Vaccines

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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

As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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

As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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

Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).

The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.

The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.

Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.

In other NIS-Teen findings:

• Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
• Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
• The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
• In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
• Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
• Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
• Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).

Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.

“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.

“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”

According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”

Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).

The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.

The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.

Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.

In other NIS-Teen findings:

• Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
• Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
• The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
• In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
• Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
• Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
• Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).

Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.

“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.

“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”

According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”

Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).

The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.

The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.

Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.

In other NIS-Teen findings:

• Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
• Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
• The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
• In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
• Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
• Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
• Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).

Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.

“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.

“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”

According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”

Vaccines against human papillomavirus have been hailed as a success: they have been shown to decrease the incidence of cervical lesions associated with the HPV types that are in the vaccine.

However, new evidence suggests that HPV vaccination makes women more susceptible than their nonvaccinated peers to HPV genotypes not covered by the vaccine.

An expert not involved in the research said the new data “tell us to be a little bit careful.” Although the HPV types not included in the vaccine are rarer and less aggressive, they can still cause cancer.

The data come from the Costa Rica HPV Vaccine Trial, which involved more than 10,000 women aged 18-25 years. The HPV vaccine used in the trial was Cervarix, from GlaxoSmithKline. It covers the two leading causes of cervical cancer, HPV-16 and -18, and provides partial protection against three other genotypes.

After a follow-up of 11 years, among vaccinated women, there was an excess of precancerous cervical lesions caused by genotypes not included in the vaccine, resulting in negative vaccine efficacy for those HPV variants.

The increase wasn’t enough to offset the overall benefit of vaccination when all genotypes were considered, said the researchers, led by Jaimie Shing, PhD, a postdoctoral research fellow at the National Cancer Institute in Bethesda, Md.

Vaccinated women “still had long-term absolute reductions in high-grade lesions,” they pointed out.

The net protection “remained considerable, emphasizing the importance of HPV vaccination for cervical cancer prevention,” the team concluded.

The findings were published online in The Lancet Oncology.

The results are likely the first evidence to date of “clinical unmasking” with HPV vaccination, meaning that protection against the strains covered by the vaccine leaves women more prone to attack from other carcinogenic HPV variants.

This phenomenon “could attenuate long-term reductions in high-grade disease following successful implementation of HPV vaccination programs,” the investigators commented.
 

Highlighting a need for caution

The take-home message from the trial is that “we have to be careful,” said Marc Steben, MD, co-President of HPV Global Action and a professor at the University of Montreal.

He noted that the Cervarix HPV vaccine used in the trial is not the vaccine that is used now in developed nations.

The current standard HPV vaccine is Gardasil 9 (Merck), which offers broader coverage against nine HPV types (types 6, 11, 16, 18, 31, 33, 45, 52, and 58).

There are 12 main carcinogenic HPV genotypes, so unmasking of other strains is still possible with Gardasil 9, he said.

There is another issue, Dr. Steben added. The success of HPV vaccinations - a nearly 90% reduction in invasive cervical cancer in women who are vaccinated at a young age – has led to questions about the future role of routine cervical cancer screening.

“Some people are saying that if we achieve 90% coverage, we might” eliminate community transmission and no longer need to screen, he said.

These trial results “tell us to be a little bit careful,” Dr. Steben continued. Those HPV types that are less aggressive and rarer than HPV-16 and -18 “can still cause cancer and might be there and surprise us. It could take more time than we thought” to get to the point where screening can be eliminated.

“There might be a little problem if we stop too early,” he said.
 

Study details

During the period 2004-2005, the investigators randomly assigned 3,727 women aged 18-25 years to receive Cervarix and 3,739 to a control group that received the hepatitis A vaccine; after 4 years, the control group also received Cervarix and exited the study. They were replaced by an unvaccinated control group of 2,836 women. The new control group and the original HPV vaccine group were followed for an additional 7 years.

In years 7-11 of the trial, the investigators found 9.2 additional cervical intraepithelial neoplasias of grade 2 or worse (CIN2+) from HPV types not covered by Cervarix per 1,000 vaccinated women in comparison with unvaccinated participants. This corresponds to –71.2% negative vaccine efficacy against CIN2+ lesions of HPV types not covered by the vaccine.

There were 8.3 additional CIN3+ lesions from nontargeted HPV strains per 1,000 vaccinated women in comparison with unvaccinated participants, which corresponds to –135% negative vaccine efficacy.

Overall, however, there was a net benefit of vaccination, with 27 fewer CIN2+ lesions when all HPV genotypes – vaccine covered or not – were considered per 1,000 vaccinated women over the entire 11 years of follow-up.

There were also 8.7 fewer CIN3+ lesions across all genotypes per 1,000 vaccinated women, but the benefit was not statistically significant.

Among the study limits, the team was unable to evaluate the effect of clinical unmasking on cervical cancer, because women were treated for high-grade cervical lesions before cases could progress to cervical cancer.

The trial was funded by the National Cancer Institute and the National Institutes of Health Office of Research on Women’s Health. GlaxoSmithKline provided the Cervarix vaccine and supported aspects of the trial. Two authors are named inventors on U.S. government–owned HPV vaccine patents with expired licenses to GlaxoSmithKline and Merck. Dr. Steben is an adviser/speaker for many companies, including GlaxoSmithKline and Merck.

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

Vaccines against human papillomavirus have been hailed as a success: they have been shown to decrease the incidence of cervical lesions associated with the HPV types that are in the vaccine.

However, new evidence suggests that HPV vaccination makes women more susceptible than their nonvaccinated peers to HPV genotypes not covered by the vaccine.

An expert not involved in the research said the new data “tell us to be a little bit careful.” Although the HPV types not included in the vaccine are rarer and less aggressive, they can still cause cancer.

The data come from the Costa Rica HPV Vaccine Trial, which involved more than 10,000 women aged 18-25 years. The HPV vaccine used in the trial was Cervarix, from GlaxoSmithKline. It covers the two leading causes of cervical cancer, HPV-16 and -18, and provides partial protection against three other genotypes.

After a follow-up of 11 years, among vaccinated women, there was an excess of precancerous cervical lesions caused by genotypes not included in the vaccine, resulting in negative vaccine efficacy for those HPV variants.

The increase wasn’t enough to offset the overall benefit of vaccination when all genotypes were considered, said the researchers, led by Jaimie Shing, PhD, a postdoctoral research fellow at the National Cancer Institute in Bethesda, Md.

Vaccinated women “still had long-term absolute reductions in high-grade lesions,” they pointed out.

The net protection “remained considerable, emphasizing the importance of HPV vaccination for cervical cancer prevention,” the team concluded.

The findings were published online in The Lancet Oncology.

The results are likely the first evidence to date of “clinical unmasking” with HPV vaccination, meaning that protection against the strains covered by the vaccine leaves women more prone to attack from other carcinogenic HPV variants.

This phenomenon “could attenuate long-term reductions in high-grade disease following successful implementation of HPV vaccination programs,” the investigators commented.
 

Highlighting a need for caution

The take-home message from the trial is that “we have to be careful,” said Marc Steben, MD, co-President of HPV Global Action and a professor at the University of Montreal.

He noted that the Cervarix HPV vaccine used in the trial is not the vaccine that is used now in developed nations.

The current standard HPV vaccine is Gardasil 9 (Merck), which offers broader coverage against nine HPV types (types 6, 11, 16, 18, 31, 33, 45, 52, and 58).

There are 12 main carcinogenic HPV genotypes, so unmasking of other strains is still possible with Gardasil 9, he said.

There is another issue, Dr. Steben added. The success of HPV vaccinations - a nearly 90% reduction in invasive cervical cancer in women who are vaccinated at a young age – has led to questions about the future role of routine cervical cancer screening.

“Some people are saying that if we achieve 90% coverage, we might” eliminate community transmission and no longer need to screen, he said.

These trial results “tell us to be a little bit careful,” Dr. Steben continued. Those HPV types that are less aggressive and rarer than HPV-16 and -18 “can still cause cancer and might be there and surprise us. It could take more time than we thought” to get to the point where screening can be eliminated.

“There might be a little problem if we stop too early,” he said.
 

Study details

During the period 2004-2005, the investigators randomly assigned 3,727 women aged 18-25 years to receive Cervarix and 3,739 to a control group that received the hepatitis A vaccine; after 4 years, the control group also received Cervarix and exited the study. They were replaced by an unvaccinated control group of 2,836 women. The new control group and the original HPV vaccine group were followed for an additional 7 years.

In years 7-11 of the trial, the investigators found 9.2 additional cervical intraepithelial neoplasias of grade 2 or worse (CIN2+) from HPV types not covered by Cervarix per 1,000 vaccinated women in comparison with unvaccinated participants. This corresponds to –71.2% negative vaccine efficacy against CIN2+ lesions of HPV types not covered by the vaccine.

There were 8.3 additional CIN3+ lesions from nontargeted HPV strains per 1,000 vaccinated women in comparison with unvaccinated participants, which corresponds to –135% negative vaccine efficacy.

Overall, however, there was a net benefit of vaccination, with 27 fewer CIN2+ lesions when all HPV genotypes – vaccine covered or not – were considered per 1,000 vaccinated women over the entire 11 years of follow-up.

There were also 8.7 fewer CIN3+ lesions across all genotypes per 1,000 vaccinated women, but the benefit was not statistically significant.

Among the study limits, the team was unable to evaluate the effect of clinical unmasking on cervical cancer, because women were treated for high-grade cervical lesions before cases could progress to cervical cancer.

The trial was funded by the National Cancer Institute and the National Institutes of Health Office of Research on Women’s Health. GlaxoSmithKline provided the Cervarix vaccine and supported aspects of the trial. Two authors are named inventors on U.S. government–owned HPV vaccine patents with expired licenses to GlaxoSmithKline and Merck. Dr. Steben is an adviser/speaker for many companies, including GlaxoSmithKline and Merck.

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

Vaccines against human papillomavirus have been hailed as a success: they have been shown to decrease the incidence of cervical lesions associated with the HPV types that are in the vaccine.

However, new evidence suggests that HPV vaccination makes women more susceptible than their nonvaccinated peers to HPV genotypes not covered by the vaccine.

An expert not involved in the research said the new data “tell us to be a little bit careful.” Although the HPV types not included in the vaccine are rarer and less aggressive, they can still cause cancer.

The data come from the Costa Rica HPV Vaccine Trial, which involved more than 10,000 women aged 18-25 years. The HPV vaccine used in the trial was Cervarix, from GlaxoSmithKline. It covers the two leading causes of cervical cancer, HPV-16 and -18, and provides partial protection against three other genotypes.

After a follow-up of 11 years, among vaccinated women, there was an excess of precancerous cervical lesions caused by genotypes not included in the vaccine, resulting in negative vaccine efficacy for those HPV variants.

The increase wasn’t enough to offset the overall benefit of vaccination when all genotypes were considered, said the researchers, led by Jaimie Shing, PhD, a postdoctoral research fellow at the National Cancer Institute in Bethesda, Md.

Vaccinated women “still had long-term absolute reductions in high-grade lesions,” they pointed out.

The net protection “remained considerable, emphasizing the importance of HPV vaccination for cervical cancer prevention,” the team concluded.

The findings were published online in The Lancet Oncology.

The results are likely the first evidence to date of “clinical unmasking” with HPV vaccination, meaning that protection against the strains covered by the vaccine leaves women more prone to attack from other carcinogenic HPV variants.

This phenomenon “could attenuate long-term reductions in high-grade disease following successful implementation of HPV vaccination programs,” the investigators commented.
 

Highlighting a need for caution

The take-home message from the trial is that “we have to be careful,” said Marc Steben, MD, co-President of HPV Global Action and a professor at the University of Montreal.

He noted that the Cervarix HPV vaccine used in the trial is not the vaccine that is used now in developed nations.

The current standard HPV vaccine is Gardasil 9 (Merck), which offers broader coverage against nine HPV types (types 6, 11, 16, 18, 31, 33, 45, 52, and 58).

There are 12 main carcinogenic HPV genotypes, so unmasking of other strains is still possible with Gardasil 9, he said.

There is another issue, Dr. Steben added. The success of HPV vaccinations - a nearly 90% reduction in invasive cervical cancer in women who are vaccinated at a young age – has led to questions about the future role of routine cervical cancer screening.

“Some people are saying that if we achieve 90% coverage, we might” eliminate community transmission and no longer need to screen, he said.

These trial results “tell us to be a little bit careful,” Dr. Steben continued. Those HPV types that are less aggressive and rarer than HPV-16 and -18 “can still cause cancer and might be there and surprise us. It could take more time than we thought” to get to the point where screening can be eliminated.

“There might be a little problem if we stop too early,” he said.
 

Study details

During the period 2004-2005, the investigators randomly assigned 3,727 women aged 18-25 years to receive Cervarix and 3,739 to a control group that received the hepatitis A vaccine; after 4 years, the control group also received Cervarix and exited the study. They were replaced by an unvaccinated control group of 2,836 women. The new control group and the original HPV vaccine group were followed for an additional 7 years.

In years 7-11 of the trial, the investigators found 9.2 additional cervical intraepithelial neoplasias of grade 2 or worse (CIN2+) from HPV types not covered by Cervarix per 1,000 vaccinated women in comparison with unvaccinated participants. This corresponds to –71.2% negative vaccine efficacy against CIN2+ lesions of HPV types not covered by the vaccine.

There were 8.3 additional CIN3+ lesions from nontargeted HPV strains per 1,000 vaccinated women in comparison with unvaccinated participants, which corresponds to –135% negative vaccine efficacy.

Overall, however, there was a net benefit of vaccination, with 27 fewer CIN2+ lesions when all HPV genotypes – vaccine covered or not – were considered per 1,000 vaccinated women over the entire 11 years of follow-up.

There were also 8.7 fewer CIN3+ lesions across all genotypes per 1,000 vaccinated women, but the benefit was not statistically significant.

Among the study limits, the team was unable to evaluate the effect of clinical unmasking on cervical cancer, because women were treated for high-grade cervical lesions before cases could progress to cervical cancer.

The trial was funded by the National Cancer Institute and the National Institutes of Health Office of Research on Women’s Health. GlaxoSmithKline provided the Cervarix vaccine and supported aspects of the trial. Two authors are named inventors on U.S. government–owned HPV vaccine patents with expired licenses to GlaxoSmithKline and Merck. Dr. Steben is an adviser/speaker for many companies, including GlaxoSmithKline and Merck.

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

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.

The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.

“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.

The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.

The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.

Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.

If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.

Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.

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

Not long ago, a pediatrician working in a local urgent care clinic called me about a teenage girl with a pruritic rash. She described vesicles and pustules located primarily on the face and arms with no surrounding cellulitis or other exam findings.

“She probably has impetigo,” my colleague said. “But I took a travel and exposure history and learned that her grandma had recently returned home from visiting family in the Congo. Do you think I need to worry about monkeypox?”

While most pediatricians in the United States have never seen a case of monkeypox, the virus is not new. An orthopox, it belongs to the same genus that includes smallpox and cowpox viruses. It was discovered in 1958 when two colonies of monkeys kept for research developed pox-like rashes. The earliest human case was reported in 1970 in the Democratic Republic of Congo and now the virus is endemic in some counties in Central and West Africa.

Monkeypox virus is a zoonotic disease – it can spread from animals to people. Rodents and other small mammals – not monkeys – are thought to be the most likely reservoir. The virus typically spreads from person to person through close contact with skin or respiratory secretions or contact with contaminated fomites. Typical infection begins with fever, lymphadenopathy, and flulike symptoms that include headache and malaise. One to four days after the onset of fever, the characteristic rash begins as macular lesions that evolve into papules, then vesicles, and finally pustules. Pustular lesions are deep-seated, well circumscribed, and are usually the same size and in the same stage of development on a given body site. The rash often starts on the face or the mouth, and then moves to the extremities, including the palms and soles. Over time, the lesions umbilicate and ultimately crust over.

On May 20, the Centers for Disease Control and Prevention issued a Health Advisory describing a case of monkeypox in a patient in Massachusetts. A single case normally wouldn’t cause too much alarm. In fact, there were two cases reported in the United States in 2021, both in travelers returning to the United States from Nigeria, a country in which the virus is endemic. No transmissions from these individuals to close contacts were identified.

The Massachusetts case was remarkable for two reasons. It occurred in an individual who had recently returned from a trip to Canada, which is not a country in which the virus is endemic. Additionally, it occurred in the context of a global outbreak of monkey pox that has, to date, disproportionately affected individuals who identify as men who have sex with men. Patients have often lacked the characteristic prodrome and many have had rash localized to the perianal and genital area, with or without symptoms of proctitis (anorectal pain, tenesmus, and bleeding). Clinically, some lesions mimicked sexually transmitted infections that the occur in the anogenital area, including herpes, syphilis, and lymphogranuloma venereum.

As of May 31, 2022, 17 persons in nine states had been diagnosed with presumed monkeypox virus infection. They ranged in age from 28 to 61 years and 16/17 identified as MSM. Fourteen reported international travel in the 3 weeks before developing symptoms. As of June 12, that number had grown to 53, while worldwide the number of confirmed and suspected cases reached 1,584. Up-to-date case counts are available at https://ourworldindata.org/monkeypox.

Back on the phone, my colleague laughed a little nervously. “I guess I’m not really worried about monkeypox in my patient.” She paused and then asked, “This isn’t going to be the next pandemic, is it?”

Public health experts at the Centers for Disease Control and Prevention and the World Health Organization have been reassuring in that regard. Two vaccines are available for the prevention of monkeypox. JYNNEOS is a nonreplicating live viral vaccine licensed as a two-dose series to prevent both monkeypox and smallpox. ACAM 2000 is a live Vaccinia virus preparation licensed to prevent smallpox. These vaccines are effective when given before exposure but are thought to also beneficial when given as postexposure prophylaxis. According to the CDC, vaccination within 4 days of exposure can prevent the development of disease. Vaccination within 14 days of exposure may not prevent the development of disease but may lessen symptoms. Treatment is generally supportive but antiviral therapy could be considered for individuals with severe disease. Tecovirmat is Food and Drug Administration approved for the treatment of smallpox but is available under nonresearch Expanded Access Investigational New Drug (EA-IND) protocol for the treatment of children and adults with severe orthopox infections, including monkeypox.

So, what’s a pediatrician to do? Take a good travel history, as my colleague did, because that is good medicine. At this point in an outbreak though, a lack of travel does not exclude the diagnosis. Perform a thorough exam of skin and mucosal areas. When there are rashes in the genital or perianal area, consider the possibility of monkeypox in addition to typical sexually transmitted infections. Ask about exposure to other persons with similar rashes, as well as close or intimate contact with a persons in a social network experiencing monkeypox infections. This includes MSM who meet partners through an online website, app, or at social events. Monkeypox can also be spread through contact with an animal (dead or alive) that is an African endemic species or use of a product derived from such animals. Public health experts encourage clinicians to be alert for rash illnesses consistent with monkeypox, regardless of a patient’s gender or sexual orientation, history of international travel, or specific risk factors.

Pediatricians see many kids with rashes, and while cases of monkeypox climb daily, the disease is still very rare. Given the media coverage of the outbreak, pediatricians should be prepared for questions from patients and their parents. Clinicians who suspect a case of monkeypox should contact their local or state health department for guidance and the need for testing. Tips for recognizing monkeypox and distinguishing it from more common viral illnesses such as chicken pox are available at www.cdc.gov/poxvirus/monkeypox/clinicians/clinical-recognition.html.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

Not long ago, a pediatrician working in a local urgent care clinic called me about a teenage girl with a pruritic rash. She described vesicles and pustules located primarily on the face and arms with no surrounding cellulitis or other exam findings.

“She probably has impetigo,” my colleague said. “But I took a travel and exposure history and learned that her grandma had recently returned home from visiting family in the Congo. Do you think I need to worry about monkeypox?”

While most pediatricians in the United States have never seen a case of monkeypox, the virus is not new. An orthopox, it belongs to the same genus that includes smallpox and cowpox viruses. It was discovered in 1958 when two colonies of monkeys kept for research developed pox-like rashes. The earliest human case was reported in 1970 in the Democratic Republic of Congo and now the virus is endemic in some counties in Central and West Africa.

Monkeypox virus is a zoonotic disease – it can spread from animals to people. Rodents and other small mammals – not monkeys – are thought to be the most likely reservoir. The virus typically spreads from person to person through close contact with skin or respiratory secretions or contact with contaminated fomites. Typical infection begins with fever, lymphadenopathy, and flulike symptoms that include headache and malaise. One to four days after the onset of fever, the characteristic rash begins as macular lesions that evolve into papules, then vesicles, and finally pustules. Pustular lesions are deep-seated, well circumscribed, and are usually the same size and in the same stage of development on a given body site. The rash often starts on the face or the mouth, and then moves to the extremities, including the palms and soles. Over time, the lesions umbilicate and ultimately crust over.

On May 20, the Centers for Disease Control and Prevention issued a Health Advisory describing a case of monkeypox in a patient in Massachusetts. A single case normally wouldn’t cause too much alarm. In fact, there were two cases reported in the United States in 2021, both in travelers returning to the United States from Nigeria, a country in which the virus is endemic. No transmissions from these individuals to close contacts were identified.

The Massachusetts case was remarkable for two reasons. It occurred in an individual who had recently returned from a trip to Canada, which is not a country in which the virus is endemic. Additionally, it occurred in the context of a global outbreak of monkey pox that has, to date, disproportionately affected individuals who identify as men who have sex with men. Patients have often lacked the characteristic prodrome and many have had rash localized to the perianal and genital area, with or without symptoms of proctitis (anorectal pain, tenesmus, and bleeding). Clinically, some lesions mimicked sexually transmitted infections that the occur in the anogenital area, including herpes, syphilis, and lymphogranuloma venereum.

As of May 31, 2022, 17 persons in nine states had been diagnosed with presumed monkeypox virus infection. They ranged in age from 28 to 61 years and 16/17 identified as MSM. Fourteen reported international travel in the 3 weeks before developing symptoms. As of June 12, that number had grown to 53, while worldwide the number of confirmed and suspected cases reached 1,584. Up-to-date case counts are available at https://ourworldindata.org/monkeypox.

Back on the phone, my colleague laughed a little nervously. “I guess I’m not really worried about monkeypox in my patient.” She paused and then asked, “This isn’t going to be the next pandemic, is it?”

Public health experts at the Centers for Disease Control and Prevention and the World Health Organization have been reassuring in that regard. Two vaccines are available for the prevention of monkeypox. JYNNEOS is a nonreplicating live viral vaccine licensed as a two-dose series to prevent both monkeypox and smallpox. ACAM 2000 is a live Vaccinia virus preparation licensed to prevent smallpox. These vaccines are effective when given before exposure but are thought to also beneficial when given as postexposure prophylaxis. According to the CDC, vaccination within 4 days of exposure can prevent the development of disease. Vaccination within 14 days of exposure may not prevent the development of disease but may lessen symptoms. Treatment is generally supportive but antiviral therapy could be considered for individuals with severe disease. Tecovirmat is Food and Drug Administration approved for the treatment of smallpox but is available under nonresearch Expanded Access Investigational New Drug (EA-IND) protocol for the treatment of children and adults with severe orthopox infections, including monkeypox.

So, what’s a pediatrician to do? Take a good travel history, as my colleague did, because that is good medicine. At this point in an outbreak though, a lack of travel does not exclude the diagnosis. Perform a thorough exam of skin and mucosal areas. When there are rashes in the genital or perianal area, consider the possibility of monkeypox in addition to typical sexually transmitted infections. Ask about exposure to other persons with similar rashes, as well as close or intimate contact with a persons in a social network experiencing monkeypox infections. This includes MSM who meet partners through an online website, app, or at social events. Monkeypox can also be spread through contact with an animal (dead or alive) that is an African endemic species or use of a product derived from such animals. Public health experts encourage clinicians to be alert for rash illnesses consistent with monkeypox, regardless of a patient’s gender or sexual orientation, history of international travel, or specific risk factors.

Pediatricians see many kids with rashes, and while cases of monkeypox climb daily, the disease is still very rare. Given the media coverage of the outbreak, pediatricians should be prepared for questions from patients and their parents. Clinicians who suspect a case of monkeypox should contact their local or state health department for guidance and the need for testing. Tips for recognizing monkeypox and distinguishing it from more common viral illnesses such as chicken pox are available at www.cdc.gov/poxvirus/monkeypox/clinicians/clinical-recognition.html.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

Not long ago, a pediatrician working in a local urgent care clinic called me about a teenage girl with a pruritic rash. She described vesicles and pustules located primarily on the face and arms with no surrounding cellulitis or other exam findings.

“She probably has impetigo,” my colleague said. “But I took a travel and exposure history and learned that her grandma had recently returned home from visiting family in the Congo. Do you think I need to worry about monkeypox?”

While most pediatricians in the United States have never seen a case of monkeypox, the virus is not new. An orthopox, it belongs to the same genus that includes smallpox and cowpox viruses. It was discovered in 1958 when two colonies of monkeys kept for research developed pox-like rashes. The earliest human case was reported in 1970 in the Democratic Republic of Congo and now the virus is endemic in some counties in Central and West Africa.

Monkeypox virus is a zoonotic disease – it can spread from animals to people. Rodents and other small mammals – not monkeys – are thought to be the most likely reservoir. The virus typically spreads from person to person through close contact with skin or respiratory secretions or contact with contaminated fomites. Typical infection begins with fever, lymphadenopathy, and flulike symptoms that include headache and malaise. One to four days after the onset of fever, the characteristic rash begins as macular lesions that evolve into papules, then vesicles, and finally pustules. Pustular lesions are deep-seated, well circumscribed, and are usually the same size and in the same stage of development on a given body site. The rash often starts on the face or the mouth, and then moves to the extremities, including the palms and soles. Over time, the lesions umbilicate and ultimately crust over.

On May 20, the Centers for Disease Control and Prevention issued a Health Advisory describing a case of monkeypox in a patient in Massachusetts. A single case normally wouldn’t cause too much alarm. In fact, there were two cases reported in the United States in 2021, both in travelers returning to the United States from Nigeria, a country in which the virus is endemic. No transmissions from these individuals to close contacts were identified.

The Massachusetts case was remarkable for two reasons. It occurred in an individual who had recently returned from a trip to Canada, which is not a country in which the virus is endemic. Additionally, it occurred in the context of a global outbreak of monkey pox that has, to date, disproportionately affected individuals who identify as men who have sex with men. Patients have often lacked the characteristic prodrome and many have had rash localized to the perianal and genital area, with or without symptoms of proctitis (anorectal pain, tenesmus, and bleeding). Clinically, some lesions mimicked sexually transmitted infections that the occur in the anogenital area, including herpes, syphilis, and lymphogranuloma venereum.

As of May 31, 2022, 17 persons in nine states had been diagnosed with presumed monkeypox virus infection. They ranged in age from 28 to 61 years and 16/17 identified as MSM. Fourteen reported international travel in the 3 weeks before developing symptoms. As of June 12, that number had grown to 53, while worldwide the number of confirmed and suspected cases reached 1,584. Up-to-date case counts are available at https://ourworldindata.org/monkeypox.

Back on the phone, my colleague laughed a little nervously. “I guess I’m not really worried about monkeypox in my patient.” She paused and then asked, “This isn’t going to be the next pandemic, is it?”

Public health experts at the Centers for Disease Control and Prevention and the World Health Organization have been reassuring in that regard. Two vaccines are available for the prevention of monkeypox. JYNNEOS is a nonreplicating live viral vaccine licensed as a two-dose series to prevent both monkeypox and smallpox. ACAM 2000 is a live Vaccinia virus preparation licensed to prevent smallpox. These vaccines are effective when given before exposure but are thought to also beneficial when given as postexposure prophylaxis. According to the CDC, vaccination within 4 days of exposure can prevent the development of disease. Vaccination within 14 days of exposure may not prevent the development of disease but may lessen symptoms. Treatment is generally supportive but antiviral therapy could be considered for individuals with severe disease. Tecovirmat is Food and Drug Administration approved for the treatment of smallpox but is available under nonresearch Expanded Access Investigational New Drug (EA-IND) protocol for the treatment of children and adults with severe orthopox infections, including monkeypox.

So, what’s a pediatrician to do? Take a good travel history, as my colleague did, because that is good medicine. At this point in an outbreak though, a lack of travel does not exclude the diagnosis. Perform a thorough exam of skin and mucosal areas. When there are rashes in the genital or perianal area, consider the possibility of monkeypox in addition to typical sexually transmitted infections. Ask about exposure to other persons with similar rashes, as well as close or intimate contact with a persons in a social network experiencing monkeypox infections. This includes MSM who meet partners through an online website, app, or at social events. Monkeypox can also be spread through contact with an animal (dead or alive) that is an African endemic species or use of a product derived from such animals. Public health experts encourage clinicians to be alert for rash illnesses consistent with monkeypox, regardless of a patient’s gender or sexual orientation, history of international travel, or specific risk factors.

Pediatricians see many kids with rashes, and while cases of monkeypox climb daily, the disease is still very rare. Given the media coverage of the outbreak, pediatricians should be prepared for questions from patients and their parents. Clinicians who suspect a case of monkeypox should contact their local or state health department for guidance and the need for testing. Tips for recognizing monkeypox and distinguishing it from more common viral illnesses such as chicken pox are available at www.cdc.gov/poxvirus/monkeypox/clinicians/clinical-recognition.html.

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

Federal advisers to the U.S. Food and Drug Administration voted unanimously June 15 to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines in infants and young children.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA voted 21-0 to say that benefits of a two-dose series of Moderna’s mRNA vaccine outweigh risk for use in infants and children 6 months through 5 years of age.

The panel then voted 21-0 to say that benefits of a three-dose series of the Pfizer-BioNTech mRNA vaccine outweigh risk for use in infants and children 6 months through 4 years of age.

The FDA is not bound to follow the suggestions of its advisory committees, but it often does. Moderna and Pfizer are seeking to expand emergency use authorization (EUA) for their vaccines. EUAs are special clearances used to allow use of products in connection with public health crises such as the pandemic.

The Pfizer vaccine has standard, nonemergency FDA approval for use in people 16 years of age and older. The FDA also has granted EUA clearance for use of the shot in people ages 5 to 15.

The VRBPAC on June 15 recommended granting EUA clearance for Moderna’s COVID-19 vaccine for people ages 6 to 17. The Moderna vaccine already has full approval for use in people 18 years of age and older.

Many parents have been waiting for a clearance of COVID vaccines for their infants and young children, seeking protection for them at a time of continued spread of the virus.

The White House on June 9 outlined plans for making 10 million doses of COVID vaccines available for children under the age of 5 in the coming weeks.

The Centers for Disease Control and Prevention (CDC) has scheduled a June 18 meeting of its Advisory Committee on Immunization Practices, where members of that panel will vote on recommendations about use of the Moderna and Pfizer-BioNTech vaccines in infants and young children. The last step in the approval process to get shots into arms will be endorsement by the CDC director if the committee votes in favor of the vaccines.

For and against

During the public session during the June 15 FDA meeting, speakers offered varied opinions.

Some urged the panel to vote against the EUA expansion, citing concerns about risks of COVID vaccines in general.

But at the close of the meeting, top FDA vaccine official Peter Marks, MD, PhD, urged the public to be cautious about drawing conclusions from reading incident reports of side effects.

He said he has seen a “Twitter storm” during the day about claims of side effects. but stressed that the FDA has reported to the public on the rare side effects linked to the COVID vaccines, such as myocarditis, with advisories based on a review of reports of side effects. But many of these reports, gathered from the Vaccine Adverse Event Reporting System (VAERS) system, will turn out on further inspection not to be related to vaccination.

Many other speakers urged members of the panel to support expanded use of the vaccines for infants and young children. These speakers emphasized how lack of a vaccine to date has isolated young children who remain unprotected, even with about 83% of those age 5 and older in the United States having received at least one COVID shot.

Dr. Marks noted that there have been 442 deaths from COVID among children under 4 years of age during the pandemic, a number that he compared with the 78 deaths reported in the H1N1 flu. He urged the panel “to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here.”

Panelist H. Cody Meissner, MD, a pediatric infectious disease specialist from Tufts University, said the vaccine should be made available -- particularly for children considered to be at high risk for complications from COVID --but health officials need to present a clear picture of the relatively low risks to children of harm from the vaccines-- and from COVID.

“That has to be communicated clearly to parents so that they can participate in the decision about vaccinating a child in this age group,” Dr. Meissner said.

The results presented June 15 from studies of the shots in younger children were less impressive than those from the initial COVID vaccine trials done in adults. This was not a surprise to panelists given the rise of the omicron variant and the evolution of the pandemic, but it still led to comments about the need for further continued study of the vaccines in young children even if they are authorized.

Consider that in 2020, Pfizer won the first EUA for a COVID vaccine of any kind with data that pegged the shot’s efficacy rate at 95%. Statisticians estimated a likely possible range, or 95% confidence interval, for the vaccine efficacy rate at 90.3% to 97.6%.

Those estimates were based on finding eight cases of COVID reported among 18,198 study participants who got the Pfizer-BioNTech shot, compared with 162 cases among the 18,325 people in the placebo group, according to the FDA review of Pifzer’s initial application.

Study data

But on June 15, FDA advisers had to consider an EUA application for which the data did not make as strong a case for the vaccine’s benefit among younger patients.

Pfizer presented what the FDA called a “preliminary descriptive analysis” of vaccine efficacy among participants in Study C4591007 who received three study vaccinations, following accrual of 10 total confirmed COVID-19 cases occurring at least 7 days after the third dose.

Looking at results for study participants ages 6 to 23 months of age, there was one case in the group that got the Pfizer-BioNTech shot and two in the placebo group, pegged as a 75.6% vaccine efficacy rate -- but one with caveats to the small numbers of cases. The 95% confidence interval for this vaccine efficacy rate was reported as-369.1% to 99.6% according to the FDA staff review.

For participants 2-4 years of age with and without evidence of prior SARS-CoV-

2 infection, there were two cases in the group that got the shot and five in the placebo group showing a vaccine efficacy rate of 82.4%, with a 95% confidence interval estimated ranging between -7.6% and 98.3%. For the combined analysis of both age groups, the efficacy rate was estimated at 80.4%, with a 95% confidence interval of 14.1% and 96.7%.

Doran Fink, MD, PhD, a top official in the FDA’s vaccines division, noted that the current EUA application for expanded pediatric use involved “some very preliminary” results that involved “a small number of cases and limited follow up time.”

But he stressed that the evidence gathered to date for the Pifzer application for use of its COVID shot in infants and young children met the threshold for conditional clearance during a crisis.

“We do feel very confident that the evidentiary standard for benefit for an EUA has been met here,” but added that more data would be needed to address questions about the efficacy of the vaccine beyond a third dose and whether an additional dose may be needed.

Pfizer also used a comparison known as “immunobridging” in support of the application. This looked at SARS- CoV-2 50% neutralizing antibody titers for the children in the age group covered by the EUA application and compared them to a randomly selected subset of 16-25-year-old participants in another study,

Key data for the pending Moderna EUA for use of its shot in infants and young children came from study P204. In it, Moderna found 51 cases of COVID among 1,511 children ages 6 months to 23 months who got the vaccines, versus 34 cases among 513 children who received a placebo, according to an FDA staff review.

That resulted in a vaccine efficacy rate pegged at 50.6%, with a 95% confidence interval of 21.4% to 68.6%.

Looking at the children ages 2 to 5 years in the P204 study, there were 119 cases out of 2,594 participants who got the shot, versus 61 cases of 858 in the placebo arm, or 7.1%. That translated to a 36.8% vaccine efficacy rate, with a confidence interval 12.5% to 54.0%.

Panelist Jay Portnoy, MD, of Children’s Mercy Hospital in Kansas City said all of the pediatricians he knows are waiting for the FDA to authorize the new uses of these vaccines in infants and young children.

“The death rate from COVID in young children may not be extremely high, but it’s absolutely terrifying to parents to have their child be sick, have to go to the hospital or even go to the emergency room or their primary care doctor because they’re sick and having trouble breathing,” said Dr. Portnoy, who served as the panel’s consumer representative.

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

This article was updated on 6/16/22.

Federal advisers to the U.S. Food and Drug Administration voted unanimously June 15 to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines in infants and young children.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA voted 21-0 to say that benefits of a two-dose series of Moderna’s mRNA vaccine outweigh risk for use in infants and children 6 months through 5 years of age.

The panel then voted 21-0 to say that benefits of a three-dose series of the Pfizer-BioNTech mRNA vaccine outweigh risk for use in infants and children 6 months through 4 years of age.

The FDA is not bound to follow the suggestions of its advisory committees, but it often does. Moderna and Pfizer are seeking to expand emergency use authorization (EUA) for their vaccines. EUAs are special clearances used to allow use of products in connection with public health crises such as the pandemic.

The Pfizer vaccine has standard, nonemergency FDA approval for use in people 16 years of age and older. The FDA also has granted EUA clearance for use of the shot in people ages 5 to 15.

The VRBPAC on June 15 recommended granting EUA clearance for Moderna’s COVID-19 vaccine for people ages 6 to 17. The Moderna vaccine already has full approval for use in people 18 years of age and older.

Many parents have been waiting for a clearance of COVID vaccines for their infants and young children, seeking protection for them at a time of continued spread of the virus.

The White House on June 9 outlined plans for making 10 million doses of COVID vaccines available for children under the age of 5 in the coming weeks.

The Centers for Disease Control and Prevention (CDC) has scheduled a June 18 meeting of its Advisory Committee on Immunization Practices, where members of that panel will vote on recommendations about use of the Moderna and Pfizer-BioNTech vaccines in infants and young children. The last step in the approval process to get shots into arms will be endorsement by the CDC director if the committee votes in favor of the vaccines.

For and against

During the public session during the June 15 FDA meeting, speakers offered varied opinions.

Some urged the panel to vote against the EUA expansion, citing concerns about risks of COVID vaccines in general.

But at the close of the meeting, top FDA vaccine official Peter Marks, MD, PhD, urged the public to be cautious about drawing conclusions from reading incident reports of side effects.

He said he has seen a “Twitter storm” during the day about claims of side effects. but stressed that the FDA has reported to the public on the rare side effects linked to the COVID vaccines, such as myocarditis, with advisories based on a review of reports of side effects. But many of these reports, gathered from the Vaccine Adverse Event Reporting System (VAERS) system, will turn out on further inspection not to be related to vaccination.

Many other speakers urged members of the panel to support expanded use of the vaccines for infants and young children. These speakers emphasized how lack of a vaccine to date has isolated young children who remain unprotected, even with about 83% of those age 5 and older in the United States having received at least one COVID shot.

Dr. Marks noted that there have been 442 deaths from COVID among children under 4 years of age during the pandemic, a number that he compared with the 78 deaths reported in the H1N1 flu. He urged the panel “to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here.”

Panelist H. Cody Meissner, MD, a pediatric infectious disease specialist from Tufts University, said the vaccine should be made available -- particularly for children considered to be at high risk for complications from COVID --but health officials need to present a clear picture of the relatively low risks to children of harm from the vaccines-- and from COVID.

“That has to be communicated clearly to parents so that they can participate in the decision about vaccinating a child in this age group,” Dr. Meissner said.

The results presented June 15 from studies of the shots in younger children were less impressive than those from the initial COVID vaccine trials done in adults. This was not a surprise to panelists given the rise of the omicron variant and the evolution of the pandemic, but it still led to comments about the need for further continued study of the vaccines in young children even if they are authorized.

Consider that in 2020, Pfizer won the first EUA for a COVID vaccine of any kind with data that pegged the shot’s efficacy rate at 95%. Statisticians estimated a likely possible range, or 95% confidence interval, for the vaccine efficacy rate at 90.3% to 97.6%.

Those estimates were based on finding eight cases of COVID reported among 18,198 study participants who got the Pfizer-BioNTech shot, compared with 162 cases among the 18,325 people in the placebo group, according to the FDA review of Pifzer’s initial application.

Study data

But on June 15, FDA advisers had to consider an EUA application for which the data did not make as strong a case for the vaccine’s benefit among younger patients.

Pfizer presented what the FDA called a “preliminary descriptive analysis” of vaccine efficacy among participants in Study C4591007 who received three study vaccinations, following accrual of 10 total confirmed COVID-19 cases occurring at least 7 days after the third dose.

Looking at results for study participants ages 6 to 23 months of age, there was one case in the group that got the Pfizer-BioNTech shot and two in the placebo group, pegged as a 75.6% vaccine efficacy rate -- but one with caveats to the small numbers of cases. The 95% confidence interval for this vaccine efficacy rate was reported as-369.1% to 99.6% according to the FDA staff review.

For participants 2-4 years of age with and without evidence of prior SARS-CoV-

2 infection, there were two cases in the group that got the shot and five in the placebo group showing a vaccine efficacy rate of 82.4%, with a 95% confidence interval estimated ranging between -7.6% and 98.3%. For the combined analysis of both age groups, the efficacy rate was estimated at 80.4%, with a 95% confidence interval of 14.1% and 96.7%.

Doran Fink, MD, PhD, a top official in the FDA’s vaccines division, noted that the current EUA application for expanded pediatric use involved “some very preliminary” results that involved “a small number of cases and limited follow up time.”

But he stressed that the evidence gathered to date for the Pifzer application for use of its COVID shot in infants and young children met the threshold for conditional clearance during a crisis.

“We do feel very confident that the evidentiary standard for benefit for an EUA has been met here,” but added that more data would be needed to address questions about the efficacy of the vaccine beyond a third dose and whether an additional dose may be needed.

Pfizer also used a comparison known as “immunobridging” in support of the application. This looked at SARS- CoV-2 50% neutralizing antibody titers for the children in the age group covered by the EUA application and compared them to a randomly selected subset of 16-25-year-old participants in another study,

Key data for the pending Moderna EUA for use of its shot in infants and young children came from study P204. In it, Moderna found 51 cases of COVID among 1,511 children ages 6 months to 23 months who got the vaccines, versus 34 cases among 513 children who received a placebo, according to an FDA staff review.

That resulted in a vaccine efficacy rate pegged at 50.6%, with a 95% confidence interval of 21.4% to 68.6%.

Looking at the children ages 2 to 5 years in the P204 study, there were 119 cases out of 2,594 participants who got the shot, versus 61 cases of 858 in the placebo arm, or 7.1%. That translated to a 36.8% vaccine efficacy rate, with a confidence interval 12.5% to 54.0%.

Panelist Jay Portnoy, MD, of Children’s Mercy Hospital in Kansas City said all of the pediatricians he knows are waiting for the FDA to authorize the new uses of these vaccines in infants and young children.

“The death rate from COVID in young children may not be extremely high, but it’s absolutely terrifying to parents to have their child be sick, have to go to the hospital or even go to the emergency room or their primary care doctor because they’re sick and having trouble breathing,” said Dr. Portnoy, who served as the panel’s consumer representative.

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

This article was updated on 6/16/22.

Federal advisers to the U.S. Food and Drug Administration voted unanimously June 15 to recommend the use of the Moderna and Pfizer-BioNTech COVID-19 vaccines in infants and young children.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA voted 21-0 to say that benefits of a two-dose series of Moderna’s mRNA vaccine outweigh risk for use in infants and children 6 months through 5 years of age.

The panel then voted 21-0 to say that benefits of a three-dose series of the Pfizer-BioNTech mRNA vaccine outweigh risk for use in infants and children 6 months through 4 years of age.

The FDA is not bound to follow the suggestions of its advisory committees, but it often does. Moderna and Pfizer are seeking to expand emergency use authorization (EUA) for their vaccines. EUAs are special clearances used to allow use of products in connection with public health crises such as the pandemic.

The Pfizer vaccine has standard, nonemergency FDA approval for use in people 16 years of age and older. The FDA also has granted EUA clearance for use of the shot in people ages 5 to 15.

The VRBPAC on June 15 recommended granting EUA clearance for Moderna’s COVID-19 vaccine for people ages 6 to 17. The Moderna vaccine already has full approval for use in people 18 years of age and older.

Many parents have been waiting for a clearance of COVID vaccines for their infants and young children, seeking protection for them at a time of continued spread of the virus.

The White House on June 9 outlined plans for making 10 million doses of COVID vaccines available for children under the age of 5 in the coming weeks.

The Centers for Disease Control and Prevention (CDC) has scheduled a June 18 meeting of its Advisory Committee on Immunization Practices, where members of that panel will vote on recommendations about use of the Moderna and Pfizer-BioNTech vaccines in infants and young children. The last step in the approval process to get shots into arms will be endorsement by the CDC director if the committee votes in favor of the vaccines.

For and against

During the public session during the June 15 FDA meeting, speakers offered varied opinions.

Some urged the panel to vote against the EUA expansion, citing concerns about risks of COVID vaccines in general.

But at the close of the meeting, top FDA vaccine official Peter Marks, MD, PhD, urged the public to be cautious about drawing conclusions from reading incident reports of side effects.

He said he has seen a “Twitter storm” during the day about claims of side effects. but stressed that the FDA has reported to the public on the rare side effects linked to the COVID vaccines, such as myocarditis, with advisories based on a review of reports of side effects. But many of these reports, gathered from the Vaccine Adverse Event Reporting System (VAERS) system, will turn out on further inspection not to be related to vaccination.

Many other speakers urged members of the panel to support expanded use of the vaccines for infants and young children. These speakers emphasized how lack of a vaccine to date has isolated young children who remain unprotected, even with about 83% of those age 5 and older in the United States having received at least one COVID shot.

Dr. Marks noted that there have been 442 deaths from COVID among children under 4 years of age during the pandemic, a number that he compared with the 78 deaths reported in the H1N1 flu. He urged the panel “to be careful that we don’t become numb to the number of pediatric deaths because of the overwhelming number of older deaths here.”

Panelist H. Cody Meissner, MD, a pediatric infectious disease specialist from Tufts University, said the vaccine should be made available -- particularly for children considered to be at high risk for complications from COVID --but health officials need to present a clear picture of the relatively low risks to children of harm from the vaccines-- and from COVID.

“That has to be communicated clearly to parents so that they can participate in the decision about vaccinating a child in this age group,” Dr. Meissner said.

The results presented June 15 from studies of the shots in younger children were less impressive than those from the initial COVID vaccine trials done in adults. This was not a surprise to panelists given the rise of the omicron variant and the evolution of the pandemic, but it still led to comments about the need for further continued study of the vaccines in young children even if they are authorized.

Consider that in 2020, Pfizer won the first EUA for a COVID vaccine of any kind with data that pegged the shot’s efficacy rate at 95%. Statisticians estimated a likely possible range, or 95% confidence interval, for the vaccine efficacy rate at 90.3% to 97.6%.

Those estimates were based on finding eight cases of COVID reported among 18,198 study participants who got the Pfizer-BioNTech shot, compared with 162 cases among the 18,325 people in the placebo group, according to the FDA review of Pifzer’s initial application.

Study data

But on June 15, FDA advisers had to consider an EUA application for which the data did not make as strong a case for the vaccine’s benefit among younger patients.

Pfizer presented what the FDA called a “preliminary descriptive analysis” of vaccine efficacy among participants in Study C4591007 who received three study vaccinations, following accrual of 10 total confirmed COVID-19 cases occurring at least 7 days after the third dose.

Looking at results for study participants ages 6 to 23 months of age, there was one case in the group that got the Pfizer-BioNTech shot and two in the placebo group, pegged as a 75.6% vaccine efficacy rate -- but one with caveats to the small numbers of cases. The 95% confidence interval for this vaccine efficacy rate was reported as-369.1% to 99.6% according to the FDA staff review.

For participants 2-4 years of age with and without evidence of prior SARS-CoV-

2 infection, there were two cases in the group that got the shot and five in the placebo group showing a vaccine efficacy rate of 82.4%, with a 95% confidence interval estimated ranging between -7.6% and 98.3%. For the combined analysis of both age groups, the efficacy rate was estimated at 80.4%, with a 95% confidence interval of 14.1% and 96.7%.

Doran Fink, MD, PhD, a top official in the FDA’s vaccines division, noted that the current EUA application for expanded pediatric use involved “some very preliminary” results that involved “a small number of cases and limited follow up time.”

But he stressed that the evidence gathered to date for the Pifzer application for use of its COVID shot in infants and young children met the threshold for conditional clearance during a crisis.

“We do feel very confident that the evidentiary standard for benefit for an EUA has been met here,” but added that more data would be needed to address questions about the efficacy of the vaccine beyond a third dose and whether an additional dose may be needed.

Pfizer also used a comparison known as “immunobridging” in support of the application. This looked at SARS- CoV-2 50% neutralizing antibody titers for the children in the age group covered by the EUA application and compared them to a randomly selected subset of 16-25-year-old participants in another study,

Key data for the pending Moderna EUA for use of its shot in infants and young children came from study P204. In it, Moderna found 51 cases of COVID among 1,511 children ages 6 months to 23 months who got the vaccines, versus 34 cases among 513 children who received a placebo, according to an FDA staff review.

That resulted in a vaccine efficacy rate pegged at 50.6%, with a 95% confidence interval of 21.4% to 68.6%.

Looking at the children ages 2 to 5 years in the P204 study, there were 119 cases out of 2,594 participants who got the shot, versus 61 cases of 858 in the placebo arm, or 7.1%. That translated to a 36.8% vaccine efficacy rate, with a confidence interval 12.5% to 54.0%.

Panelist Jay Portnoy, MD, of Children’s Mercy Hospital in Kansas City said all of the pediatricians he knows are waiting for the FDA to authorize the new uses of these vaccines in infants and young children.

“The death rate from COVID in young children may not be extremely high, but it’s absolutely terrifying to parents to have their child be sick, have to go to the hospital or even go to the emergency room or their primary care doctor because they’re sick and having trouble breathing,” said Dr. Portnoy, who served as the panel’s consumer representative.

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

This article was updated on 6/16/22.

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

People with HIV have an increased risk of breakthrough SARS-CoV-2 infections, a new study finds, and the authors say an additional primary vaccine dose should be considered for all who are living with the disease.

Currently, an additional primary dose administered 28 days after a second dose of the mRNA (Moderna or Pfizer) vaccines or after the first dose of the Johnson & Johnson (J&J) vaccine is recommended only for those with advanced or untreated HIV.

The Centers for Disease Control and Prevention recommends boosters for all adults with or without HIV.

Sally B. Coburn, PhD, of the department of epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, led the study, which was published online in JAMA Network Open. In their study, the researchers estimate the risk of breakthrough infections among fully vaccinated adults on the basis of HIV status in the United States.

Adults with HIV who were fully vaccinated before June 30, 2021, were matched with adults without HIV with regard to date of full vaccination, age, race/ethnicity, and sex. All were followed through Dec. 31, 2021.

Patients were considered fully vaccinated either 14 days after the second dose of the Pfizer or Moderna shots or 14 days after the single dose of the J&J shot.
 

Breakthrough risk 28% higher

In the study of 113,994 patients, researchers found that risk of breakthrough SARS-CoV-2 infection was low overall (3.8%) but was 28% higher among people with HIV in comparison with people without HIV (adjusted hazard ratio, 1.28; 95% confidence interval, 1.19-1.37).

The breakthrough rate was also higher in the HIV group (55 cases per 1,000 person-years, vs. 43 cases per 1,000 person-years in people without HIV).

Patients were drawn from the Corona-Infectious-Virus Epidemiology Team (CIVET)–II of the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD), which is part of the International Epidemiology Databases to Evaluate AIDS (IeDEA) collaboration involving four cohorts.

Among people with HIV, those younger than 45 years (vs. those aged 45-54) and those with a history of COVID-19 were more likely to experience breakthrough infections. Those who did not get any additional shots after the primary vaccination were more likely to have breakthrough infections, amplifying the need to get boosters, the authors wrote.

There was no link between breakthrough infections and HIV viral load suppression, but high CD4 counts (> 500 cells/mm³) were associated with fewer breakthrough cases among people with HIV, they noted.

Monica Gandhi, MD, professor of medicine and associate division chief of HIV, infectious diseases, and global medicine at the University of California, San Francisco, praised the study, noting that until now, large studies have not examined the rate of breakthrough infections among vaccinated people with HIV and people without HIV in the United States.

She told this news organization she agrees with the authors that a third dose for all who are living with HIV is needed because rates of breakthrough infections were high across all populations during the Omicron surge (which largely occurred after the period of this study).

She said she was not convinced the third shot was needed before Omicron, because breakthrough rates in both HIV and non-HIV groups were low.

“However, the most interesting part of this study for me was how well the vaccines worked in people with HIV with generally higher CD4 counts and virologic suppression, again telling us as HIV providers how well the HIV medicines work and how our patients with HIV have relatively normal immune systems if treated,” she said.

One limitation was that the study population was 92% male. Also, those without regular access to health care (who may be at greater risk for COVID-19) were less likely to be included in the study. People engaged in care may seek more frequent COVID-19 testing, which could lead to higher detection of breakthrough infections than in the general population.

“Future analyses should account for testing practices and include a larger proportion of women with HIV,” the authors wrote. “Ultimately, policy makers must determine the appropriate balance between preventing further COVID-19 infections and possibly unnecessary additional vaccinations.”

Coauthor Keri N. Althoff, PhD, told this news organization that there’s one unanswered question that would strengthen the call to action by the CDC: Do people with HIV have more severe postvaccination COVID-19 breakthrough illness?

“We have a second paper that is a preprint and currently under peer review,” she said. “In this paper, we found that people with HIV with a CD4 count less than 350 cells/mm³ were more likely to be hospitalized with postvaccination COVID-19 breakthrough illness compared to similar people without HIV. “

At a minimum, Dr. Althoff said, policymakers should consider including people with HIV with a CD4 less than 350 cells/mm³ (loosening the restriction to less than 200 cells/mm³) in their recommendations for people who are moderately or severely immunocompromised.

The research was funded with supplemental funds to the North American AIDS Cohort Collaboration on Research and Design. Dr. Coburn reports no relevant financial relationships. A coauthor has received grants from the Canadian Institutes of Health Research, Alberta Innovates, and University of Calgary/Alberta Health Services outside the submitted work. One coauthor reports serving as a consultant to Trio Health, Kennedy Dundas, and MedIQ outside the submitted work.

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

With monkeypox now circulating in the United States, expecting mothers may worry about what might happen if they contract the infection while pregnant.

As of today, 25 cases of monkeypox have been confirmed in the United States since the outbreak began in early May, according to the U.S. Centers for Disease Control and Prevention. Although none of those cases has involved a pregnant person, the World Health Organization says monkeypox can pass from mother to fetus before delivery or to newborns by close contact during and after birth.

The case count could grow as the agency continues to investigate potential infections of the virus. In a conference call Friday, health officials stressed the importance of contact tracing, testing, and vaccine treatment.

As physicians in the United States are scrambling for information on ways to treat patients, a new study, published in Ultrasound in Obstetrics & Gynecology, could help clinicians better care for pregnant people infected with monkeypox. The authors advise consistently monitoring the fetus for infection and conducting regular ultrasounds, among other precautions. 

Asma Khalil, MBBCh, MD, a professor of obstetrics and fetal medicine at St. George’s University, London, and lead author of the new study, said the monkeypox outbreak outside Africa caught many clinicians by surprise.

“We quickly realized very few physicians caring for pregnant women knew anything at all about monkeypox and how it affects pregnancy,” Dr. Khalil told this news organization. “Clinicians caring for pregnant women are likely to be faced soon with pregnant women concerned they may have the infection – because they have a rash, for example – or indeed pregnant women who do have the infection.”

According to the CDC, monkeypox can be transmitted through direct contact with the rash, sores, or scabs caused by the virus, as well as contact with clothing, bedding, towels, or other surfaces used by an infected person. Respiratory droplets and oral fluids from a person with monkeypox have also been linked to spread of the virus, as has sexual activity.

Although the condition is rarely fatal, infants and young children are at the greatest risk of developing severe symptoms, health officials said. 

The U.S. Food and Drug Administration has approved a monkeypox vaccine, Jynneos (Bavarian Nordic A/S), for general use, but it has not been specifically approved for pregnant people. However, a study of 300 pregnant women who received the vaccine reported no adverse reactions or failed pregnancies linked to the shots.

The new review suggests that women who have a confirmed infection during pregnancy should have a doctor closely monitor the fetus until birth.

If the fetus is over 26 weeks or if the mother is unwell, the fetus should be cared for with heart monitoring, either by a doctor or remotely every 2-3 days. Ultrasounds should be performed regularly to confirm that the fetus is still growing well and that the placenta is functioning properly.

Further into the pregnancy, monitoring should include measurements of the fetus and detailed assessment of the fetal organs and the amniotic fluid. Once the infection is resolved, the risk to the fetus is small, according to Dr. Khalil. However, since data are limited, she recommended an ultrasound scan every 2-4 weeks. At birth, for the protection of the infant and the mother, the baby should be isolated until infection is no longer a risk.

The Royal College of Obstetricians & Gynaecologists is preparing guidance on the management of monkeypox in pregnant people, Dr. Khalil said. The American College of Obstetricians and Gynecologists said it is “relying on the CDC for the time being,” according to a spokesperson for ACOG. 

“There is a clear need for further research in this area,” Dr. Khalil said. “The current outbreak is an ideal opportunity to make this happen.”

Dr. Khalil has disclosed no relevant financial relationships.

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

With monkeypox now circulating in the United States, expecting mothers may worry about what might happen if they contract the infection while pregnant.

As of today, 25 cases of monkeypox have been confirmed in the United States since the outbreak began in early May, according to the U.S. Centers for Disease Control and Prevention. Although none of those cases has involved a pregnant person, the World Health Organization says monkeypox can pass from mother to fetus before delivery or to newborns by close contact during and after birth.

The case count could grow as the agency continues to investigate potential infections of the virus. In a conference call Friday, health officials stressed the importance of contact tracing, testing, and vaccine treatment.

As physicians in the United States are scrambling for information on ways to treat patients, a new study, published in Ultrasound in Obstetrics & Gynecology, could help clinicians better care for pregnant people infected with monkeypox. The authors advise consistently monitoring the fetus for infection and conducting regular ultrasounds, among other precautions. 

Asma Khalil, MBBCh, MD, a professor of obstetrics and fetal medicine at St. George’s University, London, and lead author of the new study, said the monkeypox outbreak outside Africa caught many clinicians by surprise.

“We quickly realized very few physicians caring for pregnant women knew anything at all about monkeypox and how it affects pregnancy,” Dr. Khalil told this news organization. “Clinicians caring for pregnant women are likely to be faced soon with pregnant women concerned they may have the infection – because they have a rash, for example – or indeed pregnant women who do have the infection.”

According to the CDC, monkeypox can be transmitted through direct contact with the rash, sores, or scabs caused by the virus, as well as contact with clothing, bedding, towels, or other surfaces used by an infected person. Respiratory droplets and oral fluids from a person with monkeypox have also been linked to spread of the virus, as has sexual activity.

Although the condition is rarely fatal, infants and young children are at the greatest risk of developing severe symptoms, health officials said. 

The U.S. Food and Drug Administration has approved a monkeypox vaccine, Jynneos (Bavarian Nordic A/S), for general use, but it has not been specifically approved for pregnant people. However, a study of 300 pregnant women who received the vaccine reported no adverse reactions or failed pregnancies linked to the shots.

The new review suggests that women who have a confirmed infection during pregnancy should have a doctor closely monitor the fetus until birth.

If the fetus is over 26 weeks or if the mother is unwell, the fetus should be cared for with heart monitoring, either by a doctor or remotely every 2-3 days. Ultrasounds should be performed regularly to confirm that the fetus is still growing well and that the placenta is functioning properly.

Further into the pregnancy, monitoring should include measurements of the fetus and detailed assessment of the fetal organs and the amniotic fluid. Once the infection is resolved, the risk to the fetus is small, according to Dr. Khalil. However, since data are limited, she recommended an ultrasound scan every 2-4 weeks. At birth, for the protection of the infant and the mother, the baby should be isolated until infection is no longer a risk.

The Royal College of Obstetricians & Gynaecologists is preparing guidance on the management of monkeypox in pregnant people, Dr. Khalil said. The American College of Obstetricians and Gynecologists said it is “relying on the CDC for the time being,” according to a spokesperson for ACOG. 

“There is a clear need for further research in this area,” Dr. Khalil said. “The current outbreak is an ideal opportunity to make this happen.”

Dr. Khalil has disclosed no relevant financial relationships.

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

With monkeypox now circulating in the United States, expecting mothers may worry about what might happen if they contract the infection while pregnant.

As of today, 25 cases of monkeypox have been confirmed in the United States since the outbreak began in early May, according to the U.S. Centers for Disease Control and Prevention. Although none of those cases has involved a pregnant person, the World Health Organization says monkeypox can pass from mother to fetus before delivery or to newborns by close contact during and after birth.

The case count could grow as the agency continues to investigate potential infections of the virus. In a conference call Friday, health officials stressed the importance of contact tracing, testing, and vaccine treatment.

As physicians in the United States are scrambling for information on ways to treat patients, a new study, published in Ultrasound in Obstetrics & Gynecology, could help clinicians better care for pregnant people infected with monkeypox. The authors advise consistently monitoring the fetus for infection and conducting regular ultrasounds, among other precautions. 

Asma Khalil, MBBCh, MD, a professor of obstetrics and fetal medicine at St. George’s University, London, and lead author of the new study, said the monkeypox outbreak outside Africa caught many clinicians by surprise.

“We quickly realized very few physicians caring for pregnant women knew anything at all about monkeypox and how it affects pregnancy,” Dr. Khalil told this news organization. “Clinicians caring for pregnant women are likely to be faced soon with pregnant women concerned they may have the infection – because they have a rash, for example – or indeed pregnant women who do have the infection.”

According to the CDC, monkeypox can be transmitted through direct contact with the rash, sores, or scabs caused by the virus, as well as contact with clothing, bedding, towels, or other surfaces used by an infected person. Respiratory droplets and oral fluids from a person with monkeypox have also been linked to spread of the virus, as has sexual activity.

Although the condition is rarely fatal, infants and young children are at the greatest risk of developing severe symptoms, health officials said. 

The U.S. Food and Drug Administration has approved a monkeypox vaccine, Jynneos (Bavarian Nordic A/S), for general use, but it has not been specifically approved for pregnant people. However, a study of 300 pregnant women who received the vaccine reported no adverse reactions or failed pregnancies linked to the shots.

The new review suggests that women who have a confirmed infection during pregnancy should have a doctor closely monitor the fetus until birth.

If the fetus is over 26 weeks or if the mother is unwell, the fetus should be cared for with heart monitoring, either by a doctor or remotely every 2-3 days. Ultrasounds should be performed regularly to confirm that the fetus is still growing well and that the placenta is functioning properly.

Further into the pregnancy, monitoring should include measurements of the fetus and detailed assessment of the fetal organs and the amniotic fluid. Once the infection is resolved, the risk to the fetus is small, according to Dr. Khalil. However, since data are limited, she recommended an ultrasound scan every 2-4 weeks. At birth, for the protection of the infant and the mother, the baby should be isolated until infection is no longer a risk.

The Royal College of Obstetricians & Gynaecologists is preparing guidance on the management of monkeypox in pregnant people, Dr. Khalil said. The American College of Obstetricians and Gynecologists said it is “relying on the CDC for the time being,” according to a spokesperson for ACOG. 

“There is a clear need for further research in this area,” Dr. Khalil said. “The current outbreak is an ideal opportunity to make this happen.”

Dr. Khalil has disclosed no relevant financial relationships.

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