Pfizer-BioNTech Seek Approval for COVID-19 Boosters for All Adults

This week, Pfizer and BioNTech formally requested the U.S. Food and Drug Administration (FDA) to authorize their COVID-19 mRNA vaccine booster to all adults ages 18 and older. According to the companies, the request is based on efficacy and safety data from a randomized, controlled trial with more than 10,000 participants, showing efficacy of 95 percent or better for people receiving the booster.

Recall, Pfizer and BioNTech made a similar request in September, but the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) instead limited booster eligibility to people older than 65 years and younger people at an increased risk of severe COVID-19 due to underlying medical conditions, an occupation, or living situation.

The FDA has not yet scheduled a VRBPAC meeting for this month, and reports indicate the FDA may move forward on a Pfizer-BioNTech booster decision this month without seeking input from VRBPAC.

The full Pfizer-BioNTech request announcement is available here.