FDA Amends EUA for Pfizer-BioNTech Booster Dose in Certain Populations

The Food and Drug Administration (FDA) has stated it will grant an EUA for a booster dose of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2 (Comirnaty), for three population groups including: people 65 years and older; people 18 through 64 years who are deemed high risk of severe infection including people who are immunocompromised; and those people 18 through 64 years with jobs that put them at high risk, such as health care workers.

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic," Acting FDA Commissioner Janet Woodcock, MD said in a statement. "After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

In a nod to what could be a future expansion of booster doses making more Americans eligible, including those not mentioned in this most recent EUA, Woodcock said the FDA would continue to look at new data and make future considerations about booster doses based on the evolving information.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed,” Woodcock stated.

This latest EUA stems from the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) meeting late last week. On Friday, the committee decided to vote 16-2 against recommending a booster dose of the vaccine for the general population including everyone who was 16 years and older.

In an unusual move, the committee decided to create a new question to vote on. The question posed to the committee was:

Based on the totality of scientific evidence available including the safety and effectiveness data from clinical trial C4591001 do the known and potential benefits outweigh the known and potential risks of a Pfizer-BioNTech COVID-19 Vaccine booster administered at least 6 months after completion of the primary series for use in:

• Individuals 65 years and older, and
• Individuals at high risk of severe COVID-19

The committee voted 18-0 in favor.

After the second vote, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Research and Evaluation, asked the committee for their opinion on health care workers and the booster dose.

They decided to pose a poll question to the committee about this group. The specific question was:

Should health care workers or others at high risk for occupational exposure be included in this EUA?

The committee voted 18-0 in favor of including this group as well.