FDA Panel Recommends Emergency Use Authorization of Pfizer’s COVID-19 Vaccine

The Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee on Thursday voted 17 to 4 in favor of approving BNT162b2, Pfizer and BioNTech’s COVID-19, under the agency’s emergency use authorization.

The vote, however, does not mean that the agency will immediately decide to authorize the vaccine.

If approved by the FDA, The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices would also vote on if it recommends the vaccine, and who should receive it.

The CDC previously recommended that health care providers and residents and staff of long-term care facilities should be the first to get it, the Washington Post reported.

BNT162b2 is targeted at the SARS-CoV-2, the virus that causes COVID-19, spike glycoprotein (S) antigen that is encoded by RNA and formulated in lipid nanoparticles (LNPs). The vaccine, which is for people 16 years and older, is administered in two doses, 21 days apart.

The committee reviewed data from an ongoing, phase 3, double-blind placebo-controlled trial of the vaccine that included 43,448 participants— 21,720 who were randomized to receive BNT162b2, and 21,728 who were randomized to receive a placebo. In a mid-November analysis, BCT162b2 had a 95% efficacy rate of preventing COVID-19 seven or more days after the second dose.

Patients with cancer often have weakened immune systems, making them more susceptible to contracting COVID-19 or developing more severe complications from the disease.

Common low-grade side effects from the vaccine included mild or moderate pain at the injection site, fatigue and headache.

Check back for more information as this is a developing story.

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