COVID-19 Updates

The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.  

The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.

Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The Pfizer adolescent vaccine is not yet a done deal, though.

Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.

The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.

The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.

Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.

American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”

President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.

In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.” 

Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.

Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.

Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.

“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said. 

“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”

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

The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.  

The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.

Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The Pfizer adolescent vaccine is not yet a done deal, though.

Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.

The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.

The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.

Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.

American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”

President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.

In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.” 

Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.

Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.

Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.

“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said. 

“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”

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

The Food and Drug Administration on May 10 granted emergency use authorization (EUA) for the Pfizer coronavirus vaccine to be given to children 12-15 years old.  

The much-expected decision increases the likelihood that schools in the United States will fully reopen in the fall – a goal of both the Biden and Trump administrations.

Acting FDA Commissioner Janet Woodcock, MD, called the decision “a significant step” in “returning to a sense of normalcy.”

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” she said in a statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The Pfizer adolescent vaccine is not yet a done deal, though.

Next, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will decide on May 12 whether to recommend use of the vaccine in this age group. After that, CDC Director Rochelle Walensky, MD, will decide whether to give the green light for the vaccine to be administered to that age group.

The FDA action on May 10 amends the Dec. 11, 2020, emergency use authorization that allowed the Pfizer vaccine to be given to people 16 and older. Pfizer was the first company to receive an EUA for its adult vaccine and is the first to receive authorization for its adolescent vaccine. Pfizer is conducting clinical trials on much younger children, too.

The Moderna and Johnson & Johnson vaccines are authorized for people 18 and up. Moderna also has launched clinical trials in children.

Most health experts have said the United States needs to vaccinate children before the COVID-19 pandemic can truly be brought under control. The 12- to 15-year-old group represents 17 million people, about 5% of the population. Thus far, 58% of U.S. adults have had at least one dose of a vaccine and 34.8% of all Americans are fully vaccinated.

American Academy of Pediatrics President Lee Savio Beers, MD, praised the agency’s decision, calling it a “critically important step in bringing life-saving vaccines to children and adolescents. Our youngest generations have shouldered heavy burdens over the past year, and the vaccine is a hopeful sign that they will be able to begin to experience all the activities that are so important for their health and development.”

President Joe Biden recently announced a new strategy for expanding vaccinations in which vaccinating 12- to 15-year-olds was a key component. He said the administration was ready to ship the adolescent vaccine directly to pharmacies and pediatricians to speed up the vaccination rate.

In March, Anthony S. Fauci, MD, told a Senate committee, “We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape. … We ultimately would like to get and have to get children into that mix.” 

Pfizer submitted data to the FDA in late March showing its mRNA vaccine was 100% effective at preventing COVID-19 infection in children ages 12-15 in clinical trials.

Though most children have milder symptoms when infected with the coronavirus, about 1.5 million cases in children aged 11-17 were reported to the CDC between March 1, 2020, and April 30 of this year, the FDA news release said.

Albert Bourla, CEO of Pfizer, tweeted that “today brings very encouraging news for families and adolescents across the United States.

“While this is a meaningful step forward, we are still in a critical period of combating #COVID19 around the world. In the coming weeks, we hope to continue to receive authorizations from global regulators to support worldwide vaccination efforts,” he said. 

“It’s essential for children to be vaccinated against COVID-19. According to data compiled by the AAP and Children’s Hospital Association, more than 3.8 million children have tested positive for COVID-19 in the United States since the start of the pandemic,” said Dr. Savio Beers. “While fewer children than adults have suffered the most severe disease, this is not a benign disease in children. Thousands of children have been hospitalized, and hundreds have died. We will soon have a very safe, highly effective vaccine that can prevent so much suffering. I encourage parents to talk with their pediatricians about how to get the vaccine for their adolescents as soon as they are eligible.”

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

NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.

Denise Fulton/MDedge News

“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”

The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.

For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.

For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.

The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.

In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).

The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.

The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.

The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.

Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.

In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.

The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.

NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.

Denise Fulton/MDedge News

“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”

The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.

For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.

For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.

The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.

In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).

The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.

The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.

The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.

Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.

In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.

The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.

NSAIDs don’t boost the risk of more severe disease or death in hospitalized patients with COVID-19, a new study finds.

Denise Fulton/MDedge News

“To our knowledge, our prospective study includes the largest number of patients admitted to hospital with COVID-19 to date, and adds to the literature on the safety of NSAIDs and in-hospital outcomes. NSAIDs do not appear to increase the risk of worse in-hospital outcomes ...” the study authors wrote. “NSAIDs are an important analgesic modality and have a vital opioid-sparing role in pain management. Patients and clinicians should be reassured by these findings that NSAIDs are safe in the context of the pandemic.”

The report was published online May 7 in The Lancet Rheumatology and led by clinical research fellow Thomas M. Drake, MBChB, of the University of Edinburgh’s Usher Institute.

For more than a year, researchers worldwide have debated about whether NSAIDs spell trouble for people at risk of COVID-19. In March 2020, French health officials announced that use of the painkillers such as NSAIDs may increase the severity of the disease, and they recommended that patients take acetaminophen instead. The National Health Service in the United Kingdom made a similar recommendation. But other agencies didn’t believe there was enough evidence to support ditching NSAIDs, and recent research studies published in Annals of the Rheumatic Diseases and PLoS Medicine suggested they may be right.

For the new study, researchers identified 72,179 patients who were treated for COVID-19 in British hospitals during January-August 2020. About 56% were men, 74% were White, and 6% took NSAIDs on a regular basis before they entered the hospital. The average age was 70.

The researchers examined whether the patients in either group were more or less likely to die in the hospital, be admitted into a critical care unit, need oxygen treatment, need a ventilator, or suffer kidney injury.

In terms of outcomes, there weren’t any major gaps between the groups overall. The differences in most comparisons were statistically insignificant. For example, 31% of those who didn’t take NSAIDs died vs. 30% of those who did (P = .227). In both groups, 14% required critical care admission (P = .476).

The researchers then focused on two matched groups of 4,205 patients: One group used NSAIDs regularly, and the other group didn’t. The difference in risk of death in those who took NSAIDs vs. those who didn’t was statistically insignificant (odds ratio, 0.95; 95% confidence interval, 0.84-1.07; P = .35). Other comparisons were also statistically insignificant.

The findings offer insight into whether the use of NSAIDs might actually be helpful for patients who develop COVID-19. Scientists believe that COVID-19 is linked to inflammation in the body, and NSAIDs, of course, reduce inflammation. But the researchers didn’t turn up any sign of a benefit.

The new study has some weaknesses: It doesn’t say anything about whether NSAIDs have an impact on whether people get COVID-19 in the first place. Researchers don’t know if high use of NSAIDs may affect the severity of the disease. And it doesn’t examine the potential effect of acetaminophen, although other research suggests the drug also may not cause harm in patients with COVID-19.

Still, the researchers say the study is the largest of its kind to look at the use of NSAIDs by patients who are admitted to the hospital with COVID-19. “Considering all the evidence, if there was an extreme effect of NSAIDs on COVID-19 outcomes or severity, this would have been observed in one or more of the studies that have been done, including the present study,” they wrote.

In a commentary that accompanied the study, three physicians from hospitals in Denmark, led by Kristian Kragholm, MD, of Aalborg University Hospital, praised the research and wrote that it adds to “a growing body of evidence” that NSAIDs don’t make things worse for patients with COVID-19.

The study was funded by the U.K. National Institute for Health Research and the U.K. Medical Research Council. The study and commentary authors reported no relevant disclosures.

Information is scarce regarding the impact of COVID-19 on pregnant women and newborns; health care workers (HCWs), particularly pregnant women,¹ who are caring for patients during the pandemic might experience concern and uncertainty. The American College of Obstetricians and Gynecologists (ACOG) released recommendations, based on expert consensus, regarding pregnant HCWs on December 14, 2020.² We propose an appropriation of the ACOG recommendations for dermatologists and their teams caring for patients during the COVID-19 pandemic.

Risks to Pregnant HCWs

Worldwide, viral pneumonia is a leading cause of death during pregnancy,³ with higher mortality documented among pregnant patients during the 1918 influenza pandemic and the 2003 severe acute respiratory syndrome–associated coronavirus pandemic,³ and an increased rate of hospital admission documented among these patients compared to the general population during the 2009 H1N1 influenza pandemic.⁴

Data from the Centers for Disease Control and Prevention (CDC) suggest that pregnant women with symptomatic COVID-19 (n=30,415) are at increased risk for the following (compared to nonpregnant women with symptomatic COVID-19 [n=431,410])⁵:

• Admission to the intensive care unit (10.5 of every 1000 cases vs 3.9 of every 1000 cases; adjusted risk ratio [aRR]=3.0; 95% CI, 2.6-3.4)

• Receipt of invasive ventilation (2.9 of every 1000 cases vs 1.1 of every 1000 cases; aRR=2.9; 95% CI, 2.2-3.8)

• Receipt of extracorporeal membrane oxygenation (0.7 of every 1000 cases vs 0.3 of every 1000 cases; aRR=2.4; 95% CI, 1.5-4.0)

• Death (1.5 of every 1000 cases vs 1.2 of every 1000 cases; aRR=1.7; 95% CI, 1.2-2.4).

Although the absolute risk of severe COVID-19–related outcomes is low, the CDC includes pregnant women in its increased risk category for COVID-19. Furthermore, in a systematic review of 61 studies comprising 790 COVID-19–positive pregnant women and 548 newborns, the rates of cesarean delivery, premature birth, low birth weight, and adverse pregnancy events (the latter comprising preterm birth, death or stillbirth, and early termination of pregnancy) were estimated to be 72%, 23%, 7%, and 27%, respectively.⁶ In a systematic review of 39 studies (case series and cohort studies), comprising 936 SARS-CoV-2–tested newborns of mothers with COVID-19, mother-to-fetus transmission of SARS-CoV-2 occurred during the third trimester in approximately 3.2% of infected mothers.⁷

In pregnant women with COVID-19 who develop cytokine storm syndrome, a fetal inflammatory response syndrome can ensue, which has been shown to cause ventricular expansion and bleeding in animal models.⁸ In addition, underlying conditions, such as cardiovascular disease, diabetes mellitus, pre-existing lung disease, and obesity, which are well-established risks factors for severe COVID-19 in nonpregnant patients, can increase the severity of COVID-19 in pregnant women.^5,9-11

Recommendations From ACOG for Pregnant HCWs

The American College of Obstetricians and Gynecologists recommends that health care facilities consider limiting the exposure of pregnant HCWs to patients with confirmed or suspected COVID-19. They also recommend that pregnant women continue to work in patient-facing roles if they want to, if recommended personal protective equipment (PPE) is available for them to wear.² The US Food and Drug Administration issued an Emergency Use Authorization for 2 messenger RNA COVID-19 vaccines. Although these vaccines have not been tested in pregnant women, ACOG recommends that COVID-19 vaccines not be withheld from pregnant women who fulfill the criteria for vaccination; pregnant women who decline vaccination should be supported in their decision.¹² In dermatology, telemedicine is an effective alternative to face-to-face visits, reducing the risk of transmitting SARS-CoV-2 to physicians and patients.

Ideally, pregnant dermatology attending physicians and residents can continue to provide care through teledermatology. They also can continue to provide in-person care, if they choose to; however, higher-risk procedures should be avoided.¹² In dermatology, that might include ablative laser procedures to the face, prolonged surgery, such as hair transplantation, and intraoral or intranasal procedures. Alternatively, pregnant dermatology residents can be allocated to clinical rotations in which face-to-face contact with patients is not required such as dermatopathology and a research rotation. Likewise, telework options can be encouraged for other pregnant members of dermatology teams, including front-desk staff, nurses, medical assistants, and remaining ancillary staff.

Guidance on Face Masks for Pregnant HCWs

Universal masking of HCWs has been shown to reduce the rate of health care–related acquisition of SARS-CoV-2.¹³ However, extended use or reuse of N95 respirators might contribute to SARS-CoV-2 transmission.¹⁴ The American College of Obstetricians and Gynecologists recommends that all HCWs wear a face mask at all times while working in a health care facility, even if patients are wearing a face covering or face mask.² Based on CDC guidelines,¹⁵ HCWs in regions where community transmission is moderate or substantial should wear eye protection in addition to a face mask, and they should wear an N95, N95-equivalent, or higher-level respirator instead of a face mask when performing aerosol-generating procedures and surgical procedures. If working in a patient-facing role caring for patients with suspected or confirmed COVID-19, HCWs should wear an N95, N95-equivalent, or higher-level respirator; gown; gloves; and eye protection (goggles or a disposable face shield).¹⁵

Final Thoughts

COVID-19 has brought about acute and likely permanent changes to the US health care system. Dermatologists are integral members of that system and are essential to the treatment of patients with skin, hair, and nail disorders. Pregnant dermatologists and residents should refrain from patient-facing roles when feasible; however, when all recommended PPE are available, they may continue to work in patient-facing roles until they give birth if they desire to do so. Alternatively, teledermatology and non–face-to-face rotations should be encouraged. Higher-risk and aerosol-generating procedures are of particular concern regarding the risk for transmitting SARS-CoV-2 and should be avoided. Correct and universal use of PPE is paramount; when all recommended PPE is not available, pregnant HCWs should avoid exposure to patients with suspected or confirmed COVID-19. These recommendations will help safeguard pregnant members of dermatology teams during the COVID-19 pandemic while maximizing patient care.

Information is scarce regarding the impact of COVID-19 on pregnant women and newborns; health care workers (HCWs), particularly pregnant women,¹ who are caring for patients during the pandemic might experience concern and uncertainty. The American College of Obstetricians and Gynecologists (ACOG) released recommendations, based on expert consensus, regarding pregnant HCWs on December 14, 2020.² We propose an appropriation of the ACOG recommendations for dermatologists and their teams caring for patients during the COVID-19 pandemic.

Risks to Pregnant HCWs

Worldwide, viral pneumonia is a leading cause of death during pregnancy,³ with higher mortality documented among pregnant patients during the 1918 influenza pandemic and the 2003 severe acute respiratory syndrome–associated coronavirus pandemic,³ and an increased rate of hospital admission documented among these patients compared to the general population during the 2009 H1N1 influenza pandemic.⁴

Data from the Centers for Disease Control and Prevention (CDC) suggest that pregnant women with symptomatic COVID-19 (n=30,415) are at increased risk for the following (compared to nonpregnant women with symptomatic COVID-19 [n=431,410])⁵:

• Admission to the intensive care unit (10.5 of every 1000 cases vs 3.9 of every 1000 cases; adjusted risk ratio [aRR]=3.0; 95% CI, 2.6-3.4)

• Receipt of invasive ventilation (2.9 of every 1000 cases vs 1.1 of every 1000 cases; aRR=2.9; 95% CI, 2.2-3.8)

• Receipt of extracorporeal membrane oxygenation (0.7 of every 1000 cases vs 0.3 of every 1000 cases; aRR=2.4; 95% CI, 1.5-4.0)

• Death (1.5 of every 1000 cases vs 1.2 of every 1000 cases; aRR=1.7; 95% CI, 1.2-2.4).

Although the absolute risk of severe COVID-19–related outcomes is low, the CDC includes pregnant women in its increased risk category for COVID-19. Furthermore, in a systematic review of 61 studies comprising 790 COVID-19–positive pregnant women and 548 newborns, the rates of cesarean delivery, premature birth, low birth weight, and adverse pregnancy events (the latter comprising preterm birth, death or stillbirth, and early termination of pregnancy) were estimated to be 72%, 23%, 7%, and 27%, respectively.⁶ In a systematic review of 39 studies (case series and cohort studies), comprising 936 SARS-CoV-2–tested newborns of mothers with COVID-19, mother-to-fetus transmission of SARS-CoV-2 occurred during the third trimester in approximately 3.2% of infected mothers.⁷

In pregnant women with COVID-19 who develop cytokine storm syndrome, a fetal inflammatory response syndrome can ensue, which has been shown to cause ventricular expansion and bleeding in animal models.⁸ In addition, underlying conditions, such as cardiovascular disease, diabetes mellitus, pre-existing lung disease, and obesity, which are well-established risks factors for severe COVID-19 in nonpregnant patients, can increase the severity of COVID-19 in pregnant women.^5,9-11

Recommendations From ACOG for Pregnant HCWs

The American College of Obstetricians and Gynecologists recommends that health care facilities consider limiting the exposure of pregnant HCWs to patients with confirmed or suspected COVID-19. They also recommend that pregnant women continue to work in patient-facing roles if they want to, if recommended personal protective equipment (PPE) is available for them to wear.² The US Food and Drug Administration issued an Emergency Use Authorization for 2 messenger RNA COVID-19 vaccines. Although these vaccines have not been tested in pregnant women, ACOG recommends that COVID-19 vaccines not be withheld from pregnant women who fulfill the criteria for vaccination; pregnant women who decline vaccination should be supported in their decision.¹² In dermatology, telemedicine is an effective alternative to face-to-face visits, reducing the risk of transmitting SARS-CoV-2 to physicians and patients.

Ideally, pregnant dermatology attending physicians and residents can continue to provide care through teledermatology. They also can continue to provide in-person care, if they choose to; however, higher-risk procedures should be avoided.¹² In dermatology, that might include ablative laser procedures to the face, prolonged surgery, such as hair transplantation, and intraoral or intranasal procedures. Alternatively, pregnant dermatology residents can be allocated to clinical rotations in which face-to-face contact with patients is not required such as dermatopathology and a research rotation. Likewise, telework options can be encouraged for other pregnant members of dermatology teams, including front-desk staff, nurses, medical assistants, and remaining ancillary staff.

Guidance on Face Masks for Pregnant HCWs

Universal masking of HCWs has been shown to reduce the rate of health care–related acquisition of SARS-CoV-2.¹³ However, extended use or reuse of N95 respirators might contribute to SARS-CoV-2 transmission.¹⁴ The American College of Obstetricians and Gynecologists recommends that all HCWs wear a face mask at all times while working in a health care facility, even if patients are wearing a face covering or face mask.² Based on CDC guidelines,¹⁵ HCWs in regions where community transmission is moderate or substantial should wear eye protection in addition to a face mask, and they should wear an N95, N95-equivalent, or higher-level respirator instead of a face mask when performing aerosol-generating procedures and surgical procedures. If working in a patient-facing role caring for patients with suspected or confirmed COVID-19, HCWs should wear an N95, N95-equivalent, or higher-level respirator; gown; gloves; and eye protection (goggles or a disposable face shield).¹⁵

Final Thoughts

COVID-19 has brought about acute and likely permanent changes to the US health care system. Dermatologists are integral members of that system and are essential to the treatment of patients with skin, hair, and nail disorders. Pregnant dermatologists and residents should refrain from patient-facing roles when feasible; however, when all recommended PPE are available, they may continue to work in patient-facing roles until they give birth if they desire to do so. Alternatively, teledermatology and non–face-to-face rotations should be encouraged. Higher-risk and aerosol-generating procedures are of particular concern regarding the risk for transmitting SARS-CoV-2 and should be avoided. Correct and universal use of PPE is paramount; when all recommended PPE is not available, pregnant HCWs should avoid exposure to patients with suspected or confirmed COVID-19. These recommendations will help safeguard pregnant members of dermatology teams during the COVID-19 pandemic while maximizing patient care.

Information is scarce regarding the impact of COVID-19 on pregnant women and newborns; health care workers (HCWs), particularly pregnant women,¹ who are caring for patients during the pandemic might experience concern and uncertainty. The American College of Obstetricians and Gynecologists (ACOG) released recommendations, based on expert consensus, regarding pregnant HCWs on December 14, 2020.² We propose an appropriation of the ACOG recommendations for dermatologists and their teams caring for patients during the COVID-19 pandemic.

Risks to Pregnant HCWs

Worldwide, viral pneumonia is a leading cause of death during pregnancy,³ with higher mortality documented among pregnant patients during the 1918 influenza pandemic and the 2003 severe acute respiratory syndrome–associated coronavirus pandemic,³ and an increased rate of hospital admission documented among these patients compared to the general population during the 2009 H1N1 influenza pandemic.⁴

Data from the Centers for Disease Control and Prevention (CDC) suggest that pregnant women with symptomatic COVID-19 (n=30,415) are at increased risk for the following (compared to nonpregnant women with symptomatic COVID-19 [n=431,410])⁵:

• Admission to the intensive care unit (10.5 of every 1000 cases vs 3.9 of every 1000 cases; adjusted risk ratio [aRR]=3.0; 95% CI, 2.6-3.4)

• Receipt of invasive ventilation (2.9 of every 1000 cases vs 1.1 of every 1000 cases; aRR=2.9; 95% CI, 2.2-3.8)

• Receipt of extracorporeal membrane oxygenation (0.7 of every 1000 cases vs 0.3 of every 1000 cases; aRR=2.4; 95% CI, 1.5-4.0)

• Death (1.5 of every 1000 cases vs 1.2 of every 1000 cases; aRR=1.7; 95% CI, 1.2-2.4).

Although the absolute risk of severe COVID-19–related outcomes is low, the CDC includes pregnant women in its increased risk category for COVID-19. Furthermore, in a systematic review of 61 studies comprising 790 COVID-19–positive pregnant women and 548 newborns, the rates of cesarean delivery, premature birth, low birth weight, and adverse pregnancy events (the latter comprising preterm birth, death or stillbirth, and early termination of pregnancy) were estimated to be 72%, 23%, 7%, and 27%, respectively.⁶ In a systematic review of 39 studies (case series and cohort studies), comprising 936 SARS-CoV-2–tested newborns of mothers with COVID-19, mother-to-fetus transmission of SARS-CoV-2 occurred during the third trimester in approximately 3.2% of infected mothers.⁷

In pregnant women with COVID-19 who develop cytokine storm syndrome, a fetal inflammatory response syndrome can ensue, which has been shown to cause ventricular expansion and bleeding in animal models.⁸ In addition, underlying conditions, such as cardiovascular disease, diabetes mellitus, pre-existing lung disease, and obesity, which are well-established risks factors for severe COVID-19 in nonpregnant patients, can increase the severity of COVID-19 in pregnant women.^5,9-11

Recommendations From ACOG for Pregnant HCWs

The American College of Obstetricians and Gynecologists recommends that health care facilities consider limiting the exposure of pregnant HCWs to patients with confirmed or suspected COVID-19. They also recommend that pregnant women continue to work in patient-facing roles if they want to, if recommended personal protective equipment (PPE) is available for them to wear.² The US Food and Drug Administration issued an Emergency Use Authorization for 2 messenger RNA COVID-19 vaccines. Although these vaccines have not been tested in pregnant women, ACOG recommends that COVID-19 vaccines not be withheld from pregnant women who fulfill the criteria for vaccination; pregnant women who decline vaccination should be supported in their decision.¹² In dermatology, telemedicine is an effective alternative to face-to-face visits, reducing the risk of transmitting SARS-CoV-2 to physicians and patients.

Ideally, pregnant dermatology attending physicians and residents can continue to provide care through teledermatology. They also can continue to provide in-person care, if they choose to; however, higher-risk procedures should be avoided.¹² In dermatology, that might include ablative laser procedures to the face, prolonged surgery, such as hair transplantation, and intraoral or intranasal procedures. Alternatively, pregnant dermatology residents can be allocated to clinical rotations in which face-to-face contact with patients is not required such as dermatopathology and a research rotation. Likewise, telework options can be encouraged for other pregnant members of dermatology teams, including front-desk staff, nurses, medical assistants, and remaining ancillary staff.

Guidance on Face Masks for Pregnant HCWs

Universal masking of HCWs has been shown to reduce the rate of health care–related acquisition of SARS-CoV-2.¹³ However, extended use or reuse of N95 respirators might contribute to SARS-CoV-2 transmission.¹⁴ The American College of Obstetricians and Gynecologists recommends that all HCWs wear a face mask at all times while working in a health care facility, even if patients are wearing a face covering or face mask.² Based on CDC guidelines,¹⁵ HCWs in regions where community transmission is moderate or substantial should wear eye protection in addition to a face mask, and they should wear an N95, N95-equivalent, or higher-level respirator instead of a face mask when performing aerosol-generating procedures and surgical procedures. If working in a patient-facing role caring for patients with suspected or confirmed COVID-19, HCWs should wear an N95, N95-equivalent, or higher-level respirator; gown; gloves; and eye protection (goggles or a disposable face shield).¹⁵

Final Thoughts

COVID-19 has brought about acute and likely permanent changes to the US health care system. Dermatologists are integral members of that system and are essential to the treatment of patients with skin, hair, and nail disorders. Pregnant dermatologists and residents should refrain from patient-facing roles when feasible; however, when all recommended PPE are available, they may continue to work in patient-facing roles until they give birth if they desire to do so. Alternatively, teledermatology and non–face-to-face rotations should be encouraged. Higher-risk and aerosol-generating procedures are of particular concern regarding the risk for transmitting SARS-CoV-2 and should be avoided. Correct and universal use of PPE is paramount; when all recommended PPE is not available, pregnant HCWs should avoid exposure to patients with suspected or confirmed COVID-19. These recommendations will help safeguard pregnant members of dermatology teams during the COVID-19 pandemic while maximizing patient care.

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

Editor in Chief of this news organization Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and professor of molecular medicine, has been closely following COVID-19 data since the pandemic began. He spoke with writer Miriam E. Tucker about the latest on SARS-CoV-2 variants and their impact on vaccine efficacy. The conversation serves as a follow-up to his April 13, 2021, New York Times opinion piece, in which he advised readers that “all variants are innocent until proven guilty.”

You have expressed overall confidence in the efficacy of the vaccines thus far despite the emergence of variants, with some caveats. How do you see the current situation?

The Centers for Disease Control and Prevention has designated five “variants of concern,” but only three of them are real concerns – B.1.1.7, first detected in the United Kingdom; P.1, in Brazil and Japan; and B.1.351, in South Africa. Yet, all three are susceptible to our current vaccines.

The U.K. B.1.1.7 is the worst variant of all because it’s hypertransmissible, so I call it a “superspreader strain.” It also causes more severe illness independent of the spread, so it’s a double whammy. It’s clear that it also causes more deaths. The only arguable point is whether it’s 30% or 50% more deaths, but regardless, it’s more lethal and more transmissible.

The B.1.1.7 is going to be the dominant strain worldwide. It could develop new mutations within it that could come back to haunt us. We must keep watch.

But for now, it’s fully responsive to all the vaccines, which is great because if we didn’t have them, we wouldn’t have gotten through this U.S. pandemic like we have, and neither would Israel and the United Kingdom and other countries that have been able to get out of the crisis. We met the enemy and put it in check.

As for the South Africa variant of concern, B.1.351, we just got some encouraging news showing that it›s very responsive to the Pfizer/BioNTech mRNA vaccine in large numbers of people. The study was conducted in Qatar following that country’s mass immunization campaign in which a total of 385,853 people had received at least one vaccine dose and 265,410 had completed the two doses as of March 31, 2021.

At 2 weeks past the second dose, the vaccine was 75% effective at preventing any documented infection with the B.1.351 variant and 89.5% effective against B.1.1.7. The vaccine’s effectiveness against severe, critical, or fatal COVID-19 was greater than 97.4% for all circulating strains in Qatar, where B.1.1.7 and B.1.351 are most prominent.

We also know that B.1.351 is very responsive to the Johnson & Johnson vaccine and the Novavax [vaccine in development] to a lesser degree. It is the most immune-evading variant we’ve seen thus far, with the highest likelihood of providing some vaccine resistance, yet not enough to interfere with vaccination campaigns. So that’s great news.

The caveats here are that you definitely need two doses of the mRNA vaccines to combat the B.1.351 variant. Also, the AstraZeneca vaccine failed to prevent it in South Africa. However, that study was hard to judge because it was underpowered for number of people with mild infections. So, it didn’t look as if it had any efficacy, but maybe it would if tested in a real trial.

The P.1 (Brazil) variant is the second-highest concern after B.1.1.7 because it’s the only one in the United States that’s still headed up. It seems to be competing a bit with B.1.1.7 here. We know it was associated with the crisis in Brazil, in Chile, and some other South American countries. It has some immune escape, but not as bad as B.1.351. It also appears to have somewhat greater transmissibility but not as much as B.1.1.7.

With P.1, we just don’t know enough yet. It was difficult to assess in Brazil because they were in the midst of a catastrophe – like India is now – and you don’t know how much of it is dragged by the catastrophe vs driving it.

We have to respond to P.1 carefully. There are some good data that it does respond to the Chinese vaccine Sinovac and the AstraZeneca vaccine, and it appears to respond to the others as well, based on serum studies. So it doesn’t look like vaccines will be the worry with this variant. Rather, it could be competing with B.1.1.7 and could lead to breakthrough infections in vaccinated people or reinfections in unvaccinated people who had COVID-19. We need several more weeks to sort it out.

Although the B.1.427 and B.1.429 variants initially seen in California remain on the CDC’s concern list, I’m not worried about them.
 

You mentioned the current COVID-19 crisis in India, where a new variant has been described as a “double mutant,” but on Twitter you called it a “scariant.” Why?

First of all, the B.1.617 variant isn’t a double mutant. It has 15 mutations. It’s a stupid term, focusing on two mutations which largely have been put aside as to concern. One of them is the L452R, which is the same as one of the California variants, and that hasn’t proved to be particularly serious or concerning. The other is the 484Q, and it’s not clear whether that has any function.

The B.1.617 is not the driver of the catastrophe in India. It may be contributing a small amount, but it has been overhyped as the double mutant that’s causing it all. Adding to that are what I call “scariant” headlines here in the United States when a few cases of that variant have been seen.

I coined the term scariant in early February because it was a pretty clear trend. People don’t know what variants are. They know a little bit about mutations but not variants, and they’re scared. A few variants are concerning, but we keep learning more and more things to decrease the concern. That’s why I wrote the New York Times op-ed, to try to provide some reassurance, since there’s such paranoia.
 

Do you think booster vaccinations will be necessary? If so, will those be of the original vaccines or new ones that incorporate the variants?

As we go forward, there’s still potential for new variants that we haven’t seen yet that combine the worst of all features – transmissibility and immune evasion – especially since we have a world where COVID-19 is unchecked. So, we’re not out of it yet, but at least for the moment, we have vaccines that are capable of protecting against all variants.

In most people, the immune response against SARS-CoV-2 is very durable and strong and may well last for years. With the most closely related SARS-CoV-1, people still had immune responses up to 18 years later. However, some people will have less robust vaccine responses, including the elderly and the immunocompromised. If they don’t have great responses to the vaccine to start with, over time they’re likely to become more vulnerable, especially if they’re exposed to the variants with some degree of immune evasion.

I think we need to study these individuals post vaccination. A lot of people fit into those categories, including seniors, people being treated for cancer or autoimmune conditions, or post organ transplant. We could set up a prospective study to see whether they develop symptomatic COVID-19 and if so, from what – the original strain, B.1.1.7, or the newer variants.

That’s where I think booster shots may be needed. They may not be necessary across the board, but perhaps just in these special subgroups.

All of the current vaccines can be tweaked to include new variants, but the need for that is uncertain as of now. Moderna is working on a so-called bivalent vaccine that includes the original SARS-CoV-2 strain plus the B.1.351 variant, but it isn’t clear that that’s going to be necessary.

Currently, at least 200 COVID-19 vaccines are in development. There will be vaccines you can inhale, room temperature mRNA vaccines, and potentially even oral vaccines.

In the near future, Novavax is close, and there will likely be a two-dose Johnson & Johnson version that has the same potency as the mRNA vaccines. There are a lot of moving parts here.

There may be a step down in efficacy from mRNA to the others, though, and that shouldn’t be discounted. All of the available vaccines so far protect very well against severe disease and death, but some are less effective against mild to moderate infections, which may then lead to long COVID. We don’t yet know whether those who get mild infection post vaccination can still get long COVID.
 

What do you think it will take to achieve herd immunity?

I prefer the term “containment.” It’s quantitative. If you get to an infection rate of less than 1 in 100,000 people, as they’ve done in Israel, with 0.8 per 100,000, then you have the virus in check, and there will be very little spread when it’s at that controlled rate, with no outbreaks. The United States is currently at about 15 per 100,000. California is at 4. That still has to get lower.

It will be a challenge to get to President Biden’s goal of having 70% of U.S. adults given at least one dose by July 4. We’re now at about 57%. To get that next 13% of adults is going to take an all-out effort: mobile units, going to homes, making it ultraconvenient, education for people with safety concerns, incentivization, and days off.

We also need to get employers, universities, and health systems to get to the mandatory level. We haven’t done that yet. Some universities have mandated it for students, faculty, and staff. We need it in more health care systems. Right now, we only have a couple. We mandate flu shots, and flu is nothing, compared with COVID-19. And the COVID-19 vaccine is far more efficacious – flu shots are 40% efficacious, while these are 95%. COVID-19 is a tenfold more lethal and serious disease, and much more spreadable.

People are using the lack of full licensure by the Food and Drug Administration – as opposed to emergency use authorization – as an excuse not to get vaccinated. A biologics license application takes time to approve. Meanwhile, we have hundreds of millions of doses that have been well tolerated and incredibly effective.

Another aspect to consider regarding containment is that about 110 million Americans have already had COVID-19, even though only about 30 million cases have been confirmed. Most of these people have immune protection, although it’s not as good as if they have one vaccine dose. But they have enough protection to be part of the story here of the wall against COVID-19 and will help us get through this.

That’s a silver lining of having an unchecked epidemic for the entire year of 2020. The good part is that’s helping to get us to achieve an incredible level of containment when we haven’t even been close. Right now, we’re as good as the country has been in the pandemic, but we still have a long gap to get down to that 1 per 100,000. That’s what we should be working toward, and we can get there.

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

While the COVID-19 pandemic has generated anxiety and confusion in medicine, one thing should bring a sense of clarity to hospitalists: They’re needed now more than ever.

Larry Wellikson, MD, MHM, the former, longtime CEO of the Society of Hospital Medicine, in a May 6 keynote speech at SHM Converge, the annual conference of the Society of Hospital Medicine, said the COVID-19 era has underscored the singular importance of the specialty.

“I think one thing that this recent pandemic has emphasized is just how important and vital hospitalists are to the United States’ health care system,” Dr. Wellikson said. “The response to the acute care needs in this pandemic would have been impossible in the health care system that existed before hospitalists. And so this is something that we should understand and appreciate.”

The “upheaval” experienced in hospital medicine continues a trend of change that will go on, both in the corporate health care landscape and in the role that hospitalists play in providing care, he said. Insurers have been merging and looking to consolidate. Hospital medicine companies have been merging, and “newfangled bedfellows” have been a trend, such as CVS stepping beyond its pharmacy role into an expanded health care role, Cigna buying Express Scripts, and an Amazon-Berkshire Hathaway-J.P. Morgan health care partnership that ultimately did not pan out, although that hasn’t ended Amazon’s presence in health care.

“You may not realize it, but Amazon is currently one of the largest hospital supply-chain companies,” Dr. Wellikson said. “They’re attempting to become a major pharmacy benefits manager and will only further enter into health care and into our personal and professional lives.”

New models of care point to the way of the future, he said. Mount Sinai’s continuing success with its Hospital at Home program – which involves an acute care nurse and team assigned to a patient in the home – introduces a concept that will be adopted more broadly, because of its cost savings and good outcomes, he said. Mergers of hospital systems, leading to excess hospital capacity, has given rise to what he calls “ED-plus,” or using formerly full-service hospitals as more focused centers – providing emergency, obstetrician, cardiology, x-ray, or orthopedics care, or whatever is needed in a given community.

An increasing focus on population health rather than procedures plays into the strengths of hospitalists, Dr. Wellikson said, and the need for their skills will continue to deepen.

When changes in reimbursement began about 4 years ago, specialties such as cardiology entered into new contracts with hospitals, but the facilities began to notice that many of the services – such as initial heart failure and chest pain management – can be provided by hospitalists.

“They’re signing fewer cardiologists and needing therefore to hire more hospitalists,” he said.

To keep readmissions low and subsequent costs down, hospitalists will continue to handle the first few postdischarge visits with patients, he said. This is crucial in bundled payment systems.

“Most of the savings in those systems comes from being very efficient in the initial postdischarge portion of people’s care,” Dr. Wellikson said.

At the same time, hospitalists are not in “unlimited supply.”

“I think every hospital medicine group should be assessing and working on improving their clinicians’ well-being,” he said. “We need to ration somewhat, so we’re deploying hospitalists for the things that only we can do.” He predicted that hospitalists will be required to work in the electronic medical record less frequently, with this task handled by others.

Dr. Wellikson also called on the specialty to continue to expand its racial and ethnic diversity so that it reflects the patient population it serves.

“We’re looking to create pathways to leadership for everyone and not just a tokenism moving forward,” he said.

The basic strengths of hospital medicine – its flexibility, professional culture, and youth – leave it well prepared for all of these changes, he said.

“There is a bright future and hospitalists are right in the middle of this – we’re not going to be marginalized or on the periphery,” Dr. Wellikson said. “If I had one message for all of you, I would say be relevant and add value and you will not only survive, but thrive.”
 

RIV winners announced

The winners of the 2021 RIV competition were also announced at the May 6 general session of Converge. There were two winners in each of the three categories, as follows:

RESEARCH
Overall: “Suboptimal Communication During Inter-Hospital Transfer,” Stephanie Mueller, MD, MPH, SFHM

Trainee: “Mentorship in Pediatric Hospital Medicine: A Survey of Division Directors,” Brandon Palmer, MD

INNOVATIONS
Overall: “Leveraging Artificial Intelligence for a Team-Based Approach to Advance Care Planning,” Ron Li, MD

Trainee: “A Trainee-Designed Initiative Reshapes Communication for Hospital Medicine Patients During COVID-19,” Smitha Ganeshan, MD, MBA

CLINICAL VIGNETTES
Adults: “Holy Spontaneous Heparin-Induced Thrombocytopenia,” Min Hwang

Pediatrics: “The Great Pretender: A Tale of Two Systems,” Shivani Desai, MD

While the COVID-19 pandemic has generated anxiety and confusion in medicine, one thing should bring a sense of clarity to hospitalists: They’re needed now more than ever.

Larry Wellikson, MD, MHM, the former, longtime CEO of the Society of Hospital Medicine, in a May 6 keynote speech at SHM Converge, the annual conference of the Society of Hospital Medicine, said the COVID-19 era has underscored the singular importance of the specialty.

“I think one thing that this recent pandemic has emphasized is just how important and vital hospitalists are to the United States’ health care system,” Dr. Wellikson said. “The response to the acute care needs in this pandemic would have been impossible in the health care system that existed before hospitalists. And so this is something that we should understand and appreciate.”

The “upheaval” experienced in hospital medicine continues a trend of change that will go on, both in the corporate health care landscape and in the role that hospitalists play in providing care, he said. Insurers have been merging and looking to consolidate. Hospital medicine companies have been merging, and “newfangled bedfellows” have been a trend, such as CVS stepping beyond its pharmacy role into an expanded health care role, Cigna buying Express Scripts, and an Amazon-Berkshire Hathaway-J.P. Morgan health care partnership that ultimately did not pan out, although that hasn’t ended Amazon’s presence in health care.

“You may not realize it, but Amazon is currently one of the largest hospital supply-chain companies,” Dr. Wellikson said. “They’re attempting to become a major pharmacy benefits manager and will only further enter into health care and into our personal and professional lives.”

New models of care point to the way of the future, he said. Mount Sinai’s continuing success with its Hospital at Home program – which involves an acute care nurse and team assigned to a patient in the home – introduces a concept that will be adopted more broadly, because of its cost savings and good outcomes, he said. Mergers of hospital systems, leading to excess hospital capacity, has given rise to what he calls “ED-plus,” or using formerly full-service hospitals as more focused centers – providing emergency, obstetrician, cardiology, x-ray, or orthopedics care, or whatever is needed in a given community.

An increasing focus on population health rather than procedures plays into the strengths of hospitalists, Dr. Wellikson said, and the need for their skills will continue to deepen.

When changes in reimbursement began about 4 years ago, specialties such as cardiology entered into new contracts with hospitals, but the facilities began to notice that many of the services – such as initial heart failure and chest pain management – can be provided by hospitalists.

“They’re signing fewer cardiologists and needing therefore to hire more hospitalists,” he said.

To keep readmissions low and subsequent costs down, hospitalists will continue to handle the first few postdischarge visits with patients, he said. This is crucial in bundled payment systems.

“Most of the savings in those systems comes from being very efficient in the initial postdischarge portion of people’s care,” Dr. Wellikson said.

At the same time, hospitalists are not in “unlimited supply.”

“I think every hospital medicine group should be assessing and working on improving their clinicians’ well-being,” he said. “We need to ration somewhat, so we’re deploying hospitalists for the things that only we can do.” He predicted that hospitalists will be required to work in the electronic medical record less frequently, with this task handled by others.

Dr. Wellikson also called on the specialty to continue to expand its racial and ethnic diversity so that it reflects the patient population it serves.

“We’re looking to create pathways to leadership for everyone and not just a tokenism moving forward,” he said.

The basic strengths of hospital medicine – its flexibility, professional culture, and youth – leave it well prepared for all of these changes, he said.

“There is a bright future and hospitalists are right in the middle of this – we’re not going to be marginalized or on the periphery,” Dr. Wellikson said. “If I had one message for all of you, I would say be relevant and add value and you will not only survive, but thrive.”
 

RIV winners announced

The winners of the 2021 RIV competition were also announced at the May 6 general session of Converge. There were two winners in each of the three categories, as follows:

RESEARCH
Overall: “Suboptimal Communication During Inter-Hospital Transfer,” Stephanie Mueller, MD, MPH, SFHM

Trainee: “Mentorship in Pediatric Hospital Medicine: A Survey of Division Directors,” Brandon Palmer, MD

INNOVATIONS
Overall: “Leveraging Artificial Intelligence for a Team-Based Approach to Advance Care Planning,” Ron Li, MD

Trainee: “A Trainee-Designed Initiative Reshapes Communication for Hospital Medicine Patients During COVID-19,” Smitha Ganeshan, MD, MBA

CLINICAL VIGNETTES
Adults: “Holy Spontaneous Heparin-Induced Thrombocytopenia,” Min Hwang

Pediatrics: “The Great Pretender: A Tale of Two Systems,” Shivani Desai, MD

While the COVID-19 pandemic has generated anxiety and confusion in medicine, one thing should bring a sense of clarity to hospitalists: They’re needed now more than ever.

Larry Wellikson, MD, MHM, the former, longtime CEO of the Society of Hospital Medicine, in a May 6 keynote speech at SHM Converge, the annual conference of the Society of Hospital Medicine, said the COVID-19 era has underscored the singular importance of the specialty.

“I think one thing that this recent pandemic has emphasized is just how important and vital hospitalists are to the United States’ health care system,” Dr. Wellikson said. “The response to the acute care needs in this pandemic would have been impossible in the health care system that existed before hospitalists. And so this is something that we should understand and appreciate.”

The “upheaval” experienced in hospital medicine continues a trend of change that will go on, both in the corporate health care landscape and in the role that hospitalists play in providing care, he said. Insurers have been merging and looking to consolidate. Hospital medicine companies have been merging, and “newfangled bedfellows” have been a trend, such as CVS stepping beyond its pharmacy role into an expanded health care role, Cigna buying Express Scripts, and an Amazon-Berkshire Hathaway-J.P. Morgan health care partnership that ultimately did not pan out, although that hasn’t ended Amazon’s presence in health care.

“You may not realize it, but Amazon is currently one of the largest hospital supply-chain companies,” Dr. Wellikson said. “They’re attempting to become a major pharmacy benefits manager and will only further enter into health care and into our personal and professional lives.”

New models of care point to the way of the future, he said. Mount Sinai’s continuing success with its Hospital at Home program – which involves an acute care nurse and team assigned to a patient in the home – introduces a concept that will be adopted more broadly, because of its cost savings and good outcomes, he said. Mergers of hospital systems, leading to excess hospital capacity, has given rise to what he calls “ED-plus,” or using formerly full-service hospitals as more focused centers – providing emergency, obstetrician, cardiology, x-ray, or orthopedics care, or whatever is needed in a given community.

An increasing focus on population health rather than procedures plays into the strengths of hospitalists, Dr. Wellikson said, and the need for their skills will continue to deepen.

When changes in reimbursement began about 4 years ago, specialties such as cardiology entered into new contracts with hospitals, but the facilities began to notice that many of the services – such as initial heart failure and chest pain management – can be provided by hospitalists.

“They’re signing fewer cardiologists and needing therefore to hire more hospitalists,” he said.

To keep readmissions low and subsequent costs down, hospitalists will continue to handle the first few postdischarge visits with patients, he said. This is crucial in bundled payment systems.

“Most of the savings in those systems comes from being very efficient in the initial postdischarge portion of people’s care,” Dr. Wellikson said.

At the same time, hospitalists are not in “unlimited supply.”

“I think every hospital medicine group should be assessing and working on improving their clinicians’ well-being,” he said. “We need to ration somewhat, so we’re deploying hospitalists for the things that only we can do.” He predicted that hospitalists will be required to work in the electronic medical record less frequently, with this task handled by others.

Dr. Wellikson also called on the specialty to continue to expand its racial and ethnic diversity so that it reflects the patient population it serves.

“We’re looking to create pathways to leadership for everyone and not just a tokenism moving forward,” he said.

The basic strengths of hospital medicine – its flexibility, professional culture, and youth – leave it well prepared for all of these changes, he said.

“There is a bright future and hospitalists are right in the middle of this – we’re not going to be marginalized or on the periphery,” Dr. Wellikson said. “If I had one message for all of you, I would say be relevant and add value and you will not only survive, but thrive.”
 

RIV winners announced

The winners of the 2021 RIV competition were also announced at the May 6 general session of Converge. There were two winners in each of the three categories, as follows:

RESEARCH
Overall: “Suboptimal Communication During Inter-Hospital Transfer,” Stephanie Mueller, MD, MPH, SFHM

Trainee: “Mentorship in Pediatric Hospital Medicine: A Survey of Division Directors,” Brandon Palmer, MD

INNOVATIONS
Overall: “Leveraging Artificial Intelligence for a Team-Based Approach to Advance Care Planning,” Ron Li, MD

Trainee: “A Trainee-Designed Initiative Reshapes Communication for Hospital Medicine Patients During COVID-19,” Smitha Ganeshan, MD, MBA

CLINICAL VIGNETTES
Adults: “Holy Spontaneous Heparin-Induced Thrombocytopenia,” Min Hwang

Pediatrics: “The Great Pretender: A Tale of Two Systems,” Shivani Desai, MD

The use of neoadjuvant endocrine therapy (NET) increased significantly during the first 8 months of the COVID-19 pandemic for women with estrogen receptor–positive (ER+) breast cancer. These patients would normally undergo surgery first, but because of operating room restrictions, those surgeries were delayed because of the pandemic, according to a new study.
 

“We hypothesized that by offering a nontoxic therapy, we would be able to ‘hold over’ patients until such time when personal protective equipment supplies were renewed and we could get into the operating room,” lead author Lee Wilke, MD, professor of surgery, University of Wisconsin, Madison, said in an interview.

“And while a small number of women with ER+ tumors get NET anyway, we found over one-third of patients with ER+ breast cancer were treated with NET due to COVID-19 during the first 8 months of last year,” she said.

“One year later, 31% of the same patient population is still getting NET,” she added.

The study was presented during the online annual meeting of the American Society of Breast Surgeons (ASBrS).
 

COVID-specific registry

Dr. Wilke believes that this study presents an accurate snapshot of changes in treatment caused by the pandemic.

She and her colleagues compared data collected in the ASBrS Mastery Program registry to data collected in an embedded but separate COVID-19 segment. The data were for the period from March 1 to Oct. 28, 2020.

Almost three-quarters of the surgeons who entered patients into the COVID-19 segment were from urban areas; 95% reported stopping mammographic screening during part of this period.

The preliminary analysis focused on data collected from 2,476 patients in the COVID-19 segment and 2,303 patients within the Mastery registry.

For patients with ER+/HER2- breast cancer, NET was described as a usual approach in 6.5% of patients in the COVID-19 registry. In the Mastery registry, 7.8% of patients received NET.

Compared with surgery first/usual practice, which served as the reference, older patients were more likely to receive NET first because of the COVID-19 pandemic than younger patients, and they were more likely to receive NET first if they lived in the Northeast or the Southeast compared to other regions of the United States. Dr. Wilke pointed out that the Northeast and the Southeast were hardest hit by COVID-19 early on in the pandemic.

Genomic testing was carried out in a small subgroup of patients; 24% of those patients underwent testing on the core biopsy specimen because of COVID-19, the investigators noted. Genomic testing on a core biopsy specimen helps determine whether it’s feasible to forgo chemotherapy and use NET instead or whether the patient should proceed directly to surgery. The authors noted that almost 11% of patients required a change in the usual surgical approach because of COVID-19. Such changes were made primarily to avoid hospitalizations during the early phase of the pandemic for patients who were to undergo mastectomy or reconstruction.

“Patients who needed standard approaches still got them,” Dr. Wilke emphasized in a statement. For example, women with aggressive triple-negative and HER2+ tumors were treated with neoadjuvant chemotherapy, she added. “However, NET is a very good approach for a moderate subset of patients, and we think we will see it being used more often in the U.S. now,” Dr. Wilke observed.

“But especially early during the pandemic, these revised treatments were necessary because access to hospital ORs was limited or unavailable, so our algorithmic-based treatment guidelines allowed us to offer high-quality, evidence-based care fine-tuned for a patient’s specific cancer profile,” she affirmed.

Dr. Wilke has disclosed no relevant financial relationships.

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

The use of neoadjuvant endocrine therapy (NET) increased significantly during the first 8 months of the COVID-19 pandemic for women with estrogen receptor–positive (ER+) breast cancer. These patients would normally undergo surgery first, but because of operating room restrictions, those surgeries were delayed because of the pandemic, according to a new study.
 

“We hypothesized that by offering a nontoxic therapy, we would be able to ‘hold over’ patients until such time when personal protective equipment supplies were renewed and we could get into the operating room,” lead author Lee Wilke, MD, professor of surgery, University of Wisconsin, Madison, said in an interview.

“And while a small number of women with ER+ tumors get NET anyway, we found over one-third of patients with ER+ breast cancer were treated with NET due to COVID-19 during the first 8 months of last year,” she said.

“One year later, 31% of the same patient population is still getting NET,” she added.

The study was presented during the online annual meeting of the American Society of Breast Surgeons (ASBrS).
 

COVID-specific registry

Dr. Wilke believes that this study presents an accurate snapshot of changes in treatment caused by the pandemic.

She and her colleagues compared data collected in the ASBrS Mastery Program registry to data collected in an embedded but separate COVID-19 segment. The data were for the period from March 1 to Oct. 28, 2020.

Almost three-quarters of the surgeons who entered patients into the COVID-19 segment were from urban areas; 95% reported stopping mammographic screening during part of this period.

The preliminary analysis focused on data collected from 2,476 patients in the COVID-19 segment and 2,303 patients within the Mastery registry.

For patients with ER+/HER2- breast cancer, NET was described as a usual approach in 6.5% of patients in the COVID-19 registry. In the Mastery registry, 7.8% of patients received NET.

Compared with surgery first/usual practice, which served as the reference, older patients were more likely to receive NET first because of the COVID-19 pandemic than younger patients, and they were more likely to receive NET first if they lived in the Northeast or the Southeast compared to other regions of the United States. Dr. Wilke pointed out that the Northeast and the Southeast were hardest hit by COVID-19 early on in the pandemic.

Genomic testing was carried out in a small subgroup of patients; 24% of those patients underwent testing on the core biopsy specimen because of COVID-19, the investigators noted. Genomic testing on a core biopsy specimen helps determine whether it’s feasible to forgo chemotherapy and use NET instead or whether the patient should proceed directly to surgery. The authors noted that almost 11% of patients required a change in the usual surgical approach because of COVID-19. Such changes were made primarily to avoid hospitalizations during the early phase of the pandemic for patients who were to undergo mastectomy or reconstruction.

“Patients who needed standard approaches still got them,” Dr. Wilke emphasized in a statement. For example, women with aggressive triple-negative and HER2+ tumors were treated with neoadjuvant chemotherapy, she added. “However, NET is a very good approach for a moderate subset of patients, and we think we will see it being used more often in the U.S. now,” Dr. Wilke observed.

“But especially early during the pandemic, these revised treatments were necessary because access to hospital ORs was limited or unavailable, so our algorithmic-based treatment guidelines allowed us to offer high-quality, evidence-based care fine-tuned for a patient’s specific cancer profile,” she affirmed.

Dr. Wilke has disclosed no relevant financial relationships.

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

The use of neoadjuvant endocrine therapy (NET) increased significantly during the first 8 months of the COVID-19 pandemic for women with estrogen receptor–positive (ER+) breast cancer. These patients would normally undergo surgery first, but because of operating room restrictions, those surgeries were delayed because of the pandemic, according to a new study.
 

“We hypothesized that by offering a nontoxic therapy, we would be able to ‘hold over’ patients until such time when personal protective equipment supplies were renewed and we could get into the operating room,” lead author Lee Wilke, MD, professor of surgery, University of Wisconsin, Madison, said in an interview.

“And while a small number of women with ER+ tumors get NET anyway, we found over one-third of patients with ER+ breast cancer were treated with NET due to COVID-19 during the first 8 months of last year,” she said.

“One year later, 31% of the same patient population is still getting NET,” she added.

The study was presented during the online annual meeting of the American Society of Breast Surgeons (ASBrS).
 

COVID-specific registry

Dr. Wilke believes that this study presents an accurate snapshot of changes in treatment caused by the pandemic.

She and her colleagues compared data collected in the ASBrS Mastery Program registry to data collected in an embedded but separate COVID-19 segment. The data were for the period from March 1 to Oct. 28, 2020.

Almost three-quarters of the surgeons who entered patients into the COVID-19 segment were from urban areas; 95% reported stopping mammographic screening during part of this period.

The preliminary analysis focused on data collected from 2,476 patients in the COVID-19 segment and 2,303 patients within the Mastery registry.

For patients with ER+/HER2- breast cancer, NET was described as a usual approach in 6.5% of patients in the COVID-19 registry. In the Mastery registry, 7.8% of patients received NET.

Compared with surgery first/usual practice, which served as the reference, older patients were more likely to receive NET first because of the COVID-19 pandemic than younger patients, and they were more likely to receive NET first if they lived in the Northeast or the Southeast compared to other regions of the United States. Dr. Wilke pointed out that the Northeast and the Southeast were hardest hit by COVID-19 early on in the pandemic.

Genomic testing was carried out in a small subgroup of patients; 24% of those patients underwent testing on the core biopsy specimen because of COVID-19, the investigators noted. Genomic testing on a core biopsy specimen helps determine whether it’s feasible to forgo chemotherapy and use NET instead or whether the patient should proceed directly to surgery. The authors noted that almost 11% of patients required a change in the usual surgical approach because of COVID-19. Such changes were made primarily to avoid hospitalizations during the early phase of the pandemic for patients who were to undergo mastectomy or reconstruction.

“Patients who needed standard approaches still got them,” Dr. Wilke emphasized in a statement. For example, women with aggressive triple-negative and HER2+ tumors were treated with neoadjuvant chemotherapy, she added. “However, NET is a very good approach for a moderate subset of patients, and we think we will see it being used more often in the U.S. now,” Dr. Wilke observed.

“But especially early during the pandemic, these revised treatments were necessary because access to hospital ORs was limited or unavailable, so our algorithmic-based treatment guidelines allowed us to offer high-quality, evidence-based care fine-tuned for a patient’s specific cancer profile,” she affirmed.

Dr. Wilke has disclosed no relevant financial relationships.

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

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

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

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

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

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

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

Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

Reduced access to medical care, increased mental health issues, poor lifestyle habits, and concern over future care are just some of the patient-reported problems associated with the early phases of the COVID-19 pandemic, according to the results of multiple studies.

Data from the Europe-based REUMAVID study, which surveyed more 1,800 patients between April and July last year, have revealed that 58% of patients with rheumatic and musculoskeletal diseases (RMDs) had their appointments with their rheumatologists canceled, 42% could not get in touch with their primary care physicians, and 52% experienced interrupted visits to mental health specialists.

Not surprisingly, this took a toll on patients’ self-perceived health, with nearly two-thirds stating that they had fair to very poor health, and 47% reporting that their health had worsened. Furthermore, 57% of respondents reported high levels of anxiety, almost 46% were at risk for depression, and 49% reported having poor well-being overall.

“The COVID-19 pandemic has had tremendous impact,” Marco Garrido-Cumbrera, PhD, of the University of Seville, Spain, said at the British Society for Rheumatology annual conference.

Dr. Garrido-Cumbrera, who is key player in the REUMAVID initiative, explained that the project was conceived to respond to concerns raised by the president of the Spanish Federation of Spondyloarthritis Associations (CEADE) about providing the right information to their members.

“First in Italy and then in Spain, it was really difficult to deal with the pandemic and there was a lot of uncertainty from a patient perspective,” Dr. Garrido-Cumbrera said.

Victoria Navarro-Compán, MD, PhD, of La Paz University Hospital, Madrid, who was not involved in the study, observed: “I think this reflects how important collaboration between patient organizations is in order to gather relevant data, and to do it in record time.”

The REUMAVID project was the result of initial collaboration between the Health and Territory Research Group at the University of Seville and CEADE but also involved patient organizations from six other European countries: the National Axial Spondyloarthritis Society, National Rheumatoid Arthritis Society, and Arthritis Action in the United Kingdom; the French Association for the Fight against Rheumatism (AFLAR; L’Association Française de Lutte Anti-Rhumatismale); the National Association of People with Rheumatological and Rare Diseases (APMARR; Associazione Nazionale Persone con Malattie Reumatologiche e Rare) in Italy; Portuguese League Against Rheumatic Diseases (LPCDR; Liga Portuguesa contra as Doenças Reumáticas) in Portugal; the Hellenic League Against Rheumatism (ELEANA) in Greece; and the Cyprus League Against Rheumatism.
 

Pandemic presented ‘perfect storm’

“We’ve never been so well-communicated as we are now,” said Helena Marzo-Ortega, MD, PhD, a consultant rheumatologist at Leeds Teaching Hospitals NHS Trust in England who participated the REUMAVID project. The beginning of the pandemic was “the perfect storm” in that everybody jumped in to try to do something. This resulted in a myriad of research publications, surveys, and attempts to try to understand and make sense of what was happening.

“Research is being conducted in a more structured manner, and it’s given us a lot of very insightful information,” Dr. Marzo-Ortega added. Obviously, patients are important stakeholders to consult when conducting research into how the pandemic has affected them, she added, as they are the ones who had their lives turned upside down.

“A pandemic knows no boundaries, has no limits, everybody can be affected equally. But patients with rheumatic conditions were at particular risk because of the treatments,” she said. “You can remember how worried we all were initially, and thinking about the potential impact of immunosuppressants and many other aspects of these conditions.”

One of the many positives to come out of the pandemic is the “possibility of doing collaborative research at a worldwide level, not just European,” Dr. Marzo-Ortega said, referring to how the EULAR COVID-19 registries are part of the COVID-19 Global Rheumatology Alliance.

Furthermore, Dr. Marzo-Ortega believes the rheumatology community is now better prepared for any upsurges in COVID-19 or any new potentially pandemic-causing viruses.

“What we know now is that we have to be alert, and we know how to respond. We also know how to communicate effectively in order to be able to improve outcomes, not only for the health of the whole population, but also to protect patients such as ours,” she said.
 

Rheumatology practice changed practically overnight

The REUMAVID study is not alone in looking at the impact that the COVID-19 pandemic has had on RMD patients’ health and well-being, particularly during periods of lockdown or where patients were advised to “shield.”

There were “near overnight changes to rheumatology practice,” said Chris Wincup, MBBS, a clinical research fellow at University College London (UCL), who presented the findings of another large-scale survey that looked at the early effects of the pandemic nationally in the United Kingdom.

“The recovery of those services has taken time and, speaking with patients, this varies between different locations,” Dr. Wincup noted. “Unfortunately, access to care does remain a major area of unmet need [and] is something that we’re going to need to think about when planning services in the future,” he added.

Between September and October last year, Dr. Wincup and fellow UCL researchers conducted an online survey among 2,054 patients attending U.K. rheumatology clinics. As in the REUMAVID study, accessing care was difficult or very difficult for a substantial proportion of patients. However, getting medication and monitoring “were generally well maintained” despite lockdown measures.

Many patients (57%) had “extremely high levels of worry about their future care being negatively impacted as a result of the pandemic,” Dr. Wincup said, with 44% saying that their current care was worse than before the pandemic and 41% being dissatisfied with the services they were able to access.

While 48% of patients welcomed a more hybrid approach to their care, 69% thought face-to-face appointments with their rheumatologists were important and 49% wanted only face-to-face appointments. “A possible more hybrid approach, compared with pure face-to-face, is going to be something that may be required,” he said.
 

Different approach taken in CONTAIN Study

A different approach to assessing the impact of the COVID pandemic was taken by researchers at the University of Aberdeen in Scotland, observed Gary Macfarlane, MBChB, PhD.

In the COVID-19 and Musculoskeletal Heath During Lockdown (CONTAIN) study, three well-defined populations of patients from existing cohort studies were looked at prospectively. This included patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) participating in two separate British Society for Rheumatology registries, and patients at high risk for developing chronic widespread pain who had been part of the MAmMOTH (Maintaining Musculoskeletal Health) study.

“Our aim was to quantify the changes from the previous prepandemic assessment, focusing on quality of life, changes in lifestyle, and recording what has happened to their musculoskeletal health, including symptoms and disease-specific measures,” Dr. Macfarlane said.

Patients had been invited to participate in June 2020 and were reminded in October 2020 and could respond online or via a postal questionnaire. Some patients were invited to participate in in-depth interviews.

Although the participation rate was low, at 29%, this was typical of studies being conducted at this time due to “survey fatigue,” Dr. Macfarlane said. The CONTAIN study population still included a good number of patients, however, with 596 having AS, 162 PsA, and 296 at risk for chronic widespread pain.

According to Dr. Macfarlane, the CONTAIN study results were “generally reassuring.” Although there was a significant decrease in quality of life as measured by the five-level EQ-5D instrument overall, and in every subgroup population studied, “the magnitude of the decrease was small.” There was no change in disease-specific quality of life in patients with AS, for example.

Levels of pain, anxiety, or depression did increase somewhat, he reported, but the factors that influenced quality of life remained the same before and during the pandemic, such as high levels of deprivation, living in an urban location, low levels of physical activity, and sleep problems.

“Rather surprisingly, sleep problems significantly decreased overall,” Dr. Macfarlane reported. Again, it was only a small change, but “the benefit in terms of the improvement in sleep strengthened with later periods in the follow-up.”

There was also some evidence of increased low-level and high-level physical activity in patients with psoriatic arthritis.

“Mental health is a key issue not just in maintaining musculoskeletal health but also, in terms of the likelihood responding to therapy,” Dr. Macfarlane acknowledged. “Focusing on addressing anxiety is important,” he added.

“Providing enhanced support for self-management, including in relation to pain, is likely to be a priority in the absence of normal health care being available,” he suggested. Importantly, regardless of circumstances, “all patients can be affected.”

The REUMAVID study is conducted by the Health & Territory Research of the University of Seville, with the support of Novartis Pharma AG. The CONTAIN study is supported by the British Society for Rheumatology and Versus Arthritis.

No other relevant conflicts of interested were declared.
 

Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.

The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.

The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins

They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.

The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.

They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”

In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).

The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.

The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.

As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.

In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.

At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.

In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.

One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.

All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.

The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.

In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.

Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.

However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.

“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.

They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.

They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.

They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.

The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.

They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.

“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.

The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.

In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).

The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.

They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.

This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.

Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.

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

Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.

The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.

The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins

They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.

The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.

They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”

In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).

The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.

The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.

As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.

In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.

At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.

In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.

One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.

All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.

The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.

In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.

Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.

However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.

“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.

They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.

They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.

They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.

The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.

They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.

“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.

The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.

In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).

The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.

They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.

This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.

Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.

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

Use of mRNA COVID-19 vaccines should be considered as the preferable option in the United States rather than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in women aged under 50 years, according to one group of experts.

The group made their recommendation in an editorial in JAMA published online April 30, 2021, accompanying a paper describing details of 12 case reports of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine.

The editorialists are Ruth A. Karron, MD, professor of international health at Johns Hopkins University, Baltimore; Nigel S. Key, MD, professor of hematology at the University of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, associate dean for public health practice at Johns Hopkins

They noted that, after an initial pause following reports of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the recommendation of the Advisory Committee on Immunization Practices, the United States has permitted the use of the J&J vaccine in all adults with information on the risk of TTS added to educational materials.

The editorialists pointed out that no cases of TTS have been confirmed following administration of more than 180 million doses of the mRNA vaccines in the United States.

They said that, while the J&J vaccine will still be needed for individuals with allergies to components of the mRNA vaccines and for those who live in remote locations where the cold chain for transport and storage of mRNA vaccines cannot be maintained, “U.S. public health agencies and clinicians should consider recommending mRNA vaccines as safer options for those who may be at substantially higher risk for TTS after Ad26.COV2.S vaccination, currently women younger than 50 years.”

In the main JAMA paper, a group led by Isaac See, MD, Centers for Disease Control and Prevention COVID-19 Response Team, reported full details of 12 cases of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the U.S. Vaccine Adverse Event Reporting System (VAERS).

The 12 U.S. case reports, 3 of which were fatal, show many similarities to cases described in Europe after the AstraZeneca vaccine.

The authors noted that, by April 12, approximately 7 million doses of the J&J vaccine had been given in the United States. The 12 cases of CVST and thrombocytopenia following receipt of the vaccine were reported to VAERS between March 2 and April 21. All 12 cases were in White women, 11 of whom were aged under 50 years.

As of April 25, a further two cases have been confirmed and reported to VAERS; one in a man younger than 40 years, the other in a woman aged between 40 and 59 years.

In the 12 cases reported in detail, symptoms started between 6 and 15 days post vaccination.

At least one risk factor for CVST was identified in seven patients (obesity in six, hypothyroidism in one, and use of combined oral contraceptives in one). None of the patients was pregnant or within 12 weeks post partum, had prior thrombosis, a personal or family history of thrombophilia, or documented prior exposure to heparin.

In addition to CVST, seven patients had intracerebral hemorrhage and eight had non-CVST thromboses.

One patient reported a history of SARS-CoV-2 infection approximately 4 months prior to vaccination. Of the other 11 patients, 4 had negative serologic tests and 7 were not tested.

All 12 patients were hospitalized and 10 were admitted to an ICU. At the time of the last follow-up, three patients had died (all of whom had intraparenchymal hemorrhage), three remained in the ICU, two were still hospitalized but not in an ICU, and four had been discharged home.

The authors pointed out that the U.S. cases of CVST with thrombocytopenia following the J&J vaccine have many similarities to those reported in Europe after the AstraZeneca vaccine, occurring primarily in women younger than 40 years and in patients without diagnosed thrombophilia. Both European and U.S. patients had a median platelet nadir count of 19 x 103/mcL and several also had non-CVST large-vessel thrombosis.

In the European cases of CVST with thrombocytopenia, 50% of patients died, compared with 25% of U.S. patients.

Like the European cases, the U.S. cases had positive heparin-PF4 HIT antibody enzyme-linked immunosorbent assay tests in the absence of prior exposure to heparin, as would be seen in autoimmune HIT.

However, in the initial European CVST reports, 88% of patients tested with functional platelet HIT antibody tests had positive results, compared with only 11% of the U.S. cases. But the authors noted that lack of standardization in functional platelet HIT antibody assays may lead to differences in results by different laboratories.

“It may be important to notify testing laboratories that postvaccination TTS is being evaluated, so that testing methods can be adjusted if needed,” they said.

They concluded that these case reports suggest that the pathogenesis of TTS may be similar to autoimmune HIT, triggered by the formation of antibodies directed against PF4, a constituent of platelet alpha granules released during platelet activation. In contrast to classic HIT in which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.

They noted that the precise mechanism of TTS in relation to COVID-19 vaccination has not yet been established. The Global Advisory Committee on Vaccine Safety has stated that a platform-specific mechanism related to adenovirus vector vaccines cannot be excluded. Both the J&J and AstraZeneca vaccines use an adenoviral vector, but they are different; J&J uses a human vector, while AstraZeneca uses a chimpanzee vector.

They also pointed out that CVST and thrombocytopenia following SARS-CoV-2 infection has been reported in at least two cases, but HIT testing was not done in these cases. There have not so far been any reports to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.

The authors said these findings have important clinical and public health implications, noting that the CDC has updated its interim clinical considerations for use of authorized COVID-19 vaccines to indicate that women aged 18-49 years should be aware of the increased risk of TTS after receipt of the J&J vaccine, and to use a nonheparin anticoagulant in suspected cases.

They noted that a subacute presentation of headache is present in 90% of patients with typical CVST. While headache is a common symptom after the J&J vaccination, most headaches begin and resolve within 2 days. Whereas in the U.S. cases of CVST after vaccination, headache symptoms began at least 6 days after vaccination and persisted for at least a week for most.

“Urgent consultation with a neurologist is prudent when a patient is suspected or confirmed to have CVST. In addition, since the median time from symptom onset to hospitalization was 7 days in the U.S. CVST case series, patient and clinician education might shorten the time to clinical evaluation and therefore treatment,” they stated.

The authors also note that VAERS is a passive surveillance system, so cases of CVST with thrombocytopenia may be underreported.

In their accompanying editorial, Dr. Karron and colleagues pointed out that, in addition to the 12 patients with CVST with thrombocytopenia described in this case series, at least three patients without CVST but meeting diagnostic criteria for TTS have been reported to VAERS (as of April 21), all in women aged 18-59 years (median age, 37 years).

The editorialists reported that the rate of CVST with thrombocytopenia after the J&J vaccine is approximately 5 per million women aged 18-50 years. This is compared with a background rate of approximately 0.05-0.13 per million per month.

They said that the availability of an interim standardized case definition of this adverse effect will facilitate prospective case ascertainment through review of large linked databases and active case finding.

This will also permit greater understanding of whether individuals who are otherwise at increased risk for hypercoagulation in general and for CVST in particular (for example, women taking hormonal contraceptive medications or who are pregnant) are also at increased risk for TTS.

Obtaining this information will support dynamic country-specific assessments of the risks of each vaccine, compared with the risk of COVID-19 disease for their populations and subpopulations, they added.

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

A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

“One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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

A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

“One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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

A novel program that coaches healthcare workers effectively bolsters wellness and resilience in the face of the ongoing COVID-19 pandemic.

Investigators found the program they developed successfully reduced the severity of mental health threats in healthcare workers.

The pandemic has been “an enormous threat to the resilience of healthcare workers,” said program leader Benjamin Rosen, MD, assistant professor, department of psychiatry, University of Toronto, and staff psychiatrist at Sinai Health in Toronto.

“Working at a hospital this year, you’re not only worried about battling COVID, but you’re also enduring uncertainty and fear and moral distress, which has contributed to unprecedented levels of burnout,” Dr. Rosen added.

The findings were presented at the annual meeting of the American Psychiatric Association, held virtually this year.
 

‘Psychological PPE’

Building on previous experience supporting colleagues through the 2003 severe acute respiratory syndrome (SARS) outbreak in Toronto, Dr. Rosen’s team designed and implemented an initiative to support colleagues’ wellness and resilience early in the COVID-19 pandemic.

The Resilience Coaching for Healthcare Workers program is designed to support psychological well-being during times of chronic stress and help healthcare workers “keep their heads in the game so that they can sustain the focus and the rigor that they need to do their work,” Dr. Rosen said during a press briefing.

Participating coaches are mental health clinicians with training in psychological first aid, resilience, and psychotherapy to provide peer support to units and teams working on the front line. The program provides a kind of “psychological PPE” to complement other protective measures, Dr. Rosen explained.

There are currently 15 coaches working with 17 units and clinical teams at Sinai Health, which encompasses Mount Sinai Hospital and Bridgepoint Active Health, both in Toronto. Most coaches provide support to groups of up to 15 people either virtually or in person. More than 5,300 staff members have received coaching support since the program’s launch in April 2020.  

Mary Preisman, MD, consultation liaison psychiatrist at Mount Sinai Hospital, who is involved with the program, said it’s important to note that coaches are not in clinical relationships with healthcare providers, but rather are applying diverse psychotherapeutic tools to deliver collegial support. When clinical support is requested, coaches facilitate connection with other psychiatrists.
 

‘An excellent model’

Preliminary analysis of qualitative data, which includes interviews with coaches and providers, suggests that coaching is successful in mitigating the severity of mental health threats that healthcare workers face.

“The feedback so far is that coaching has really helped to strengthen team cohesiveness and resilience, which has been really encouraging for us,” Dr. Rosen said.

For example, some participants said the coaching improved relationships with their colleagues, decreased loneliness, and increased the sense of support from their employer.

Others commented on the value of regularly scheduled coaching “huddles” that are embedded within the work environment.

Dr. Rosen said the program is funded by academic grants through the end of next year, which is key given that Toronto is currently in the middle of a third wave of the pandemic.

“One of the things that we learned from previous pandemics is that the psychological impact on healthcare workers usually exceeds the infectious outbreak. There have been studies that show, even years after a pandemic or an epidemic has ended, the psychological consequences of anxiety and distress persist,” Dr. Rosen said.

Briefing moderator Jeffrey Borenstein, MD, president and CEO, Brain & Behavior Research Foundation and editor-in-chief, Psychiatric News, said the Toronto team has developed “an excellent model that could be used around the world to support the well-being of healthcare workers who are on the front lines of a pandemic.”

This research had no commercial funding. Dr. Rosen, Dr. Preisman, and Dr. Borenstein have reported no relevant financial relationships.

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