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  • The Food and Drug Administration approved Pfizer-BioNTech boosters for people ages 65 and older.
  • The approval also includes people ages 18 through 64 at high risk of severe COVID-19 or at higher risk of infection due to their job or the institution where they live.
  • 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 will soon be able to get a third dose of the Pfizer-BioNTech COVID-19 vaccine at least 6 months after their second injection.

The Food and Drug Administration (FDA) updated the existing emergency use authorization (EUA) for this vaccine to allow the use of a single booster dose in people:

  • ages 65 and older
  • ages 18 through 64 who are at high risk of severe COVID-19
  • ages 18 through 64 who are at higher risk of contracting an infection due to their occupation or the institution in which they live

The booster can be given at least 6 months after the second dose.

This change only applies to the Pfizer-BioNTech vaccine. The FDA will review booster applications from Moderna and Johnson & Johnson at a later date.

On Monday, the FDA’s vaccine advisory committee voted unanimously to recommend almost identical eligibility criteria for boosters of this vaccine. The one addition made by the FDA was institutional risk of infection.

Acting FDA Commissioner Dr. Janet Woodcock also provided some insight into which subgroups fall under the EUA.

The authorization would allow for booster doses “in certain populations such as healthcare workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” she said in a news release.

“This is a really amazing… 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,” FDA committee member Dr. Amanda Cohn, a chief medical officer at the Centers for Disease Control and Prevention (CDC), said on Monday.

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.

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, and 15- and 16-year-olds, would not be eligible for boosters at this time.

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

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.

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.

However, even if the CDC makes a different recommendation on boosters, healthcare professionals can offer booster doses of the Pfizer-BioNTech vaccine to anyone who meets the FDA’s eligibility criteria.

During the daylong meeting on Monday, 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.

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.

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 committee 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.