• The Food and Drug Administration’s vaccine advisory committee voted unanimously to recommend boosters for people ages 65 and older.
  • The recommendation also includes people ages 16 and up at high risk of severe COVID-19.
  • The Pfizer-BioNTech COVID-19 vaccine is currently fully approved in the United States as a two-dose regimen for people 16 years and older under the brand name Comirnaty.

People ages 65 and up and those at high risk of severe COVID-19 or infection may soon be able to get a third dose of the Pfizer-BioNTech COVID-19 vaccine.

The Food and Drug Administration (FDA) vaccine advisory committee voted unanimously today to recommend boosters for people ages 65 and up who received two doses of the Pfizer-BioNTech vaccine at least 6 months ago.

Also included in the recommendation are people ages 16 and older at high risk of severe COVID-19.

If the FDA follows the committee’s recommendations, the approval would be granted as an emergency use authorization (EUA), rather than a full approval.

The Pfizer-BioNTech vaccine is currently fully approved in the United States as a two-dose regimen for people ages 16 and older under the brand name Comirnaty.

Initial doses of the vaccine are also available under an EUA for 12- to 15-year-olds. This group would not be eligible for boosters at this time. 

Emergency approval, which was used initially for all COVID-19 vaccines, is a faster regulatory route intended for a public health emergency, such as a pandemic.

As part of the EUA, the FDA will continue to monitor data on the safety and effectiveness of booster doses for these groups.

After the vote, the independent panel of experts also informally recommended that the EUA be modified to include “healthcare workers or others at high risk for occupational exposure.”

All members were in agreement with this addition.

“This is a really amazing vote for people who are at severe risk for COVID: older adults, as well as people who are at risk [of infection] in healthcare settings and other high-risk settings. A third dose will protect them,” said committee member Dr. Amanda Cohn, a chief medical officer at the Centers for Disease Control and Prevention (CDC).

She pointed out that many of the people in these high-risk groups were vaccinated in December 2020 or January of this year, so they’re more likely to be at risk of infection due to waning immunity after vaccination.

People with weakened immune systems are already able to get a third dose of an mRNA vaccine in the United States. These are not considered a booster dose, but a way to help boost people’s initial immune response.

The FDA does not have to follow the panel’s advice, but it generally does. 

The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet to discuss whether the CDC should recommend the rollout of Pfizer-BioNTech boosters for these groups.

Pfizer makes case for booster doses

During the daylong meeting, the FDA advisory group reviewed evidence from Pfizer on the safety and effectiveness of a third dose of its vaccine.

The panel also heard from two Israeli researchers, who presented data from that country suggesting a drop in protection offered by the vaccine several months after the second dose.

The data showed that all age groups saw waning protection against infection 6 months after vaccination.

There was also a drop in protection against severe illness among people 60 years or older. This trend was less clear for younger age groups.

In making its case for approval, Pfizer scientists cited the real-world data from Israel, as well as data from laboratory studies and clinical trials.

Lab data showed a boost in antibody levels after a third dose given at least 6 months after the second dose.

Clinical trial data found that the side effects of the third dose were similar to the first two. In some cases, the side effects were less severe after the third dose.

“These data, and the larger body of scientific evidence presented at the meeting, underscore our belief that boosters will be a critical tool in the ongoing effort to control the spread of this virus,” Kathrin U. Jansen, PhD, senior vice president and head of vaccine research and development at Pfizer, said in a news release.

Clearer booster benefits for older adults

The FDA’s advisory committee initially voted on whether to recommend boosters for everyone 16 years or older. 

This vote failed, with 2 members voting for and 16 members voting against.

Some members felt that while there was strong evidence of the benefit of a booster for older adults, more safety data is needed for younger age groups.

In particular, they focused on the risk of heart inflammation: myocarditis and pericarditis. These conditions can occur after vaccination with an mRNA vaccine.

They are more common after the second dose, and in male adolescents and young adults. Most people recover quickly with treatment.

Israel recently started rolling out boosters of the Pfizer-BioNTech vaccine to younger age groups.

Dr. Sharon Alroy-Preis, director of public health services at the Israel Ministry of Health, said during the meeting that more than 6,000 16- to 18-year-olds have received a third dose.

The Israel Ministry of Health is actively monitoring all cases of heart inflammation in this group. 

So far, the rate of myocarditis or pericarditis appears to be smaller after the third dose than the second dose, she said. However, Alroy-Preis added that these young adults have been followed for fewer than 30 days.

Some members of the FDA committee felt a longer follow-up would be needed to know the true risk of heart inflammation after a booster dose.

Healthcare workers included in EUA

Not all fully vaccinated healthcare workers are at risk of severe COVID-19, although many are at risk of contracting the coronavirus due to exposure to COVID-19 patients.

However, several members felt that this group should be included in the EUA because of the impact infections among healthcare workers would have on hospitals’ ability to deal with surges of severely ill patients.

“The [healthcare] systems are so overstretched now that we can’t even have healthcare workers get mild infections or be positive, because by staying home, that [creates] even more of a risk of failure of the whole system,” said committee member Dr. Stanley Perlman, a professor of microbiology and immunology and pediatrics at the University of Iowa.

Committee members also decided to broaden their informal recommendation to include others at high risk of infection due to their job.

This could include other frontline workers, infrastructure workers, and teachers. 

When the ACIP meets, it will “fine-tune some of our recommendations,” said Dr. Arnold Monto, acting chair of the FDA’s advisory committee and a professor of epidemiology at the University of Michigan.

Our partners: