FDA Anticipated to Issue EUA for Pfizer COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) is widely anticipated to issue its first emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine at any point in the coming days. Yesterday, during a day-long meeting, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) deliberated the safety and efficacy of the vaccine candidate, ultimately recommending the FDA issue an EUA approval for the vaccine among individuals 16 years of age or older on a 17-4 vote, with one abstention.

The FDA today indicated it will accept the recommendation of the VRBPAC and rapidly work to finalize and issue an EUA for the vaccine candidate. The FDA has notified the U.S. Centers for Disease Control and Prevention (CDC) and Operation Warp Speed to begin preparations for executing plans for timely vaccine distribution nationwide. The first doses are likely to reach patients within approximately one day of being authorized.

Amid an unprecedented surge in COVID-19 cases and hospitalizations in California and the U.S., the first U.S. approval of a COVID-19 vaccine is anticipated to be welcome news. Additional vaccine candidates, including Moderna’s mRNA vaccine, are likely to be approved over the coming weeks and months.