FDA Committee Votes to Recommend EUA of COVID-19 Booster Dose in Older, High-Risk People

After deciding to vote against recommending the approval of a booster dose for people 16 years and older earlier today, the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) decided to create a new question to vote on an Emergency Use Authorization (EUA) for a booster dose for people 65 years and older and those deemed high risk of COVID-19.

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

Committee members voiced their concerns about the lack of data to feel comfortable with having such a large amount of the American population eligible for the booster dose.

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 healthcare workers or others at high risk for occupational exposure be included in this EUA?

The committee voted 18-0 in favor of including healthcare workers.