with increased household stress (Table 3). We can encourage patients to have clear communication with their loved ones regarding new expectations, roles, and their feelings. Demarcating specific areas within living spaces to each person in the household can help each member feel a sense of autonomy, regardless of how small their area may be. Clinicians can help patients learn to take the time as a family to work on establishing new household routines. Telepsychiatry offers clinicians a unique window into patients’ lives and family dynamics, and we can use this perspective to deepen our understanding of the patient’s context and household relationships and help them navigate the situation thrust upon them.

Grief

Following a psychiatric hospitalization for an acute exacerbation of psychosis, Ms. S, age 79, is transferred to a rehabilitation facility, where she contracts COVID-19. Because Ms. S did not have a history of chronic medical illness, her family anticipates a full recovery. Early in the course of Ms. S’s admission, the rehabilitation facility restricts visitations, and her family is unable to see her. Ms. S dies in this facility without her family’s presence and without her family having the opportunity to say goodbye. Ms. S’s psychiatrist offers her family a virtual session to provide support. During the virtual session, the psychiatrist notes signs of complicated bereavement among Ms. S’s family members, including nonacceptance of the death, rumination about the circumstances of the death, and describing life as having no purpose.

The COVID-19 pandemic has complicated the natural process of loss and grief across multiple dimensions. Studies have shown that an inability to say goodbye before death, a lack of social support,¹³ and a lack of preparation for loss¹⁴ are associated with complicated bereavement and depression. Many people are experiencing the loss of loved ones without having a chance to appropriately mourn. Forbidding visits to family members who are hospitalized also prevents the practice of religious and spiritual rituals that typically occur at the end of life. This is worsened by truncated or absent funeral services. Support for those who are grieving may be offered from a distance, if at all. When surviving family members have been with the deceased prior to hospitalization, they may be required to self-quarantine, potentially exacerbating their grief and other symptoms associated with loss.

Interventions. Because social support is a protective factor against complicated grief,¹⁴ there are several recommendations for survivors as they work through the process of grief (Table 4). These include preparing families for a potential death; discussing desired spiritual and memorial services¹⁵; connecting families to resources such as community grief support programs, counseling/therapy, funeral services, video conferencing, and other communication tools; and planning for additional support for surviving family and friends, both immediately after the death and in the long term. It is also important to provide appropriate counseling and support for surviving family members to focus on their own well-being by exercising, eating nutritious meals, getting enough sleep, and abstaining from alcohol and drugs of abuse.¹⁶

Continue to: An ongoing challenge

 

 

An ongoing challenge

Our clinical team recommends further investigation to define additional psycho­therapeutic themes arising from the COVID-19 pandemic and provide evidence-based interventions to address these categories, which we expect will increase in clinical salience in the months and years ahead. Close monitoring, follow-up by clinical and research staff, and evidence-based interventions will help address these dominant themes, with the goal of alleviating patient suffering.

Bottom Line

Our team identified 4 dominant clinical themes emerging across our patients’ experiences during the coronavirus disease 2019 pandemic: isolation, uncertainty, household stress, and grief. Clinicians can implement specific interventions to reduce the impact of these themes, which we expect to remain clinically relevant in the upcoming months and years.

Related Resources

• Sharma RA, Maheshwari S, Bronsther R. COVID-19 in the era of loneliness. Current Psychiatry. 2020;19(5):31-32,39.
• Carr D, Boerner K, Moorman S. Bereavement in the time of coronavirus: unprecedented challenges demand novel interventions. J Aging Soc Policy. 2020;32(4-5):425-431.

Drug Brand Names

Eszopiclone • Lunesta
Zolpidem • Ambien

Delayed health care brought on by the pandemic is taking its toll on patients, a survey of primary care doctors shows. 

More than half (56%) of responding clinicians reported seeing a decline in patient health because of delayed or inaccessible care amid the pandemic, according to the results of the latest survey by the Larry A. Green Center and the Primary Care Collaborative. The survey was conducted in mid-October and the results were published online Nov. 17.  

In addition, 37% of respondents said their patients with chronic conditions showed “noticeably worse health resulting from the pandemic.” And a resounding 85% said patient mental health had worsened. 

“I think it’s worse than we thought,” said Rebecca Etz, PhD, codirector of the Larry Green Center. “It’s the outcome of not sufficiently sending resources to primary care either before or during the pandemic.” According to Dr. Etz, survey respondents noted substantial increases in patient weight gain as well as weight loss, anxiety and depression, sleep issues, domestic abuse, and poor oral and eye health, among others.

One clinician from Pennsylvania wrote: “Patients are becoming sicker during the pandemic. I’m seeing more uncontrolled [diabetes]and new [patients with diabetes]. They prefer telehealth yet [have] no access to glucose monitoring or a blood pressure cuff. I am concerned about patients’ isolation and mental health. People are delaying care.”

Now, with COVID numbers peaking across much of the country, many clinicians are trying to close the gap in care with telehealth – something they’re more prepared to do now than they were in March. Over two-thirds of practices are using telehealth for visits to keep up with patients who have stable chronic conditions, according to the survey.

Over 60% of physicians report using telehealth for mental health visits. But a much smaller number – only 16% of respondents – said their practice had added staff to help manage the rising number of behavioral and mental health cases. About one-third (35%) of practices say they’re not financially able to take on new staff.

“We’ve been looking for more ways for patients to do self-support. A big part of chronic disease is health behaviors,” Alex Krist, MD, MPH, a family doctor in Fairfax, Va., and chairperson of the U.S. Preventive Services Task Force, said in an interview. And unfortunately, on top of limited access to basic care, healthy habits that are essential to managing many chronic conditions have become more difficult and less consistent during the pandemic. 

The survey – the 22nd iteration in a series of surveys the Green Center and the Primary Care Collaborative have conducted – received 580 respondents from 47 states and Guam. Over two-thirds of respondents were primary care physicians (MDs and DOs). Over half were owners, partners, or employees of a private practice, 66% of which were family medicine practices. And one fifth of respondents provided care in a rural area.

Funding and support for primary care has been wildly insufficient, Dr. Etz said in an interview. If that doesn’t change, patient health, clinic staffing, and public health strategies amid the pandemic will continue to suffer.

“When you think of the COVID vaccine, who do you think is going to be sending that out?” Dr. Etz asked. “If we don’t bolster primary care now how are they going to handle that.”
 

A version of this article originally appeared on Medscape.com.

Delayed health care brought on by the pandemic is taking its toll on patients, a survey of primary care doctors shows. 

More than half (56%) of responding clinicians reported seeing a decline in patient health because of delayed or inaccessible care amid the pandemic, according to the results of the latest survey by the Larry A. Green Center and the Primary Care Collaborative. The survey was conducted in mid-October and the results were published online Nov. 17.  

In addition, 37% of respondents said their patients with chronic conditions showed “noticeably worse health resulting from the pandemic.” And a resounding 85% said patient mental health had worsened. 

“I think it’s worse than we thought,” said Rebecca Etz, PhD, codirector of the Larry Green Center. “It’s the outcome of not sufficiently sending resources to primary care either before or during the pandemic.” According to Dr. Etz, survey respondents noted substantial increases in patient weight gain as well as weight loss, anxiety and depression, sleep issues, domestic abuse, and poor oral and eye health, among others.

One clinician from Pennsylvania wrote: “Patients are becoming sicker during the pandemic. I’m seeing more uncontrolled [diabetes]and new [patients with diabetes]. They prefer telehealth yet [have] no access to glucose monitoring or a blood pressure cuff. I am concerned about patients’ isolation and mental health. People are delaying care.”

Now, with COVID numbers peaking across much of the country, many clinicians are trying to close the gap in care with telehealth – something they’re more prepared to do now than they were in March. Over two-thirds of practices are using telehealth for visits to keep up with patients who have stable chronic conditions, according to the survey.

Over 60% of physicians report using telehealth for mental health visits. But a much smaller number – only 16% of respondents – said their practice had added staff to help manage the rising number of behavioral and mental health cases. About one-third (35%) of practices say they’re not financially able to take on new staff.

“We’ve been looking for more ways for patients to do self-support. A big part of chronic disease is health behaviors,” Alex Krist, MD, MPH, a family doctor in Fairfax, Va., and chairperson of the U.S. Preventive Services Task Force, said in an interview. And unfortunately, on top of limited access to basic care, healthy habits that are essential to managing many chronic conditions have become more difficult and less consistent during the pandemic. 

The survey – the 22nd iteration in a series of surveys the Green Center and the Primary Care Collaborative have conducted – received 580 respondents from 47 states and Guam. Over two-thirds of respondents were primary care physicians (MDs and DOs). Over half were owners, partners, or employees of a private practice, 66% of which were family medicine practices. And one fifth of respondents provided care in a rural area.

Funding and support for primary care has been wildly insufficient, Dr. Etz said in an interview. If that doesn’t change, patient health, clinic staffing, and public health strategies amid the pandemic will continue to suffer.

“When you think of the COVID vaccine, who do you think is going to be sending that out?” Dr. Etz asked. “If we don’t bolster primary care now how are they going to handle that.”
 

A version of this article originally appeared on Medscape.com.

Delayed health care brought on by the pandemic is taking its toll on patients, a survey of primary care doctors shows. 

More than half (56%) of responding clinicians reported seeing a decline in patient health because of delayed or inaccessible care amid the pandemic, according to the results of the latest survey by the Larry A. Green Center and the Primary Care Collaborative. The survey was conducted in mid-October and the results were published online Nov. 17.  

In addition, 37% of respondents said their patients with chronic conditions showed “noticeably worse health resulting from the pandemic.” And a resounding 85% said patient mental health had worsened. 

“I think it’s worse than we thought,” said Rebecca Etz, PhD, codirector of the Larry Green Center. “It’s the outcome of not sufficiently sending resources to primary care either before or during the pandemic.” According to Dr. Etz, survey respondents noted substantial increases in patient weight gain as well as weight loss, anxiety and depression, sleep issues, domestic abuse, and poor oral and eye health, among others.

One clinician from Pennsylvania wrote: “Patients are becoming sicker during the pandemic. I’m seeing more uncontrolled [diabetes]and new [patients with diabetes]. They prefer telehealth yet [have] no access to glucose monitoring or a blood pressure cuff. I am concerned about patients’ isolation and mental health. People are delaying care.”

Now, with COVID numbers peaking across much of the country, many clinicians are trying to close the gap in care with telehealth – something they’re more prepared to do now than they were in March. Over two-thirds of practices are using telehealth for visits to keep up with patients who have stable chronic conditions, according to the survey.

Over 60% of physicians report using telehealth for mental health visits. But a much smaller number – only 16% of respondents – said their practice had added staff to help manage the rising number of behavioral and mental health cases. About one-third (35%) of practices say they’re not financially able to take on new staff.

“We’ve been looking for more ways for patients to do self-support. A big part of chronic disease is health behaviors,” Alex Krist, MD, MPH, a family doctor in Fairfax, Va., and chairperson of the U.S. Preventive Services Task Force, said in an interview. And unfortunately, on top of limited access to basic care, healthy habits that are essential to managing many chronic conditions have become more difficult and less consistent during the pandemic. 

The survey – the 22nd iteration in a series of surveys the Green Center and the Primary Care Collaborative have conducted – received 580 respondents from 47 states and Guam. Over two-thirds of respondents were primary care physicians (MDs and DOs). Over half were owners, partners, or employees of a private practice, 66% of which were family medicine practices. And one fifth of respondents provided care in a rural area.

Funding and support for primary care has been wildly insufficient, Dr. Etz said in an interview. If that doesn’t change, patient health, clinic staffing, and public health strategies amid the pandemic will continue to suffer.

“When you think of the COVID vaccine, who do you think is going to be sending that out?” Dr. Etz asked. “If we don’t bolster primary care now how are they going to handle that.”
 

A version of this article originally appeared on Medscape.com.

On Nov. 9, the Biden-Harris administration announced the members of its COVID-19 Advisory Board. Among them were many esteemed infectious disease and public health experts – encouraging, given that, for now, the COVID-19 pandemic shows no signs of slowing down. Not among them was a mental health professional.

As psychiatrists, we did not find this omission surprising, given the sidelined role our specialty too often plays among medical professionals. But we did find it disappointing. Not having a single behavioral health provider on the advisory board will prove to be a mistake that could affect millions of Americans.

Studies continue to roll in showing that patients with COVID-19 can present during and after infection with neuropsychiatric symptoms, including delirium, psychosis, and anxiety. In July, a meta-analysis published in The Lancet regarding the neuropsychological outcomes of earlier diseases caused by coronaviruses – severe acute respiratory syndrome and Middle East respiratory syndrome – suggested that, in the short term, close to one-quarter of patients experienced confusion representative of delirium. In the long term, following recovery, respondents frequently reported emotional lability, impaired concentration, and traumatic memories. Additionally, more recent research published in The Lancet suggests that rates of psychiatric disorders, dementia, and insomnia are significantly higher among survivors of COVID-19. This study echoes the findings of an article in JAMA from September that reported that, among patients who were hospitalized for COVID-19, mortality rates were higher for those who had previously been diagnosed with a psychiatric condition. And overall, the pandemic has been associated with significantly increased rates of anxiety and depression symptoms.

Although this research is preliminary, it would be irresponsible – and at the very least myopic — not to take seriously the downstream consequences of the damage to the American people’s psyches when planning how our system can adapt to ensure that there is access to care and treatment.

This is especially true when you consider the following:

• It is very difficult to diagnose and treat mental health symptoms in a primary care setting that is already overburdened. Doing so results in delayed treatment and increased costs.
• In the long term, COVID-19 survivors will overburden the already underfunded mental healthcare system.
• Additional unforeseen psychological outcomes stem from the myriad traumas of events in 2020 (eg, racial unrest, children out of school, loss of jobs, the recent election).

Psychiatric disorders are notoriously difficult to diagnose and treat in the outpatient primary care setting, which is why mental health professionals will need to be a more integral part of the postpandemic treatment model and should be represented on the advisory board. Each year in the United States, there are more than 8 million doctors’ visits for depression, and more than half of these are in the primary care setting. Yet fewer than half of those patients leave with a diagnosis of depression or are treated for it.

Historically, screening for depression in the primary care setting is difficult given its broad presentation of symptoms, which include nonspecific physical complaints, such as digestive problems, headaches, insomnia, or general aches and pains. These shortcomings exist despite multiple changes in guidelines, such as regarding the use of self-screening tools and general screening for specific populations, such as postpartum women.

But screening alone has not been an effective strategy, especially when certain groups are less likely to be screened. These include older adults, Black persons, and men, all of whom are at higher risk for mortality after COVID-19. There is a failure to consistently apply standards of universal screening across all patient groups, and even if it occurs, there is a failure to establish reliable treatment and follow-up regimens. As clinicians, imagine how challenging diagnosis and treatment of more complicated psychiatric syndromes, such as somatoform disorder, will be in the primary care setting after the pandemic.

When almost two-thirds of symptoms in primary care are already “medically unexplained,” how do we expect primary care doctors to differentiate between those presenting with vague coronavirus-related “brain fog,” the run of the mill worrywart, and the 16%-34% with legitimate hypochondriasis of somatoform disorder who won’t improve without the involvement of a mental health provider?
 

A specialty in short supply

The mental health system we have now is inadequate for those who are currently diagnosed with mental disorders. Before the pandemic, emergency departments were boarding increasing numbers of patients with psychiatric illness because beds on inpatient units were unavailable. Individuals with insurance faced difficulty finding psychiatrists or psychotherapists who took insurance or who were availabile to accept new patients, given the growing shortage of providers in general. Community health centers continued to grapple with decreases in federal and state funding despite public political support for parity. Individuals with substance use faced few options for the outpatient, residential, or pharmacologic treatment that many needed to maintain sobriety.

Since the pandemic, we have seen rates of anxiety, depression, and suicidal thinking increase among adults and youth while many clinics have been forced to lay off employees, reduce services, or close their doors. As psychiatrists, we not only see the lack of treatment options for our patients but are forced to find creative solutions to meet their needs. How are we supposed to adapt (or feel confident) when individuals with or without previous mental illness face downstream consequences after COVID-19 when not one of our own is represented in the advisory board? How can we feel confident that downstream solutions acknowledge and address the intricacy of the behavioral health system that we, as mental health providers, know so intimately?

And what about the cumulative impact of everything else that has happened in 2020 in addition to the pandemic?! Although cataloging the various negative events that have happened this year is beyond the scope of this discussion, such lists have been compiled by the mainstream media and include the Australian brush fires, the crisis in Armenia, racial protests, economic uncertainties, and the run-up to and occurrence of the 2020 presidential election. Research is solid in its assertion that chronic stress can disturb our immune and cardiovascular systems, as well as mental health, leading to depression or anxiety. As a result of the pandemic itself, plus the events of this year, mental health providers are already warning not only of the current trauma underlying our day-to-day lives but also that of years to come.

More importantly, healthcare providers, both those represented by members of the advisory board and those who are not, are not immune to these issues. Before the pandemic, rates of suicide among doctors were already above average compared with other professions. After witnessing death repeatedly, self-isolation, the risk for infection to family, and dealing with the continued resistance to wearing masks, who knows what the eventual psychological toll our medical workforce will be?

Mental health providers have stepped up to the plate to provide care outside of traditional models to meet the needs that patients have now. One survey found that 81% of behavioral health providers began using telehealth for the first time in the past 6 months, owing to the COVID-19 pandemic. If not for the sake of the mental health of the Biden-Harris advisory board members themselves, who as doctors are likely to downplay the impact when struggling with mental health concerns in their own lives, a mental health provider deserves a seat at the table.

Plus, the outcomes speak for themselves when behavioral health providers collaborate with primary care providers to give treatment or when mental health experts are members of health crisis teams. Why wouldn’t the same be true for the Biden-Harris advisory board?


Kali Cyrus, MD, MPH, is an assistant professor of psychiatry and behavioral medicine at the Johns Hopkins School of Medicine, Baltimore, Maryland. She sees patients in private practice and offers consultation services in diversity strategy. Ranna Parekh, MD, MPH, is past deputy medical director and director of diversity and health equity for the American Psychiatric Association. She is currently a consultant psychiatrist at the Massachusetts General Hospital, Boston, and the chief diversity and inclusion officer at the American College of Cardiology.
 

A version of this article originally appeared on Medscape.com.

On Nov. 9, the Biden-Harris administration announced the members of its COVID-19 Advisory Board. Among them were many esteemed infectious disease and public health experts – encouraging, given that, for now, the COVID-19 pandemic shows no signs of slowing down. Not among them was a mental health professional.

As psychiatrists, we did not find this omission surprising, given the sidelined role our specialty too often plays among medical professionals. But we did find it disappointing. Not having a single behavioral health provider on the advisory board will prove to be a mistake that could affect millions of Americans.

Studies continue to roll in showing that patients with COVID-19 can present during and after infection with neuropsychiatric symptoms, including delirium, psychosis, and anxiety. In July, a meta-analysis published in The Lancet regarding the neuropsychological outcomes of earlier diseases caused by coronaviruses – severe acute respiratory syndrome and Middle East respiratory syndrome – suggested that, in the short term, close to one-quarter of patients experienced confusion representative of delirium. In the long term, following recovery, respondents frequently reported emotional lability, impaired concentration, and traumatic memories. Additionally, more recent research published in The Lancet suggests that rates of psychiatric disorders, dementia, and insomnia are significantly higher among survivors of COVID-19. This study echoes the findings of an article in JAMA from September that reported that, among patients who were hospitalized for COVID-19, mortality rates were higher for those who had previously been diagnosed with a psychiatric condition. And overall, the pandemic has been associated with significantly increased rates of anxiety and depression symptoms.

Although this research is preliminary, it would be irresponsible – and at the very least myopic — not to take seriously the downstream consequences of the damage to the American people’s psyches when planning how our system can adapt to ensure that there is access to care and treatment.

This is especially true when you consider the following:

• It is very difficult to diagnose and treat mental health symptoms in a primary care setting that is already overburdened. Doing so results in delayed treatment and increased costs.
• In the long term, COVID-19 survivors will overburden the already underfunded mental healthcare system.
• Additional unforeseen psychological outcomes stem from the myriad traumas of events in 2020 (eg, racial unrest, children out of school, loss of jobs, the recent election).

Psychiatric disorders are notoriously difficult to diagnose and treat in the outpatient primary care setting, which is why mental health professionals will need to be a more integral part of the postpandemic treatment model and should be represented on the advisory board. Each year in the United States, there are more than 8 million doctors’ visits for depression, and more than half of these are in the primary care setting. Yet fewer than half of those patients leave with a diagnosis of depression or are treated for it.

Historically, screening for depression in the primary care setting is difficult given its broad presentation of symptoms, which include nonspecific physical complaints, such as digestive problems, headaches, insomnia, or general aches and pains. These shortcomings exist despite multiple changes in guidelines, such as regarding the use of self-screening tools and general screening for specific populations, such as postpartum women.

But screening alone has not been an effective strategy, especially when certain groups are less likely to be screened. These include older adults, Black persons, and men, all of whom are at higher risk for mortality after COVID-19. There is a failure to consistently apply standards of universal screening across all patient groups, and even if it occurs, there is a failure to establish reliable treatment and follow-up regimens. As clinicians, imagine how challenging diagnosis and treatment of more complicated psychiatric syndromes, such as somatoform disorder, will be in the primary care setting after the pandemic.

When almost two-thirds of symptoms in primary care are already “medically unexplained,” how do we expect primary care doctors to differentiate between those presenting with vague coronavirus-related “brain fog,” the run of the mill worrywart, and the 16%-34% with legitimate hypochondriasis of somatoform disorder who won’t improve without the involvement of a mental health provider?
 

A specialty in short supply

The mental health system we have now is inadequate for those who are currently diagnosed with mental disorders. Before the pandemic, emergency departments were boarding increasing numbers of patients with psychiatric illness because beds on inpatient units were unavailable. Individuals with insurance faced difficulty finding psychiatrists or psychotherapists who took insurance or who were availabile to accept new patients, given the growing shortage of providers in general. Community health centers continued to grapple with decreases in federal and state funding despite public political support for parity. Individuals with substance use faced few options for the outpatient, residential, or pharmacologic treatment that many needed to maintain sobriety.

Since the pandemic, we have seen rates of anxiety, depression, and suicidal thinking increase among adults and youth while many clinics have been forced to lay off employees, reduce services, or close their doors. As psychiatrists, we not only see the lack of treatment options for our patients but are forced to find creative solutions to meet their needs. How are we supposed to adapt (or feel confident) when individuals with or without previous mental illness face downstream consequences after COVID-19 when not one of our own is represented in the advisory board? How can we feel confident that downstream solutions acknowledge and address the intricacy of the behavioral health system that we, as mental health providers, know so intimately?

And what about the cumulative impact of everything else that has happened in 2020 in addition to the pandemic?! Although cataloging the various negative events that have happened this year is beyond the scope of this discussion, such lists have been compiled by the mainstream media and include the Australian brush fires, the crisis in Armenia, racial protests, economic uncertainties, and the run-up to and occurrence of the 2020 presidential election. Research is solid in its assertion that chronic stress can disturb our immune and cardiovascular systems, as well as mental health, leading to depression or anxiety. As a result of the pandemic itself, plus the events of this year, mental health providers are already warning not only of the current trauma underlying our day-to-day lives but also that of years to come.

More importantly, healthcare providers, both those represented by members of the advisory board and those who are not, are not immune to these issues. Before the pandemic, rates of suicide among doctors were already above average compared with other professions. After witnessing death repeatedly, self-isolation, the risk for infection to family, and dealing with the continued resistance to wearing masks, who knows what the eventual psychological toll our medical workforce will be?

Mental health providers have stepped up to the plate to provide care outside of traditional models to meet the needs that patients have now. One survey found that 81% of behavioral health providers began using telehealth for the first time in the past 6 months, owing to the COVID-19 pandemic. If not for the sake of the mental health of the Biden-Harris advisory board members themselves, who as doctors are likely to downplay the impact when struggling with mental health concerns in their own lives, a mental health provider deserves a seat at the table.

Plus, the outcomes speak for themselves when behavioral health providers collaborate with primary care providers to give treatment or when mental health experts are members of health crisis teams. Why wouldn’t the same be true for the Biden-Harris advisory board?


Kali Cyrus, MD, MPH, is an assistant professor of psychiatry and behavioral medicine at the Johns Hopkins School of Medicine, Baltimore, Maryland. She sees patients in private practice and offers consultation services in diversity strategy. Ranna Parekh, MD, MPH, is past deputy medical director and director of diversity and health equity for the American Psychiatric Association. She is currently a consultant psychiatrist at the Massachusetts General Hospital, Boston, and the chief diversity and inclusion officer at the American College of Cardiology.
 

A version of this article originally appeared on Medscape.com.

On Nov. 9, the Biden-Harris administration announced the members of its COVID-19 Advisory Board. Among them were many esteemed infectious disease and public health experts – encouraging, given that, for now, the COVID-19 pandemic shows no signs of slowing down. Not among them was a mental health professional.

As psychiatrists, we did not find this omission surprising, given the sidelined role our specialty too often plays among medical professionals. But we did find it disappointing. Not having a single behavioral health provider on the advisory board will prove to be a mistake that could affect millions of Americans.

Studies continue to roll in showing that patients with COVID-19 can present during and after infection with neuropsychiatric symptoms, including delirium, psychosis, and anxiety. In July, a meta-analysis published in The Lancet regarding the neuropsychological outcomes of earlier diseases caused by coronaviruses – severe acute respiratory syndrome and Middle East respiratory syndrome – suggested that, in the short term, close to one-quarter of patients experienced confusion representative of delirium. In the long term, following recovery, respondents frequently reported emotional lability, impaired concentration, and traumatic memories. Additionally, more recent research published in The Lancet suggests that rates of psychiatric disorders, dementia, and insomnia are significantly higher among survivors of COVID-19. This study echoes the findings of an article in JAMA from September that reported that, among patients who were hospitalized for COVID-19, mortality rates were higher for those who had previously been diagnosed with a psychiatric condition. And overall, the pandemic has been associated with significantly increased rates of anxiety and depression symptoms.

Although this research is preliminary, it would be irresponsible – and at the very least myopic — not to take seriously the downstream consequences of the damage to the American people’s psyches when planning how our system can adapt to ensure that there is access to care and treatment.

This is especially true when you consider the following:

• It is very difficult to diagnose and treat mental health symptoms in a primary care setting that is already overburdened. Doing so results in delayed treatment and increased costs.
• In the long term, COVID-19 survivors will overburden the already underfunded mental healthcare system.
• Additional unforeseen psychological outcomes stem from the myriad traumas of events in 2020 (eg, racial unrest, children out of school, loss of jobs, the recent election).

Psychiatric disorders are notoriously difficult to diagnose and treat in the outpatient primary care setting, which is why mental health professionals will need to be a more integral part of the postpandemic treatment model and should be represented on the advisory board. Each year in the United States, there are more than 8 million doctors’ visits for depression, and more than half of these are in the primary care setting. Yet fewer than half of those patients leave with a diagnosis of depression or are treated for it.

Historically, screening for depression in the primary care setting is difficult given its broad presentation of symptoms, which include nonspecific physical complaints, such as digestive problems, headaches, insomnia, or general aches and pains. These shortcomings exist despite multiple changes in guidelines, such as regarding the use of self-screening tools and general screening for specific populations, such as postpartum women.

But screening alone has not been an effective strategy, especially when certain groups are less likely to be screened. These include older adults, Black persons, and men, all of whom are at higher risk for mortality after COVID-19. There is a failure to consistently apply standards of universal screening across all patient groups, and even if it occurs, there is a failure to establish reliable treatment and follow-up regimens. As clinicians, imagine how challenging diagnosis and treatment of more complicated psychiatric syndromes, such as somatoform disorder, will be in the primary care setting after the pandemic.

When almost two-thirds of symptoms in primary care are already “medically unexplained,” how do we expect primary care doctors to differentiate between those presenting with vague coronavirus-related “brain fog,” the run of the mill worrywart, and the 16%-34% with legitimate hypochondriasis of somatoform disorder who won’t improve without the involvement of a mental health provider?
 

A specialty in short supply

The mental health system we have now is inadequate for those who are currently diagnosed with mental disorders. Before the pandemic, emergency departments were boarding increasing numbers of patients with psychiatric illness because beds on inpatient units were unavailable. Individuals with insurance faced difficulty finding psychiatrists or psychotherapists who took insurance or who were availabile to accept new patients, given the growing shortage of providers in general. Community health centers continued to grapple with decreases in federal and state funding despite public political support for parity. Individuals with substance use faced few options for the outpatient, residential, or pharmacologic treatment that many needed to maintain sobriety.

Since the pandemic, we have seen rates of anxiety, depression, and suicidal thinking increase among adults and youth while many clinics have been forced to lay off employees, reduce services, or close their doors. As psychiatrists, we not only see the lack of treatment options for our patients but are forced to find creative solutions to meet their needs. How are we supposed to adapt (or feel confident) when individuals with or without previous mental illness face downstream consequences after COVID-19 when not one of our own is represented in the advisory board? How can we feel confident that downstream solutions acknowledge and address the intricacy of the behavioral health system that we, as mental health providers, know so intimately?

And what about the cumulative impact of everything else that has happened in 2020 in addition to the pandemic?! Although cataloging the various negative events that have happened this year is beyond the scope of this discussion, such lists have been compiled by the mainstream media and include the Australian brush fires, the crisis in Armenia, racial protests, economic uncertainties, and the run-up to and occurrence of the 2020 presidential election. Research is solid in its assertion that chronic stress can disturb our immune and cardiovascular systems, as well as mental health, leading to depression or anxiety. As a result of the pandemic itself, plus the events of this year, mental health providers are already warning not only of the current trauma underlying our day-to-day lives but also that of years to come.

More importantly, healthcare providers, both those represented by members of the advisory board and those who are not, are not immune to these issues. Before the pandemic, rates of suicide among doctors were already above average compared with other professions. After witnessing death repeatedly, self-isolation, the risk for infection to family, and dealing with the continued resistance to wearing masks, who knows what the eventual psychological toll our medical workforce will be?

Mental health providers have stepped up to the plate to provide care outside of traditional models to meet the needs that patients have now. One survey found that 81% of behavioral health providers began using telehealth for the first time in the past 6 months, owing to the COVID-19 pandemic. If not for the sake of the mental health of the Biden-Harris advisory board members themselves, who as doctors are likely to downplay the impact when struggling with mental health concerns in their own lives, a mental health provider deserves a seat at the table.

Plus, the outcomes speak for themselves when behavioral health providers collaborate with primary care providers to give treatment or when mental health experts are members of health crisis teams. Why wouldn’t the same be true for the Biden-Harris advisory board?


Kali Cyrus, MD, MPH, is an assistant professor of psychiatry and behavioral medicine at the Johns Hopkins School of Medicine, Baltimore, Maryland. She sees patients in private practice and offers consultation services in diversity strategy. Ranna Parekh, MD, MPH, is past deputy medical director and director of diversity and health equity for the American Psychiatric Association. She is currently a consultant psychiatrist at the Massachusetts General Hospital, Boston, and the chief diversity and inclusion officer at the American College of Cardiology.
 

A version of this article originally appeared on Medscape.com.

The Moderna COVID-19 vaccine in development was 94.1% effective in the final analysis of its 30,000-participant phase 3 study. Bolstered by the new findings, the company plans to file for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) today, according to a company release.

A total of 11 people in the mRNA-1273 vaccinated group later tested positive for COVID-19, compared with 185 participants given two placebo injections, resulting in a point estimate of 94.1% efficacy. This finding aligns with the 94.5% efficacy in interim trial results announced on November 16, as reported by Medscape Medical News.

Furthermore, Moderna announced that the vaccine prevented serious cases of infection. All 30 severe infections occurred among those people randomly assigned to placebo.

The FDA plans to review the Moderna vaccine safety and efficacy data at the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for December 17. If and when approved, healthcare providers can use the new 91301 CPT code specific to mRNA-1273 vaccination.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, MBA, MEng, chief executive officer of Moderna, in the news release. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

Vaccine efficacy remained consistent across different groups analyzed by age, race/ethnicity, and gender. The 196 COVID-19 cases in the trial included 33 adults older than 65 years and 42 people from diverse communities, including 29 Hispanic or Latinx, six Black or African Americans, four Asian Americans, and three multiracial participants, the company reported.
 

No serious vaccine-related safety issues

The mRNA-1273 vaccine was generally well tolerated and no serious safety concerns with the vaccine have been identified to date, the company reported. 

Injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site were the most common solicited adverse events in a prior analysis. The company noted that these solicited adverse reactions increased in frequency and severity after the second vaccine dose. A continuous review of safety data is ongoing.

One COVID-19-related death in the study occurred in the placebo group.
 

Ready to start shipping

Moderna expects to have approximately 20 million doses of mRNA-1273 available in the United States by the end of this year. The company reports that it’s on track to manufacture 500 million to 1 billion doses globally in 2021.

The company also is seeking approval from nations and organizations worldwide, including a conditional approval from the European Medicines Agency (EMA). The  study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Moderna will be the second company to file an EUA with the FDA for a COVID vaccine, after Pfizer requested one for its mRNA vaccine earlier this month.

This article first appeared on Medscape.com.

The Moderna COVID-19 vaccine in development was 94.1% effective in the final analysis of its 30,000-participant phase 3 study. Bolstered by the new findings, the company plans to file for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) today, according to a company release.

A total of 11 people in the mRNA-1273 vaccinated group later tested positive for COVID-19, compared with 185 participants given two placebo injections, resulting in a point estimate of 94.1% efficacy. This finding aligns with the 94.5% efficacy in interim trial results announced on November 16, as reported by Medscape Medical News.

Furthermore, Moderna announced that the vaccine prevented serious cases of infection. All 30 severe infections occurred among those people randomly assigned to placebo.

The FDA plans to review the Moderna vaccine safety and efficacy data at the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for December 17. If and when approved, healthcare providers can use the new 91301 CPT code specific to mRNA-1273 vaccination.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, MBA, MEng, chief executive officer of Moderna, in the news release. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

Vaccine efficacy remained consistent across different groups analyzed by age, race/ethnicity, and gender. The 196 COVID-19 cases in the trial included 33 adults older than 65 years and 42 people from diverse communities, including 29 Hispanic or Latinx, six Black or African Americans, four Asian Americans, and three multiracial participants, the company reported.
 

No serious vaccine-related safety issues

The mRNA-1273 vaccine was generally well tolerated and no serious safety concerns with the vaccine have been identified to date, the company reported. 

Injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site were the most common solicited adverse events in a prior analysis. The company noted that these solicited adverse reactions increased in frequency and severity after the second vaccine dose. A continuous review of safety data is ongoing.

One COVID-19-related death in the study occurred in the placebo group.
 

Ready to start shipping

Moderna expects to have approximately 20 million doses of mRNA-1273 available in the United States by the end of this year. The company reports that it’s on track to manufacture 500 million to 1 billion doses globally in 2021.

The company also is seeking approval from nations and organizations worldwide, including a conditional approval from the European Medicines Agency (EMA). The  study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Moderna will be the second company to file an EUA with the FDA for a COVID vaccine, after Pfizer requested one for its mRNA vaccine earlier this month.

This article first appeared on Medscape.com.

The Moderna COVID-19 vaccine in development was 94.1% effective in the final analysis of its 30,000-participant phase 3 study. Bolstered by the new findings, the company plans to file for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) today, according to a company release.

A total of 11 people in the mRNA-1273 vaccinated group later tested positive for COVID-19, compared with 185 participants given two placebo injections, resulting in a point estimate of 94.1% efficacy. This finding aligns with the 94.5% efficacy in interim trial results announced on November 16, as reported by Medscape Medical News.

Furthermore, Moderna announced that the vaccine prevented serious cases of infection. All 30 severe infections occurred among those people randomly assigned to placebo.

The FDA plans to review the Moderna vaccine safety and efficacy data at the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting scheduled for December 17. If and when approved, healthcare providers can use the new 91301 CPT code specific to mRNA-1273 vaccination.

“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, MBA, MEng, chief executive officer of Moderna, in the news release. “We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death.”

Vaccine efficacy remained consistent across different groups analyzed by age, race/ethnicity, and gender. The 196 COVID-19 cases in the trial included 33 adults older than 65 years and 42 people from diverse communities, including 29 Hispanic or Latinx, six Black or African Americans, four Asian Americans, and three multiracial participants, the company reported.
 

No serious vaccine-related safety issues

The mRNA-1273 vaccine was generally well tolerated and no serious safety concerns with the vaccine have been identified to date, the company reported. 

Injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site were the most common solicited adverse events in a prior analysis. The company noted that these solicited adverse reactions increased in frequency and severity after the second vaccine dose. A continuous review of safety data is ongoing.

One COVID-19-related death in the study occurred in the placebo group.
 

Ready to start shipping

Moderna expects to have approximately 20 million doses of mRNA-1273 available in the United States by the end of this year. The company reports that it’s on track to manufacture 500 million to 1 billion doses globally in 2021.

The company also is seeking approval from nations and organizations worldwide, including a conditional approval from the European Medicines Agency (EMA). The  study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.

Moderna will be the second company to file an EUA with the FDA for a COVID vaccine, after Pfizer requested one for its mRNA vaccine earlier this month.

This article first appeared on Medscape.com.

Hyperglycemia at hospital admission – regardless of diabetes status – is a key predictor of COVID-19-related death and severity among noncritical patients, new research from Spain finds.

The observational study, the largest to date to investigate this association, was published online Nov. 23 in Annals of Medicine by Francisco Javier Carrasco-Sánchez, MD, PhD, and colleagues.

Among more than 11,000 patients with confirmed COVID-19 from March to May 2020 in a nationwide Spanish registry involving 109 hospitals, admission hyperglycemia independently predicted progression from noncritical to critical condition and death, regardless of prior diabetes history. 

Those with abnormally high glucose levels were more than twice as likely to die from the virus than those with normal readings (41.4% vs 15.7%). They also had an increased need for a ventilator and intensive care unit (ICU) admission.

“These results provided a simple and practical way to stratify risk of death in hospitalized patients with COVID-19. Hence, admission hyperglycemia should not be overlooked, but rather detected and appropriately treated to improve the outcomes of COVID-19 patients with and without diabetes,” Dr. Carrasco-Sánchez and colleagues wrote.

The findings confirm those of previous retrospective observational studies, but the current study “has, by far, the biggest number of patients involved in this kind of study [to date]. All conclusions are consistent to other studies,” Dr. Carrasco-Sánchez, of University Hospital Juan Ramón Jiménez, Huelva, Spain, said in an interview.

However, a surprising finding, he said, “was how hyperglycemia works in the nondiabetic population and [that] glucose levels over 140 [mg/dL] ... increase the risk of death.”
 

Pay attention to even mild hyperglycemia from admission

The study also differs from some of the prior observational ones in that it examines outcome by admission glycemia rather than during the hospital stay, therefore eliminating the effect of any inpatient treatment, such as dexamethasone, he noted.

Although blood glucose measurement at admission is routine for all patients in Spain, as it is in the United States and elsewhere, a mildly elevated level in a person without a diagnosis of diabetes may not be recognized as important.

“In patients with diabetes we start the protocol to control and treat hyperglycemia during hospitalization. However, in nondiabetic patients blood glucose levels under 180 [mg/dL], and even greater, are usually overlooked. This means there is not a correct follow-up of the patients during hospitalization.

“After this study we learned that we need to pay attention to this population ... who develop hyperglycemia from the beginning,” he said.  

The study was limited in that patients who had previously undiagnosed diabetes couldn’t always be distinguished from those with acute “stress hyperglycemia.”

However, both need to be managed during hospitalization, he said. “Unfortunately, there is high variability in inpatient glucose management. The working group of diabetes of the Spanish Society of Internal Medicine is working on specific protocols,” said Dr. Carrasco-Sánchez.
 

All-cause death, progress to critical care higher with hyperglycemia

The retrospective, multicenter study was based on data from 11,312 adult patients with confirmed COVID-19 in 109 hospitals participating in Spain’s SEMI-COVID-19 registry as of May 29, 2020. They had a mean age of 67 years, 57% were male, and 19% had a diagnosis of diabetes. A total of 20% (n = 2,289) died during hospitalization.

Overall all-cause mortality was 41.1% among those with admission blood glucose levels above 180 mg/dL, 33.0% for those with glucose levels 140-180 mg/dL, and 15.7% for levels below 140 mg/dL. All differences were significant (P < .0001), but there were no differences in mortality rates within each blood glucose category between patients with or without a previous diagnosis of diabetes.

After adjustment for confounding factors, elevated admission blood glucose level remained a significant predictor of death. Compared to < 140 mg/dL, the hazard ratios for 140-180 mg/dL and > 180 mg/dL were 1.48 and 1.50, respectively (both P < .001). (Adjustments included age, gender, hypertension, diabetes, chronic obstructive pulmonary disease, lymphopenia, anemia (hemoglobin < 10 g/dL), serum creatinine, C-reactive protein > 60 mg/L, lactate dehydrogenase > 400 U/L and D-dimer >1000 ng/mL.)

Length of stay was 12, 11.5, and 11.1 days for those with admission blood glucose levels > 180, 140-180, and < 140 mg/dL, respectively (P = .011).

Use of mechanical ventilation and admission to intensive care also rose with higher admission blood glucose levels. For the composite of death, mechanical ventilation, and/or ICU admission, odds ratios for 140-180 mg/dL and > 180 mg/dL compared with < 140 mg/dL were 1.70 and 2.02, respectively (both P < .001). 

The study was supported by the Spanish Federation of Internal Medicine. The authors have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Hyperglycemia at hospital admission – regardless of diabetes status – is a key predictor of COVID-19-related death and severity among noncritical patients, new research from Spain finds.

The observational study, the largest to date to investigate this association, was published online Nov. 23 in Annals of Medicine by Francisco Javier Carrasco-Sánchez, MD, PhD, and colleagues.

Among more than 11,000 patients with confirmed COVID-19 from March to May 2020 in a nationwide Spanish registry involving 109 hospitals, admission hyperglycemia independently predicted progression from noncritical to critical condition and death, regardless of prior diabetes history. 

Those with abnormally high glucose levels were more than twice as likely to die from the virus than those with normal readings (41.4% vs 15.7%). They also had an increased need for a ventilator and intensive care unit (ICU) admission.

“These results provided a simple and practical way to stratify risk of death in hospitalized patients with COVID-19. Hence, admission hyperglycemia should not be overlooked, but rather detected and appropriately treated to improve the outcomes of COVID-19 patients with and without diabetes,” Dr. Carrasco-Sánchez and colleagues wrote.

The findings confirm those of previous retrospective observational studies, but the current study “has, by far, the biggest number of patients involved in this kind of study [to date]. All conclusions are consistent to other studies,” Dr. Carrasco-Sánchez, of University Hospital Juan Ramón Jiménez, Huelva, Spain, said in an interview.

However, a surprising finding, he said, “was how hyperglycemia works in the nondiabetic population and [that] glucose levels over 140 [mg/dL] ... increase the risk of death.”
 

Pay attention to even mild hyperglycemia from admission

The study also differs from some of the prior observational ones in that it examines outcome by admission glycemia rather than during the hospital stay, therefore eliminating the effect of any inpatient treatment, such as dexamethasone, he noted.

Although blood glucose measurement at admission is routine for all patients in Spain, as it is in the United States and elsewhere, a mildly elevated level in a person without a diagnosis of diabetes may not be recognized as important.

“In patients with diabetes we start the protocol to control and treat hyperglycemia during hospitalization. However, in nondiabetic patients blood glucose levels under 180 [mg/dL], and even greater, are usually overlooked. This means there is not a correct follow-up of the patients during hospitalization.

“After this study we learned that we need to pay attention to this population ... who develop hyperglycemia from the beginning,” he said.  

The study was limited in that patients who had previously undiagnosed diabetes couldn’t always be distinguished from those with acute “stress hyperglycemia.”

However, both need to be managed during hospitalization, he said. “Unfortunately, there is high variability in inpatient glucose management. The working group of diabetes of the Spanish Society of Internal Medicine is working on specific protocols,” said Dr. Carrasco-Sánchez.
 

All-cause death, progress to critical care higher with hyperglycemia

The retrospective, multicenter study was based on data from 11,312 adult patients with confirmed COVID-19 in 109 hospitals participating in Spain’s SEMI-COVID-19 registry as of May 29, 2020. They had a mean age of 67 years, 57% were male, and 19% had a diagnosis of diabetes. A total of 20% (n = 2,289) died during hospitalization.

Overall all-cause mortality was 41.1% among those with admission blood glucose levels above 180 mg/dL, 33.0% for those with glucose levels 140-180 mg/dL, and 15.7% for levels below 140 mg/dL. All differences were significant (P < .0001), but there were no differences in mortality rates within each blood glucose category between patients with or without a previous diagnosis of diabetes.

After adjustment for confounding factors, elevated admission blood glucose level remained a significant predictor of death. Compared to < 140 mg/dL, the hazard ratios for 140-180 mg/dL and > 180 mg/dL were 1.48 and 1.50, respectively (both P < .001). (Adjustments included age, gender, hypertension, diabetes, chronic obstructive pulmonary disease, lymphopenia, anemia (hemoglobin < 10 g/dL), serum creatinine, C-reactive protein > 60 mg/L, lactate dehydrogenase > 400 U/L and D-dimer >1000 ng/mL.)

Length of stay was 12, 11.5, and 11.1 days for those with admission blood glucose levels > 180, 140-180, and < 140 mg/dL, respectively (P = .011).

Use of mechanical ventilation and admission to intensive care also rose with higher admission blood glucose levels. For the composite of death, mechanical ventilation, and/or ICU admission, odds ratios for 140-180 mg/dL and > 180 mg/dL compared with < 140 mg/dL were 1.70 and 2.02, respectively (both P < .001). 

The study was supported by the Spanish Federation of Internal Medicine. The authors have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Hyperglycemia at hospital admission – regardless of diabetes status – is a key predictor of COVID-19-related death and severity among noncritical patients, new research from Spain finds.

The observational study, the largest to date to investigate this association, was published online Nov. 23 in Annals of Medicine by Francisco Javier Carrasco-Sánchez, MD, PhD, and colleagues.

Among more than 11,000 patients with confirmed COVID-19 from March to May 2020 in a nationwide Spanish registry involving 109 hospitals, admission hyperglycemia independently predicted progression from noncritical to critical condition and death, regardless of prior diabetes history. 

Those with abnormally high glucose levels were more than twice as likely to die from the virus than those with normal readings (41.4% vs 15.7%). They also had an increased need for a ventilator and intensive care unit (ICU) admission.

“These results provided a simple and practical way to stratify risk of death in hospitalized patients with COVID-19. Hence, admission hyperglycemia should not be overlooked, but rather detected and appropriately treated to improve the outcomes of COVID-19 patients with and without diabetes,” Dr. Carrasco-Sánchez and colleagues wrote.

The findings confirm those of previous retrospective observational studies, but the current study “has, by far, the biggest number of patients involved in this kind of study [to date]. All conclusions are consistent to other studies,” Dr. Carrasco-Sánchez, of University Hospital Juan Ramón Jiménez, Huelva, Spain, said in an interview.

However, a surprising finding, he said, “was how hyperglycemia works in the nondiabetic population and [that] glucose levels over 140 [mg/dL] ... increase the risk of death.”
 

Pay attention to even mild hyperglycemia from admission

The study also differs from some of the prior observational ones in that it examines outcome by admission glycemia rather than during the hospital stay, therefore eliminating the effect of any inpatient treatment, such as dexamethasone, he noted.

Although blood glucose measurement at admission is routine for all patients in Spain, as it is in the United States and elsewhere, a mildly elevated level in a person without a diagnosis of diabetes may not be recognized as important.

“In patients with diabetes we start the protocol to control and treat hyperglycemia during hospitalization. However, in nondiabetic patients blood glucose levels under 180 [mg/dL], and even greater, are usually overlooked. This means there is not a correct follow-up of the patients during hospitalization.

“After this study we learned that we need to pay attention to this population ... who develop hyperglycemia from the beginning,” he said.  

The study was limited in that patients who had previously undiagnosed diabetes couldn’t always be distinguished from those with acute “stress hyperglycemia.”

However, both need to be managed during hospitalization, he said. “Unfortunately, there is high variability in inpatient glucose management. The working group of diabetes of the Spanish Society of Internal Medicine is working on specific protocols,” said Dr. Carrasco-Sánchez.
 

All-cause death, progress to critical care higher with hyperglycemia

The retrospective, multicenter study was based on data from 11,312 adult patients with confirmed COVID-19 in 109 hospitals participating in Spain’s SEMI-COVID-19 registry as of May 29, 2020. They had a mean age of 67 years, 57% were male, and 19% had a diagnosis of diabetes. A total of 20% (n = 2,289) died during hospitalization.

Overall all-cause mortality was 41.1% among those with admission blood glucose levels above 180 mg/dL, 33.0% for those with glucose levels 140-180 mg/dL, and 15.7% for levels below 140 mg/dL. All differences were significant (P < .0001), but there were no differences in mortality rates within each blood glucose category between patients with or without a previous diagnosis of diabetes.

After adjustment for confounding factors, elevated admission blood glucose level remained a significant predictor of death. Compared to < 140 mg/dL, the hazard ratios for 140-180 mg/dL and > 180 mg/dL were 1.48 and 1.50, respectively (both P < .001). (Adjustments included age, gender, hypertension, diabetes, chronic obstructive pulmonary disease, lymphopenia, anemia (hemoglobin < 10 g/dL), serum creatinine, C-reactive protein > 60 mg/L, lactate dehydrogenase > 400 U/L and D-dimer >1000 ng/mL.)

Length of stay was 12, 11.5, and 11.1 days for those with admission blood glucose levels > 180, 140-180, and < 140 mg/dL, respectively (P = .011).

Use of mechanical ventilation and admission to intensive care also rose with higher admission blood glucose levels. For the composite of death, mechanical ventilation, and/or ICU admission, odds ratios for 140-180 mg/dL and > 180 mg/dL compared with < 140 mg/dL were 1.70 and 2.02, respectively (both P < .001). 

The study was supported by the Spanish Federation of Internal Medicine. The authors have reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

While stressing the urgent need to vaccinate the whole U.S. population, infectious disease experts and medical ethicists are raising questions about the clinical trials needed to answer important questions about the new COVID-19 vaccines.

In a statement released on Nov. 20, Barbara Alexander, MD, president of the Infectious Diseases Society of America (IDSA) and a professor at Duke University, Durham, N.C., commented on Pfizer and BioNTech’s application to the Food and Drug Administration for an emergency use authorization (EUA) for its COVID-19 vaccine. Besides emphasizing the need for a transparent review of the companies’ trial data prior to the FDA’s granting an EUA, she said, “If emergency use authorization is granted, clinical trials and data collection must continue.”

In an interview, Dr. Alexander said she is convinced that both Pfizer and Moderna, which is also expected to seek an EUA soon, will continue their clinical trials to monitor the long-term safety and efficacy of their vaccines.

“The EUA guidance for COVID vaccine authorization is very clear that clinical trials will move forward,” she said. “Any EUA request would have to include a strategy to ensure that the long-term safety and efficacy of a vaccine could be monitored. I see no evidence that either Pfizer or Moderna is not prepared to follow those regulations.”

Eventually, she added, the drug makers will have to seek full FDA approval to replace an EUA, which as its name signifies, is designed for public health emergencies. “The EUA is a tool to help us get the vaccine into circulation and have it start working as quickly as possible in the current health crisis,” she said. “But once the crisis is over, if the sponsors want to continue to market their vaccines, they have to go forward and get full approval.”

Medical ethicists, however, point out there may be ethical and practical dilemmas involved in continuing or initiating clinical trials once a vaccine has been approved for use even on an emergency basis.

In a commentary in Annals of Internal Medicine, Rafael Dal-Re, MD, PhD, Arthur L. Caplan, PhD, and two other ethicists stipulated that the pandemic requires early licensing and deployment of COVID-19 vaccines. Nevertheless, they noted, additional months of data are required to establish the long-term efficacy and safety of the vaccines. “Moreover, early deployment could interfere with the acquisition of long-term data,” both on these vaccines and on others coming through the pipeline, they wrote.

In countries where an approved vaccine is deployed, the ethicists noted, investigators must inform participants in an ongoing trial about the approved vaccine’s status and ask if they want to continue in the study. If enough participants decline, the trial might have to be terminated early. At that point, researchers may not have sufficient long-term data to identify late-term safety issues, determine how long efficacy lasts, determine whether waning immunity is associated with reduced levels of antibodies, or identify the level of neutralizing antibodies that correlates with immunity.

Moreover, they observed, long-term trials are especially important for vaccines that use mRNA technology, because less is known about them than about traditional kinds of vaccines.

The authors also pointed out that early licensing of any vaccine might make it harder to evaluate vaccines that haven’t yet been approved. “Once a vaccine is licensed, new placebo-controlled RCTs [randomized controlled trials] of other vaccines will not be acceptable ethically, and noninferiority RCTs will be the most likely alternative.

“The goal of noninferiority trials will be to demonstrate that the immune response (that is, neutralizing antibody titers or levels) of the candidate vaccine is not inferior to that of the approved vaccine within a prespecified margin, which the FDA has established as less than 10% for COVID-19 vaccines,” the authors noted. 
 

More data with more study designs

Dial Hewlett Jr., MD, medical director for disease control services, Westchester County Department of Health, White Plains, N.Y., said in an interview that the ethicists raise important issues that have been discussed in other forums, including a recent webinar of the National Academy of Medicine.

“As the authors point out, once you have a vaccine that has been shown to be effective and safe, it’s no longer ethical to enroll people in placebo trials,” he said.

Therefore, he said, Pfizer and Moderna will undoubtedly offer their vaccines to the people in their studies’ placebo groups after the vaccines receive an EUA. Then they will follow everyone who has been vaccinated for 2 years to determine long-term safety. Efficacy will also continue to be measured as an adjunct of safety, he said.

With regard to the difficulty of reconsenting individuals to enter a new clinical trial after a vaccine has been approved, he said, “I’d agree that trying to get all the same participants to come into another study would be a challenge. You can, however, design studies that will allow you to obtain the same information. You will have a large number of people out there who haven’t been vaccinated, and you can do single-arm longitudinal studies and measure a number of things in the individuals who are enrolled in those studies,” he said.

“You can look at the immunologic markers, both antibody and T-cell. You can follow these individuals longitudinally to see if they do develop disease over a period of time. If they do, you can determine what their levels of response were,” he added. “So there are opportunities to design studies that would give you some of the same information, although it would not be in the same population that was in the randomized trials.”

For newer vaccines that have yet to be tested, he said, developers can compare “historical controls” from the trials of approved vaccines, i.e., data from the unvaccinated participants in those studies, with the data from inoculating people with the novel agents. The historical data can be sex- and age-matched, among other things, to individuals in the new trials. Moreover, because the study protocols have been harmonized for all trials under Operation Warp Speed, it doesn’t matter what kind of vaccine they’re testing, he said.

It may be necessary to do additional studies to find out how long immunity lasts after people have been vaccinated, Dr. Hewlett pointed out.

“You may have a different trial design. You don’t need a control arm to determine how long immunity lasts. You’re just comparing the patients who were vaccinated to nothing,” he said. “So you could have a single-arm trial on a group of people who consent to be immunized and followed. You can see what their antibody levels are and other surrogate markers, and you can see when they might develop disease, if they do. You’d need a large sample, but you can do that.”

Dr. Hewlett noted that additional studies will be required to determine whether the new vaccines stop transmission of the coronavirus or just prevent symptoms of COVID-19. Until it’s established that a vaccine halts transmission or the country achieves herd immunity, he said, “we’ll still have to wear masks and take other precautions, because a significant portion of people will still be at risk.”
 

‘A lot of redundancy’

Dr. Alexander emphasized that any safety or efficacy issues with the first COVID-19 vaccines must be identified before the vaccine is offered to a large portion of the U.S. population.

“While the data from the Pfizer and Moderna trials are said to be favorable, we at IDSA want to make sure that whatever vaccine comes to market is safe,” she said. “Having an unsafe vaccine on the market would be worse than no vaccine, because you’re compromising the public confidence. We have to make sure the public trusts the process and that sufficient data have been evaluated to ensure the vaccine is safe and efficacious.

“I believe the FDA is being very careful and thoughtful in [its] response,” Dr. Alexander said. “They realize how important it is to get a vaccine and save lives. While they’re doing things differently and moving much faster than before, they’re still trying to be thoughtful and reasonable. They don’t seem to be putting people at risk or circumventing the regulatory standards.”

Moreover, she pointed out, the FDA’s Vaccines and Related Biological Products Advisory Committee, which is expected to meet on Dec. 10, will review the trial data before the agency grants an EUA to Pfizer or Moderna. Then the FDA will post the data publicly.

The next step is for the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention to look at the data and decide who in the United States should receive the vaccine first, she pointed out. And both Pfizer and Moderna have shown their data to advisory panels of outside experts.

“There’s a lot of redundancy, and a lot of people are looking at the data,” Dr. Alexander said. “So I don’t think we’re cutting corners to get it out there more quickly.”

A version of this article originally appeared on Medscape.com.

While stressing the urgent need to vaccinate the whole U.S. population, infectious disease experts and medical ethicists are raising questions about the clinical trials needed to answer important questions about the new COVID-19 vaccines.

In a statement released on Nov. 20, Barbara Alexander, MD, president of the Infectious Diseases Society of America (IDSA) and a professor at Duke University, Durham, N.C., commented on Pfizer and BioNTech’s application to the Food and Drug Administration for an emergency use authorization (EUA) for its COVID-19 vaccine. Besides emphasizing the need for a transparent review of the companies’ trial data prior to the FDA’s granting an EUA, she said, “If emergency use authorization is granted, clinical trials and data collection must continue.”

In an interview, Dr. Alexander said she is convinced that both Pfizer and Moderna, which is also expected to seek an EUA soon, will continue their clinical trials to monitor the long-term safety and efficacy of their vaccines.

“The EUA guidance for COVID vaccine authorization is very clear that clinical trials will move forward,” she said. “Any EUA request would have to include a strategy to ensure that the long-term safety and efficacy of a vaccine could be monitored. I see no evidence that either Pfizer or Moderna is not prepared to follow those regulations.”

Eventually, she added, the drug makers will have to seek full FDA approval to replace an EUA, which as its name signifies, is designed for public health emergencies. “The EUA is a tool to help us get the vaccine into circulation and have it start working as quickly as possible in the current health crisis,” she said. “But once the crisis is over, if the sponsors want to continue to market their vaccines, they have to go forward and get full approval.”

Medical ethicists, however, point out there may be ethical and practical dilemmas involved in continuing or initiating clinical trials once a vaccine has been approved for use even on an emergency basis.

In a commentary in Annals of Internal Medicine, Rafael Dal-Re, MD, PhD, Arthur L. Caplan, PhD, and two other ethicists stipulated that the pandemic requires early licensing and deployment of COVID-19 vaccines. Nevertheless, they noted, additional months of data are required to establish the long-term efficacy and safety of the vaccines. “Moreover, early deployment could interfere with the acquisition of long-term data,” both on these vaccines and on others coming through the pipeline, they wrote.

In countries where an approved vaccine is deployed, the ethicists noted, investigators must inform participants in an ongoing trial about the approved vaccine’s status and ask if they want to continue in the study. If enough participants decline, the trial might have to be terminated early. At that point, researchers may not have sufficient long-term data to identify late-term safety issues, determine how long efficacy lasts, determine whether waning immunity is associated with reduced levels of antibodies, or identify the level of neutralizing antibodies that correlates with immunity.

Moreover, they observed, long-term trials are especially important for vaccines that use mRNA technology, because less is known about them than about traditional kinds of vaccines.

The authors also pointed out that early licensing of any vaccine might make it harder to evaluate vaccines that haven’t yet been approved. “Once a vaccine is licensed, new placebo-controlled RCTs [randomized controlled trials] of other vaccines will not be acceptable ethically, and noninferiority RCTs will be the most likely alternative.

“The goal of noninferiority trials will be to demonstrate that the immune response (that is, neutralizing antibody titers or levels) of the candidate vaccine is not inferior to that of the approved vaccine within a prespecified margin, which the FDA has established as less than 10% for COVID-19 vaccines,” the authors noted. 
 

More data with more study designs

Dial Hewlett Jr., MD, medical director for disease control services, Westchester County Department of Health, White Plains, N.Y., said in an interview that the ethicists raise important issues that have been discussed in other forums, including a recent webinar of the National Academy of Medicine.

“As the authors point out, once you have a vaccine that has been shown to be effective and safe, it’s no longer ethical to enroll people in placebo trials,” he said.

Therefore, he said, Pfizer and Moderna will undoubtedly offer their vaccines to the people in their studies’ placebo groups after the vaccines receive an EUA. Then they will follow everyone who has been vaccinated for 2 years to determine long-term safety. Efficacy will also continue to be measured as an adjunct of safety, he said.

With regard to the difficulty of reconsenting individuals to enter a new clinical trial after a vaccine has been approved, he said, “I’d agree that trying to get all the same participants to come into another study would be a challenge. You can, however, design studies that will allow you to obtain the same information. You will have a large number of people out there who haven’t been vaccinated, and you can do single-arm longitudinal studies and measure a number of things in the individuals who are enrolled in those studies,” he said.

“You can look at the immunologic markers, both antibody and T-cell. You can follow these individuals longitudinally to see if they do develop disease over a period of time. If they do, you can determine what their levels of response were,” he added. “So there are opportunities to design studies that would give you some of the same information, although it would not be in the same population that was in the randomized trials.”

For newer vaccines that have yet to be tested, he said, developers can compare “historical controls” from the trials of approved vaccines, i.e., data from the unvaccinated participants in those studies, with the data from inoculating people with the novel agents. The historical data can be sex- and age-matched, among other things, to individuals in the new trials. Moreover, because the study protocols have been harmonized for all trials under Operation Warp Speed, it doesn’t matter what kind of vaccine they’re testing, he said.

It may be necessary to do additional studies to find out how long immunity lasts after people have been vaccinated, Dr. Hewlett pointed out.

“You may have a different trial design. You don’t need a control arm to determine how long immunity lasts. You’re just comparing the patients who were vaccinated to nothing,” he said. “So you could have a single-arm trial on a group of people who consent to be immunized and followed. You can see what their antibody levels are and other surrogate markers, and you can see when they might develop disease, if they do. You’d need a large sample, but you can do that.”

Dr. Hewlett noted that additional studies will be required to determine whether the new vaccines stop transmission of the coronavirus or just prevent symptoms of COVID-19. Until it’s established that a vaccine halts transmission or the country achieves herd immunity, he said, “we’ll still have to wear masks and take other precautions, because a significant portion of people will still be at risk.”
 

‘A lot of redundancy’

Dr. Alexander emphasized that any safety or efficacy issues with the first COVID-19 vaccines must be identified before the vaccine is offered to a large portion of the U.S. population.

“While the data from the Pfizer and Moderna trials are said to be favorable, we at IDSA want to make sure that whatever vaccine comes to market is safe,” she said. “Having an unsafe vaccine on the market would be worse than no vaccine, because you’re compromising the public confidence. We have to make sure the public trusts the process and that sufficient data have been evaluated to ensure the vaccine is safe and efficacious.

“I believe the FDA is being very careful and thoughtful in [its] response,” Dr. Alexander said. “They realize how important it is to get a vaccine and save lives. While they’re doing things differently and moving much faster than before, they’re still trying to be thoughtful and reasonable. They don’t seem to be putting people at risk or circumventing the regulatory standards.”

Moreover, she pointed out, the FDA’s Vaccines and Related Biological Products Advisory Committee, which is expected to meet on Dec. 10, will review the trial data before the agency grants an EUA to Pfizer or Moderna. Then the FDA will post the data publicly.

The next step is for the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention to look at the data and decide who in the United States should receive the vaccine first, she pointed out. And both Pfizer and Moderna have shown their data to advisory panels of outside experts.

“There’s a lot of redundancy, and a lot of people are looking at the data,” Dr. Alexander said. “So I don’t think we’re cutting corners to get it out there more quickly.”

A version of this article originally appeared on Medscape.com.

While stressing the urgent need to vaccinate the whole U.S. population, infectious disease experts and medical ethicists are raising questions about the clinical trials needed to answer important questions about the new COVID-19 vaccines.

In a statement released on Nov. 20, Barbara Alexander, MD, president of the Infectious Diseases Society of America (IDSA) and a professor at Duke University, Durham, N.C., commented on Pfizer and BioNTech’s application to the Food and Drug Administration for an emergency use authorization (EUA) for its COVID-19 vaccine. Besides emphasizing the need for a transparent review of the companies’ trial data prior to the FDA’s granting an EUA, she said, “If emergency use authorization is granted, clinical trials and data collection must continue.”

In an interview, Dr. Alexander said she is convinced that both Pfizer and Moderna, which is also expected to seek an EUA soon, will continue their clinical trials to monitor the long-term safety and efficacy of their vaccines.

“The EUA guidance for COVID vaccine authorization is very clear that clinical trials will move forward,” she said. “Any EUA request would have to include a strategy to ensure that the long-term safety and efficacy of a vaccine could be monitored. I see no evidence that either Pfizer or Moderna is not prepared to follow those regulations.”

Eventually, she added, the drug makers will have to seek full FDA approval to replace an EUA, which as its name signifies, is designed for public health emergencies. “The EUA is a tool to help us get the vaccine into circulation and have it start working as quickly as possible in the current health crisis,” she said. “But once the crisis is over, if the sponsors want to continue to market their vaccines, they have to go forward and get full approval.”

Medical ethicists, however, point out there may be ethical and practical dilemmas involved in continuing or initiating clinical trials once a vaccine has been approved for use even on an emergency basis.

In a commentary in Annals of Internal Medicine, Rafael Dal-Re, MD, PhD, Arthur L. Caplan, PhD, and two other ethicists stipulated that the pandemic requires early licensing and deployment of COVID-19 vaccines. Nevertheless, they noted, additional months of data are required to establish the long-term efficacy and safety of the vaccines. “Moreover, early deployment could interfere with the acquisition of long-term data,” both on these vaccines and on others coming through the pipeline, they wrote.

In countries where an approved vaccine is deployed, the ethicists noted, investigators must inform participants in an ongoing trial about the approved vaccine’s status and ask if they want to continue in the study. If enough participants decline, the trial might have to be terminated early. At that point, researchers may not have sufficient long-term data to identify late-term safety issues, determine how long efficacy lasts, determine whether waning immunity is associated with reduced levels of antibodies, or identify the level of neutralizing antibodies that correlates with immunity.

Moreover, they observed, long-term trials are especially important for vaccines that use mRNA technology, because less is known about them than about traditional kinds of vaccines.

The authors also pointed out that early licensing of any vaccine might make it harder to evaluate vaccines that haven’t yet been approved. “Once a vaccine is licensed, new placebo-controlled RCTs [randomized controlled trials] of other vaccines will not be acceptable ethically, and noninferiority RCTs will be the most likely alternative.

“The goal of noninferiority trials will be to demonstrate that the immune response (that is, neutralizing antibody titers or levels) of the candidate vaccine is not inferior to that of the approved vaccine within a prespecified margin, which the FDA has established as less than 10% for COVID-19 vaccines,” the authors noted. 
 

More data with more study designs

Dial Hewlett Jr., MD, medical director for disease control services, Westchester County Department of Health, White Plains, N.Y., said in an interview that the ethicists raise important issues that have been discussed in other forums, including a recent webinar of the National Academy of Medicine.

“As the authors point out, once you have a vaccine that has been shown to be effective and safe, it’s no longer ethical to enroll people in placebo trials,” he said.

Therefore, he said, Pfizer and Moderna will undoubtedly offer their vaccines to the people in their studies’ placebo groups after the vaccines receive an EUA. Then they will follow everyone who has been vaccinated for 2 years to determine long-term safety. Efficacy will also continue to be measured as an adjunct of safety, he said.

With regard to the difficulty of reconsenting individuals to enter a new clinical trial after a vaccine has been approved, he said, “I’d agree that trying to get all the same participants to come into another study would be a challenge. You can, however, design studies that will allow you to obtain the same information. You will have a large number of people out there who haven’t been vaccinated, and you can do single-arm longitudinal studies and measure a number of things in the individuals who are enrolled in those studies,” he said.

“You can look at the immunologic markers, both antibody and T-cell. You can follow these individuals longitudinally to see if they do develop disease over a period of time. If they do, you can determine what their levels of response were,” he added. “So there are opportunities to design studies that would give you some of the same information, although it would not be in the same population that was in the randomized trials.”

For newer vaccines that have yet to be tested, he said, developers can compare “historical controls” from the trials of approved vaccines, i.e., data from the unvaccinated participants in those studies, with the data from inoculating people with the novel agents. The historical data can be sex- and age-matched, among other things, to individuals in the new trials. Moreover, because the study protocols have been harmonized for all trials under Operation Warp Speed, it doesn’t matter what kind of vaccine they’re testing, he said.

It may be necessary to do additional studies to find out how long immunity lasts after people have been vaccinated, Dr. Hewlett pointed out.

“You may have a different trial design. You don’t need a control arm to determine how long immunity lasts. You’re just comparing the patients who were vaccinated to nothing,” he said. “So you could have a single-arm trial on a group of people who consent to be immunized and followed. You can see what their antibody levels are and other surrogate markers, and you can see when they might develop disease, if they do. You’d need a large sample, but you can do that.”

Dr. Hewlett noted that additional studies will be required to determine whether the new vaccines stop transmission of the coronavirus or just prevent symptoms of COVID-19. Until it’s established that a vaccine halts transmission or the country achieves herd immunity, he said, “we’ll still have to wear masks and take other precautions, because a significant portion of people will still be at risk.”
 

‘A lot of redundancy’

Dr. Alexander emphasized that any safety or efficacy issues with the first COVID-19 vaccines must be identified before the vaccine is offered to a large portion of the U.S. population.

“While the data from the Pfizer and Moderna trials are said to be favorable, we at IDSA want to make sure that whatever vaccine comes to market is safe,” she said. “Having an unsafe vaccine on the market would be worse than no vaccine, because you’re compromising the public confidence. We have to make sure the public trusts the process and that sufficient data have been evaluated to ensure the vaccine is safe and efficacious.

“I believe the FDA is being very careful and thoughtful in [its] response,” Dr. Alexander said. “They realize how important it is to get a vaccine and save lives. While they’re doing things differently and moving much faster than before, they’re still trying to be thoughtful and reasonable. They don’t seem to be putting people at risk or circumventing the regulatory standards.”

Moreover, she pointed out, the FDA’s Vaccines and Related Biological Products Advisory Committee, which is expected to meet on Dec. 10, will review the trial data before the agency grants an EUA to Pfizer or Moderna. Then the FDA will post the data publicly.

The next step is for the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention to look at the data and decide who in the United States should receive the vaccine first, she pointed out. And both Pfizer and Moderna have shown their data to advisory panels of outside experts.

“There’s a lot of redundancy, and a lot of people are looking at the data,” Dr. Alexander said. “So I don’t think we’re cutting corners to get it out there more quickly.”

A version of this article originally appeared on Medscape.com.

Immune checkpoint inhibitor (ICI) therapy does not increase the risk of developing or dying from COVID-19, according to a pair of studies presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.

However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.

In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).

In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).

Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
 

COVID-19 incidence with ICIs

Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.

The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).

In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).

Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.

“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”

COVID-19 mortality with ICIs

For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.

Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.

In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.

Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).

At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.

The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.

“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.

“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
 

ICI therapy can continue, with precautions

“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.

“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.

SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.

Immune checkpoint inhibitor (ICI) therapy does not increase the risk of developing or dying from COVID-19, according to a pair of studies presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.

However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.

In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).

In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).

Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
 

COVID-19 incidence with ICIs

Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.

The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).

In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).

Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.

“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”

COVID-19 mortality with ICIs

For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.

Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.

In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.

Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).

At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.

The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.

“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.

“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
 

ICI therapy can continue, with precautions

“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.

“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.

SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.

Immune checkpoint inhibitor (ICI) therapy does not increase the risk of developing or dying from COVID-19, according to a pair of studies presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

Cytokine storm plays a major role in the pathogenesis of COVID-19, according to research published in The Lancet Respiratory Medicine. This has generated concern about using ICIs during the pandemic, given their immunostimulatory activity and the risk of immune-related adverse effects.

However, two retrospective studies suggest ICIs do not increase the risk of developing COVID-19 or dying from the disease.

In a study of 1,545 cancer patients prescribed ICIs and 20,418 matched controls, the incidence of COVID-19 was 1.4% with ICI therapy and 1.0% without it (odds ratio, 1.38; P = .15).

In a case-control study of 50 patients with cancer and COVID-19, 28% of patients who had received ICIs died from COVID-19, compared with 36% of patients who had not received ICIs (OR, 0.36; P = .23).

Vartan Pahalyants and Kevin Tyan, both students in Harvard University’s joint MD/MBA program in Boston, presented these studies at the meeting.
 

COVID-19 incidence with ICIs

Mr. Pahalyants and colleagues analyzed data from cancer patients treated in the Mass General Brigham health care system. The researchers compared 1,545 patients with at least one ICI prescription between July 1, 2019, and Feb. 29, 2020, with 20,418 matched cancer patients not prescribed ICIs. The team assessed COVID-19 incidence based on positive test results through June 19, 2020, from public health data.

The incidence of COVID-19 was low in both groups – 1.4% in the ICI group and 1.0% in the matched control group (P = .16). Among COVID-19–positive patients, the all-cause death rate was 40.9% in the ICI group and 28.6% in the control group (P = .23).

In multivariate analysis, patients prescribed ICIs did not have a significantly elevated risk for COVID-19 relative to peers not prescribed ICIs (OR, 1.38; P = .15). However, risk was significantly increased for female patients (OR, 1.74; P < .001), those living in a town or county with higher COVID-19 positivity rate (OR, 1.59; P < .001), and those with severe comorbidity (vs. mild or moderate; OR, 9.77; P = .02).

Among COVID-19–positive patients, those prescribed ICIs did not have a significantly elevated risk for all-cause mortality (OR, 1.60; P = .71), but male sex and lower income were associated with an increased risk of death.

“We did not identify an increased risk of [COVID-19] diagnosis among patients prescribed ICIs compared to the controls,” Mr. Pahalyants said. “This information may assist patients and their providers in decision-making around continuation of therapy during this protracted pandemic. However, more research needs to be conducted to determine potential behavioral and testing factors that may have affected COVID-19 diagnosis susceptibility among patients included in the study.”

COVID-19 mortality with ICIs

For their study, Mr. Tyan and colleagues identified 25 cancer patients who had received ICIs in the year before a COVID-19 diagnosis between March 20, 2020, and June 3, 2020, at the Dana-Farber Cancer Institute and Mass General Brigham network. The researchers then matched each patient with a cancer patient having a COVID-19 diagnosis who had not received ICIs during the preceding year.

Overall, 28% of patients who had received ICIs before their COVID-19 diagnosis died from COVID-19, compared with 36% of those who had not received ICIs.

In multivariate analysis, ICI therapy did not predict COVID-19 mortality (OR, 0.36; P = .23). However, the risk of death from COVID-19 increased with age (OR, 1.14; P = .01) and for patients with chronic obstructive pulmonary disease (OR, 12.26; P = .01), and risk was lower for statin users (OR, 0.08; P = .02). Findings were similar in an analysis restricted to hospitalized patients in the ICI group and their matched controls.

Two ICI-treated patients with COVID-19 had persistent immune-related adverse events (hypophysitis in both cases), and one ICI-treated patient developed a new immune-related adverse event (hypothyroidism).

At COVID-19 presentation, relative to counterparts who had not received ICIs, patients who had received ICIs had higher platelet counts (P = .017) and higher D-dimer levels (P = .037). In the context of similar levels of other biomarkers, this finding is “of unclear significance, as all deaths in the cohort were due to respiratory failure as opposed to hypercoagulability,” Mr. Tyan said.

The patients treated with ICIs were more likely to die from COVID-19 if they had elevated troponin levels (P = .01), whereas no such association was seen for those not treated with ICIs.

“We found that ICI therapy is not associated with greater risk for COVID-19 mortality. Our period of follow-up was relatively short, but we did not observe a high incidence of new or persistent immune-related adverse events among our patients taking ICIs,” Mr. Tyan said.

“While larger prospective trials are needed to evaluate long-term safety in the context of COVID-19 infection, our findings support the continuation of ICI therapy during the pandemic as it does not appear to worsen outcomes for cancer patients,” he concluded.
 

ICI therapy can continue, with precautions

“The question of susceptibility to COVID-19 has been unclear as ICIs do not necessarily cause immunosuppression but certainly result in modulation of a patient’s immune system,” said Deborah Doroshow, MD, PhD, assistant professor at the Tisch Cancer Institute Icahn School of Medicine at Mount Sinai, New York. She was not involved in these studies.

“The findings of the study by Pahalyants and colleagues, which used a very large sample size, appear to convincingly demonstrate that ICI receipt is not associated with an increased susceptibility to COVID-19,” Dr. Doroshow said in an interview.

SOURCE: Pahalyants V et al. SITC 2020, Abstract 826. Tyan K et al. SITC 2020, Abstract 481.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.

On Monday, members of an influential federal panel delved into the challenges ahead in deciding who will get the first doses of COVID-19 vaccines, including questions about which healthcare workers need those initial vaccinations the most.

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) did not take any votes or seek to establish formal positions. Instead, the meeting served as a forum for experts to discuss the thorny issues ahead. The US Food and Drug Administration (FDA) could make a decision next month regarding clearance for the first COVID-19 vaccine.

An FDA advisory committee will meet December 10 to review the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, in partnership with BioNTech. Moderna Inc said on November 16 that it expects to soon ask the FDA for an EUA of its rival COVID vaccine.

ACIP will face a two-part task after the FDA clears COVID-19 vaccines, said Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases. ACIP will need to first decide whether to recommend use of the vaccine and then address the “complicated and difficult” question of which groups should get the initial limited quantities.

“There aren’t any perfect decisions,” she told the ACIP members. “I know this is something that most of you didn’t anticipate doing, making these kinds of huge decisions in the midst of a pandemic.”

There has been considerable public discussion of prioritization of COVID-19 vaccines, including a set of recommendations offered by a special committee created by the National Academies of Sciences, Engineering and Medicine. In addition, CDC staff and members of ACIP outlined what they termed the “four ethical principles” meant to guide these decisions in a November 23 report in the agency’s Morbidity and Mortality Weekly Report. These four principles are to maximize benefits and minimize harms; promote justice; mitigate health inequities; and promote transparency.

But as the issuing of the first EUA nears, it falls to ACIP to move beyond endorsing broad goals. The panel will need to make decisions as to which groups will have to wait for COVID-19 vaccines.

ACIP members on Monday delved into these kinds of more detailed questions, using a proposed three-stage model as a discussion point.

In phase 1a of this model, healthcare workers and residents of long-term care facilities would be the first people to be vaccinated. Phase 1b would include those deemed essential workers, including police officers, firefighters, and those in education, transportation, food, and agriculture sectors. Phase 1c would include adults with high-risk medical conditions and those aged 65 years and older.

ACIP member Grace M. Lee, MD, MPH, of Stanford University, Stanford, California, questioned whether healthcare workers who are not seeing patients in person should wait to get the vaccines. There has been a marked rise in the use of telehealth during the pandemic, which has spared some clinicians from in-person COVID-19 patient visits in their practices.

“Close partnership with our public health colleagues will be critically important to make sure that we are not trying to vaccinate 100% of our healthcare workforce, if some proportion of our workforce can work from home,” Lee said.

ACIP member Pablo Sánchez, MD, of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, concurred. Some clinicians, he noted, may have better access to personal protective equipment than others, he said.

“Unfortunately, not all healthcare workers are equal in terms of risk,” Sánchez said. “Within institutions, we’re going to have to prioritize which ones will get” the vaccine.

Clinicians may also make judgments about their own risk and need for early access to COVID-19 vaccinations, Sánchez said.

“I’m 66, and I’d rather give it to somebody much older and sicker than me,” he said.
 

Broader access

Fairly large populations will essentially be competing for limited doses of the first vaccines to reach the market.

The overlap is significant in the four priority groups put forward by CDC. The CDC staff estimated that about 21 million people would fall into the healthcare personnel category, which includes hospital staff, pharmacists, and those working in long-term care facilities. There are about 87 million people in the essential workers groups. More than 100 million adults in the United States, such as those with diabetes and cancers, fall into the high-risk medical conditions group. Another 53 million people are aged 65 and older.

Department of Health and Human Services Secretary Alex Azar on November 18 said the federal government expects to have about 40 million doses of these two vaccines by the end of December, which is enough to provide the two-dose regimen for about 20 million. If all goes as expected, Pfizer and Moderna will ramp up production.

Moderna has said that it expects by the end of this year to have approximately 20 million doses of its vaccine ready to ship in the United States and that it is on track to manufacture 500 million to 1 billion doses globally in 2021. Pfizer and BioNTech have said they expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021.

At the Monday meeting, several ACIP panelists stressed the need to ensure that essential workers get early doses of vaccines.

In many cases, these workers serve in jobs with significant public interaction and live in poor communities. They put themselves and their families at risk. Many of them lack the resources to take precautions available to those better able to isolate, said ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, Washington.

“These essential workers are out there putting themselves at risk to allow the rest of us to socially distance,” she said. “Recognizing that not all of them may want to be vaccinated at this stage, we need to provide them with the opportunity early on in the process.”

In Bell’s view, the initial rollout of COVID-19 vaccines will send an important message about sharing this resource.

“If we’re serious about valuing equity, we need to have that baked in early on in the vaccination program,” she said.

Bell also said she was in favor of including people living in nursing homes in the initial wave of vaccinations. Concerns were raised about the frailty of this population.

“Given the mortality impact on the healthcare system from the number of nursing home residents that have been dying, I think on balance it makes sense to include them in phase 1a,” Bell said.

Other ACIP panelists said missteps with early vaccination of people in nursing homes could undermine faith in the treatments. Because of the ages and medical conditions of people in nursing homes, many of them may die after receiving the COVID-19 vaccine. Such deaths would not be associated with vaccine, but the medical community would not yet have evidence to disprove a connection.

There could be a backlash, with people falsely linking the death of a grandparent to the vaccine.

Fellow ACIP member Robert L. Atmar, MD, Baylor College of Medicine, Houston, Texas, was among those who had raised concerns about including people living in long-term care facilities in phase 1a. He said there are not yet enough data to judge the balance of benefits and harms of vaccination for this population.

The Pfizer and Moderna vaccines are “reactagenic,” meaning people may not feel well in the days after receiving the shots. The symptoms could lead to additional health evaluations of older people in nursing homes as clinicians try to figure out whether the patient’s reactions to the vaccine are caused by some condition or infection, Atmar said.

“Those of us who see these patients in the hospital recognize that there are often medical interventions that are done in the pursuit of a diagnosis, of a change in clinical status, that in and of themselves can lead to harm,” Atmar said.

Clinicians likely will have to encourage their patients of all ages to receive second doses of COVID-19 vaccines, despite the malaise they may provoke.

“We really need to make patients aware that this is not going to be a walk in the park. I mean, they’re going to know they had a vaccine, they’re probably not going to feel wonderful, but they’ve got to come back for that second dose,” said Sandra Adamson Fryhofer, MD, who represented the American Medical Association.

ACIP is expected to meet again to offer specific recommendations on the Pfizer and Moderna vaccines. ACIP’s recommendations trigger reimbursement processes, Azar said at a Tuesday press conference. ACIP’s work will inform decisions made by the federal government and governors about deploying shipments of COVID-19 vaccines, he said.

“At the end of the day, that is a decision, though, of the US government to make, which is where to recommend the prioritization,” Azar said. “It will be our nation’s governors in implementing the distribution plans to tell us” where to ship the vaccine.

This article first appeared on Medscape.com.