FDA May Authorize Pfizer-BioNTech COVID-19 Booster for All Adults This Week

The Food and Drug Administration (FDA) will likely authorize the COVID-19 vaccine booster dose from Pfizer-BioNTech for all US adults as soon as Thursday, according to a report.

In news that coincides with an announced meeting of the Centers for Disease Control and Prevention (CDC) Advisory Committee for Immunization Practices (ACIP), regulators are anticipated to make BNT162b2 the first widely-available COVID-19 vaccine booster dose for fully-vaccinated adults with an emergency use authorization (EUA) and a possible supporting ACIP vote by the end of this week.

The EUA would allow for adults who received a second dose of the mRNA vaccine in the last ≥6 months to receive a booster dose as soon as this weekend. According to the report from The New York Times, Moderna is anticipated to also seek EUA approval for its booster dose of mRNA-1273 in all US adults in the near future.

Pfizer-BioNTech originally submitted the EUA last week—a technical expansion that proceeds the FDA’s emergency authorization of BNT162b2 booster doses for individuals aged 18 to 64 years old with frequent or occupational exposure to SARS-CoV-2 in late October.

Though experts have varied greatly on the utility and prioritization of COVID-19 vaccine boosters in differing adult populations, previous real-world data has supported the waning immunogenic effect of the 2-dose vaccine after 6 or more months of full vaccination. The 7-day US average of new COVID-19 cases has been steadily climbing since late October while full vaccination rate among the population has slowly climbed toward 60%.

“It’s time,” William Schaffner, MD, Professor of Preventive Medicine at Vanderbilt University Medical Center, told Contagion. “We’re ready for them, the public is ready for them, and providers are ready to recommend and give them.”