FDA Advisory Panel Recommends Pfizer-BioNTech Boosters for Adults 65+, Others at High Risk

• 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.