MDedge Infectious Disease

Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

• Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
• Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
• Consider including virologic testing in the diagnostic workup of sexually active youth.
• Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
• Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
• Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
• For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

• Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
• Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
• Consider including virologic testing in the diagnostic workup of sexually active youth.
• Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
• Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
• Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
• For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

Pediatricians should take a more proactive role in protecting children and adolescents from HIV infections, according to updated guidance from the American Academy of Pediatrics. The comprehensive new recommendations stress winning the trust and confidence of pediatric patients and reaffirm support for testing and treating adolescents without parental consent where state laws allow.

While the number of HIV-infected people in the United States remains high, most sexually active youth do not believe they are at risk and have never been tested, noted authors Katherine K. Hsu, MD, MPH, of the Massachusetts Department of Public Health and Boston University Medical Center, and Natella Yurievna Rakhmanina, MD, PhD, of Children’s National Hospital and George Washington University, both in Washington.

That is a knowledge gap that pediatricians are well situated to fill. “Pediatricians can play a key role in preventing and controlling HIV infection by promoting risk-reduction counseling and offering routine HIV testing and prophylaxis to adolescent and young adult (youth) patients,” they wrote on Dec. 20, 2021, in their study published in Pediatrics.

Key components of youth encounters, they stressed, is creating safe environments for obtaining an accurate sexual and reproductive health assessment and providing nonstigmatizing risk counseling.

According to Dr. Rakhmanina, major barriers to addressing preventive HIV counseling have included pediatricians’ lack of time, cultural differences, adolescents’ inaccurate responses, discomfort discussing sexual issues, and adolescents’ fear of parent or caregiver notification. Other concerns have been lack of adequate payment and insufficient training in how to talk to adolescents about sexual and reproductive issues.

According to the Centers for Disease Control and Prevention, at year end in 2018 an estimated 1,173,900 people age 13 or older were living with HIV infection in the United States, of whom 47,800 (4%) were adolescents and young adults 13-24 years of age.

These estimates include diagnosed and undiagnosed individuals. Between 2014 and 2018, new diagnoses of HIV infection accounted for 21% (7,817 of 37,515) of all new HIV diagnoses in the United States.

The new AAP clinical report updates policy statements from 2001 and again 2011 that encouraged HIV testing of all sexually active youth.

It reflects changes in epidemiology, advances in diagnostic testing with improved immunoassays, and updated recommendations for HIV testing and postexposure prophylaxis (PEP), as well as new guidance for pre-exposure prophylaxis (PrEP).

A 2017 study found that the 2011 HIV testing guidelines was associated with only a slight increase in HIV screening and a shift toward testing younger people and away from testing on the basis of risk.

Against this backdrop of persistent HIV infection and to-date modest uptake of earlier guidance, the 2021 statement made 14 main recommendations to pediatricians. Among these:
 

• Foster open discussion of gender and sexual orientation and behavior, as well as reproductive health issues.
• Recognize the clinical presentation of the acute retroviral syndrome, which can present as syndromes resembling infectious mononucleosis and influenza.
• Consider including virologic testing in the diagnostic workup of sexually active youth.
• Consider routine HIV screening for all youth 15 years or older at least once and rescreening high-risk youth. Those at higher risk should be rescreened at least annually, and potentially as frequently as every 3-6 months.
• Youth at substantial risk should be routinely offered PrEP, while PEP with antiretroviral drugs is indicated after unsafe exposures such as unsafe sexual activity, unsafe needle use, or sexual violence. Survivors of sexual violence should have baseline HIV testing and sexually transmitted infection (STI) screening and treatment. They should also be offered mental health and other supportive counseling.
• Test youth who request HIV screening at any time even in the absence of reported risk factors. Although parent or guardian involvement is preferable, in most legal settings the adolescent’s consent should suffice for testing and treatment.
• For youth with a positive HIV test, facilitate and confirm prompt linkage to age-appropriate HIV specialty care.

Will the current report’s recommendations be met with greater uptake than previous iterations? Yes, according to Maria E. Trent, MD, MPH, chief of the division of adolescent/young adult medicine at Johns Hopkins University, Baltimore, but a fundamental first step will be the establishment of honesty and confidentiality. “Pediatricians are essential stakeholders in HIV prevention and intervention efforts in the United States. Recent data, however, suggest that pediatricians often struggle to create the essential alone time with adolescents and young adults to conduct critical sexual health conversations that allow for adequate STI/HIV risk screening,” said Dr. Trent, who was not involved in the report. “Consistently creating that space will be the first task for ensuring adherence to these recommendations.”

Strategies to optimize risk screening for clinical decision support, such as confidential online previsit questionnaires that link to the electronic medical record, may facilitate discussions during the visit while maintaining clinician efficiency, she added.

Furthermore, while one-time general HIV screening during adolescence will be an easy goal, “integrating annual testing, biomedical intervention for PrEP/PEP, and ongoing follow-up and testing for those on biomedical intervention may present practical but not insurmountable challenges,” Dr. Trent said.

When pediatricians recognize that care is suboptimal in practice, ensuring that pediatricians have established linkages to adolescent-friendly services for free or low-cost HIV testing, PrEP/PEP, and HIV management will prevent gaps in care, Dr. Trent continued. “The most exciting development in health care is that telemedicine can now be used to work with young people, giving the practicing pediatrician more opportunities and flexibility to deliver and triage care.”

Will any of the guidelines such as an adolescent’s right to independent consent be considered unacceptable by parents? “While this part of the recommendations is not new, the thought that their adolescent can initiate and receive confidential care for HIV prevention or intervention without their knowledge or consent may initially be challenging to process,” Dr. Trent said. “Ultimately, what I’ve observed in practice is that parents are relieved and often proud of their young person for taking the initiative to engage in self-care to maintain their health and relieved to be involved as a critical support person.”

She added that pediatricians need to make their practice policies clear and have information available for parents on state laws related to confidential care. “They also need to carefully use the electronic health record to avoid errors in disclosures to proxies without patient consent.”

Dr. Rakhmanina agreed there will likely be greater adherence to this round of recommendations. “The culture of addressing sexual and reproductive health issues among adolescents in the U.S. is changing among pediatric providers, and we start seeing more champions of PrEP and HIV testing in our communities,” she said.

This study received no external funding. The authors had no financial relationships or potential conflicts of interest to disclose. Dr. Trent disclosed no competing interests relevant to her comments.

With emergency departments straining to keep up with the latest COVID surge, the American College of Emergency Physicians (ACEP) issued a plea this week for a “collaborative effort” to solve the nursing shortage.

The organization said that it is “very concerned that nursing shortages in emergency departments can complicate patient access to care and add to incredible levels of stress already on physician-led care teams,” according to a press release.

ACEP President Gillian Schmitz, MD, told this news organization, “The situation is dire in many emergency departments around the country. Emergency physicians are seeing more patients with fewer resources and less staff.

“Emergency physicians in the hardest hit communities are scrambling to locate available experts, exhausting federal support, and doing all they can to adapt to the demands of the current surge – everyone is being stretched to their limit.”

The Emergency Nurses Association (ENA) agrees with ACEP’s call for a team approach to stemming the shortage.

ENA President Ron Kraus, MSN, RN, said in an interview, “The pandemic has only amplified several long-standing issues impacting emergency nurses, such as workplace violence, a healthy work environment, and concerns about staffing shortages and the pipeline of new nurses. That said, we can’t lose focus on what’s most important in these challenging moments – ensuring every patient receives the high quality of care.”

The responsibility falls on the “collaborative effort” of the emergency department with emergency nurses playing a pivotal role, he said. But the stress, fatigue, and burnout driving nurses away from their jobs “should not be viewed as added inconvenience to anyone during a pandemic, but as a long-term threat to our health care system.”

ACEP’s press release stated that with fewer nurses available in the emergency department, team members are clocking extra hours, caring for more patients, and stretched to take on additional clinical and nonclinical duties.

“I am hearing from colleagues from Washington state to Michigan to New York that this is the worst they have seen since the beginning of the pandemic,” Dr. Schmitz said. “Everyone available is filling gaps as best they can, but the current path for many frontline workers is not sustainable,” she said in the release.

Meanwhile, ACEP is also tackling violence in the emergency department and has initiatives to protect the mental health of those working on the front lines, the release states.

“Emergency physicians will continue to do everything necessary to treat patients,” Dr. Schmitz said in the release, “but it will take a collaborative effort with legislators, policymakers and health system leaders to strengthen care teams, improve access and address capacity concerns with solutions that can save lives right now and in the months ahead.”

Dr. Schmitz stated that in Washington state, ICUs are at 97% to 100% capacity and less than 30 pediatric inpatient beds are available in the western part of the state.

“In Michigan and New York, several emergency departments are overflowing, and doctors are being called in to triage people in the waiting room because all of the emergency department beds are holding admissions. There are scenarios where entire hospitals are backing up into the emergency department and waiting room and we are physically running out of space and nursing staff.”

ACEP represents its 40,000 emergency physician members.

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

With emergency departments straining to keep up with the latest COVID surge, the American College of Emergency Physicians (ACEP) issued a plea this week for a “collaborative effort” to solve the nursing shortage.

The organization said that it is “very concerned that nursing shortages in emergency departments can complicate patient access to care and add to incredible levels of stress already on physician-led care teams,” according to a press release.

ACEP President Gillian Schmitz, MD, told this news organization, “The situation is dire in many emergency departments around the country. Emergency physicians are seeing more patients with fewer resources and less staff.

“Emergency physicians in the hardest hit communities are scrambling to locate available experts, exhausting federal support, and doing all they can to adapt to the demands of the current surge – everyone is being stretched to their limit.”

The Emergency Nurses Association (ENA) agrees with ACEP’s call for a team approach to stemming the shortage.

ENA President Ron Kraus, MSN, RN, said in an interview, “The pandemic has only amplified several long-standing issues impacting emergency nurses, such as workplace violence, a healthy work environment, and concerns about staffing shortages and the pipeline of new nurses. That said, we can’t lose focus on what’s most important in these challenging moments – ensuring every patient receives the high quality of care.”

The responsibility falls on the “collaborative effort” of the emergency department with emergency nurses playing a pivotal role, he said. But the stress, fatigue, and burnout driving nurses away from their jobs “should not be viewed as added inconvenience to anyone during a pandemic, but as a long-term threat to our health care system.”

ACEP’s press release stated that with fewer nurses available in the emergency department, team members are clocking extra hours, caring for more patients, and stretched to take on additional clinical and nonclinical duties.

“I am hearing from colleagues from Washington state to Michigan to New York that this is the worst they have seen since the beginning of the pandemic,” Dr. Schmitz said. “Everyone available is filling gaps as best they can, but the current path for many frontline workers is not sustainable,” she said in the release.

Meanwhile, ACEP is also tackling violence in the emergency department and has initiatives to protect the mental health of those working on the front lines, the release states.

“Emergency physicians will continue to do everything necessary to treat patients,” Dr. Schmitz said in the release, “but it will take a collaborative effort with legislators, policymakers and health system leaders to strengthen care teams, improve access and address capacity concerns with solutions that can save lives right now and in the months ahead.”

Dr. Schmitz stated that in Washington state, ICUs are at 97% to 100% capacity and less than 30 pediatric inpatient beds are available in the western part of the state.

“In Michigan and New York, several emergency departments are overflowing, and doctors are being called in to triage people in the waiting room because all of the emergency department beds are holding admissions. There are scenarios where entire hospitals are backing up into the emergency department and waiting room and we are physically running out of space and nursing staff.”

ACEP represents its 40,000 emergency physician members.

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

With emergency departments straining to keep up with the latest COVID surge, the American College of Emergency Physicians (ACEP) issued a plea this week for a “collaborative effort” to solve the nursing shortage.

The organization said that it is “very concerned that nursing shortages in emergency departments can complicate patient access to care and add to incredible levels of stress already on physician-led care teams,” according to a press release.

ACEP President Gillian Schmitz, MD, told this news organization, “The situation is dire in many emergency departments around the country. Emergency physicians are seeing more patients with fewer resources and less staff.

“Emergency physicians in the hardest hit communities are scrambling to locate available experts, exhausting federal support, and doing all they can to adapt to the demands of the current surge – everyone is being stretched to their limit.”

The Emergency Nurses Association (ENA) agrees with ACEP’s call for a team approach to stemming the shortage.

ENA President Ron Kraus, MSN, RN, said in an interview, “The pandemic has only amplified several long-standing issues impacting emergency nurses, such as workplace violence, a healthy work environment, and concerns about staffing shortages and the pipeline of new nurses. That said, we can’t lose focus on what’s most important in these challenging moments – ensuring every patient receives the high quality of care.”

The responsibility falls on the “collaborative effort” of the emergency department with emergency nurses playing a pivotal role, he said. But the stress, fatigue, and burnout driving nurses away from their jobs “should not be viewed as added inconvenience to anyone during a pandemic, but as a long-term threat to our health care system.”

ACEP’s press release stated that with fewer nurses available in the emergency department, team members are clocking extra hours, caring for more patients, and stretched to take on additional clinical and nonclinical duties.

“I am hearing from colleagues from Washington state to Michigan to New York that this is the worst they have seen since the beginning of the pandemic,” Dr. Schmitz said. “Everyone available is filling gaps as best they can, but the current path for many frontline workers is not sustainable,” she said in the release.

Meanwhile, ACEP is also tackling violence in the emergency department and has initiatives to protect the mental health of those working on the front lines, the release states.

“Emergency physicians will continue to do everything necessary to treat patients,” Dr. Schmitz said in the release, “but it will take a collaborative effort with legislators, policymakers and health system leaders to strengthen care teams, improve access and address capacity concerns with solutions that can save lives right now and in the months ahead.”

Dr. Schmitz stated that in Washington state, ICUs are at 97% to 100% capacity and less than 30 pediatric inpatient beds are available in the western part of the state.

“In Michigan and New York, several emergency departments are overflowing, and doctors are being called in to triage people in the waiting room because all of the emergency department beds are holding admissions. There are scenarios where entire hospitals are backing up into the emergency department and waiting room and we are physically running out of space and nursing staff.”

ACEP represents its 40,000 emergency physician members.

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

The Centers for Disease Control and Prevention has announced that students who are exposed to the coronavirus can still attend school as long as they continue to test negative for the virus in the following days.

The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.

“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.

When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.

In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.

“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”

In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.

The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.

Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.

In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.

The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.

In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.

The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.

Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.

“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.

“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.

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

The Centers for Disease Control and Prevention has announced that students who are exposed to the coronavirus can still attend school as long as they continue to test negative for the virus in the following days.

The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.

“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.

When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.

In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.

“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”

In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.

The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.

Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.

In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.

The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.

In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.

The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.

Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.

“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.

“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.

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

The Centers for Disease Control and Prevention has announced that students who are exposed to the coronavirus can still attend school as long as they continue to test negative for the virus in the following days.

The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.

“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.

When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.

In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.

“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”

In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.

The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.

Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.

In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.

The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.

In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.

The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.

Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.

“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.

“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.

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

Pfizer’s COVID-19 vaccine for children ages 2 to 5 years old fizzled in clinical trials, the company said on Friday, signaling a further delay in getting a vaccine to preschoolers just as Omicron bears down on the U.S.

In a news release, Pfizer reported that while its 3-microgram dose – which is less than one-third of the dose given to older children – generated a protective immune response in babies and toddlers ages 6 to 24 months, it didn’t generate adequate immunity in children ages 2 to 5.

The company plans to change its clinical trial to add a third dose for younger children in hopes of improving those results. It also plans to test a third dose of its 10-microgram vaccine for children ages 5 to 12.

If the trials are successful, Pfizer said it would submit data to the FDA for an emergency use authorization (EUA) in the first half of 2022.

That pushes the timeline of getting a vaccine to younger children back by several months. In November, Anthony Fauci, MD, head of the National Institute of Allergy Infectious Diseases, predicted a vaccine would be ready for preschoolers by spring.

“On one hand, parents are understandably disappointed,” said Jill Foster, MD, a pediatric infectious disease doctor at the University of Minnesota Medical School. “On the other, it shows that the system for testing vaccines is working. Children are not little adults and have complex immune systems, so it’s not just a matter of making the dose smaller and expecting that it will work,” she said, noting that data from Moderna’s KidCOVE study in preschoolers is pending.

Until there’s a vaccine, Dr. Foster says parents should protect babies and toddlers by making sure everyone around them is vaccinated, promote the use of face masks for everyone around them and for all children over age 2, and continue to avoid crowded gatherings, particularly those that are indoors.

“Hand sanitizer is important, but this virus, especially the Omicron variant, is very easily spread through the air, so keep the air clear of virus as much as possible,” she said.

While the youngest children are still waiting for an effective vaccine, there was reassuring news Dec. 16 about the safety of Pfizer’s vaccine for school-aged kids – those ages 5 through 11.

Out of more than 7 million doses given since this vaccine was authorized for emergency use in late October, most reactions to the vaccine – including arm pain, swelling, and fatigue – have been mild and gone away quickly, without the need to miss school or see a doctor, the CDC reported to a meeting of its Advisory Committee on Immunization Practices, or ACIP.

Many experts had been waiting to see if this vaccine would cause rare cases of heart inflammation called myocarditis, as a higher dose did in teens and young adults.

The news on this front was excellent. About 6 weeks after this vaccine became available, the CDC says there have been only eight confirmed cases of myocarditis in this age group. Six more cases are under investigation.

To put this risk into context, data collected by the American Academy of Pediatrics and the Children’s Hospital Association shows that about 1% of children who test positive for COVID-19 are hospitalized for their infections, while the risk of getting a case of myocarditis after vaccination is .0002%, making it about 5,000 times more likely that a child would need to be hospitalized for COVID-19 than for myocarditis after vaccination.

John Su, MD, who is a member of the CDC’s Vaccine Safety Team, reported there had been two deaths in children after a COVID-19 vaccination. Both were girls, ages 5 and 6. Both had complicated medical histories for several medical disorders. It’s not clear their deaths were linked to the vaccine, and the causes of their deaths are still under investigation.

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

Pfizer’s COVID-19 vaccine for children ages 2 to 5 years old fizzled in clinical trials, the company said on Friday, signaling a further delay in getting a vaccine to preschoolers just as Omicron bears down on the U.S.

In a news release, Pfizer reported that while its 3-microgram dose – which is less than one-third of the dose given to older children – generated a protective immune response in babies and toddlers ages 6 to 24 months, it didn’t generate adequate immunity in children ages 2 to 5.

The company plans to change its clinical trial to add a third dose for younger children in hopes of improving those results. It also plans to test a third dose of its 10-microgram vaccine for children ages 5 to 12.

If the trials are successful, Pfizer said it would submit data to the FDA for an emergency use authorization (EUA) in the first half of 2022.

That pushes the timeline of getting a vaccine to younger children back by several months. In November, Anthony Fauci, MD, head of the National Institute of Allergy Infectious Diseases, predicted a vaccine would be ready for preschoolers by spring.

“On one hand, parents are understandably disappointed,” said Jill Foster, MD, a pediatric infectious disease doctor at the University of Minnesota Medical School. “On the other, it shows that the system for testing vaccines is working. Children are not little adults and have complex immune systems, so it’s not just a matter of making the dose smaller and expecting that it will work,” she said, noting that data from Moderna’s KidCOVE study in preschoolers is pending.

Until there’s a vaccine, Dr. Foster says parents should protect babies and toddlers by making sure everyone around them is vaccinated, promote the use of face masks for everyone around them and for all children over age 2, and continue to avoid crowded gatherings, particularly those that are indoors.

“Hand sanitizer is important, but this virus, especially the Omicron variant, is very easily spread through the air, so keep the air clear of virus as much as possible,” she said.

While the youngest children are still waiting for an effective vaccine, there was reassuring news Dec. 16 about the safety of Pfizer’s vaccine for school-aged kids – those ages 5 through 11.

Out of more than 7 million doses given since this vaccine was authorized for emergency use in late October, most reactions to the vaccine – including arm pain, swelling, and fatigue – have been mild and gone away quickly, without the need to miss school or see a doctor, the CDC reported to a meeting of its Advisory Committee on Immunization Practices, or ACIP.

Many experts had been waiting to see if this vaccine would cause rare cases of heart inflammation called myocarditis, as a higher dose did in teens and young adults.

The news on this front was excellent. About 6 weeks after this vaccine became available, the CDC says there have been only eight confirmed cases of myocarditis in this age group. Six more cases are under investigation.

To put this risk into context, data collected by the American Academy of Pediatrics and the Children’s Hospital Association shows that about 1% of children who test positive for COVID-19 are hospitalized for their infections, while the risk of getting a case of myocarditis after vaccination is .0002%, making it about 5,000 times more likely that a child would need to be hospitalized for COVID-19 than for myocarditis after vaccination.

John Su, MD, who is a member of the CDC’s Vaccine Safety Team, reported there had been two deaths in children after a COVID-19 vaccination. Both were girls, ages 5 and 6. Both had complicated medical histories for several medical disorders. It’s not clear their deaths were linked to the vaccine, and the causes of their deaths are still under investigation.

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

Pfizer’s COVID-19 vaccine for children ages 2 to 5 years old fizzled in clinical trials, the company said on Friday, signaling a further delay in getting a vaccine to preschoolers just as Omicron bears down on the U.S.

In a news release, Pfizer reported that while its 3-microgram dose – which is less than one-third of the dose given to older children – generated a protective immune response in babies and toddlers ages 6 to 24 months, it didn’t generate adequate immunity in children ages 2 to 5.

The company plans to change its clinical trial to add a third dose for younger children in hopes of improving those results. It also plans to test a third dose of its 10-microgram vaccine for children ages 5 to 12.

If the trials are successful, Pfizer said it would submit data to the FDA for an emergency use authorization (EUA) in the first half of 2022.

That pushes the timeline of getting a vaccine to younger children back by several months. In November, Anthony Fauci, MD, head of the National Institute of Allergy Infectious Diseases, predicted a vaccine would be ready for preschoolers by spring.

“On one hand, parents are understandably disappointed,” said Jill Foster, MD, a pediatric infectious disease doctor at the University of Minnesota Medical School. “On the other, it shows that the system for testing vaccines is working. Children are not little adults and have complex immune systems, so it’s not just a matter of making the dose smaller and expecting that it will work,” she said, noting that data from Moderna’s KidCOVE study in preschoolers is pending.

Until there’s a vaccine, Dr. Foster says parents should protect babies and toddlers by making sure everyone around them is vaccinated, promote the use of face masks for everyone around them and for all children over age 2, and continue to avoid crowded gatherings, particularly those that are indoors.

“Hand sanitizer is important, but this virus, especially the Omicron variant, is very easily spread through the air, so keep the air clear of virus as much as possible,” she said.

While the youngest children are still waiting for an effective vaccine, there was reassuring news Dec. 16 about the safety of Pfizer’s vaccine for school-aged kids – those ages 5 through 11.

Out of more than 7 million doses given since this vaccine was authorized for emergency use in late October, most reactions to the vaccine – including arm pain, swelling, and fatigue – have been mild and gone away quickly, without the need to miss school or see a doctor, the CDC reported to a meeting of its Advisory Committee on Immunization Practices, or ACIP.

Many experts had been waiting to see if this vaccine would cause rare cases of heart inflammation called myocarditis, as a higher dose did in teens and young adults.

The news on this front was excellent. About 6 weeks after this vaccine became available, the CDC says there have been only eight confirmed cases of myocarditis in this age group. Six more cases are under investigation.

To put this risk into context, data collected by the American Academy of Pediatrics and the Children’s Hospital Association shows that about 1% of children who test positive for COVID-19 are hospitalized for their infections, while the risk of getting a case of myocarditis after vaccination is .0002%, making it about 5,000 times more likely that a child would need to be hospitalized for COVID-19 than for myocarditis after vaccination.

John Su, MD, who is a member of the CDC’s Vaccine Safety Team, reported there had been two deaths in children after a COVID-19 vaccination. Both were girls, ages 5 and 6. Both had complicated medical histories for several medical disorders. It’s not clear their deaths were linked to the vaccine, and the causes of their deaths are still under investigation.

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

Top infectious disease officials expect a surge of COVID-19 cases after the holidays and say Omicron will soon take over as the dominant strain in the United States.

The best way to stay protected is by getting vaccinated and boosted, they said.

“For the unvaccinated, you’re looking at a winter of severe illness and death – for yourselves, families, and the hospitals who may soon overwhelm,” White House COVID-19 Response Coordinator Jeff Zients said at a news briefing Dec. 17. “We need the American people to do their part.”

The Omicron variant has been detected in at least 39 states and 75 countries, according to CDC director Rochelle Walensky, MD.

The strain is more transmissible than the already highly infectious Delta variant, and although there was early evidence that it caused more mild disease, she said that is likely because many of those infected have been vaccinated and boosted.

“Although Delta continues to circulate widely in the United States, Omicron is increasing rapidly and we expect it to become the dominant strain in the United States, as it has in other countries, in the coming weeks,” Dr. Walensky said.

The United States is averaging close to 1,300 deaths from COVID-19 each day. New cases, deaths, and hospitalizations are higher now than in the previous winter – before vaccines were so widely available. The New York Times reported on Dec. 17 that new infections in Connecticut and Maine have grown 150% in the past 2 weeks, and Ohio and Indiana are seeing hospitalization rates nearing the worst of 2020-2021’s winter surge.

Dueling reports released recently gave cause for relief and concern about Omicron.

A study from South Africa released on Dec. 14 shows lower hospitalizations during the first 3 weeks of the Omicron wave than during earlier waves from other variants. That’s the good news.

The concerning news is out of the United Kingdom, where Imperial College London reported Dec. 17 that the risk of reinfection with COVID-19 from Omicron is more than 5 times as high and that cases of Omicron-based COVID-19 are doubling every 2 days.

What’s more, the study “finds no evidence of Omicron having lower severity than Delta, judged by either the proportion of people testing positive who report symptoms, or by the proportion of cases seeking hospital care after infection. However, hospitalization data remains very limited at this time,” the researchers said.

“We have no evidence that the virus itself is more mild,” Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape, told PBS NewsHour. “Until we have that, we have to assume that people who don’t have any protection are highly vulnerable to getting very ill.”

The White House COVID-19 team continues to urge parents and guardians to get their children vaccinated, especially in anticipation of a post-holiday spike. Dr. Walensky said the CDC’s vaccine advisory board met on Dec. 16 to continue the safety discussion about COVID-19 vaccinations in children.

So far, 20 million children under 17 and 5 million under 11 have received their shots.

“Looking specifically at vaccine safety data from over 50,000 children 5-11 years old, we found no evidence of serious safety concerns,” Dr. Walensky said.

Top infectious disease expert Anthony S. Fauci, MD, highlighted the importance of getting vaccinated and boosted to avoid serious disease from Delta and Omicron.

“We’re in a situation where we are now facing a very important Delta surge and we are looking over our shoulder at an oncoming Omicron surge,” he said. “The optimum protection is fully vaccinated plus a boost.”

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

Top infectious disease officials expect a surge of COVID-19 cases after the holidays and say Omicron will soon take over as the dominant strain in the United States.

The best way to stay protected is by getting vaccinated and boosted, they said.

“For the unvaccinated, you’re looking at a winter of severe illness and death – for yourselves, families, and the hospitals who may soon overwhelm,” White House COVID-19 Response Coordinator Jeff Zients said at a news briefing Dec. 17. “We need the American people to do their part.”

The Omicron variant has been detected in at least 39 states and 75 countries, according to CDC director Rochelle Walensky, MD.

The strain is more transmissible than the already highly infectious Delta variant, and although there was early evidence that it caused more mild disease, she said that is likely because many of those infected have been vaccinated and boosted.

“Although Delta continues to circulate widely in the United States, Omicron is increasing rapidly and we expect it to become the dominant strain in the United States, as it has in other countries, in the coming weeks,” Dr. Walensky said.

The United States is averaging close to 1,300 deaths from COVID-19 each day. New cases, deaths, and hospitalizations are higher now than in the previous winter – before vaccines were so widely available. The New York Times reported on Dec. 17 that new infections in Connecticut and Maine have grown 150% in the past 2 weeks, and Ohio and Indiana are seeing hospitalization rates nearing the worst of 2020-2021’s winter surge.

Dueling reports released recently gave cause for relief and concern about Omicron.

A study from South Africa released on Dec. 14 shows lower hospitalizations during the first 3 weeks of the Omicron wave than during earlier waves from other variants. That’s the good news.

The concerning news is out of the United Kingdom, where Imperial College London reported Dec. 17 that the risk of reinfection with COVID-19 from Omicron is more than 5 times as high and that cases of Omicron-based COVID-19 are doubling every 2 days.

What’s more, the study “finds no evidence of Omicron having lower severity than Delta, judged by either the proportion of people testing positive who report symptoms, or by the proportion of cases seeking hospital care after infection. However, hospitalization data remains very limited at this time,” the researchers said.

“We have no evidence that the virus itself is more mild,” Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape, told PBS NewsHour. “Until we have that, we have to assume that people who don’t have any protection are highly vulnerable to getting very ill.”

The White House COVID-19 team continues to urge parents and guardians to get their children vaccinated, especially in anticipation of a post-holiday spike. Dr. Walensky said the CDC’s vaccine advisory board met on Dec. 16 to continue the safety discussion about COVID-19 vaccinations in children.

So far, 20 million children under 17 and 5 million under 11 have received their shots.

“Looking specifically at vaccine safety data from over 50,000 children 5-11 years old, we found no evidence of serious safety concerns,” Dr. Walensky said.

Top infectious disease expert Anthony S. Fauci, MD, highlighted the importance of getting vaccinated and boosted to avoid serious disease from Delta and Omicron.

“We’re in a situation where we are now facing a very important Delta surge and we are looking over our shoulder at an oncoming Omicron surge,” he said. “The optimum protection is fully vaccinated plus a boost.”

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

Top infectious disease officials expect a surge of COVID-19 cases after the holidays and say Omicron will soon take over as the dominant strain in the United States.

The best way to stay protected is by getting vaccinated and boosted, they said.

“For the unvaccinated, you’re looking at a winter of severe illness and death – for yourselves, families, and the hospitals who may soon overwhelm,” White House COVID-19 Response Coordinator Jeff Zients said at a news briefing Dec. 17. “We need the American people to do their part.”

The Omicron variant has been detected in at least 39 states and 75 countries, according to CDC director Rochelle Walensky, MD.

The strain is more transmissible than the already highly infectious Delta variant, and although there was early evidence that it caused more mild disease, she said that is likely because many of those infected have been vaccinated and boosted.

“Although Delta continues to circulate widely in the United States, Omicron is increasing rapidly and we expect it to become the dominant strain in the United States, as it has in other countries, in the coming weeks,” Dr. Walensky said.

The United States is averaging close to 1,300 deaths from COVID-19 each day. New cases, deaths, and hospitalizations are higher now than in the previous winter – before vaccines were so widely available. The New York Times reported on Dec. 17 that new infections in Connecticut and Maine have grown 150% in the past 2 weeks, and Ohio and Indiana are seeing hospitalization rates nearing the worst of 2020-2021’s winter surge.

Dueling reports released recently gave cause for relief and concern about Omicron.

A study from South Africa released on Dec. 14 shows lower hospitalizations during the first 3 weeks of the Omicron wave than during earlier waves from other variants. That’s the good news.

The concerning news is out of the United Kingdom, where Imperial College London reported Dec. 17 that the risk of reinfection with COVID-19 from Omicron is more than 5 times as high and that cases of Omicron-based COVID-19 are doubling every 2 days.

What’s more, the study “finds no evidence of Omicron having lower severity than Delta, judged by either the proportion of people testing positive who report symptoms, or by the proportion of cases seeking hospital care after infection. However, hospitalization data remains very limited at this time,” the researchers said.

“We have no evidence that the virus itself is more mild,” Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape, told PBS NewsHour. “Until we have that, we have to assume that people who don’t have any protection are highly vulnerable to getting very ill.”

The White House COVID-19 team continues to urge parents and guardians to get their children vaccinated, especially in anticipation of a post-holiday spike. Dr. Walensky said the CDC’s vaccine advisory board met on Dec. 16 to continue the safety discussion about COVID-19 vaccinations in children.

So far, 20 million children under 17 and 5 million under 11 have received their shots.

“Looking specifically at vaccine safety data from over 50,000 children 5-11 years old, we found no evidence of serious safety concerns,” Dr. Walensky said.

Top infectious disease expert Anthony S. Fauci, MD, highlighted the importance of getting vaccinated and boosted to avoid serious disease from Delta and Omicron.

“We’re in a situation where we are now facing a very important Delta surge and we are looking over our shoulder at an oncoming Omicron surge,” he said. “The optimum protection is fully vaccinated plus a boost.”

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

The first large population study to investigate the association between different COVID-19 vaccines types and cardiac effects and adverse events shows a small increase in the risk for acute myocarditis with both the mRNA-based vaccines and – in what may a first in the literature – an adenovirus-vector vaccine.

Ivan Pantic/Getty Images

The excess risk was seen following the first dose of the ChAdOc1 (AstraZeneca/Oxford), the adenovirus-based vaccine, and the mRNA-based BNT162b2 (Pfizer/BioNTech). It was observed after first and second doses of the mRNA-1273 (Moderna) vaccine.

The incidence rate ratios for myocarditis 1-7 days after the first AstraZeneca, Pfizer, and Moderna injections were 1.76, 1.45, and 8.38, respectively, and 23.1 after the second dose of the Moderna vaccine.

“There’s a bit more uncertainty and worry about mRNA vaccines because it’s quite a new vector for vaccination and, therefore, there’s been more focus on the potential side effects,” said Nicholas Mills, MD.

“But it doesn’t surprise me the signal is present for all types of vaccines because they’re designed to generate a systemic immune response and that is, unfortunately, where you can cause small risks for immune-mediated illnesses like myocarditis,” Dr. Mills, from the University of Edinburgh, told this news organization. Dr. Mills is a coauthor on the study, published Dec. 14 in Nature Medicine.

To put the risks in context, the group estimated between 1 and 10 additional myocarditis hospitalizations or deaths per 1 million people vaccinated, but 40 excess myocarditis events per million following a positive SARS-CoV-2 test result.

As reported, rates of excess myocarditis events associated with a first dose were 2 per million injections of the AstraZeneca vaccine, 1 per million for the Pfizer vaccine, and 6 per million with the Moderna vaccine.

Following a second dose, there were 10 additional myocarditis events per million people receiving the Moderna vaccine and none among recipients of the AstraZeneca or Pfizer vaccines.

“It was particularly seen within the first 7 days of the first dose, which is very consistent with what we see in people who have viral myocarditis,” Dr. Mills said. “So it looks like a real signal but it’s very small.”

The results are in line with previous studies of the Pfizer vaccine in Israel and studies of the Moderna vaccine in the United States, Biykem Bozkurt, MD, PhD, professor of medicine at Baylor College of Medicine, Houston, told this news organization.

“What this paper does is confirm that cardiovascular complications – and they are only looking at a small component of those cardiovascular complications – are markedly higher with the COVID-19 infection than with the vaccines,” she said.

It also adds a new twist to the search for the mechanisms of myocarditis, which has focused on the immunogenicity of the RNA in the Pfizer and Moderna vaccines but also hypothesized that molecular mimicry between the SARS-CoV-2 spike glycoprotein and cell antigens, antibody production against cardiac proteins, and testosterone may play a role.

“But now it doesn’t look like the risk is solely confined to the mRNA vaccine platform because it’s also happening with the adenovirus,” Dr. Bozkurt said. “The mechanisms require future experimental and clinical research and we’ll need more granular data with cohorts that are closely followed up as well as subclinical follow-up.”

James de Lemos, MD, professor of medicine at the University of Texas Southwestern Medical Center, Dallas, and cochair of the American Heart Association’s COVID-19 CVD Registry, said he was also not surprised by a myocarditis signal with AstraZeneca’s adenovirus vaccine.

“Looking at relative risks has biological implications, but the clinical and public health implications are that the absolute risk with the adenovirus is trivial. And you see that with their estimations of absolute risk where it’s literally sort of a needle in the haystack of 1 or 2 per million,” he said in an interview.
 

Large-scale data

The investigators examined the rates of hospital admission or death from myocarditis, pericarditis, and cardiac arrhythmia in the 28 days following SARS-CoV-2 vaccination or infection by linking the English National Immunisation Database of COVID-19 vaccination with a national patient-level health care database of 38.6 million people, aged 16 years or older, vaccinated from Dec.1, 2020, to Aug. 24, 2021.

The number of people admitted to the hospital or who died during the study period was 1,615 for myocarditis, 1,574 for pericarditis, and 385,508 for cardiac arrhythmia.

There was no evidence of an increased risk for pericarditis or cardiac arrhythmia following vaccination, except for arrhythmia in the 28 days following a second dose of the Moderna vaccine (IRR, 1.46).

In contrast, the risk was increased for pericarditis (IRR, 2.79) and cardiac arrhythmia (IRR, 5.35) in the 28 days following a positive SARS-CoV-2 test result.

Although the scale of the analysis allows for more precise estimates than what’s been possible in smaller data sets, there is the challenge of diagnosing COVID-19 from billing codes and the potential for ascertainment bias, noted Dr. de Lemos.  

“Having said that, I think it’s a really important study, because it’s the first study to put the incidence in context in the same general population the risks of myocarditis with various vaccines and with COVID-19,” he said.

“That’s really important and provides a lot of reassurance for those who are trying to balance the risks and benefits of vaccination.”
 

Analyses by sex and age

A subgroup analysis by age showed increased risks for myocarditis with the mRNA vaccines only in those younger than 40, whereas no association was found with the Oxford adenovirus vaccine.

“We’re not seeing any signal here that would make us change the recommendation for vaccination in children as a consequence of this risk,” Dr. Mills said during a press briefing.

Dr. Bozkurt pointed out, however, that the estimated excess in myocarditis events following a second dose of the Moderna vaccine in these younger adults reportedly exceeded that for SARS-CoV-2 infection (15 per million vs. 10 per million).

“For that age group, it’s concerning and needs further clarification. This hasn’t been seen before,” she said.

The average age was 39 years for those receiving two doses of the Moderna vaccine and 55 for recipients of the Pfizer and Oxford vaccines. The Moderna vaccine wasn’t rolled out until April 2021 in the United Kingdom, the authors noted, so the number of patients who received this vaccine is lower.

Although reports have suggested young males are at greater risk for myocarditis after vaccination, an analysis by sex found that women had an increased risk for myocarditis after a first dose of the AstraZeneca (IRR, 1.40) and Pfizer (IRR, 1.54) vaccines and following a positive COVID-19 test result (IRR, 11.00).

“Women being at increased risk is rather a new message,” Dr. Bozkurt said. “But the incidence rate ratios are being compared against the unvaccinated, so when you see the increase in women, it doesn’t mean it’s increased against men. It would be helpful for sex-specific incidence rate ratios to be reported for younger age subgroups, such as ages 16-20 and 20-30, to determine whether there’s an increased risk for males compared to females at younger ages.”

Age and sex differences are huge questions, but “I think we’ll learn a lot about myocarditis in general from what is going to be an explosion of research into the vaccine-associated causes,” Dr. de Lemos said.

“That will help us understand myocarditis more broadly and prepare us for the next generation of vaccines, which inevitably will be mRNA based.”

Dr. Mills reported having no relevant disclosures. Dr. Bozkurt reported consulting for Bayer and scPharmaceuticals and serving on a clinical-events committee for a trial supported by Abbott Pharmaceuticals and on a data and safety monitoring board for a trial supported by Liva Nova Pharmaceuticals. Dr. De Lemos reported having no relevant conflicts of interest.

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

The first large population study to investigate the association between different COVID-19 vaccines types and cardiac effects and adverse events shows a small increase in the risk for acute myocarditis with both the mRNA-based vaccines and – in what may a first in the literature – an adenovirus-vector vaccine.

Ivan Pantic/Getty Images

The excess risk was seen following the first dose of the ChAdOc1 (AstraZeneca/Oxford), the adenovirus-based vaccine, and the mRNA-based BNT162b2 (Pfizer/BioNTech). It was observed after first and second doses of the mRNA-1273 (Moderna) vaccine.

The incidence rate ratios for myocarditis 1-7 days after the first AstraZeneca, Pfizer, and Moderna injections were 1.76, 1.45, and 8.38, respectively, and 23.1 after the second dose of the Moderna vaccine.

“There’s a bit more uncertainty and worry about mRNA vaccines because it’s quite a new vector for vaccination and, therefore, there’s been more focus on the potential side effects,” said Nicholas Mills, MD.

“But it doesn’t surprise me the signal is present for all types of vaccines because they’re designed to generate a systemic immune response and that is, unfortunately, where you can cause small risks for immune-mediated illnesses like myocarditis,” Dr. Mills, from the University of Edinburgh, told this news organization. Dr. Mills is a coauthor on the study, published Dec. 14 in Nature Medicine.

To put the risks in context, the group estimated between 1 and 10 additional myocarditis hospitalizations or deaths per 1 million people vaccinated, but 40 excess myocarditis events per million following a positive SARS-CoV-2 test result.

As reported, rates of excess myocarditis events associated with a first dose were 2 per million injections of the AstraZeneca vaccine, 1 per million for the Pfizer vaccine, and 6 per million with the Moderna vaccine.

Following a second dose, there were 10 additional myocarditis events per million people receiving the Moderna vaccine and none among recipients of the AstraZeneca or Pfizer vaccines.

“It was particularly seen within the first 7 days of the first dose, which is very consistent with what we see in people who have viral myocarditis,” Dr. Mills said. “So it looks like a real signal but it’s very small.”

The results are in line with previous studies of the Pfizer vaccine in Israel and studies of the Moderna vaccine in the United States, Biykem Bozkurt, MD, PhD, professor of medicine at Baylor College of Medicine, Houston, told this news organization.

“What this paper does is confirm that cardiovascular complications – and they are only looking at a small component of those cardiovascular complications – are markedly higher with the COVID-19 infection than with the vaccines,” she said.

It also adds a new twist to the search for the mechanisms of myocarditis, which has focused on the immunogenicity of the RNA in the Pfizer and Moderna vaccines but also hypothesized that molecular mimicry between the SARS-CoV-2 spike glycoprotein and cell antigens, antibody production against cardiac proteins, and testosterone may play a role.

“But now it doesn’t look like the risk is solely confined to the mRNA vaccine platform because it’s also happening with the adenovirus,” Dr. Bozkurt said. “The mechanisms require future experimental and clinical research and we’ll need more granular data with cohorts that are closely followed up as well as subclinical follow-up.”

James de Lemos, MD, professor of medicine at the University of Texas Southwestern Medical Center, Dallas, and cochair of the American Heart Association’s COVID-19 CVD Registry, said he was also not surprised by a myocarditis signal with AstraZeneca’s adenovirus vaccine.

“Looking at relative risks has biological implications, but the clinical and public health implications are that the absolute risk with the adenovirus is trivial. And you see that with their estimations of absolute risk where it’s literally sort of a needle in the haystack of 1 or 2 per million,” he said in an interview.
 

Large-scale data

The investigators examined the rates of hospital admission or death from myocarditis, pericarditis, and cardiac arrhythmia in the 28 days following SARS-CoV-2 vaccination or infection by linking the English National Immunisation Database of COVID-19 vaccination with a national patient-level health care database of 38.6 million people, aged 16 years or older, vaccinated from Dec.1, 2020, to Aug. 24, 2021.

The number of people admitted to the hospital or who died during the study period was 1,615 for myocarditis, 1,574 for pericarditis, and 385,508 for cardiac arrhythmia.

There was no evidence of an increased risk for pericarditis or cardiac arrhythmia following vaccination, except for arrhythmia in the 28 days following a second dose of the Moderna vaccine (IRR, 1.46).

In contrast, the risk was increased for pericarditis (IRR, 2.79) and cardiac arrhythmia (IRR, 5.35) in the 28 days following a positive SARS-CoV-2 test result.

Although the scale of the analysis allows for more precise estimates than what’s been possible in smaller data sets, there is the challenge of diagnosing COVID-19 from billing codes and the potential for ascertainment bias, noted Dr. de Lemos.  

“Having said that, I think it’s a really important study, because it’s the first study to put the incidence in context in the same general population the risks of myocarditis with various vaccines and with COVID-19,” he said.

“That’s really important and provides a lot of reassurance for those who are trying to balance the risks and benefits of vaccination.”
 

Analyses by sex and age

A subgroup analysis by age showed increased risks for myocarditis with the mRNA vaccines only in those younger than 40, whereas no association was found with the Oxford adenovirus vaccine.

“We’re not seeing any signal here that would make us change the recommendation for vaccination in children as a consequence of this risk,” Dr. Mills said during a press briefing.

Dr. Bozkurt pointed out, however, that the estimated excess in myocarditis events following a second dose of the Moderna vaccine in these younger adults reportedly exceeded that for SARS-CoV-2 infection (15 per million vs. 10 per million).

“For that age group, it’s concerning and needs further clarification. This hasn’t been seen before,” she said.

The average age was 39 years for those receiving two doses of the Moderna vaccine and 55 for recipients of the Pfizer and Oxford vaccines. The Moderna vaccine wasn’t rolled out until April 2021 in the United Kingdom, the authors noted, so the number of patients who received this vaccine is lower.

Although reports have suggested young males are at greater risk for myocarditis after vaccination, an analysis by sex found that women had an increased risk for myocarditis after a first dose of the AstraZeneca (IRR, 1.40) and Pfizer (IRR, 1.54) vaccines and following a positive COVID-19 test result (IRR, 11.00).

“Women being at increased risk is rather a new message,” Dr. Bozkurt said. “But the incidence rate ratios are being compared against the unvaccinated, so when you see the increase in women, it doesn’t mean it’s increased against men. It would be helpful for sex-specific incidence rate ratios to be reported for younger age subgroups, such as ages 16-20 and 20-30, to determine whether there’s an increased risk for males compared to females at younger ages.”

Age and sex differences are huge questions, but “I think we’ll learn a lot about myocarditis in general from what is going to be an explosion of research into the vaccine-associated causes,” Dr. de Lemos said.

“That will help us understand myocarditis more broadly and prepare us for the next generation of vaccines, which inevitably will be mRNA based.”

Dr. Mills reported having no relevant disclosures. Dr. Bozkurt reported consulting for Bayer and scPharmaceuticals and serving on a clinical-events committee for a trial supported by Abbott Pharmaceuticals and on a data and safety monitoring board for a trial supported by Liva Nova Pharmaceuticals. Dr. De Lemos reported having no relevant conflicts of interest.

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

The first large population study to investigate the association between different COVID-19 vaccines types and cardiac effects and adverse events shows a small increase in the risk for acute myocarditis with both the mRNA-based vaccines and – in what may a first in the literature – an adenovirus-vector vaccine.

Ivan Pantic/Getty Images

The excess risk was seen following the first dose of the ChAdOc1 (AstraZeneca/Oxford), the adenovirus-based vaccine, and the mRNA-based BNT162b2 (Pfizer/BioNTech). It was observed after first and second doses of the mRNA-1273 (Moderna) vaccine.

The incidence rate ratios for myocarditis 1-7 days after the first AstraZeneca, Pfizer, and Moderna injections were 1.76, 1.45, and 8.38, respectively, and 23.1 after the second dose of the Moderna vaccine.

“There’s a bit more uncertainty and worry about mRNA vaccines because it’s quite a new vector for vaccination and, therefore, there’s been more focus on the potential side effects,” said Nicholas Mills, MD.

“But it doesn’t surprise me the signal is present for all types of vaccines because they’re designed to generate a systemic immune response and that is, unfortunately, where you can cause small risks for immune-mediated illnesses like myocarditis,” Dr. Mills, from the University of Edinburgh, told this news organization. Dr. Mills is a coauthor on the study, published Dec. 14 in Nature Medicine.

To put the risks in context, the group estimated between 1 and 10 additional myocarditis hospitalizations or deaths per 1 million people vaccinated, but 40 excess myocarditis events per million following a positive SARS-CoV-2 test result.

As reported, rates of excess myocarditis events associated with a first dose were 2 per million injections of the AstraZeneca vaccine, 1 per million for the Pfizer vaccine, and 6 per million with the Moderna vaccine.

Following a second dose, there were 10 additional myocarditis events per million people receiving the Moderna vaccine and none among recipients of the AstraZeneca or Pfizer vaccines.

“It was particularly seen within the first 7 days of the first dose, which is very consistent with what we see in people who have viral myocarditis,” Dr. Mills said. “So it looks like a real signal but it’s very small.”

The results are in line with previous studies of the Pfizer vaccine in Israel and studies of the Moderna vaccine in the United States, Biykem Bozkurt, MD, PhD, professor of medicine at Baylor College of Medicine, Houston, told this news organization.

“What this paper does is confirm that cardiovascular complications – and they are only looking at a small component of those cardiovascular complications – are markedly higher with the COVID-19 infection than with the vaccines,” she said.

It also adds a new twist to the search for the mechanisms of myocarditis, which has focused on the immunogenicity of the RNA in the Pfizer and Moderna vaccines but also hypothesized that molecular mimicry between the SARS-CoV-2 spike glycoprotein and cell antigens, antibody production against cardiac proteins, and testosterone may play a role.

“But now it doesn’t look like the risk is solely confined to the mRNA vaccine platform because it’s also happening with the adenovirus,” Dr. Bozkurt said. “The mechanisms require future experimental and clinical research and we’ll need more granular data with cohorts that are closely followed up as well as subclinical follow-up.”

James de Lemos, MD, professor of medicine at the University of Texas Southwestern Medical Center, Dallas, and cochair of the American Heart Association’s COVID-19 CVD Registry, said he was also not surprised by a myocarditis signal with AstraZeneca’s adenovirus vaccine.

“Looking at relative risks has biological implications, but the clinical and public health implications are that the absolute risk with the adenovirus is trivial. And you see that with their estimations of absolute risk where it’s literally sort of a needle in the haystack of 1 or 2 per million,” he said in an interview.
 

Large-scale data

The investigators examined the rates of hospital admission or death from myocarditis, pericarditis, and cardiac arrhythmia in the 28 days following SARS-CoV-2 vaccination or infection by linking the English National Immunisation Database of COVID-19 vaccination with a national patient-level health care database of 38.6 million people, aged 16 years or older, vaccinated from Dec.1, 2020, to Aug. 24, 2021.

The number of people admitted to the hospital or who died during the study period was 1,615 for myocarditis, 1,574 for pericarditis, and 385,508 for cardiac arrhythmia.

There was no evidence of an increased risk for pericarditis or cardiac arrhythmia following vaccination, except for arrhythmia in the 28 days following a second dose of the Moderna vaccine (IRR, 1.46).

In contrast, the risk was increased for pericarditis (IRR, 2.79) and cardiac arrhythmia (IRR, 5.35) in the 28 days following a positive SARS-CoV-2 test result.

Although the scale of the analysis allows for more precise estimates than what’s been possible in smaller data sets, there is the challenge of diagnosing COVID-19 from billing codes and the potential for ascertainment bias, noted Dr. de Lemos.  

“Having said that, I think it’s a really important study, because it’s the first study to put the incidence in context in the same general population the risks of myocarditis with various vaccines and with COVID-19,” he said.

“That’s really important and provides a lot of reassurance for those who are trying to balance the risks and benefits of vaccination.”
 

Analyses by sex and age

A subgroup analysis by age showed increased risks for myocarditis with the mRNA vaccines only in those younger than 40, whereas no association was found with the Oxford adenovirus vaccine.

“We’re not seeing any signal here that would make us change the recommendation for vaccination in children as a consequence of this risk,” Dr. Mills said during a press briefing.

Dr. Bozkurt pointed out, however, that the estimated excess in myocarditis events following a second dose of the Moderna vaccine in these younger adults reportedly exceeded that for SARS-CoV-2 infection (15 per million vs. 10 per million).

“For that age group, it’s concerning and needs further clarification. This hasn’t been seen before,” she said.

The average age was 39 years for those receiving two doses of the Moderna vaccine and 55 for recipients of the Pfizer and Oxford vaccines. The Moderna vaccine wasn’t rolled out until April 2021 in the United Kingdom, the authors noted, so the number of patients who received this vaccine is lower.

Although reports have suggested young males are at greater risk for myocarditis after vaccination, an analysis by sex found that women had an increased risk for myocarditis after a first dose of the AstraZeneca (IRR, 1.40) and Pfizer (IRR, 1.54) vaccines and following a positive COVID-19 test result (IRR, 11.00).

“Women being at increased risk is rather a new message,” Dr. Bozkurt said. “But the incidence rate ratios are being compared against the unvaccinated, so when you see the increase in women, it doesn’t mean it’s increased against men. It would be helpful for sex-specific incidence rate ratios to be reported for younger age subgroups, such as ages 16-20 and 20-30, to determine whether there’s an increased risk for males compared to females at younger ages.”

Age and sex differences are huge questions, but “I think we’ll learn a lot about myocarditis in general from what is going to be an explosion of research into the vaccine-associated causes,” Dr. de Lemos said.

“That will help us understand myocarditis more broadly and prepare us for the next generation of vaccines, which inevitably will be mRNA based.”

Dr. Mills reported having no relevant disclosures. Dr. Bozkurt reported consulting for Bayer and scPharmaceuticals and serving on a clinical-events committee for a trial supported by Abbott Pharmaceuticals and on a data and safety monitoring board for a trial supported by Liva Nova Pharmaceuticals. Dr. De Lemos reported having no relevant conflicts of interest.

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

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

The Food and Drug Administration has stopped trials of oral and implant formulations of islatravir for HIV, the investigational drug’s developer, Merck, announced in a press release.

Investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP); the injectable formulation of islatravir for treatment and prophylaxis; and the oral doravirine/islatravir (DOR/ISL) once-daily treatment, the company announced.

The FDA’s hold followed observations that total lymphocyte and T-cell counts had dropped in some participants receiving islatravir in clinical studies.

The trials have dealt a major setback to Merck’s HIV program momentum: Thirteen trials are now on hold (six on partial hold and seven on full hold). Seven of the trials were in phase 3. But primarily the news is disappointing for patients looking for options with the confounding disease.

Tristan Barber, MD, an HIV consultant with Royal Free London National Health Service Foundation Trust, told this news organization that “the hold on these studies is a blow for those hoping for longer-acting therapies for HIV treatment and prevention. Islatravir and [investigational drug] MK-8507 were being explored in oral and other formulations and potentially would offer a non-integrase, two-drug option, increasing options for people with HIV. Whilst we don’t know the clinical significance of these CD4 drops, [Merck] made the correct decision in pausing these studies until the data is clearer.”

Merck announced in November that it had stopped dosing in the phase 2 IMAGINE-DR clinical trial of islatravir in combination with MK-8507. MK-8507 and islatravir, alone and combined, are investigational and not approved for use.

In that trial as well, decreases were observed in total lymphocyte and T-cell counts in study participants randomly assigned to receive the combination. A review by the external Data Monitoring Committee determined that the drop was related to treatment with the combination.

“We are grateful to the participants and the study investigators for their ongoing contributions to this research,” Joan Butterton, MD, vice president of infectious diseases in Global Clinical Development at Merck Research Laboratories, said in a statement. “Merck continues to investigate the potential of islatravir and nucleoside reverse transcriptase translocation inhibitors and remains committed to helping to address unmet needs in HIV treatment and prevention.”

In light of the hold, no new studies using islatravir may be initiated. People currently receiving islatravir as part of the studies for PrEP, as well as injectable islatravir for treatment and prophylaxis, will no longer receive the study drug, and T-cell and lymphocyte counts will be monitored for recovery.

Those participating in the PrEP studies will be offered approved, once-daily, oral PrEP and those in studies of DOR/ISL who already started treatment will continue to receive study medication under a partial clinical hold.

A full list of the trials that have been placed on full or partial clinical holds can be found in the press release.

In an interview with this news organization, Monica Gandhi, MD, MPH, director of University of California, San Francisco’s Gladstone Center for AIDS Research, described the news of the islatravir trial holds as “very disappointing.”

“There were high hopes for this drug,” she said, adding that the hope was it would be paired with Gilead’s lenacapavir (another long-acting agent) for treatment and be able to give a once-weekly option for HIV treatment.

Lenacapavir is Gilead’s potential first-in-class, long-acting HIV-1 capsid inhibitor in development for treatment and prevention of HIV.

“Moreover,” she said, “additional hope was that, because of [islatravir’s] long half-life, it could be used as a monthly medication for pre-exposure prophylaxis.”

Gilead and Merck have decided to stop all dosing of participants in the phase 2 clinical trial evaluating an oral, weekly combination treatment of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy, according to Merck’s press release.

Participants in that trial will stop taking the study drug and restart their previous antiretroviral regimen. According to the press release, both companies are considering whether a different dosing of islatravir combined with lenacapavir may become a once-weekly oral therapy option for people living with HIV.

Neither Merck nor Gilead representatives responded to request for comment by publication time.

Dr. Barber reported conference support, speaker fees, and advisory board honoraria from Gilead, Janssen, Merck, Roche, Thera, and ViiV and research/educational grants from Gilead, Roche, and ViiV. Dr. Gandhi has disclosed no relevant financial relationships.

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

An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.

“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.

“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.

The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.

The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.

“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.

“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”

The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.

Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.

Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
 

Clinician awareness of low vaccination rates lacking

Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.

Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.

But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.

“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
 

Opioid use a key factor in rising infection rates

Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.

“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.

Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.

Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.

However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.

“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.

“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
 

Implementation of vaccine recommendations key

Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:

• Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
• Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
• Follow-up: Systems should be established to remind patients to receive follow-up doses.
• Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
• Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.

Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.

Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.

“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”

Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.

“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”

Dr. Kuwahara and Mr. Hood had no disclosures to report.

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

An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.

“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.

“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.

The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.

The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.

“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.

“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”

The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.

Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.

Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
 

Clinician awareness of low vaccination rates lacking

Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.

Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.

But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.

“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
 

Opioid use a key factor in rising infection rates

Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.

“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.

Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.

Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.

However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.

“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.

“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
 

Implementation of vaccine recommendations key

Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:

• Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
• Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
• Follow-up: Systems should be established to remind patients to receive follow-up doses.
• Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
• Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.

Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.

Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.

“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”

Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.

“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”

Dr. Kuwahara and Mr. Hood had no disclosures to report.

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

An updated recommendation from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) calling for universal hepatitis B vaccination of all adults aged 59 and younger has boosted the call to improve clinicians’ awareness of the increasing infection and low vaccination rates – and raise the issue with patients.

“This new recommendation from [the] ACIP will be instrumental [in] raising adult hepatitis B vaccination rates in the U.S. to levels that will allow us to finally eliminate hepatitis B in this country,” said Rita K. Kuwahara, MD, a primary care internal medicine physician and health policy fellow at Georgetown University, in Washington, D.C., in addressing the issue at the U.S. Conference on HIV/AIDS (USCHA) this month.

“We have the tools to prevent hepatitis B, and since we have such safe and highly effective vaccines to protect against community [spread], we should not have a single new infection in our nation,” she asserted.

The unanimously approved updated ACIP recommendation was issued in November and still requires adoption by the CDC director. The ACIP specifically recommends that adults aged 19 to 59 and those 60 years and older with risk factors for infection “should” receive the hepatitis B vaccine, and it further stipulates that those 60 years and older without known risk factors for hepatitis B “may” receive the vaccine.

The recommendation was previously only for adults at risk for hepatitis B infection due to a variety of factors, including sexual exposure, percutaneous or mucosal exposure to blood, hepatitis C infection, chronic liver disease, end-stage renal disease, and HIV infection.

“The number of risk factors was long, and for a busy primary care provider to have to go through a lengthy risk-based protocol like that, it may not happen,” Dr. Kuwahara told this news organization.

“Now we have a really helpful new recommendation that is simply age based, and clinicians can just tell patients that if they were born before this certain period, a hepatitis B vaccination is recommended.”

The change comes amid a troubling trajectory of hepatitis B, with up to 2.4 million individuals currently having chronic hepatitis B in the U.S. and infection rates soaring by 100% to more than 400% in states with high opioid use, such as West Virginia, Kentucky, Tennessee, and Maine, Dr. Kuwahara said.

Notably, hepatitis B is the leading cause of liver disease, and one in four individuals with unmanaged chronic hepatitis B goes on to develop liver failure and/or cirrhosis or liver cancer, which has a 5-year survival rate of only 18%.

Despite the rising infection rates, only 25%-30% of adults in the U.S. are reported to be currently vaccinated for hepatitis B, even though safe and highly effective vaccines are available, notably including a new two-dose vaccine (Heplisav-B) that can be provided over just a month (vs. other hepatitis B vaccines requiring 3 doses over 6 months).
 

Clinician awareness of low vaccination rates lacking

Dr. Kuwahara noted that awareness among clinicians of the issues surrounding hepatitis B appears low, with one small survey that she and her colleagues conducted of 30 primary care physicians showing that not one of the respondents was aware of the low vaccination rate.

Dr. Kuwahara says a key reason for the low awareness to discuss the hepatitis B vaccination with adults is the common impression that the responsibility for the vaccination lies in the hands of pediatricians.

But that’s only half correct – universal vaccination for hepatitis B in all infants and children is indeed currently the policy in the U.S. – but that was not implemented in all states until the mid-to-late ‘90s, meaning the millions of adults over the age of about 25 to 30, born before that period, are likely not fully vaccinated against hepatitis B.

“When I was in medical school, there wasn’t a lot of discussion of how low the hepatitis B vaccination rate was because everyone knew there was universal childhood vaccination, and I think there was an assumption that it had been going on for a long time,” Dr. Kuwahara said. “So I think it’s clearly a misconception, and it’s really important to improve clinician awareness around the issue.”
 

Opioid use a key factor in rising infection rates

Importantly, a large proportion of opioid users are among the population of patients born before the mid-’90s – and those adults have a particularly high risk of transmission, with data indicating that 36% of new hepatitis B infections are the result of the opioid epidemic, Dr. Kuwahara noted.

“In the opioid epidemic, we have seen some of the greatest increases in acute hepatitis B presenting in adults aged 30 to 49 years old, as most adults in this age range would not have been vaccinated as children in the U.S.,” she said.

Approximately two-thirds of individuals with chronic hepatitis B are reportedly not even aware of their infection status due to ineffective prevention and vaccination programs, adding to the spread of infection, Dr. Kuwahara said.

Meanwhile, COVID-19 has only exacerbated the problem, with record-high instances of overdoses and overdose-related deaths during the pandemic, she explained.

However, the pandemic, and specifically the sweeping innovations that have been implemented in desperate efforts to bring COVID-19 vaccines to the public, could in fact represent a critical opportunity for hepatitis B prevention, Dr. Kuwahara said.

“Significant resources and federal funding have already been invested to develop a robust infrastructure for multi-dose COVID-19 vaccine administration during the pandemic, which has resulted in millions of people across the U.S. receiving the COVID-19 vaccine in easily accessible settings within their communities,” she said.

“It is essential that we expand the infrastructure development ... so that we may use this infrastructure to administer other vaccines such as the hepatitis B vaccine to adults throughout the nation and prevent additional outbreaks.”
 

Implementation of vaccine recommendations key

Dr. Kuwahara outlined key measures that will be important in implementing the hepatitis B vaccine recommendations:

• Awareness of the hepatitis B vaccination recommendations at the primary care level: “The first step in implementing universal [guidelines] will be to ensure that health care providers, particularly in primary care, are aware of the new ACIP guidelines so that they can speak with their patients about this and appropriately order hepatitis B testing and vaccination,” she said.
• Availability of vaccines: In addition to making sure primary care clinics are well stocked with hepatitis B vaccines, the vaccines should also be available in pharmacies and other convenient nonclinical settings through community outreach, similar to COVID-19 vaccines.
• Follow-up: Systems should be established to remind patients to receive follow-up doses.
• Public funding for vaccines: Policy changes will need to occur to allocate appropriate Section 317 funding to provide hepatitis B vaccines to adults without health insurance coverage, Dr. Kuwahara said, underscoring concerns about health equity in vaccination.
• Track vaccinations: Communication should be established between places administering vaccines and primary care providers to make sure that vaccination status can be documented in a reliable setting.

Dr. Kuwahara also noted that a federal immunization information system will be essential to track vaccines across a lifespan, providing one integrated vaccine record that can be accessed even when patients travel or move to different states.

Commenting on the issue, Frank Hood, manager of hepatitis advocacy for The AIDS Institute in Washington, D.C., added that, in addition to simplifying the process, the new age-based recommendation removes the issue of perceived judgement from the advice.

“The previous recommendations were more risk based, and patients may tend to say ‘oh, I don’t have any of those behaviors,’ and there can be some stigma,” he said. “But having something that says everyone in these age groups should be or may be vaccinated just makes it much easier and covers a greater number of individuals.”

Mr. Hood further underscored the need for continued diligence in improving measures to prevent and eradicate HBV as well as other infectious diseases.

“It is imperative that the systems being built now to respond to future infectious disease outbreaks are done so in a way to equitably support the efforts and end goal of eliminating current infectious disease epidemics like viral hepatitis and HIV,” he emphasized.“Elimination can’t be achieved if we leave people behind.”

Dr. Kuwahara and Mr. Hood had no disclosures to report.

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

The number of reported circulating vaccine-derived poliovirus (cVDPV) outbreaks more than tripled to 29 since Jan. 2017. Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.

The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.

The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”

Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”

The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.

The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”

The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.

Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”

Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.

Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”

“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.

For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.

Dr. Wenger and Dr. Wassilak report no relevant financial relationships.

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

The number of reported circulating vaccine-derived poliovirus (cVDPV) outbreaks more than tripled to 29 since Jan. 2017. Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.

The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.

The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”

Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”

The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.

The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”

The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.

Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”

Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.

Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”

“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.

For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.

Dr. Wenger and Dr. Wassilak report no relevant financial relationships.

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

The number of reported circulating vaccine-derived poliovirus (cVDPV) outbreaks more than tripled to 29 since Jan. 2017. Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.

The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.

The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”

Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”

The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.

The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”

The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.

Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”

Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.

Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”

“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.

For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.

Dr. Wenger and Dr. Wassilak report no relevant financial relationships.

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

A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

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

A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

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

A panel of experts that advises the Centers for Disease Control and Prevention on the use of vaccines said the Pfizer and Moderna mRNA COVID-19 vaccines should be the preferred shots for adults in the United States because the Johnson & Johnson shot carries the risk of a rare but potentially fatal side effect that causes blood clots and bleeding in the brain.

In an emergency meeting on December 16, the CDC’s Advisory Committee on Immunization Practices, or ACIP, voted unanimously (15-0) to state a preference for the mRNA vaccines over the Johnson & Johnson shot. The vote came after the panel heard a safety update on cases of thrombosis with thrombocytopenia syndrome, or TTS, a condition that causes large clots that deplete the blood of platelets, resulting in uncontrolled bleeding.

The move brings the United States in line with other wealthy countries. In May, Denmark dropped the Johnson & Johnson shot from its vaccination program because of this risk. Australia and Greece have limited the use of a similar vaccine, made by AstraZeneca, in younger people because of the TTS risk. Both vaccines use the envelope of a different kind of virus, called an adenovirus, to sneak the vaccine instructions into cells. On Dec. 16, health officials said they had determined that TTS was likely due to a class effect, meaning it happens with all adenovirus vector vaccines.

The risk of dying from TTS after a Johnson & Johnson shot is extremely rare. There is an estimated 1 death for every 2 million doses of the vaccine given in the general population. That risk is higher for women ages 30 to 49, rising to about 2 deaths for every 1 million doses given in this age group. There’s no question that the Johnson & Johnson shot has saved many more lives than it has taken, experts said

Still, the committee previously paused the use of the Johnson & Johnson vaccine in April after the first cases of TTS came to light. That pause was lifted just 10 days later, after a new warning was added to the vaccine’s label to raise awareness of the risk.

In updating the safety information on Johnson & Johnson, the panel noted that the warning label had not sufficiently lowered the risk of death from TTS. Doctors seem to be aware of the condition because none of the patients who had developed TTS had been treated with the blood thinner heparin, which can make the syndrome worse. But patients continued to die even after the label was added, the panel noted, because TTS can progress so quickly that doctors simply don’t have time to treat it.

For that reason, and because there are other, safer vaccines available, the panel decided to make what’s called a preferential statement, saying the Pfizer and Moderna mRNA vaccines should be preferred over Johnson & Johnson.

The statement leaves the J&J vaccine on the market and available to patients who are at risk of a severe allergic reaction to the mRNA vaccines. It also means that people can still choose the J&J vaccine if they still want it after being informed about the risks.

About 17 million first doses and 900,000 second doses of the Johnson & Johnson vaccine have been given in the United States. Through the end of August, 54 cases of thrombosis with thrombocytopenia syndrome (TTS) have occurred after the J&J shots in the United States. Nearly half of those were in women ages 30 to 49. There have been nine deaths from TTS after Johnson & Johnson shots.

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