FDA VRBPAC Votes to Recommend COVID-19 Boosters for Older Adults and High-Risk Groups
Today, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend authorizing a booster shot for recipients of the Pfizer-BioNTech COVID-19 vaccine who are 65 years of age and older or are at high risk of severe COVID-19.
The recommendation for COVID-19 booster shots for older adults and high-risk groups followed a vote by the VRBPAC overwhelmingly recommending against a Pfizer-BioNTech booster dose for persons ages 16 and older. The committee engaged in lengthy discussions throughout the day, scrutinizing whether COVID-19 booster doses are needed to maintain protection against the virus and for whom. Many members of the VRBPAC raised concerns with the data provided by Pfizer and BioNTech about the need for booster shots for such a large swath of the country’s population.
While the FDA is not obligated to comply with the VRBPAC recommendation, the agency rarely departs from the guidance provided by the independent panel. Today’s vote complicates the Biden-Harris Administration’s announcement last month that it planned to make booster shots available to vaccinated Americans beginning on Monday, September 20. The announcement by the administration has been viewed as controversial, given the need for the FDA and CDC to adequately review data and decide about the safety and effectiveness of a third dose.
The FDA must decide whether to act upon the VRBPAC recommendation, which is expected over the coming days. The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is scheduled to meet next week to recommend how exactly the extra doses should be used. Previous public conversations among the group have suggested ACIP may be leaning toward offering booster shots to older adults and vulnerable populations.
Additional information about the FDA’s meeting held today is available here.