Kathleen Doheny

In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. About 700 women die each year either during their pregnancy or in the weeks after the birth. And another 60,000 have pregnancy-related or childbirth-related health issues.

Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.

In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.

“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”

“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.

As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:

U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.

At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.

A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.

President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.

Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
 

Best hospitals for maternity

For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.

To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.

Of those, 237 were identified as best for maternity.

As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.

On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.

The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
 

A call to action: Expand coverage

Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”

Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.

“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.

“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.

A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.

The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.

According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
 

Congressional actions

Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.

“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.

Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
 

Explaining and fixing the disparities

No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.

Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.

According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
 

When statistics hit home

Many who work to improve maternal health have gone through issues themselves or had loved ones who did.

Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.

For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.

“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”

She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.

“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.

Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.

U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.

Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.

In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.

The child’s question is understandable and heartbreaking: She wants to know where her mommy is.

“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”

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

In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. About 700 women die each year either during their pregnancy or in the weeks after the birth. And another 60,000 have pregnancy-related or childbirth-related health issues.

Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.

In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.

“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”

“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.

As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:

U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.

At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.

A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.

President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.

Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
 

Best hospitals for maternity

For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.

To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.

Of those, 237 were identified as best for maternity.

As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.

On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.

The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
 

A call to action: Expand coverage

Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”

Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.

“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.

“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.

A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.

The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.

According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
 

Congressional actions

Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.

“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.

Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
 

Explaining and fixing the disparities

No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.

Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.

According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
 

When statistics hit home

Many who work to improve maternal health have gone through issues themselves or had loved ones who did.

Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.

For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.

“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”

She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.

“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.

Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.

U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.

Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.

In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.

The child’s question is understandable and heartbreaking: She wants to know where her mommy is.

“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”

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

In the United States, nearly 4 million women a year prepare to give birth, looking forward to the joy to come. But for some, the dream turns tragic. About 700 women die each year either during their pregnancy or in the weeks after the birth. And another 60,000 have pregnancy-related or childbirth-related health issues.

Causes of death vary greatly, including hemorrhage during pregnancy or during delivery, heart conditions, and mental health issues such as substance abuse and suicide after the birth.

In 2019, the U.S. maternal death rate was 20.1 per 100,000 women, according to the CDC, significantly higher than the 17.4 per 100,000 recorded in 2018. For Black women, the maternal death rate was more than double the overall – 44 per 100,000 in 2019.

“We have to address our horrendous maternal health care system and also need to address the inequities,” says Laurie Zephyrin, MD, vice president for advancing health equity for the Commonwealth Fund, a foundation supporting independent research on health care issues. “This is an issue that has needed national attention for a long time.”

“If we look overall, our maternal death rate is more than twice that of more than 10 other high-income countries,” she said.

As sobering as the problem is, recent developments have sparked hope that reversing the course is possible. Among them:

U.S. News & World Report, long known for its rankings of hospitals, issued its first ever “Best Hospitals for Maternity” rankings Dec. 7, highlighting facilities that perform well on key quality indicators. It plans to update the report annually.

At the first-ever White House Maternal Health Day of Action on Dec. 7, Vice President Kamala Harris urged a call to action to reduce maternal deaths and pregnancy-related health problems, with extension of postpartum coverage through Medicaid programs, among other actions.

A new hospital designation called ‘’Birthing Friendly” will be established by the Centers for Medicare & Medicaid Services. The label will be given to facilities that take part in a program aimed at improving maternal outcomes and that use patient safety practices.

President Joe Biden’s proposed Build Back Better plan includes maternal health provisions, including $3 billion in new maternal health funding. The money will aim to grow and diversify the workforce caring for pregnant women, coordinate care better, and step up research on maternal health, among other projects.

Ongoing efforts in Congress are aimed at fixing the wide disparities in maternal health affecting Black women. Regardless of income level or education, Black women are at a higher risk of maternal death and other health issues than are White women. A Black woman with a college education is at 60% higher risk of maternal death than a White or Hispanic woman who didn’t graduate high school, according to the Commonwealth Fund.
 

Best hospitals for maternity

For its rankings, U.S. News and World Report reached out to the 2,700 U.S. hospitals that offer maternity services, said Ben Harder, chief of health analysis and managing editor at U.S. News & World Report.

To be recognized, a hospital had to submit data from 2019 and meet the publication’s maternity care standards. The publication received responses from just 571 hospitals, representing about two of every five births in the country.

Of those, 237 were identified as best for maternity.

As to why the response rate was not higher, Mr. Harder cited the reporting burden and says it is understandable. Some hospitals likely did not have the staff available, especially during the pandemic, to gather the data needed to be evaluated by U.S. News & World Report.

On their other evaluations, the rankings are based on Medicare data, “so hospitals don’t have to lift a finger.” He expects more hospitals will respond for their future evaluations of maternity care.

The evaluators focused on five quality measures, making a score based on the cesarean section delivery rate among first-time mothers, early elective delivery rates, unexpected newborn complication rates, breastfeeding rates, and option for vaginal birth after C-section.
 

A call to action: Expand coverage

Speaking at the White House Maternal Health Day of Action, Mrs. Harris told participants: “The challenge is urgent, and it is important, and it will take all of us.”

Being pregnant and giving birth, she said, should not carry such great risks. She zeroed in on systemic inequities in the way women are treated and the dramatic impact maternal death and health issues have on the economy.

“A healthy economy requires healthy mothers and healthy babies,” Mrs. Harris said.

“Before, during, and after childbirth, women in our nation are dying at a higher rate than any other developed nation in our world,” she said, noting that research shows that Black women, Native Americans, and women in rural America more likely to suffer.

A major strategy in the call to action, according to Mrs. Harris, is encouraging states to expand postpartum coverage to pregnant women enrolled in Medicaid or the Children’s Health Insurance Program from the existing 60 days to a full year. Together, these two programs cover over 42% of births in the country, so expanding the coverage is expected to have a great impact.

The 60 days of coverage is not enough, as many deaths and complications happen more than 60 days after childbirth, Mrs. Harris said. The logistics for states to extend coverage were established by the American Rescue Plan and will become available by April 2022. Some states have already extended the postpartum coverage.

According to the Centers for Medicare and Medicaid Services, if every state did adopt an extension, as the Build Back Better Act proposes, the number of Americans getting coverage for a full year after childbirth would about double, extending the coverage for about 720,000 each year.
 

Congressional actions

Congress is working on the issue as well. The Black Maternal Health Momnibus Act of 2021, for instance, proposes several measures, including improving maternal nutrition, expanding affordable housing, and extending the maternal workforce to include more doulas and midwives.

“And for so many women, let’s note doulas are literally a lifeline,” Mrs. Harris said at the White House event.

Doulas are trained to offer women physical, emotional, and informational support before, during, and after childbirth. No reliable statistics are available on their numbers in the United States, but a March of Dimes report estimates that about 9,000 were included in a registration database in 2018.
 

Explaining and fixing the disparities

No one can explain for sure why Black women, in particular, are at higher risk of dying from pregnancy-related complications. Systemic inequity is one likely reason, Mrs. Harris said, noting there are differences in how people are treated based on who they are.

Inherent and unconscious bias in offering women treatment plays a role, experts say. Training could reverse or reduce that bias. Some women of color also may have less access to care, as do women in some rural areas.

According to Mrs. Harris, more than 20 companies and nonprofits have pledged to invest more than $20 million in maternal health efforts in the United States and more than $150 million globally. Among the proposed programs: remote-care monitors in rural areas, better care models for the postpartum period, and improved education programs for maternal health providers.
 

When statistics hit home

Many who work to improve maternal health have gone through issues themselves or had loved ones who did.

Jill Arnold, founder of the Maternal Safety Foundation in Bentonville, Ark., became a consumer advocate after giving birth to her two daughters, now teenagers. With the first birth, Ms. Arnold said she was intensely pressured at the last minute to have a C-section. She held out, resisted, and delivered a healthy baby vaginally.

For her second childbirth, she chose an accredited birth center that allowed her to have a doula and a midwife.

“The care I received was night and day,” she said. “The overwhelming pressure to consent to a C-section wasn’t there.”

She welcomes the information provided by the new U.S. News & World Report rankings as well as the upcoming “Birthing Friendly” designations.

“The onus shouldn’t be on patients, on individuals, on pregnant people to do the research,” Ms. Arnold said.

Rather, women and their partners need information at their fingertips so they can make an informed decision about how to give birth and where.

U.S. Rep. Lauren Underwood (D-Ill.), who cofounded the Black Maternal Health Caucus in April 2019, with Rep. Alma Adams (D-N.C.), wrote a touching blog in the journal Health Affairs to explain her passion in improving maternal health.

Her former classmate, Shalon Irving, who went on to become a CDC epidemiologist, died in February 2017 at age 36, just 3 weeks after giving birth, when she developed complications from high blood pressure.

In the blog, Ms. Underwood cited statistics and provides details of the Black Maternal Health Momnibus Act of 2021, then ends the blog, published in 2020, with an update on how Ms. Irving’s then 3-year-old daughter, raised by her grandmother, is doing. While Soleil is “curious, joyful, and brilliant,” the grandmother told Ms. Underwood that she has also walked into a room and found the little girl clutching a framed photograph of her mother.

The child’s question is understandable and heartbreaking: She wants to know where her mommy is.

“Soleil’s question is my motivation,” Ms. Underwood wrote. “To honor Shalon, and all the women like her who we have lost, let us take the serious and urgent action that is required to save our moms.”

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

Using sunscreen and following other sun-protective behaviors such as wearing long sleeves or staying in the shade do not decrease bone mineral density overall or increase the risk of osteoporotic fracture, according to a new study that included more than 3,000 men and women.

Aja Koska/Getty Images

“We have objective data for the first time, and in a large-scale representative population of the U.S. adults, to indicate sun protection is not associated with negative bone-related outcomes,” said study lead author Mohsen Afarideh, MD, MPH, a postdoctoral research fellow at the autoimmune skin diseases unit at the University of Pennsylvania, Philadelphia.

The study, published online in JAMA Dermatology, goes a step further than previous research by others that has found sunscreen use does not compromise vitamin D synthesis and has little effect on circulating 25-hydroxyvitamin D levels.

In the new study, researchers looked at three sun-protective behaviors – sunscreen use, staying in the shade, wearing long sleeves – and their effects on bone mineral density and the risk of fractures.

While the effects of sun-protective habits on blood levels of vitamin D and BMD scores are important, ‘’what we are more interested to know is if the sun-protective behaviors actually cause or increase the risk of fracture,” Dr. Afarideh said in an interview. “The answer to that is a firm ‘No.’ These data are very reassuring and will help clinicians to keep recommending sun protection to the public.”

Study details

Dr. Afarideh and his colleagues from the Mayo Clinic in Rochester, Minn., looked at data from the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2018, obtaining final information on 3,403 men and women, ages 20-59, who completed a dermatology questionnaire The men and women reported on the three sun-protective habits, and noted whether they followed these practices always or most of the time, sometimes, or never or rarely.

The frequency of the three behaviors was not widespread. Frequent staying in the shade was reported by 31.6% of the sample, wearing long sleeves by 11.8%, and sunscreen use by 26.1%.

The researchers also had data on the participants’ bone mineral density (BMD) scores along with dietary information such as milk consumption, vitamin D supplement use, taking steroid drugs, and exercise activity.

“Moderate sunscreen use was linked with a slightly lower lumbar BMD score,” Dr. Afarideh said, which was “the only significant association that could be interpreted as concerning.” And this was more likely to be seen in older respondents, he said.

However, otherwise they found the practice of the three behaviors was not associated with lower total or site-specific BMD z scores, nor was it linked with an increased risk of osteoporotic fractures. (The BMD z score compares an individual’s bone density to the average bone density of someone their same age and gender.)

The focus on fracture risk is the more important outcome, Dr. Afarideh said. And they found no increased risk overall of osteoporotic fractures in those who practiced sun-protective behaviors.

Moderate to frequent staying in the shade was actually linked with a reduced prevalence of spine fractures in the multivariate model (odds ratio, 0.19; 95% confidence interval, 0.04-0.86, P = .02). The researchers say that may be attributable to these respondents also being careful in other areas of life, such as avoiding falls and not participating in high-risk activities that would increase the chance of fractures. “However, this is just an assumption,” Dr. Afarideh said.

Expert perspectives

Other dermatologists not involved in the new research said the study results provide some “real-world” information that’s valuable for clinicians to share with patients.

“I think this is an important study on multiple levels,” said Henry W. Lim, MD, a former president of the American Academy of Dermatology who is a member of the department of dermatology and senior vice president of academic affairs at Henry Ford Health System, Detroit. “It is a well-done study, involving a large number. It is a real-life situation, asking people their photo protective behaviors and then looking at their bone mineral density.” The bottom line, he said: “Bone health is not affected by photo protection habits in real life.”

The findings are important but not surprising, said Antony R. Young, PhD, emeritus professor of experimental photobiology at St. John’s Institute of Dermatology, King’s College, London, who has researched sunscreens and vitamin D status. “My study showed that correct sunscreen use, albeit with a relatively low SPF of 15, did prevent sunburn in a high UVR [ultraviolet radiation] environment but did allow very good vitamin D synthesis. I think this is because the necessary dose of UVB is very low.”

Michele Green, MD, a New York dermatologist and clinical staff member at Lenox Hill Hospital there, said she often hears concerns about bone health from patients. “Every week, patients ask, ‘Why would I wear sunblock? Don’t I need sun for bone health? Don’t I need it for vitamin D?’’’

Now, she said, ‘’Dermatologists can point to the study and say ‘Don’t worry.’ It clarifies that using sunscreen won’t cause you to have osteoporosis.’’

Dr. Afarideh, who was a postdoctoral research fellow at the Mayo Clinic, and his coauthors, Megha M. Tollefson, MD, and Julio C. Sartori-Valinotti, of the Mayo Clinic, and Dr. Green had no disclosures. Dr. Lim and Dr. Young consult for the sunscreen industry.

Using sunscreen and following other sun-protective behaviors such as wearing long sleeves or staying in the shade do not decrease bone mineral density overall or increase the risk of osteoporotic fracture, according to a new study that included more than 3,000 men and women.

Aja Koska/Getty Images

“We have objective data for the first time, and in a large-scale representative population of the U.S. adults, to indicate sun protection is not associated with negative bone-related outcomes,” said study lead author Mohsen Afarideh, MD, MPH, a postdoctoral research fellow at the autoimmune skin diseases unit at the University of Pennsylvania, Philadelphia.

The study, published online in JAMA Dermatology, goes a step further than previous research by others that has found sunscreen use does not compromise vitamin D synthesis and has little effect on circulating 25-hydroxyvitamin D levels.

In the new study, researchers looked at three sun-protective behaviors – sunscreen use, staying in the shade, wearing long sleeves – and their effects on bone mineral density and the risk of fractures.

While the effects of sun-protective habits on blood levels of vitamin D and BMD scores are important, ‘’what we are more interested to know is if the sun-protective behaviors actually cause or increase the risk of fracture,” Dr. Afarideh said in an interview. “The answer to that is a firm ‘No.’ These data are very reassuring and will help clinicians to keep recommending sun protection to the public.”

Study details

Dr. Afarideh and his colleagues from the Mayo Clinic in Rochester, Minn., looked at data from the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2018, obtaining final information on 3,403 men and women, ages 20-59, who completed a dermatology questionnaire The men and women reported on the three sun-protective habits, and noted whether they followed these practices always or most of the time, sometimes, or never or rarely.

The frequency of the three behaviors was not widespread. Frequent staying in the shade was reported by 31.6% of the sample, wearing long sleeves by 11.8%, and sunscreen use by 26.1%.

The researchers also had data on the participants’ bone mineral density (BMD) scores along with dietary information such as milk consumption, vitamin D supplement use, taking steroid drugs, and exercise activity.

“Moderate sunscreen use was linked with a slightly lower lumbar BMD score,” Dr. Afarideh said, which was “the only significant association that could be interpreted as concerning.” And this was more likely to be seen in older respondents, he said.

However, otherwise they found the practice of the three behaviors was not associated with lower total or site-specific BMD z scores, nor was it linked with an increased risk of osteoporotic fractures. (The BMD z score compares an individual’s bone density to the average bone density of someone their same age and gender.)

The focus on fracture risk is the more important outcome, Dr. Afarideh said. And they found no increased risk overall of osteoporotic fractures in those who practiced sun-protective behaviors.

Moderate to frequent staying in the shade was actually linked with a reduced prevalence of spine fractures in the multivariate model (odds ratio, 0.19; 95% confidence interval, 0.04-0.86, P = .02). The researchers say that may be attributable to these respondents also being careful in other areas of life, such as avoiding falls and not participating in high-risk activities that would increase the chance of fractures. “However, this is just an assumption,” Dr. Afarideh said.

Expert perspectives

Other dermatologists not involved in the new research said the study results provide some “real-world” information that’s valuable for clinicians to share with patients.

“I think this is an important study on multiple levels,” said Henry W. Lim, MD, a former president of the American Academy of Dermatology who is a member of the department of dermatology and senior vice president of academic affairs at Henry Ford Health System, Detroit. “It is a well-done study, involving a large number. It is a real-life situation, asking people their photo protective behaviors and then looking at their bone mineral density.” The bottom line, he said: “Bone health is not affected by photo protection habits in real life.”

The findings are important but not surprising, said Antony R. Young, PhD, emeritus professor of experimental photobiology at St. John’s Institute of Dermatology, King’s College, London, who has researched sunscreens and vitamin D status. “My study showed that correct sunscreen use, albeit with a relatively low SPF of 15, did prevent sunburn in a high UVR [ultraviolet radiation] environment but did allow very good vitamin D synthesis. I think this is because the necessary dose of UVB is very low.”

Michele Green, MD, a New York dermatologist and clinical staff member at Lenox Hill Hospital there, said she often hears concerns about bone health from patients. “Every week, patients ask, ‘Why would I wear sunblock? Don’t I need sun for bone health? Don’t I need it for vitamin D?’’’

Now, she said, ‘’Dermatologists can point to the study and say ‘Don’t worry.’ It clarifies that using sunscreen won’t cause you to have osteoporosis.’’

Dr. Afarideh, who was a postdoctoral research fellow at the Mayo Clinic, and his coauthors, Megha M. Tollefson, MD, and Julio C. Sartori-Valinotti, of the Mayo Clinic, and Dr. Green had no disclosures. Dr. Lim and Dr. Young consult for the sunscreen industry.

Using sunscreen and following other sun-protective behaviors such as wearing long sleeves or staying in the shade do not decrease bone mineral density overall or increase the risk of osteoporotic fracture, according to a new study that included more than 3,000 men and women.

Aja Koska/Getty Images

“We have objective data for the first time, and in a large-scale representative population of the U.S. adults, to indicate sun protection is not associated with negative bone-related outcomes,” said study lead author Mohsen Afarideh, MD, MPH, a postdoctoral research fellow at the autoimmune skin diseases unit at the University of Pennsylvania, Philadelphia.

The study, published online in JAMA Dermatology, goes a step further than previous research by others that has found sunscreen use does not compromise vitamin D synthesis and has little effect on circulating 25-hydroxyvitamin D levels.

In the new study, researchers looked at three sun-protective behaviors – sunscreen use, staying in the shade, wearing long sleeves – and their effects on bone mineral density and the risk of fractures.

While the effects of sun-protective habits on blood levels of vitamin D and BMD scores are important, ‘’what we are more interested to know is if the sun-protective behaviors actually cause or increase the risk of fracture,” Dr. Afarideh said in an interview. “The answer to that is a firm ‘No.’ These data are very reassuring and will help clinicians to keep recommending sun protection to the public.”

Study details

Dr. Afarideh and his colleagues from the Mayo Clinic in Rochester, Minn., looked at data from the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2018, obtaining final information on 3,403 men and women, ages 20-59, who completed a dermatology questionnaire The men and women reported on the three sun-protective habits, and noted whether they followed these practices always or most of the time, sometimes, or never or rarely.

The frequency of the three behaviors was not widespread. Frequent staying in the shade was reported by 31.6% of the sample, wearing long sleeves by 11.8%, and sunscreen use by 26.1%.

The researchers also had data on the participants’ bone mineral density (BMD) scores along with dietary information such as milk consumption, vitamin D supplement use, taking steroid drugs, and exercise activity.

“Moderate sunscreen use was linked with a slightly lower lumbar BMD score,” Dr. Afarideh said, which was “the only significant association that could be interpreted as concerning.” And this was more likely to be seen in older respondents, he said.

However, otherwise they found the practice of the three behaviors was not associated with lower total or site-specific BMD z scores, nor was it linked with an increased risk of osteoporotic fractures. (The BMD z score compares an individual’s bone density to the average bone density of someone their same age and gender.)

The focus on fracture risk is the more important outcome, Dr. Afarideh said. And they found no increased risk overall of osteoporotic fractures in those who practiced sun-protective behaviors.

Moderate to frequent staying in the shade was actually linked with a reduced prevalence of spine fractures in the multivariate model (odds ratio, 0.19; 95% confidence interval, 0.04-0.86, P = .02). The researchers say that may be attributable to these respondents also being careful in other areas of life, such as avoiding falls and not participating in high-risk activities that would increase the chance of fractures. “However, this is just an assumption,” Dr. Afarideh said.

Expert perspectives

Other dermatologists not involved in the new research said the study results provide some “real-world” information that’s valuable for clinicians to share with patients.

“I think this is an important study on multiple levels,” said Henry W. Lim, MD, a former president of the American Academy of Dermatology who is a member of the department of dermatology and senior vice president of academic affairs at Henry Ford Health System, Detroit. “It is a well-done study, involving a large number. It is a real-life situation, asking people their photo protective behaviors and then looking at their bone mineral density.” The bottom line, he said: “Bone health is not affected by photo protection habits in real life.”

The findings are important but not surprising, said Antony R. Young, PhD, emeritus professor of experimental photobiology at St. John’s Institute of Dermatology, King’s College, London, who has researched sunscreens and vitamin D status. “My study showed that correct sunscreen use, albeit with a relatively low SPF of 15, did prevent sunburn in a high UVR [ultraviolet radiation] environment but did allow very good vitamin D synthesis. I think this is because the necessary dose of UVB is very low.”

Michele Green, MD, a New York dermatologist and clinical staff member at Lenox Hill Hospital there, said she often hears concerns about bone health from patients. “Every week, patients ask, ‘Why would I wear sunblock? Don’t I need sun for bone health? Don’t I need it for vitamin D?’’’

Now, she said, ‘’Dermatologists can point to the study and say ‘Don’t worry.’ It clarifies that using sunscreen won’t cause you to have osteoporosis.’’

Dr. Afarideh, who was a postdoctoral research fellow at the Mayo Clinic, and his coauthors, Megha M. Tollefson, MD, and Julio C. Sartori-Valinotti, of the Mayo Clinic, and Dr. Green had no disclosures. Dr. Lim and Dr. Young consult for the sunscreen industry.

As a pediatric kidney doctor, Elaine S. Kamil, MD, is used to long hours helping children and teens with a variety of issues, some very serious, and also makes time to give back to her specialty.

In late 2013, she was in Washington, D.C., planning a meeting of the American Society of Nephrology. When the organizers decided at the last minute that another session was needed, she stayed late, putting it together. Then she hopped on a plane and returned home to Los Angeles on a Saturday night.

Right after midnight, Dr. Kamil knew something was wrong.

“I had really severe chest pain,” she says. “I have reflux, and I know what that feels like. This was much more intense. It really hurt.” She debated: “Should I wake up my husband?”

Soon, the pain got so bad, she had to.

At the hospital, an electrocardiogram was slightly abnormal, as was a blood test that measures damage to the heart. Next, she got an angiogram, an imaging technique to visualize the heart. Once doctors looked at the image on the screen during the angiogram, they knew the diagnosis: Broken heart syndrome, known medically as takotsubo cardiomyopathy or stress-induced cardiomyopathy. As the name suggests, it’s triggered by extreme stress or loss.

The common symptoms are chest pain that can seem to come from a heart attack, shortness of breath, and fainting. The telltale clue to the diagnosis is the appearance of the walls of the heart’s left ventricle, its main pumping chamber. When the condition is present, the left ventricle changes shape, developing a narrow neck and a round bottom, resembling an octopus pot called takotsubo used by fishermen in Japan, where the condition was first recognized in 1990.

Like most who are affected, Dr. Kamil, now 74, is fine now. She is still actively working, as a researcher and professor emerita at Cedars-Sinai Medical Center and a health sciences clinical professor of pediatrics at UCLA. But she focuses more now on stress reduction.
 

Study: condition on the rise

New research from Cedars-Sinai suggests that broken heart syndrome, while still not common, is not as rare as once thought. And it’s on the rise, especially among middle-age and older women.

This ‘’middle” group – women ages 50 to 74 – had the greatest rate of increase over the years studied, 2006-2017, says Susan Cheng, MD, lead author of the study, published in the Journal of the American Heart Association. She is the director of the Institute for Research on Healthy Aging at the Smidt Heart Institute at Cedars-Sinai Medical Center.

Dr. Cheng and her team used national hospital inpatient data collected from more than 135,000 men and women diagnosed with the condition during the 12 years of the study. More than 88% of all cases were women, especially in those age 50 or older. When the researchers looked more closely, they found the diagnosis has been increasing at least 6 to 10 times more rapidly for women in the 50-to-74 age group than in any other group.

For every case of the condition in younger women, or in men of all age groups, the researchers found an additional 10 cases for middle-aged women and six additional cases for older women. For example, while the syndrome occurred in 15 younger women per million per year, it occurred in 128 middle aged women per year.

The age groups found most at risk was surprising, says Dr. Cheng, who expected the risk would be highest in the oldest age group of women, those over 75.

While doctors are more aware of the condition now, “it’s not just the increased recognition,” she says. “There is something going on” driving the continual increase. It probably has something to do with environmental changes, she says.

Hormones and hormonal differences between men and women aren’t the whole story either, she says. Her team will study it further, hoping eventually to find who might be more likely to get the condition by talking to those who have had it and collecting clues. “There probably is some underlying genetic predisposition,” she says.

“The neural hormones that drive the flight-or-fight response (such as adrenaline) are definitely elevated,” she says. “The brain and the heart are talking to each other.”

Experts say these surging stress hormones essentially “stun” the heart, affecting how it functions. The question is, what makes women particularly more susceptible to being excessively triggered when exposed to stress? That is unclear, Dr. Cheng says.

While the condition is a frightening experience, ‘’the overall prognosis is much better than having a garden-variety heart attack,” she says.

But researchers are still figuring out long-term outcomes, and she can’t tell patients if they are likely to have another episode.
 

Research findings reflected in practice

Other cardiologists say they are not surprised by the new findings.

“I think it’s very consistent with what I am seeing clinically,” says Tracy Stevens, MD, a cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, MO. In the last 5 years, she has diagnosed at least 100 cases, she says. The increase is partly but not entirely due to increased awareness by doctors of the condition, she agrees.

If a postmenopausal woman comes to the hospital with chest pain, the condition is more likely now than in the past to be suspected, says Dr. Stevens, who’s also the medical director of the Muriel I. Kauffman Women’s Heart Center at Saint Luke’s. The octopus pot-like image is hard to miss.

“What we see at the base of the left ventricle is, it is squeezing like crazy, it is ballooning.”

“We probably see at least five to ten a month,” says Kevin Bybee, MD, an associate professor of medicine at the University of Missouri-Kansas City School of Medicine.

The increase in numbers found by the Los Angeles researchers may not even capture the true picture of how many people have gotten this condition, he says. He suspects some women whose deaths are blamed on sudden cardiac death might actually have had broken heart syndrome.

“I have always wondered how many don’t make it to the hospital.”

Dr. Bybee, who’s also medical director of cardiovascular services at St. Luke’s South in Overland Park, KS, became interested in the syndrome during his fellowship at Mayo Clinic when he diagnosed three patients in just 2 months. He and his team published the case histories of seven patients in 2004. Since then, many more reports have been published.

Researchers from Texas used the same national database as the Cedars researchers to look at cases from 2005 to 2014, and also found an increase. But study co-author Abhijeet Dhoble, MD, a cardiologist and associate professor of medicine at UT Health Science Center and Memorial Hermann-Texas Medical Center in Houston, believes more recognition explains most of the increase.

And the pandemic is now playing a role in driving up cases, he says.

“In the last 2 years, we have been noticing increasing numbers of cases, probably due to the pandemic,” he says.
 

Profiles of cases

Over the years, Dr. Bybee has collected information on what is happening before the heart begins to go haywire.

“Fifteen to twenty percent of the time, there is no obvious trigger,” he says.

Other times, a stressful emotional event, such as the death of a spouse or a severe car accident, can trigger it.

One patient with an extreme fear of public speaking had to give a talk in front of a large group when she was new to a job. Another woman lost money at a casino before it happened, Dr. Bybee says. Yet another patient took her dog out for a walk in the woods, and the dog got caught in a raccoon trap.

Fierce arguments as well as surprise parties have triggered the condition, Dr. Bybee says. Physical problems such as asthma or sepsis, a life-threatening complication of an infection, can also trigger broken heart.

“It’s challenging because this is unpredictable,” he says.
 

Treatments and recovery

The condition is rarely fatal, say experts from Harvard and Mayo Clinic, but some can have complications such as heart failure.

There are no standard guidelines for treatment, Dr. Dhoble, of Memorial Hermann, says. “We give medications to keep blood pressures in the optimal range.” Doctors may also prescribe lipid-lowering medicines and blood thinner medications. “Most patients recover within 3 to 7 days.”

“Usually within a month, their [heart] function returns to normal,” Dr. Stevens says.

Getting one’s full energy back can take longer, as Dr. Kamil found. “It was about 6 months before I was up to speed.”
 

Survivors talk

Looking back, Dr. Kamil realizes now how much stress she was under before her episode.

“I took care of chronically ill kids,” she says, and worried about them. “I’m kind of a mother hen.”

Besides patient care and her cross-county meeting planning, she was flying back and forth to Florida to tend to her mother, who had chronic health problems. She was also managing that year’s annual media prize at a San Diego university that she and her husband established after the death of their adult son several years before.

“I was busy with that, and it is a bittersweet experience,” she says.

She is trying to take her cardiologist’s advice to slow down.

“I used to be notorious for saying, ‘I need to get one more thing done,’” she says.

Joanie Simpson says she, too, has slowed down. She was diagnosed with broken heart in 2016, after a cascade of stressful events. Her son was facing back surgery, her son-in-law had lost his job, and her tiny Yorkshire terrier Meha died. And she and her husband, Benny, had issues with their rental property.

Now 66 and retired in Camp Wood, Texas, she has learned to enjoy life and worry a little less. Music is one way.

“We’re Parrotheads,” she says, referencing the nickname given to fans of singer Jimmy Buffett. “We listen to Buffett and to ’60s, ’70s, ’80s music. We dance around the house. We aren’t big tavern goers, so we dance around the living room and hope we don’t fall over the coffee table. So far, so good.”

They have plans to buy a small pontoon boat and go fishing. Benny especially loves that idea, she says, laughing, as he finds it’s the only time she stops talking.
 

Reducing the what-ifs

Patients have a common question and worry: What if it happens again?

“I definitely worried more about it in the beginning,” Dr. Kamil says. “Could I have permanent heart damage? Will I be a cardiac cripple?” Her worry has eased.

If you suspect the condition, ‘’get yourself to a provider who knows about it,” she says.

Cardiologists are very likely to suspect the condition, Dr. Bybee says, as are doctors working in a large-volume emergency department.

Dr. Stevens, of St. Luke’s, is straightforward, telling her patients what is known and what is not about the condition. She recommends her patients go to cardiac rehab.

“It gives them that confidence to know what they can do,” she says.

She also gives lifestyle advice, suggesting patients get a home blood pressure cuff and use it. She suggests paying attention to good nutrition and exercise and not lifting anything so heavy that grunting is necessary.

Focus on protecting heart health, Dr. Cheng tells patients. She encourages them to find the stress reduction plan that works for them. Most important, she tells patients to understand that it is not their fault.

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

As a pediatric kidney doctor, Elaine S. Kamil, MD, is used to long hours helping children and teens with a variety of issues, some very serious, and also makes time to give back to her specialty.

In late 2013, she was in Washington, D.C., planning a meeting of the American Society of Nephrology. When the organizers decided at the last minute that another session was needed, she stayed late, putting it together. Then she hopped on a plane and returned home to Los Angeles on a Saturday night.

Right after midnight, Dr. Kamil knew something was wrong.

“I had really severe chest pain,” she says. “I have reflux, and I know what that feels like. This was much more intense. It really hurt.” She debated: “Should I wake up my husband?”

Soon, the pain got so bad, she had to.

At the hospital, an electrocardiogram was slightly abnormal, as was a blood test that measures damage to the heart. Next, she got an angiogram, an imaging technique to visualize the heart. Once doctors looked at the image on the screen during the angiogram, they knew the diagnosis: Broken heart syndrome, known medically as takotsubo cardiomyopathy or stress-induced cardiomyopathy. As the name suggests, it’s triggered by extreme stress or loss.

The common symptoms are chest pain that can seem to come from a heart attack, shortness of breath, and fainting. The telltale clue to the diagnosis is the appearance of the walls of the heart’s left ventricle, its main pumping chamber. When the condition is present, the left ventricle changes shape, developing a narrow neck and a round bottom, resembling an octopus pot called takotsubo used by fishermen in Japan, where the condition was first recognized in 1990.

Like most who are affected, Dr. Kamil, now 74, is fine now. She is still actively working, as a researcher and professor emerita at Cedars-Sinai Medical Center and a health sciences clinical professor of pediatrics at UCLA. But she focuses more now on stress reduction.
 

Study: condition on the rise

New research from Cedars-Sinai suggests that broken heart syndrome, while still not common, is not as rare as once thought. And it’s on the rise, especially among middle-age and older women.

This ‘’middle” group – women ages 50 to 74 – had the greatest rate of increase over the years studied, 2006-2017, says Susan Cheng, MD, lead author of the study, published in the Journal of the American Heart Association. She is the director of the Institute for Research on Healthy Aging at the Smidt Heart Institute at Cedars-Sinai Medical Center.

Dr. Cheng and her team used national hospital inpatient data collected from more than 135,000 men and women diagnosed with the condition during the 12 years of the study. More than 88% of all cases were women, especially in those age 50 or older. When the researchers looked more closely, they found the diagnosis has been increasing at least 6 to 10 times more rapidly for women in the 50-to-74 age group than in any other group.

For every case of the condition in younger women, or in men of all age groups, the researchers found an additional 10 cases for middle-aged women and six additional cases for older women. For example, while the syndrome occurred in 15 younger women per million per year, it occurred in 128 middle aged women per year.

The age groups found most at risk was surprising, says Dr. Cheng, who expected the risk would be highest in the oldest age group of women, those over 75.

While doctors are more aware of the condition now, “it’s not just the increased recognition,” she says. “There is something going on” driving the continual increase. It probably has something to do with environmental changes, she says.

Hormones and hormonal differences between men and women aren’t the whole story either, she says. Her team will study it further, hoping eventually to find who might be more likely to get the condition by talking to those who have had it and collecting clues. “There probably is some underlying genetic predisposition,” she says.

“The neural hormones that drive the flight-or-fight response (such as adrenaline) are definitely elevated,” she says. “The brain and the heart are talking to each other.”

Experts say these surging stress hormones essentially “stun” the heart, affecting how it functions. The question is, what makes women particularly more susceptible to being excessively triggered when exposed to stress? That is unclear, Dr. Cheng says.

While the condition is a frightening experience, ‘’the overall prognosis is much better than having a garden-variety heart attack,” she says.

But researchers are still figuring out long-term outcomes, and she can’t tell patients if they are likely to have another episode.
 

Research findings reflected in practice

Other cardiologists say they are not surprised by the new findings.

“I think it’s very consistent with what I am seeing clinically,” says Tracy Stevens, MD, a cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, MO. In the last 5 years, she has diagnosed at least 100 cases, she says. The increase is partly but not entirely due to increased awareness by doctors of the condition, she agrees.

If a postmenopausal woman comes to the hospital with chest pain, the condition is more likely now than in the past to be suspected, says Dr. Stevens, who’s also the medical director of the Muriel I. Kauffman Women’s Heart Center at Saint Luke’s. The octopus pot-like image is hard to miss.

“What we see at the base of the left ventricle is, it is squeezing like crazy, it is ballooning.”

“We probably see at least five to ten a month,” says Kevin Bybee, MD, an associate professor of medicine at the University of Missouri-Kansas City School of Medicine.

The increase in numbers found by the Los Angeles researchers may not even capture the true picture of how many people have gotten this condition, he says. He suspects some women whose deaths are blamed on sudden cardiac death might actually have had broken heart syndrome.

“I have always wondered how many don’t make it to the hospital.”

Dr. Bybee, who’s also medical director of cardiovascular services at St. Luke’s South in Overland Park, KS, became interested in the syndrome during his fellowship at Mayo Clinic when he diagnosed three patients in just 2 months. He and his team published the case histories of seven patients in 2004. Since then, many more reports have been published.

Researchers from Texas used the same national database as the Cedars researchers to look at cases from 2005 to 2014, and also found an increase. But study co-author Abhijeet Dhoble, MD, a cardiologist and associate professor of medicine at UT Health Science Center and Memorial Hermann-Texas Medical Center in Houston, believes more recognition explains most of the increase.

And the pandemic is now playing a role in driving up cases, he says.

“In the last 2 years, we have been noticing increasing numbers of cases, probably due to the pandemic,” he says.
 

Profiles of cases

Over the years, Dr. Bybee has collected information on what is happening before the heart begins to go haywire.

“Fifteen to twenty percent of the time, there is no obvious trigger,” he says.

Other times, a stressful emotional event, such as the death of a spouse or a severe car accident, can trigger it.

One patient with an extreme fear of public speaking had to give a talk in front of a large group when she was new to a job. Another woman lost money at a casino before it happened, Dr. Bybee says. Yet another patient took her dog out for a walk in the woods, and the dog got caught in a raccoon trap.

Fierce arguments as well as surprise parties have triggered the condition, Dr. Bybee says. Physical problems such as asthma or sepsis, a life-threatening complication of an infection, can also trigger broken heart.

“It’s challenging because this is unpredictable,” he says.
 

Treatments and recovery

The condition is rarely fatal, say experts from Harvard and Mayo Clinic, but some can have complications such as heart failure.

There are no standard guidelines for treatment, Dr. Dhoble, of Memorial Hermann, says. “We give medications to keep blood pressures in the optimal range.” Doctors may also prescribe lipid-lowering medicines and blood thinner medications. “Most patients recover within 3 to 7 days.”

“Usually within a month, their [heart] function returns to normal,” Dr. Stevens says.

Getting one’s full energy back can take longer, as Dr. Kamil found. “It was about 6 months before I was up to speed.”
 

Survivors talk

Looking back, Dr. Kamil realizes now how much stress she was under before her episode.

“I took care of chronically ill kids,” she says, and worried about them. “I’m kind of a mother hen.”

Besides patient care and her cross-county meeting planning, she was flying back and forth to Florida to tend to her mother, who had chronic health problems. She was also managing that year’s annual media prize at a San Diego university that she and her husband established after the death of their adult son several years before.

“I was busy with that, and it is a bittersweet experience,” she says.

She is trying to take her cardiologist’s advice to slow down.

“I used to be notorious for saying, ‘I need to get one more thing done,’” she says.

Joanie Simpson says she, too, has slowed down. She was diagnosed with broken heart in 2016, after a cascade of stressful events. Her son was facing back surgery, her son-in-law had lost his job, and her tiny Yorkshire terrier Meha died. And she and her husband, Benny, had issues with their rental property.

Now 66 and retired in Camp Wood, Texas, she has learned to enjoy life and worry a little less. Music is one way.

“We’re Parrotheads,” she says, referencing the nickname given to fans of singer Jimmy Buffett. “We listen to Buffett and to ’60s, ’70s, ’80s music. We dance around the house. We aren’t big tavern goers, so we dance around the living room and hope we don’t fall over the coffee table. So far, so good.”

They have plans to buy a small pontoon boat and go fishing. Benny especially loves that idea, she says, laughing, as he finds it’s the only time she stops talking.
 

Reducing the what-ifs

Patients have a common question and worry: What if it happens again?

“I definitely worried more about it in the beginning,” Dr. Kamil says. “Could I have permanent heart damage? Will I be a cardiac cripple?” Her worry has eased.

If you suspect the condition, ‘’get yourself to a provider who knows about it,” she says.

Cardiologists are very likely to suspect the condition, Dr. Bybee says, as are doctors working in a large-volume emergency department.

Dr. Stevens, of St. Luke’s, is straightforward, telling her patients what is known and what is not about the condition. She recommends her patients go to cardiac rehab.

“It gives them that confidence to know what they can do,” she says.

She also gives lifestyle advice, suggesting patients get a home blood pressure cuff and use it. She suggests paying attention to good nutrition and exercise and not lifting anything so heavy that grunting is necessary.

Focus on protecting heart health, Dr. Cheng tells patients. She encourages them to find the stress reduction plan that works for them. Most important, she tells patients to understand that it is not their fault.

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

As a pediatric kidney doctor, Elaine S. Kamil, MD, is used to long hours helping children and teens with a variety of issues, some very serious, and also makes time to give back to her specialty.

In late 2013, she was in Washington, D.C., planning a meeting of the American Society of Nephrology. When the organizers decided at the last minute that another session was needed, she stayed late, putting it together. Then she hopped on a plane and returned home to Los Angeles on a Saturday night.

Right after midnight, Dr. Kamil knew something was wrong.

“I had really severe chest pain,” she says. “I have reflux, and I know what that feels like. This was much more intense. It really hurt.” She debated: “Should I wake up my husband?”

Soon, the pain got so bad, she had to.

At the hospital, an electrocardiogram was slightly abnormal, as was a blood test that measures damage to the heart. Next, she got an angiogram, an imaging technique to visualize the heart. Once doctors looked at the image on the screen during the angiogram, they knew the diagnosis: Broken heart syndrome, known medically as takotsubo cardiomyopathy or stress-induced cardiomyopathy. As the name suggests, it’s triggered by extreme stress or loss.

The common symptoms are chest pain that can seem to come from a heart attack, shortness of breath, and fainting. The telltale clue to the diagnosis is the appearance of the walls of the heart’s left ventricle, its main pumping chamber. When the condition is present, the left ventricle changes shape, developing a narrow neck and a round bottom, resembling an octopus pot called takotsubo used by fishermen in Japan, where the condition was first recognized in 1990.

Like most who are affected, Dr. Kamil, now 74, is fine now. She is still actively working, as a researcher and professor emerita at Cedars-Sinai Medical Center and a health sciences clinical professor of pediatrics at UCLA. But she focuses more now on stress reduction.
 

Study: condition on the rise

New research from Cedars-Sinai suggests that broken heart syndrome, while still not common, is not as rare as once thought. And it’s on the rise, especially among middle-age and older women.

This ‘’middle” group – women ages 50 to 74 – had the greatest rate of increase over the years studied, 2006-2017, says Susan Cheng, MD, lead author of the study, published in the Journal of the American Heart Association. She is the director of the Institute for Research on Healthy Aging at the Smidt Heart Institute at Cedars-Sinai Medical Center.

Dr. Cheng and her team used national hospital inpatient data collected from more than 135,000 men and women diagnosed with the condition during the 12 years of the study. More than 88% of all cases were women, especially in those age 50 or older. When the researchers looked more closely, they found the diagnosis has been increasing at least 6 to 10 times more rapidly for women in the 50-to-74 age group than in any other group.

For every case of the condition in younger women, or in men of all age groups, the researchers found an additional 10 cases for middle-aged women and six additional cases for older women. For example, while the syndrome occurred in 15 younger women per million per year, it occurred in 128 middle aged women per year.

The age groups found most at risk was surprising, says Dr. Cheng, who expected the risk would be highest in the oldest age group of women, those over 75.

While doctors are more aware of the condition now, “it’s not just the increased recognition,” she says. “There is something going on” driving the continual increase. It probably has something to do with environmental changes, she says.

Hormones and hormonal differences between men and women aren’t the whole story either, she says. Her team will study it further, hoping eventually to find who might be more likely to get the condition by talking to those who have had it and collecting clues. “There probably is some underlying genetic predisposition,” she says.

“The neural hormones that drive the flight-or-fight response (such as adrenaline) are definitely elevated,” she says. “The brain and the heart are talking to each other.”

Experts say these surging stress hormones essentially “stun” the heart, affecting how it functions. The question is, what makes women particularly more susceptible to being excessively triggered when exposed to stress? That is unclear, Dr. Cheng says.

While the condition is a frightening experience, ‘’the overall prognosis is much better than having a garden-variety heart attack,” she says.

But researchers are still figuring out long-term outcomes, and she can’t tell patients if they are likely to have another episode.
 

Research findings reflected in practice

Other cardiologists say they are not surprised by the new findings.

“I think it’s very consistent with what I am seeing clinically,” says Tracy Stevens, MD, a cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, MO. In the last 5 years, she has diagnosed at least 100 cases, she says. The increase is partly but not entirely due to increased awareness by doctors of the condition, she agrees.

If a postmenopausal woman comes to the hospital with chest pain, the condition is more likely now than in the past to be suspected, says Dr. Stevens, who’s also the medical director of the Muriel I. Kauffman Women’s Heart Center at Saint Luke’s. The octopus pot-like image is hard to miss.

“What we see at the base of the left ventricle is, it is squeezing like crazy, it is ballooning.”

“We probably see at least five to ten a month,” says Kevin Bybee, MD, an associate professor of medicine at the University of Missouri-Kansas City School of Medicine.

The increase in numbers found by the Los Angeles researchers may not even capture the true picture of how many people have gotten this condition, he says. He suspects some women whose deaths are blamed on sudden cardiac death might actually have had broken heart syndrome.

“I have always wondered how many don’t make it to the hospital.”

Dr. Bybee, who’s also medical director of cardiovascular services at St. Luke’s South in Overland Park, KS, became interested in the syndrome during his fellowship at Mayo Clinic when he diagnosed three patients in just 2 months. He and his team published the case histories of seven patients in 2004. Since then, many more reports have been published.

Researchers from Texas used the same national database as the Cedars researchers to look at cases from 2005 to 2014, and also found an increase. But study co-author Abhijeet Dhoble, MD, a cardiologist and associate professor of medicine at UT Health Science Center and Memorial Hermann-Texas Medical Center in Houston, believes more recognition explains most of the increase.

And the pandemic is now playing a role in driving up cases, he says.

“In the last 2 years, we have been noticing increasing numbers of cases, probably due to the pandemic,” he says.
 

Profiles of cases

Over the years, Dr. Bybee has collected information on what is happening before the heart begins to go haywire.

“Fifteen to twenty percent of the time, there is no obvious trigger,” he says.

Other times, a stressful emotional event, such as the death of a spouse or a severe car accident, can trigger it.

One patient with an extreme fear of public speaking had to give a talk in front of a large group when she was new to a job. Another woman lost money at a casino before it happened, Dr. Bybee says. Yet another patient took her dog out for a walk in the woods, and the dog got caught in a raccoon trap.

Fierce arguments as well as surprise parties have triggered the condition, Dr. Bybee says. Physical problems such as asthma or sepsis, a life-threatening complication of an infection, can also trigger broken heart.

“It’s challenging because this is unpredictable,” he says.
 

Treatments and recovery

The condition is rarely fatal, say experts from Harvard and Mayo Clinic, but some can have complications such as heart failure.

There are no standard guidelines for treatment, Dr. Dhoble, of Memorial Hermann, says. “We give medications to keep blood pressures in the optimal range.” Doctors may also prescribe lipid-lowering medicines and blood thinner medications. “Most patients recover within 3 to 7 days.”

“Usually within a month, their [heart] function returns to normal,” Dr. Stevens says.

Getting one’s full energy back can take longer, as Dr. Kamil found. “It was about 6 months before I was up to speed.”
 

Survivors talk

Looking back, Dr. Kamil realizes now how much stress she was under before her episode.

“I took care of chronically ill kids,” she says, and worried about them. “I’m kind of a mother hen.”

Besides patient care and her cross-county meeting planning, she was flying back and forth to Florida to tend to her mother, who had chronic health problems. She was also managing that year’s annual media prize at a San Diego university that she and her husband established after the death of their adult son several years before.

“I was busy with that, and it is a bittersweet experience,” she says.

She is trying to take her cardiologist’s advice to slow down.

“I used to be notorious for saying, ‘I need to get one more thing done,’” she says.

Joanie Simpson says she, too, has slowed down. She was diagnosed with broken heart in 2016, after a cascade of stressful events. Her son was facing back surgery, her son-in-law had lost his job, and her tiny Yorkshire terrier Meha died. And she and her husband, Benny, had issues with their rental property.

Now 66 and retired in Camp Wood, Texas, she has learned to enjoy life and worry a little less. Music is one way.

“We’re Parrotheads,” she says, referencing the nickname given to fans of singer Jimmy Buffett. “We listen to Buffett and to ’60s, ’70s, ’80s music. We dance around the house. We aren’t big tavern goers, so we dance around the living room and hope we don’t fall over the coffee table. So far, so good.”

They have plans to buy a small pontoon boat and go fishing. Benny especially loves that idea, she says, laughing, as he finds it’s the only time she stops talking.
 

Reducing the what-ifs

Patients have a common question and worry: What if it happens again?

“I definitely worried more about it in the beginning,” Dr. Kamil says. “Could I have permanent heart damage? Will I be a cardiac cripple?” Her worry has eased.

If you suspect the condition, ‘’get yourself to a provider who knows about it,” she says.

Cardiologists are very likely to suspect the condition, Dr. Bybee says, as are doctors working in a large-volume emergency department.

Dr. Stevens, of St. Luke’s, is straightforward, telling her patients what is known and what is not about the condition. She recommends her patients go to cardiac rehab.

“It gives them that confidence to know what they can do,” she says.

She also gives lifestyle advice, suggesting patients get a home blood pressure cuff and use it. She suggests paying attention to good nutrition and exercise and not lifting anything so heavy that grunting is necessary.

Focus on protecting heart health, Dr. Cheng tells patients. She encourages them to find the stress reduction plan that works for them. Most important, she tells patients to understand that it is not their fault.

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

The Food and Drug Administration has approved a modification to the isotretinoin risk-mitigation program to make it more inclusive for transgender patients.

Beginning on Dec. 13, 2021, patients prescribed isotretinoin for acne will be assigned to one of two risk categories – those who can get pregnant and those who cannot for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). Previously, there were three risk categories: females of reproductive potential, females not of reproductive potential, and males.

In recent years, dermatologists and others have advocated for the change, hoping to make the process more inclusive and less intrusive for their transgender patients.

Isotretinoin (Accutane, Absorica, Amnesteem, Claravis, others) has a high risk of severe birth defects, and has been linked with other health issues, making it crucial for those with the ability to become pregnant to take contraceptive precautions while on the medication. Under the iPLEDGE program, physicians, patients, and pharmacies prescribing, using, or dispensing the drug must all be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy testing for patients who can become pregnant.

The FDA had given notification in June 2018 that the REMS modification and labeling change would be required, replacing the gender-specific language with gender-neutral language, according to an FDA spokesperson. The change was based on feedback that the gender-specific language can be a barrier to access for some patients. The FDA approved the modification on Oct. 8.
 

Expert reactions

“This is an exciting and welcome change from the FDA on iPLEDGE that many dermatologists, myself included, have advocated for quite a few years,” Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, said in an interview.

In a report on the dermatologic care for lesbian, gay, bisexual, and transgender persons published in the Journal of the American Academy of Dermatology, Dr. Yeung and his colleagues noted that more than 10 million lesbian, gay, bisexual and transgender people live in the United States and that improving their health is a public health priority.

“For cisgender patients, nothing has changed – patients will continue to receive appropriate educational material related to isotretinoin based on their pregnancy potential,” Dr. Yeung said. “For transgender and gender diverse patients, this is a huge step forward.”

Under the previous system, doctors were asked to register patients using gender binary categories, “which were confusing when they did not reflect reality” for these patients, Dr. Yeung said. The new system, Dr. Yeung added, “will make my job easier. I no longer have to struggle between respecting the patient’s gender identity and providing medically necessary care for patients with severe acne.”

“The new terminology is not just respectful, it also is simpler and makes more sense,” agreed Joshua D. Safer, MD, executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai, New York. “As it stood, a transgender man with his uterus and ovaries in place might be missed in the pregnancy surveillance system because he could simply be labeled a man and not followed further. At the same time, both transgender women and cisgender women who were at no risk of pregnancy could be subject to more medical scrutiny that might have been consider intrusive.”

The change “validates the important point that pregnancy potential is not exclusively defined by sociocultural constructs of gender and allow dermatologists to focus purely on what matters when prescribing isotretinoin – whether an individual is able to become pregnant or not, regardless of their gender identity,” Klint Peebles, MD, a dermatologist at Kaiser Permanente in Washington, D.C., and suburban Maryland, who has also advocated for the change, said in an interview.

 

FDA elaborates

The modification includes important changes for doctors, pharmacists, and patients alike, according to the FDA.

Health care providers must assign and confirm their currently enrolled patient’s risk category when they first log in to the IPLEDGE REMS website on or after Dec. 13, the effective date. They should be sure any patient whose prescription RMA (iPLEDGE authorization) expires on Dec. 11-12 is told to obtain their prescription before midnight, Eastern time, Dec. 10.

Pharmacists will be affected, too, since the iPLEDGE REMS changed to a new platform vendor and the current “switch” pharmacy management system will be removed as a method to verify authorization to dispense isotretinoin. With these changes, as of Dec. 13, pharmacists can’t use the switch system to obtain a predispense authorization, or RMA (risk management authorization). They will need to obtain an RMA online by accessing the iPLEDGE REMS website or via telephone to the PLEDGE REMS center, 866-495-0654, before dispensing the prescription.

Patients, beginning Dec. 13, will have the option of presenting a unique QR code at the pharmacy on their smartphone rather than providing the iPLEDGE identification number. The code can be accessed by logging into their account on the iPLEDGE REMS website.

Patients with an isotretinoin prescription RMA that expires Dec. 11-12, must obtain the prescription before 11:59 p.m. Eastern time on Dec. 10. If the RMA expires before the prescription is picked up, the patient must begin the authorization process all over again.

Dr. Safer, Dr. Yeung, and Dr. Peebles have no relevant disclosures.

More information on the update and the isotretinoin REMS program is available on the FDA website.

The Food and Drug Administration has approved a modification to the isotretinoin risk-mitigation program to make it more inclusive for transgender patients.

Beginning on Dec. 13, 2021, patients prescribed isotretinoin for acne will be assigned to one of two risk categories – those who can get pregnant and those who cannot for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). Previously, there were three risk categories: females of reproductive potential, females not of reproductive potential, and males.

In recent years, dermatologists and others have advocated for the change, hoping to make the process more inclusive and less intrusive for their transgender patients.

Isotretinoin (Accutane, Absorica, Amnesteem, Claravis, others) has a high risk of severe birth defects, and has been linked with other health issues, making it crucial for those with the ability to become pregnant to take contraceptive precautions while on the medication. Under the iPLEDGE program, physicians, patients, and pharmacies prescribing, using, or dispensing the drug must all be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy testing for patients who can become pregnant.

The FDA had given notification in June 2018 that the REMS modification and labeling change would be required, replacing the gender-specific language with gender-neutral language, according to an FDA spokesperson. The change was based on feedback that the gender-specific language can be a barrier to access for some patients. The FDA approved the modification on Oct. 8.
 

Expert reactions

“This is an exciting and welcome change from the FDA on iPLEDGE that many dermatologists, myself included, have advocated for quite a few years,” Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, said in an interview.

In a report on the dermatologic care for lesbian, gay, bisexual, and transgender persons published in the Journal of the American Academy of Dermatology, Dr. Yeung and his colleagues noted that more than 10 million lesbian, gay, bisexual and transgender people live in the United States and that improving their health is a public health priority.

“For cisgender patients, nothing has changed – patients will continue to receive appropriate educational material related to isotretinoin based on their pregnancy potential,” Dr. Yeung said. “For transgender and gender diverse patients, this is a huge step forward.”

Under the previous system, doctors were asked to register patients using gender binary categories, “which were confusing when they did not reflect reality” for these patients, Dr. Yeung said. The new system, Dr. Yeung added, “will make my job easier. I no longer have to struggle between respecting the patient’s gender identity and providing medically necessary care for patients with severe acne.”

“The new terminology is not just respectful, it also is simpler and makes more sense,” agreed Joshua D. Safer, MD, executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai, New York. “As it stood, a transgender man with his uterus and ovaries in place might be missed in the pregnancy surveillance system because he could simply be labeled a man and not followed further. At the same time, both transgender women and cisgender women who were at no risk of pregnancy could be subject to more medical scrutiny that might have been consider intrusive.”

The change “validates the important point that pregnancy potential is not exclusively defined by sociocultural constructs of gender and allow dermatologists to focus purely on what matters when prescribing isotretinoin – whether an individual is able to become pregnant or not, regardless of their gender identity,” Klint Peebles, MD, a dermatologist at Kaiser Permanente in Washington, D.C., and suburban Maryland, who has also advocated for the change, said in an interview.

 

FDA elaborates

The modification includes important changes for doctors, pharmacists, and patients alike, according to the FDA.

Health care providers must assign and confirm their currently enrolled patient’s risk category when they first log in to the IPLEDGE REMS website on or after Dec. 13, the effective date. They should be sure any patient whose prescription RMA (iPLEDGE authorization) expires on Dec. 11-12 is told to obtain their prescription before midnight, Eastern time, Dec. 10.

Pharmacists will be affected, too, since the iPLEDGE REMS changed to a new platform vendor and the current “switch” pharmacy management system will be removed as a method to verify authorization to dispense isotretinoin. With these changes, as of Dec. 13, pharmacists can’t use the switch system to obtain a predispense authorization, or RMA (risk management authorization). They will need to obtain an RMA online by accessing the iPLEDGE REMS website or via telephone to the PLEDGE REMS center, 866-495-0654, before dispensing the prescription.

Patients, beginning Dec. 13, will have the option of presenting a unique QR code at the pharmacy on their smartphone rather than providing the iPLEDGE identification number. The code can be accessed by logging into their account on the iPLEDGE REMS website.

Patients with an isotretinoin prescription RMA that expires Dec. 11-12, must obtain the prescription before 11:59 p.m. Eastern time on Dec. 10. If the RMA expires before the prescription is picked up, the patient must begin the authorization process all over again.

Dr. Safer, Dr. Yeung, and Dr. Peebles have no relevant disclosures.

More information on the update and the isotretinoin REMS program is available on the FDA website.

The Food and Drug Administration has approved a modification to the isotretinoin risk-mitigation program to make it more inclusive for transgender patients.

Beginning on Dec. 13, 2021, patients prescribed isotretinoin for acne will be assigned to one of two risk categories – those who can get pregnant and those who cannot for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). Previously, there were three risk categories: females of reproductive potential, females not of reproductive potential, and males.

In recent years, dermatologists and others have advocated for the change, hoping to make the process more inclusive and less intrusive for their transgender patients.

Isotretinoin (Accutane, Absorica, Amnesteem, Claravis, others) has a high risk of severe birth defects, and has been linked with other health issues, making it crucial for those with the ability to become pregnant to take contraceptive precautions while on the medication. Under the iPLEDGE program, physicians, patients, and pharmacies prescribing, using, or dispensing the drug must all be registered, with requirements that include the use of two forms of an effective contraceptive and regular pregnancy testing for patients who can become pregnant.

The FDA had given notification in June 2018 that the REMS modification and labeling change would be required, replacing the gender-specific language with gender-neutral language, according to an FDA spokesperson. The change was based on feedback that the gender-specific language can be a barrier to access for some patients. The FDA approved the modification on Oct. 8.
 

Expert reactions

“This is an exciting and welcome change from the FDA on iPLEDGE that many dermatologists, myself included, have advocated for quite a few years,” Howa Yeung, MD, MSc, assistant professor of dermatology at Emory University, Atlanta, said in an interview.

In a report on the dermatologic care for lesbian, gay, bisexual, and transgender persons published in the Journal of the American Academy of Dermatology, Dr. Yeung and his colleagues noted that more than 10 million lesbian, gay, bisexual and transgender people live in the United States and that improving their health is a public health priority.

“For cisgender patients, nothing has changed – patients will continue to receive appropriate educational material related to isotretinoin based on their pregnancy potential,” Dr. Yeung said. “For transgender and gender diverse patients, this is a huge step forward.”

Under the previous system, doctors were asked to register patients using gender binary categories, “which were confusing when they did not reflect reality” for these patients, Dr. Yeung said. The new system, Dr. Yeung added, “will make my job easier. I no longer have to struggle between respecting the patient’s gender identity and providing medically necessary care for patients with severe acne.”

“The new terminology is not just respectful, it also is simpler and makes more sense,” agreed Joshua D. Safer, MD, executive director of the Center for Transgender Medicine and Surgery at Mount Sinai Health System and professor of medicine at the Icahn School of Medicine at Mount Sinai, New York. “As it stood, a transgender man with his uterus and ovaries in place might be missed in the pregnancy surveillance system because he could simply be labeled a man and not followed further. At the same time, both transgender women and cisgender women who were at no risk of pregnancy could be subject to more medical scrutiny that might have been consider intrusive.”

The change “validates the important point that pregnancy potential is not exclusively defined by sociocultural constructs of gender and allow dermatologists to focus purely on what matters when prescribing isotretinoin – whether an individual is able to become pregnant or not, regardless of their gender identity,” Klint Peebles, MD, a dermatologist at Kaiser Permanente in Washington, D.C., and suburban Maryland, who has also advocated for the change, said in an interview.

 

FDA elaborates

The modification includes important changes for doctors, pharmacists, and patients alike, according to the FDA.

Health care providers must assign and confirm their currently enrolled patient’s risk category when they first log in to the IPLEDGE REMS website on or after Dec. 13, the effective date. They should be sure any patient whose prescription RMA (iPLEDGE authorization) expires on Dec. 11-12 is told to obtain their prescription before midnight, Eastern time, Dec. 10.

Pharmacists will be affected, too, since the iPLEDGE REMS changed to a new platform vendor and the current “switch” pharmacy management system will be removed as a method to verify authorization to dispense isotretinoin. With these changes, as of Dec. 13, pharmacists can’t use the switch system to obtain a predispense authorization, or RMA (risk management authorization). They will need to obtain an RMA online by accessing the iPLEDGE REMS website or via telephone to the PLEDGE REMS center, 866-495-0654, before dispensing the prescription.

Patients, beginning Dec. 13, will have the option of presenting a unique QR code at the pharmacy on their smartphone rather than providing the iPLEDGE identification number. The code can be accessed by logging into their account on the iPLEDGE REMS website.

Patients with an isotretinoin prescription RMA that expires Dec. 11-12, must obtain the prescription before 11:59 p.m. Eastern time on Dec. 10. If the RMA expires before the prescription is picked up, the patient must begin the authorization process all over again.

Dr. Safer, Dr. Yeung, and Dr. Peebles have no relevant disclosures.

More information on the update and the isotretinoin REMS program is available on the FDA website.

Soon after Merck announced on Oct. 1 that it would ask federal regulators for emergency use authorization (EUA) for its auspicious new COVID-19 pill, the accolades began.

Former Food and Drug Administration chief Scott Gottlieb, MD, told CNBC the drug was “a profound game changer.” Top infectious disease expert Anthony S. Fauci, MD, called the early data “impressive.” The World Health Organization termed it “certainly good news,” while saying it awaits more data.

Merck, partnering with Ridgeback Biotherapeutics on the investigational oral antiviral medicine molnupiravir, plans to submit applications to regulatory agencies worldwide, hoping to deliver the first oral antiviral medication for COVID-19. 

Interim clinical trial results show that the drug may slash the risk for hospitalization or death by 50% in those with mild to moderate COVID-19.

When the results were found to be so favorable, the study was halted at the recommendation of an independent data-monitoring committee and in consultation with the FDA.

That initial enthusiasm is now tempered with some perspective on the pros and cons. “This anticipated drug has gotten a little more hype than it deserves,” said William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn. He and others suggest a reality check.

“It’s not exactly a home run, like penicillin for strep throat,” agreed Carl Fichtenbaum, MD, professor of infectious diseases at the University of Cincinnati, who is investigating a similar pill for a rival company, Atea, partnering with Roche. 

“But it is encouraging,” he said. “It will probably be an incremental improvement on what we have.” The fact that it can be taken at home is a plus: “Anything we can do to keep people from getting sicker is a good thing.”

“The data show in this higher risk group [those who were studied had at least one risk factor for severe COVID-19, such as age or a medical condition], it reduces the risk of advancing to severe disease by 50%,” Dr. Schaffner said. While that’s a clear benefit for half, it of course leaves the other half without benefit, he said.

Others critiqued the predicted cost of the drug. The U.S. government has already agreed to pay about $700 per patient, according to a new report from Harvard T. H. Chan School of Public Health, Boston, and King’s College Hospital, London. That analysis concluded that the actual cost of production for the 5-day course is $17.74.

“We fully expect that having an oral treatment that reduces the risk of hospitalizations will be significantly cost effective for society,” Melissa Moody, a Merck spokesperson, told this news organization. “We are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”

Merck expects to produce 10 million courses of treatment by the end of the year, with additional doses expected to be produced in 2022, according to a company press release. Earlier in 2021, Merck finalized its agreement with the U.S. government to supply about 1.7 million courses of the drug at the $700 price, once an EUA or FDA approval is given.

Merck also has supply and purchase agreements with other governments worldwide, pending regulatory approval.
 

Study details

Details about the study findings came from a Merck press release. In the planned interim analysis, Merck and Ridgeback evaluated data from 775 patients initially enrolled in the phase 3 MOVe-OUT trial.

All adults had lab-confirmed mild to moderate COVID-19, and reported onset of symptoms within 5 days of being randomly assigned to the drug or placebo. All had at least one risk factor linked with poor disease outcome (such as older age or obesity).

The drug is a ribonucleoside and works by creating mutations in the virus’s genome, halting the ability of the virus to replicate.

Through day 29 of the study, the drug reduced the risk or hospitalization or death by about 50%. While 7.3% of those who received the drug either died or were hospitalized by day 29, 14.1% of those on placebo did, a statistically significant difference (P = .0012).

Side effects were similar in both groups, with 35% of the drug-treated and 40% of the placebo group reporting some side effect, Merck reported. Adverse drug-related events were 12% in the drug group and 11% in the placebo group. While 1.3% of the drug-treated group quit the study because of an adverse event, 3.4% of the placebo group quit.
 

Pros, cons, and unknowns

The ability to take the drug orally, and at home, is a definite plus, Dr. Schaffner said,  compared with the monoclonal antibody treatment currently approved that must be given intravenously or subcutaneously and in certain locations.

More people could be reached and helped with the option of an at-home, oral medicine, he and others agreed.

The regimen for molnupiravir is four pills, two times daily, for 5 days, even if symptoms are mild. As with other prescription drugs, “there will always be folks who don’t comply completely” with the prescribed regimen, Dr. Schaffner said. With this pill, that might be especially true if the symptoms are very mild.

The 50% reduction is not as effective as the benefit often quoted for monoclonal antibody treatment. In clinical trials of Regeneron’s monoclonal antibody treatment, the regimen reduced COVID-19–related hospitalization or death in high-risk patients by 70%.

Even so, the new pill could change the pandemic’s course, others say. “I think molnupiravir has the potential to change how we take care of people who have COVID and risk factors for developing severe disease,” Rajesh Tim Gandhi, MD, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization. 

“What we’ll need to do, however, is make sure that people get tested quickly after they develop symptoms and, if they’re confirmed to have COVID, start on the pills within 5 days of developing symptoms,” he said, while warning that more data are needed about the drug and the trial results.

Another concern is that the promise of a pill will stall vaccination rates, with some people figuring why get vaccinated when they can obtain the pill if they do get sick.

Relying on treatment alone won’t work, Dr. Schaffner said. “Let’s [also] focus on prevention, which is the vaccine. We have to keep working both sides of the street.”

Dr. Gandhi added: “It’s important to remember that even though molnupiravir reduced the likelihood of hospitalization and death, a number of people who received the drug still got sick enough to end up in the hospital.”

Also unknown, he said, is how severe their disease was and whether they will develop long COVID.

The Merck study included only unvaccinated people. Might it work for those vaccinated people who get a breakthrough infection? “From a purely scientific perspective, there is no reason to believe molnupiravir would not work in people who are vaccinated, but the overall efficacy on top of the vaccine is likely dependent on how well they were able to mount a protective immune response to the vaccine,” Ms. Moody said. Still, Merck believes the pill could be of benefit for these infections too, she added.

As for the expected cost, Ms. Moody said that the company takes into account a number of factors in setting pricing, “but fundamentally we look at the impact of the disease, the benefits that the drug delivers to patients and to society, and at supporting ongoing drug development.”
 

On Merck’s heels: Pfizer, Roche, Atea

Pfizer is studying an antiviral pill, PF-07321332, a protease inhibitor that blocks the protease enzymes and halts replication of the virus.

In addition to studying the drug in infected patients at high risk of severe illness and in those at typical risk, Pfizer launched a phase 2-3 study in late September that will enroll people who live in the same household as a person with a confirmed, symptomatic COVID-19 infection to see if the drug can prevent disease in those who have been exposed.

Atea and Roche’s COVID pill, AT527, is in phase 3 trials as well. AT527 is an inhibitor of polymerase, an enzyme many viruses have, to stop replications. Atea is evaluating the drug to reduce disease “burden” and for both pre- and postexposure prevention.
 

Big picture: Role of COVID-19 pills

It may be necessary to target the coronavirus with more than one antiviral agent, said Dr. Fichtenbaum, a principal investigator for the AT527 trials. 

“Sometimes viruses require two or three active agents to control their replication,” he said, citing information gleaned from other viral research, such as HIV. For control of HIV infection, a cocktail or combination of antivirals is often recommended.

That may well be the case for COVID-19, Dr. Fichtenbaum said. The goal would be to attack the virus at more than one pathway.

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

Soon after Merck announced on Oct. 1 that it would ask federal regulators for emergency use authorization (EUA) for its auspicious new COVID-19 pill, the accolades began.

Former Food and Drug Administration chief Scott Gottlieb, MD, told CNBC the drug was “a profound game changer.” Top infectious disease expert Anthony S. Fauci, MD, called the early data “impressive.” The World Health Organization termed it “certainly good news,” while saying it awaits more data.

Merck, partnering with Ridgeback Biotherapeutics on the investigational oral antiviral medicine molnupiravir, plans to submit applications to regulatory agencies worldwide, hoping to deliver the first oral antiviral medication for COVID-19. 

Interim clinical trial results show that the drug may slash the risk for hospitalization or death by 50% in those with mild to moderate COVID-19.

When the results were found to be so favorable, the study was halted at the recommendation of an independent data-monitoring committee and in consultation with the FDA.

That initial enthusiasm is now tempered with some perspective on the pros and cons. “This anticipated drug has gotten a little more hype than it deserves,” said William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn. He and others suggest a reality check.

“It’s not exactly a home run, like penicillin for strep throat,” agreed Carl Fichtenbaum, MD, professor of infectious diseases at the University of Cincinnati, who is investigating a similar pill for a rival company, Atea, partnering with Roche. 

“But it is encouraging,” he said. “It will probably be an incremental improvement on what we have.” The fact that it can be taken at home is a plus: “Anything we can do to keep people from getting sicker is a good thing.”

“The data show in this higher risk group [those who were studied had at least one risk factor for severe COVID-19, such as age or a medical condition], it reduces the risk of advancing to severe disease by 50%,” Dr. Schaffner said. While that’s a clear benefit for half, it of course leaves the other half without benefit, he said.

Others critiqued the predicted cost of the drug. The U.S. government has already agreed to pay about $700 per patient, according to a new report from Harvard T. H. Chan School of Public Health, Boston, and King’s College Hospital, London. That analysis concluded that the actual cost of production for the 5-day course is $17.74.

“We fully expect that having an oral treatment that reduces the risk of hospitalizations will be significantly cost effective for society,” Melissa Moody, a Merck spokesperson, told this news organization. “We are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”

Merck expects to produce 10 million courses of treatment by the end of the year, with additional doses expected to be produced in 2022, according to a company press release. Earlier in 2021, Merck finalized its agreement with the U.S. government to supply about 1.7 million courses of the drug at the $700 price, once an EUA or FDA approval is given.

Merck also has supply and purchase agreements with other governments worldwide, pending regulatory approval.
 

Study details

Details about the study findings came from a Merck press release. In the planned interim analysis, Merck and Ridgeback evaluated data from 775 patients initially enrolled in the phase 3 MOVe-OUT trial.

All adults had lab-confirmed mild to moderate COVID-19, and reported onset of symptoms within 5 days of being randomly assigned to the drug or placebo. All had at least one risk factor linked with poor disease outcome (such as older age or obesity).

The drug is a ribonucleoside and works by creating mutations in the virus’s genome, halting the ability of the virus to replicate.

Through day 29 of the study, the drug reduced the risk or hospitalization or death by about 50%. While 7.3% of those who received the drug either died or were hospitalized by day 29, 14.1% of those on placebo did, a statistically significant difference (P = .0012).

Side effects were similar in both groups, with 35% of the drug-treated and 40% of the placebo group reporting some side effect, Merck reported. Adverse drug-related events were 12% in the drug group and 11% in the placebo group. While 1.3% of the drug-treated group quit the study because of an adverse event, 3.4% of the placebo group quit.
 

Pros, cons, and unknowns

The ability to take the drug orally, and at home, is a definite plus, Dr. Schaffner said,  compared with the monoclonal antibody treatment currently approved that must be given intravenously or subcutaneously and in certain locations.

More people could be reached and helped with the option of an at-home, oral medicine, he and others agreed.

The regimen for molnupiravir is four pills, two times daily, for 5 days, even if symptoms are mild. As with other prescription drugs, “there will always be folks who don’t comply completely” with the prescribed regimen, Dr. Schaffner said. With this pill, that might be especially true if the symptoms are very mild.

The 50% reduction is not as effective as the benefit often quoted for monoclonal antibody treatment. In clinical trials of Regeneron’s monoclonal antibody treatment, the regimen reduced COVID-19–related hospitalization or death in high-risk patients by 70%.

Even so, the new pill could change the pandemic’s course, others say. “I think molnupiravir has the potential to change how we take care of people who have COVID and risk factors for developing severe disease,” Rajesh Tim Gandhi, MD, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization. 

“What we’ll need to do, however, is make sure that people get tested quickly after they develop symptoms and, if they’re confirmed to have COVID, start on the pills within 5 days of developing symptoms,” he said, while warning that more data are needed about the drug and the trial results.

Another concern is that the promise of a pill will stall vaccination rates, with some people figuring why get vaccinated when they can obtain the pill if they do get sick.

Relying on treatment alone won’t work, Dr. Schaffner said. “Let’s [also] focus on prevention, which is the vaccine. We have to keep working both sides of the street.”

Dr. Gandhi added: “It’s important to remember that even though molnupiravir reduced the likelihood of hospitalization and death, a number of people who received the drug still got sick enough to end up in the hospital.”

Also unknown, he said, is how severe their disease was and whether they will develop long COVID.

The Merck study included only unvaccinated people. Might it work for those vaccinated people who get a breakthrough infection? “From a purely scientific perspective, there is no reason to believe molnupiravir would not work in people who are vaccinated, but the overall efficacy on top of the vaccine is likely dependent on how well they were able to mount a protective immune response to the vaccine,” Ms. Moody said. Still, Merck believes the pill could be of benefit for these infections too, she added.

As for the expected cost, Ms. Moody said that the company takes into account a number of factors in setting pricing, “but fundamentally we look at the impact of the disease, the benefits that the drug delivers to patients and to society, and at supporting ongoing drug development.”
 

On Merck’s heels: Pfizer, Roche, Atea

Pfizer is studying an antiviral pill, PF-07321332, a protease inhibitor that blocks the protease enzymes and halts replication of the virus.

In addition to studying the drug in infected patients at high risk of severe illness and in those at typical risk, Pfizer launched a phase 2-3 study in late September that will enroll people who live in the same household as a person with a confirmed, symptomatic COVID-19 infection to see if the drug can prevent disease in those who have been exposed.

Atea and Roche’s COVID pill, AT527, is in phase 3 trials as well. AT527 is an inhibitor of polymerase, an enzyme many viruses have, to stop replications. Atea is evaluating the drug to reduce disease “burden” and for both pre- and postexposure prevention.
 

Big picture: Role of COVID-19 pills

It may be necessary to target the coronavirus with more than one antiviral agent, said Dr. Fichtenbaum, a principal investigator for the AT527 trials. 

“Sometimes viruses require two or three active agents to control their replication,” he said, citing information gleaned from other viral research, such as HIV. For control of HIV infection, a cocktail or combination of antivirals is often recommended.

That may well be the case for COVID-19, Dr. Fichtenbaum said. The goal would be to attack the virus at more than one pathway.

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

Soon after Merck announced on Oct. 1 that it would ask federal regulators for emergency use authorization (EUA) for its auspicious new COVID-19 pill, the accolades began.

Former Food and Drug Administration chief Scott Gottlieb, MD, told CNBC the drug was “a profound game changer.” Top infectious disease expert Anthony S. Fauci, MD, called the early data “impressive.” The World Health Organization termed it “certainly good news,” while saying it awaits more data.

Merck, partnering with Ridgeback Biotherapeutics on the investigational oral antiviral medicine molnupiravir, plans to submit applications to regulatory agencies worldwide, hoping to deliver the first oral antiviral medication for COVID-19. 

Interim clinical trial results show that the drug may slash the risk for hospitalization or death by 50% in those with mild to moderate COVID-19.

When the results were found to be so favorable, the study was halted at the recommendation of an independent data-monitoring committee and in consultation with the FDA.

That initial enthusiasm is now tempered with some perspective on the pros and cons. “This anticipated drug has gotten a little more hype than it deserves,” said William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn. He and others suggest a reality check.

“It’s not exactly a home run, like penicillin for strep throat,” agreed Carl Fichtenbaum, MD, professor of infectious diseases at the University of Cincinnati, who is investigating a similar pill for a rival company, Atea, partnering with Roche. 

“But it is encouraging,” he said. “It will probably be an incremental improvement on what we have.” The fact that it can be taken at home is a plus: “Anything we can do to keep people from getting sicker is a good thing.”

“The data show in this higher risk group [those who were studied had at least one risk factor for severe COVID-19, such as age or a medical condition], it reduces the risk of advancing to severe disease by 50%,” Dr. Schaffner said. While that’s a clear benefit for half, it of course leaves the other half without benefit, he said.

Others critiqued the predicted cost of the drug. The U.S. government has already agreed to pay about $700 per patient, according to a new report from Harvard T. H. Chan School of Public Health, Boston, and King’s College Hospital, London. That analysis concluded that the actual cost of production for the 5-day course is $17.74.

“We fully expect that having an oral treatment that reduces the risk of hospitalizations will be significantly cost effective for society,” Melissa Moody, a Merck spokesperson, told this news organization. “We are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”

Merck expects to produce 10 million courses of treatment by the end of the year, with additional doses expected to be produced in 2022, according to a company press release. Earlier in 2021, Merck finalized its agreement with the U.S. government to supply about 1.7 million courses of the drug at the $700 price, once an EUA or FDA approval is given.

Merck also has supply and purchase agreements with other governments worldwide, pending regulatory approval.
 

Study details

Details about the study findings came from a Merck press release. In the planned interim analysis, Merck and Ridgeback evaluated data from 775 patients initially enrolled in the phase 3 MOVe-OUT trial.

All adults had lab-confirmed mild to moderate COVID-19, and reported onset of symptoms within 5 days of being randomly assigned to the drug or placebo. All had at least one risk factor linked with poor disease outcome (such as older age or obesity).

The drug is a ribonucleoside and works by creating mutations in the virus’s genome, halting the ability of the virus to replicate.

Through day 29 of the study, the drug reduced the risk or hospitalization or death by about 50%. While 7.3% of those who received the drug either died or were hospitalized by day 29, 14.1% of those on placebo did, a statistically significant difference (P = .0012).

Side effects were similar in both groups, with 35% of the drug-treated and 40% of the placebo group reporting some side effect, Merck reported. Adverse drug-related events were 12% in the drug group and 11% in the placebo group. While 1.3% of the drug-treated group quit the study because of an adverse event, 3.4% of the placebo group quit.
 

Pros, cons, and unknowns

The ability to take the drug orally, and at home, is a definite plus, Dr. Schaffner said,  compared with the monoclonal antibody treatment currently approved that must be given intravenously or subcutaneously and in certain locations.

More people could be reached and helped with the option of an at-home, oral medicine, he and others agreed.

The regimen for molnupiravir is four pills, two times daily, for 5 days, even if symptoms are mild. As with other prescription drugs, “there will always be folks who don’t comply completely” with the prescribed regimen, Dr. Schaffner said. With this pill, that might be especially true if the symptoms are very mild.

The 50% reduction is not as effective as the benefit often quoted for monoclonal antibody treatment. In clinical trials of Regeneron’s monoclonal antibody treatment, the regimen reduced COVID-19–related hospitalization or death in high-risk patients by 70%.

Even so, the new pill could change the pandemic’s course, others say. “I think molnupiravir has the potential to change how we take care of people who have COVID and risk factors for developing severe disease,” Rajesh Tim Gandhi, MD, an infectious disease physician at Massachusetts General Hospital and Harvard Medical School in Boston, told this news organization. 

“What we’ll need to do, however, is make sure that people get tested quickly after they develop symptoms and, if they’re confirmed to have COVID, start on the pills within 5 days of developing symptoms,” he said, while warning that more data are needed about the drug and the trial results.

Another concern is that the promise of a pill will stall vaccination rates, with some people figuring why get vaccinated when they can obtain the pill if they do get sick.

Relying on treatment alone won’t work, Dr. Schaffner said. “Let’s [also] focus on prevention, which is the vaccine. We have to keep working both sides of the street.”

Dr. Gandhi added: “It’s important to remember that even though molnupiravir reduced the likelihood of hospitalization and death, a number of people who received the drug still got sick enough to end up in the hospital.”

Also unknown, he said, is how severe their disease was and whether they will develop long COVID.

The Merck study included only unvaccinated people. Might it work for those vaccinated people who get a breakthrough infection? “From a purely scientific perspective, there is no reason to believe molnupiravir would not work in people who are vaccinated, but the overall efficacy on top of the vaccine is likely dependent on how well they were able to mount a protective immune response to the vaccine,” Ms. Moody said. Still, Merck believes the pill could be of benefit for these infections too, she added.

As for the expected cost, Ms. Moody said that the company takes into account a number of factors in setting pricing, “but fundamentally we look at the impact of the disease, the benefits that the drug delivers to patients and to society, and at supporting ongoing drug development.”
 

On Merck’s heels: Pfizer, Roche, Atea

Pfizer is studying an antiviral pill, PF-07321332, a protease inhibitor that blocks the protease enzymes and halts replication of the virus.

In addition to studying the drug in infected patients at high risk of severe illness and in those at typical risk, Pfizer launched a phase 2-3 study in late September that will enroll people who live in the same household as a person with a confirmed, symptomatic COVID-19 infection to see if the drug can prevent disease in those who have been exposed.

Atea and Roche’s COVID pill, AT527, is in phase 3 trials as well. AT527 is an inhibitor of polymerase, an enzyme many viruses have, to stop replications. Atea is evaluating the drug to reduce disease “burden” and for both pre- and postexposure prevention.
 

Big picture: Role of COVID-19 pills

It may be necessary to target the coronavirus with more than one antiviral agent, said Dr. Fichtenbaum, a principal investigator for the AT527 trials. 

“Sometimes viruses require two or three active agents to control their replication,” he said, citing information gleaned from other viral research, such as HIV. For control of HIV infection, a cocktail or combination of antivirals is often recommended.

That may well be the case for COVID-19, Dr. Fichtenbaum said. The goal would be to attack the virus at more than one pathway.

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

Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.

But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.

In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”

After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.

Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
 

Challenge: Reaching the rest

With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.

And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.

But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?

Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.

So what does work, according to these experts?

• Emphasizing the trends of more people getting vaccinated.
• Focusing on everyone’s freedom of choice.
• Listening to concerns without judgment.
• Offering credible information.
• Correcting myths when necessary.
• Helping them fit vaccination into their “world view.”

Stories over statistics

Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.

Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”

A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”

If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”

“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”

This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.

Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”

The person decided to get the vaccine.
 

‘Live in that space’

“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.

“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”

Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”

Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.

For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.

For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.

One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.

Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
 

From peer to peer

A theme that runs through many of these persuasion techniques is peer pressure.

One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.

“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”

For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.

Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
 

Let them talk, give them time

Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.

The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”

It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”

Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”

With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.

When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”

Those conversations are what convinced her to get vaccinated this summer.
 

Simpson’s transformation

Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.

Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.

Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.

So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.

These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”

So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.

“Facts help once you are already moved,” Ms. Simpson said.

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

Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.

But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.

In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”

After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.

Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
 

Challenge: Reaching the rest

With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.

And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.

But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?

Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.

So what does work, according to these experts?

• Emphasizing the trends of more people getting vaccinated.
• Focusing on everyone’s freedom of choice.
• Listening to concerns without judgment.
• Offering credible information.
• Correcting myths when necessary.
• Helping them fit vaccination into their “world view.”

Stories over statistics

Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.

Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”

A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”

If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”

“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”

This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.

Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”

The person decided to get the vaccine.
 

‘Live in that space’

“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.

“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”

Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”

Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.

For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.

For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.

One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.

Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
 

From peer to peer

A theme that runs through many of these persuasion techniques is peer pressure.

One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.

“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”

For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.

Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
 

Let them talk, give them time

Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.

The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”

It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”

Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”

With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.

When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”

Those conversations are what convinced her to get vaccinated this summer.
 

Simpson’s transformation

Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.

Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.

Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.

So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.

These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”

So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.

“Facts help once you are already moved,” Ms. Simpson said.

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

Not so long ago, Heather Simpson of Dallas was known as the anti-vaccine mom who dressed as “the measles” for Halloween. She painted red spots on her face and posted her photo on Facebook, joking: “Was trying to think of the least scary thing I could be for Halloween … so I became the measles.” It went viral with the anti-vaccine crowd.

But between that Halloween and today, a series of “aha” moments transformed Ms. Simpson’s attitudes toward vaccines.

In January 2021, one of those moments involved her daughter, now 4, who was scratched by a feral cat, raising concerns about tetanus. Her daughter had been bitten by a dog when she was just 1, and Ms. Simpson turned down advice then to get a tetanus shot. “I was convinced the tetanus shot would kill her faster than the tetanus.”

After the cat incident, the anxiety was so exhausting, she listened to the nurse practitioner at the clinic, whom she trusted. The nurse gently reassured Ms. Simpson that the shot was less risky than the possibility of tetanus – but did not bombard her with statistics – and that won over Ms. Simpson and triggered an overall rethinking of her vaccine stance.

Fast-forward to February, and that “aha” turned into action when Ms. Simpson launched a “Back to the Vax” effort with a fellow former vaccine opponent. Through their website, Facebook page, and podcasts, they now encourage people to get the COVID-19 vaccine, as well as other immunizations.
 

Challenge: Reaching the rest

With just over 52% of those eligible in the United States fully vaccinated as of Sept. 1, health care providers and others have a continuing challenge ahead: Trying to convince those who are eligible but still holding out to get vaccinated.

Recent data and a poll show some movement in the right direction, as immunizations are increasing and hesitancy is declining among certain groups. According to federal officials, about 14 million people in the United States got their first dose in August, an increase of 4 million, compared to the numbers who got it in July.

And a new poll from the Axios-IPSOS Coronavirus Index found only one in five Americans, or 20%, say they are not likely to get the vaccine, while “hard opposition,” those not at all likely, has dropped to 14% of those adults.

But there is still a lot of work to do. So, how do medical professionals or concerned citizens reach those who haven’t gotten vaccinated yet, whatever their reason?

Many experts in communication and persuasion that this news organization talked to agree that throwing statistics at people hesitant to get the COVID-19 vaccine is generally useless and often backfires.

So what does work, according to these experts?

• Emphasizing the trends of more people getting vaccinated.
• Focusing on everyone’s freedom of choice.
• Listening to concerns without judgment.
• Offering credible information.
• Correcting myths when necessary.
• Helping them fit vaccination into their “world view.”

Stories over statistics

Talking about the trends of vaccinations can definitely change minds about getting vaccinated, said Robert Cialdini, PhD, regents professor emeritus of psychology and marketing at Arizona State University, Tempe, and author of the recently updated book, “Influence: The Psychology of Persuasion,” which has sold over 5 million copies since it was first published in 1984.

Face-to-face with a hesitant patient, a doctor can say: “More and more people are being vaccinated every day,” Dr. Cialdini says. “The reason you say more and more is [that] it conveys a trend. When people see a trend, they project it into the future that it is going to get even larger.”

A focus on choice can also help people change their minds and accept the vaccine, he says. “A lot of conspiracy theorists claim they don’t want to do it because they are being pushed or forced by the government, and they are resisting that.”

If that’s the case, presenting people with new information, such as the increased infectiousness of the Delta variant, and suggesting that a decision be made based on the new information, can work, Dr. Cialdini says, but be sure to end with: “It’s completely up to you.”

“This removes all their sense of being pushed. It says, ‘Here is all the evidence.’ ” At this point, a doctor’s personal recommendation with a patient who trusts him or her may sway them, Dr. Cialdini said. “I think you have to personalize the communication in both directions. That is, to say, ‘For someone in your situation, I would personally recommend that you get the vaccine.’ ” A health care professional’s authority and expertise can carry the day, he says, although “not always.”

This approach worked, Dr. Cialdini says, with a friend of the family hesitant about the COVID-19 vaccine. “I told him: ‘We have gotten it. You trust us, right?’ ” He waited for the person to say yes.

Then: “For someone in your position, my personal recommendation is to get vaccinated. There is new information about the vaccine, and more and more people are getting vaccinated. And of course, it is completely up to you.”

The person decided to get the vaccine.
 

‘Live in that space’

“People develop negative attitudes [about vaccines] by accessing alternative sources of information, anecdotes, and personal stories,” said Matthew Seeger, PhD, dean of the College of Fine, Performing, and Communication Arts and codirector of the Center for Emerging Infectious Diseases at Wayne State University in Detroit.

“If we are going to change their opinion, we need to live in that space.” That means listening first, he says. Ask: “Where did you get that information? How credible do you think the sources are? What do you mean about the vaccine changing DNA?”

Then, you might respond, he said, by addressing that specific information, such as, “We have no cases of DNA being changed.”

Dr. Seeger recalls that his mother would simply talk louder when she couldn’t understand someone who wasn’t a native English speaker. “That’s what we are trying to do with the vaccine-hesitant,” he says. “In some cases, we are yelling at them.” Instead, he says, probe their sources of information.

For some who are vaccine-hesitant, Dr. Seeger said, it is not just about the vaccine. The attitude about vaccines is tied in, often, with a distrust of government and feelings about personal freedom. “That’s one reason it’s so hard to change the attitude.” For some, getting the vaccine in a family against the vaccine might also disrupt their social structure or even get them ostracized.

For these people, a health care provider might give opportunities to get the vaccine without affecting either what they see as their political stance or upsetting family harmony. “There are places you can go, make an appointment, get a vaccine, and nobody knows,” Dr. Seeger said.

One Missouri doctor told CNN that some people calling for a vaccine appointment do request privacy, such as going through a drive-thru or having the shot as they sit in their cars. She said the hospital tries to accommodate them, reasoning that every additional vaccine shot is a win.

Dr. Seeger agrees. “Of course there are still public records,” he says, “but you can still claim you are a vaccine denier. It’s very difficult to persuade people to give up their whole world. Vaccine denial is part of that world. At this point, we need to do whatever we can to get people vaccinated.”
 

From peer to peer

A theme that runs through many of these persuasion techniques is peer pressure.

One example, while a bit more profane and confrontational than some groups, is COVIDAteMyFace, a subgroup, or “subreddit,” of the popular online site Reddit, which hosts numerous forums inviting users to share news and comments on a variety of topics. The subreddit has over 20,000 members. Its purpose, says the sub’s creator, “was to document the folks who denied COVID, then got bitten in the ass by it.” Reports are of actual cases.

“It’s interesting and powerful that Reddit users are taking this on,” Dr. Seeger said. And this kind of peer pressure, or peer-to-peer information, can be persuasive, he says. “We often seek consensual validation from peers about risk messages and risk behaviors.”

For instance, hurricane evacuation notices are more effective, he said, when people learn their neighbors are leaving.

Peer information – “the number of others who are doing or believing or responding to something – definitely persuades people,” agreed Dr. Cialdini. “When a lot of others are responding in a particular way – for example, getting vaccinated – people follow for three reasons: The action seems more appropriate or correct, it appears more feasible to perform, and it avoids social disapproval from those others.”
 

Let them talk, give them time

Gladys Jimenez is a contact tracer and “vaccine ambassador” for Tracing Health, a partnership between the Oregon Public Health Institute and the Public Health Institute that has nearly 300 bilingual contract tracers who serve the ethnic communities they’re from. During a typical week, she talks to 50 people or more, and promoting the vaccine is top of mind.

The conversations, Ms. Jimenez said, are like a dance. She presents information, then steps back and lets them talk. “I want to hear the person talk, where they are coming from, where they are at.” Depending on what they say, she gives them more information or corrects their misinformation. “They often will say, ‘Oh, I didn’t know that.’ ”

It’s rarely one conversation that convinces hesitant people, she said. “I’m planting this seed in their brain. ... people want someone to listen to them ... they want to vent.”

Once you let them do that, Ms. Jimenez said, “I can tell the person is in a different state of mind.” She also knows that people “will make the decision in their own time.”

With time, people can change their minds, as a Southern California woman who resisted at first (and asked to remain anonymous) can attest. “When the vaccine first came out, I remember thinking [that] it was a quick fix to a very big problem,” she said. The lack of full FDA approval, which has since been granted, was also an issue. She doesn’t oppose vaccines, she said, but was leery just of the COVID-19 vaccine.

When her longtime partner got his vaccine, he urged her to go right away for hers. She stalled. He got his second dose and grew impatient with her hesitancy. It began to wear on the relationship. Finally, the woman talked to two health care professionals she knew socially. They both follow the science, and “they both could explain vaccination to me in a way that resonated. The information was coming from sources I already trusted.”

Those conversations are what convinced her to get vaccinated this summer.
 

Simpson’s transformation

Ms. Simpson of Back to the Vax got her first COVID-19 immunization April 16. She had an allergic reaction, including severe itchiness and a bad headache, and needed emergency care, she said. Even so, she scheduled her second shot appointment.

Like many who turned against vaccines as adults, Ms. Simpson had all her childhood vaccines, but she developed a distrust after watching a lengthy documentary series that warned of vaccine dangers as an adult.

Looking back at that documentary, she thought about how it seems to blame everything – childhood cancer, ADHD, autism, allergies – on vaccinations. That suddenly seemed like sketchy science to her.

So did the claim from a family friend who said she knew someone who got the flu shot and began walking backward. She researched on her own, and with time, she decided to be pro-vaccines.

These days, she continues to find that stories, not statistics, are changing the minds of many who decide to get vaccinated. If the nurse practitioner urging the tetanus shot for her daughter had told her that the tetanus shot is linked with problems in one of a specific number of people who get it, no matter how large that second number was, Ms. Simpson said she would have thought: “What if she is that one?”

So she relies on stories that point out how universally vulnerable people are to COVID-19 first, facts next.

“Facts help once you are already moved,” Ms. Simpson said.

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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

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

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

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

When the Delta variant of the coronavirus was first identified in India in December 2020, the threat may have seemed too remote to trigger worry in the United States, although the horror of it ripping through the country was soon hard to ignore.

Within months, the Delta variant had spread to more than 98 countries, including Scotland, the United Kingdom, Israel, and now, of course, the United States. The CDC said this week the Delta variant now accounts for 93% of all COVID cases.

Fueled by Delta, COVID-19 cases, hospitalizations, and deaths are increasing in nearly all states, according to the latest CDC data. After the 7-day average number of cases dipped by June 22 to about 11,000, it rose by Aug. 3 to more than 85,000.

Some experts are heartened by the recent decrease in COVID-19 cases in the United Kingdom and India, both hard-hit with the Delta variant. COVID-19 cases in India peaked at more than 400,000 a day in May; by Aug. 2, that had dropped to about 30,500 daily.

Andy Slavitt, former Biden White House senior adviser for COVID-19 response, tweeted July 26 that, if the Delta variant acted the same in the United Kingdom as in India, it would have a quick rise and a quick drop.

The prediction seems to have come true. As of Aug. 3, U.K. cases have dropped to 7,467, compared with more than 46,800 July 19.

So the question of the summer has become: “When will Delta burn out here?”

Like other pandemic predictions, these are all over the board. Here are five predictions about when COVID cases will peak, then fall. They range from less than 2 weeks to more than 2 months:

• Mid-August: Among the most optimistic predictions of when the Delta-driven COVID-19 cases will decline is from Scott Gottlieb, MD, former FDA director. He told CNBC on July 28 that he would expect cases to decline in 2-3 weeks – so by August 11.
• Mid-August to mid-September: Ali Mokdad, PhD, chief strategy officer for population health at the University of Washington, Seattle, said that, “right now for the U.S. as a country, cases will peak mid-August” and then decline. He is citing projections by the university’s Institute for Health Metrics and Evaluation. In its “most likely” scenario, it predicts COVID deaths will peak at about 1,000 daily by mid-September, then decline. (As of Aug. 3, daily deaths averaged 371.)
• September: “I am hoping we get over this Delta hump [by then],” says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape. “But sometimes, I am too much of an optimist.”
• Mid-October: Experts at the COVID-19 Scenario Modeling Hub, a consortium of researchers from leading institutions who consult with the CDC, said the Delta-fueled pandemic will steadily increase through summer and fall, with a mid-October peak.
• Unclear: Because cases are underestimated, “I think it is unclear when we will see a peak of Delta,” says Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore. He predicts a decline in cases as “more people get infected and develop natural immunity.”

The predictions are based on different scenarios, such as most likely or worst case. Factors such as personal behaviors, public mandates, and vaccination rates could all alter the projections.
 

What a difference vaccination may make

An uptick in vaccinations could change all the models and predictions, experts agree. As of Aug. 3, almost half (49.7%) of the total U.S. population was fully vaccinated, the CDC said. (And 80.1% of those 65 and over were.)

But that’s a long way from the 70% or 80% figure often cited to reach herd immunity. Recently, Ricardo Franco, MD, of the University of Alabama at Birmingham, said at a briefing by the Infectious Diseases Society of America that the infectiousness of the Delta variant may mean the herd immunity threshold is actually closer to 90%.

Dr. Mokdad estimates that by Nov. 1, based on the current rate of infections, 64% of people in the United States will be immune to a variant like Delta, taking into account those already infected and those vaccinated against COVID-19.

Justin Lessler, PhD, a University of North Carolina at Chapel Hill epidemiologist involved in the modeling hub, says if enough people get vaccinated, it could stop the Delta variant in its tracks. But that percentage is high.

“I am relatively confident that if we could get 90% or more of the eligible population vaccinated that we would see the epidemic begin to recede,” he says.

It’s a huge leap from 50%, or even 64%, to 90%. Could the Delta surge really motivate that many people to head to a vaccination site?

That’s hard to predict, Dr. Topol said. Some unvaccinated people may feel like soldiers in a foxhole, especially if they are in hard-hit states like Louisiana, and rush to get the vaccine as soon as possible. Others, hearing about the “breakthrough” cases in the vaccinated, may dig in their heels and ask: “Why bother?” as they mistakenly conclude that the vaccine has not done its job.
 

Roles of public policy, individual behavior

Besides an increase in vaccinations, individual behaviors and mandates can change the scenario. Doctors can remind even vaccinated patients that behaviors such as social distancing and masks still matter, experts said.

“Don’t ‘stress test’ your vaccine, “ Dr. Topol said.

The vaccines against COVID are good but not perfect and, he notes, they offer less protection if many months have passed since the vaccines were given.

The best advice now, Dr. Topol said, is: “Don’t be inside without a mask.”

Even if outdoors, depending on how close others are and the level of the conversation, a mask might be wise, he says.

Dr. Mokdad finds that “when cases go up, people put on their best behavior,” such as going back to masks and social distancing.

“Unfortunately, we have two countries,” he said, referring to the way public health measures and mandates vary from state to state.
 

Once the Delta variant subsides, what’s next?

It’s not a matter of if there is another variant on the heels of Delta, but when, Dr. Topol and other experts said. A new variant, Lambda, was first identified in Peru in August 2020 but now makes up about 90% of the country’s infections.

There’s also Delta-plus, just found in two people in South Korea.

Future variants could be even more transmissible than Delta, “which would be a horror show,” Dr. Topol said. “This [Delta] is by far the worst version. The virus is going to keep evolving. It is not done with us.”
 

On the horizon: Variant-proof vaccines

What’s needed to tackle the next variant is another approach to vaccine development, according to Dr. Topol and his colleague, Dennis R. Burton, a professor of immunology and microbiology at Scripps Research Institute.

Writing a commentary in Nature published in 2021, the two propose using a special class of protective antibodies, known as broadly neutralizing antibodies, to develop these vaccines. The success of the current COVID-19 vaccines is likely because of the vaccine’s ability to prompt the body to make protective neutralizing antibodies. These proteins bind to the viruses and prevent them from infecting the body’s cells.

The broadly neutralizing antibodies, however, can act against many different strains of related viruses, Dr. Topol and Mr. Burton wrote. Using this approach, which is already under study, scientists could make vaccines that would be effective against a family of viruses. The goal: to stop future outbreaks from becoming epidemics and then pandemics.

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

Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

Jack Resneck Jr., MD, a dermatologist in the San Francisco Bay area, is the new president-elect of the American Medical Association and will take over as president in June 2022

Known for his advocacy efforts – promoting telemedicine and digital health and fighting rising prescription drug prices, among other issues – he has testified in Congressional hearings on all those topics and other issues crucial for a functioning U.S. health care system.

Colleagues describe him as well informed, intelligent, and an excellent listener who is skilled at understanding all sides of difficult issues.

“I am committed to relentlessly advocating for physicians and patients on issues that matter most to us, and look forward to the continued meaningful advancements our AMA will make as we strive to improve the health of the nation,” Dr. Resneck said in a statement issued by the AMA. “Now more than ever, I am proud to be part of an AMA that is dedicated to driving the future of medicine, removing obstacles to patient care, and leading the charge to prevent chronic disease and confront public health crises – all while prioritizing our goal of eliminating longstanding health inequities.”

Dr. Resneck called this a “pivotal time of learning from the COVID-19 pandemic experience as we plan for the future of medicine and public health.”

“Jack is one of the most well-informed people I know,” Barbara L. McAneny, MD, president of the AMA from 2018 to 2019 and CEO of the New Mexico Cancer Center, Albuquerque, said in an interview. “Now that the pandemic is slowly decreasing, the underlying problems in our health care system will resurface. Jack understands how the insurance industry uses prior authorization and other techniques to harm physicians and patients. He is very well positioned to be a voice of reason that is sorely needed in today’s healthcare industry.”

David O. Barbe, MD, MHA, president of the World Medical Association and president of the AMA from 2017 to 2018, calls Dr. Resneck “extremely smart, very analytical. I think one of his great strengths is, he is an excellent listener and can capture the essence of all sides of the issues. He does a remarkable job at achieving consensus.” Dr. Barbe is a family physician in Mountain Grove, Mo.

Dr. Resneck has a long history of serving the AMA, the California Medical Association, and dermatology organizations such as the American Academy of Dermatology.

“Dr. Resneck’s exemplary leadership on a number of AAD/A committees and councils and as a member of the boards of directors has made a lasting impact on the academy, and he is poised to do the same as president-elect of the American Medical Association,” AAD president Ken Tomecki, MD, said in a statement provided by the AAD. “We congratulate Dr. Resneck on his achievement, and we’re proud to have a dermatologist serving as a leading voice in the house of medicine.”

First elected to the AMA board of trustees in 2014, Dr. Resneck held the office of board chair from 2018 to 2019. He was also chair of the AMA Council on Legislation and was a delegate to the AMA House of Delegates. He has had leadership roles in the California Society of Dermatology and Dermatologic Surgery, the American Academy of Dermatology and the California Medical Association. He is vice chair and professor of dermatology at the University of California, San Francisco, with a joint appointment at the Philip R. Lee Institute for Health Policy Studies.

As a researcher, his citation list includes numerous published studies about patient access to care, telemedicine, quality metrics, prior authorization, and public health. He is on the editorial board of the Journal of the American Academy of Dermatology and the board of directors of the National Quality Forum. His undergraduate degree in public policy is from Brown University, Providence, R.I. He earned his medical degree from UCSF, where he also completed an internal medicine internship, a residency training in dermatology and a health policy fellowship.

Gerald Harmon, MD, a family practice physician in coastal South Carolina, will be inaugurated as the AMA president for 2021-2022 on June 15.
 

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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

The Centers for Disease Control and Prevention’s latest guidance on what fully vaccinated people can do safely – including not socially distancing and not wearing a mask indoors or outdoors unless other regulations require it – has been widely misinterpreted and caused confusion, two infectious disease experts said at a briefing on May 20 hosted by the Infectious Diseases Society of America (IDSA).

The CDC did not ‘’lift” the mask mandate, but rather supplied guidance for those who are fully vaccinated. However, many questions and gray areas remain, and the experts addressed those. ‘’The CDC guidance is really directed at people who are fully vaccinated and who we know are likely to have a really solid response to the vaccine,” said Jeanne Marrazzo, MD, MPH, director of infectious diseases at the University of Alabama at Birmingham and an IDSA board member.

That message was largely lost, said Dr. Marrazzo and Jeffrey Duchin, MD, health officer of public health for Seattle and King County, Washington, and also an IDSA board member. Dr. Duchin said many people mistakenly regarded the new guidance as a message that the pandemic is over.

Among their practical tips on how to interpret the guidance:
 

To mask or not?

To make the decision, people need to think about not only the numbers of vaccinated versus unvaccinated individuals in their community but the local rates of disease, the experts said.  And they need to know that the CDC guidance doesn’t apply if regulations by federal or state authorities or businesses and workplace are in conflict.

Deciding on mask use sometimes depends on where you are going. What about going into grocery stores or large bin stores without a mask? “If you are fully vaccinated and have no other conditions that compromise your immune system, and the rates of COVID are relatively low where you live, and the vaccination rates are high, I would be 100% fine” without a mask, Dr. Marrazzo said. But it’s important to think of all these factors in calculating your risk.

“I’m still wearing a mask when I go anywhere in public,” she said, citing vaccination rates that have not yet reached 50% in her area.

If that rate reached 80%, the typical percentage talked about for herd immunity, and new cases were low, Dr. Marrazzo said she might shed the mask.

The CDC also continues to recommend masks on mass transit for all.

One population that also must be considered, and who must evaluate their risk, even if vaccinated, are the immunocompromised, Dr. Marrazzo said. While people think of the immunocompromised as those with HIV or organ transplants, the numbers are actually much larger.

“A study a couple of years ago indicated up to 3% of Americans may actually have been told by their physician they have some of level of being immunocompromised,” she said. Among the examples are those who are on dialysis, on chemotherapy, or those taking any of the medications that modify the immune system.

“Millions of people fit this bill, and we have [very] little data on whether the vaccine works in them. We think it does,” Dr. Marrazzo said.

Still, she said, it’s a reason for these people to be cautious. For some other vaccines, the dose is modified for those who are immunocompromised. What’s not known yet is whether additional doses of the COVID vaccines might boost protection for those who are immunocompromised.

Many people, even after vaccination, may choose to keep wearing a mask especially in indoor, crowded settings, Dr. Duchin said. “We need to expect, accept, and respect continued mask wearing by anyone at any time.”

In most outdoor settings, he said, “I think masks are probably not necessary, vaccinated or not, regardless of age.” One exception: close face-to-face contact, such as in certain sports.
 

How to protect toddlers and infants

With masks not practical or recommended for infants and toddlers under 2 years old, Dr. Marrazzo said adults should remember that ‘’those very little kids don’t do poorly at all [even if infected], although there is not a ton of data.”

Adults should still treat young children as vulnerable, especially newborns. Adults not yet vaccinated should wear a mask when around them, she said.
 

J & J vaccine recipients

With less ‘’real world” data on the Johnson & Johnson vaccine, should those who got it think of themselves in a different risk group than those who got Moderna or Pfizer and adjust their behavior accordingly? 

“The J&J vaccine, based on everything we know, does provide a great deal of protection,” Dr. Marrazzo said. ‘’We don’t know as much about prevention of transmission in the asymptomatic cases in the J&J.”

Most of that data, she said, is from the mRNA vaccines Pfizer and Moderna. “I think it’s an important area to study and learn about.” But all three vaccines, overall, provide a high level of protection, she said.

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