FDA Panel Endorses Widespread Use of Pfizer COVID-19 Vaccine
December 14, 2020, 9:07am
The U.S. Food and Drug Administration (FDA) recently announced that an advisory panel has endorsed an Emergency Use Authorization (EUA) for widespread use of drugmaker Pfizer Inc.’s COVID-19 vaccine, developed in partnership with German drugmaker BioNTech.
This endorsement is a critical milestone, as the next step would be for the FDA to approve the vaccine for EUA. The agency is likely to issue an authorization within days, which would give health care workers and long-term care residents priority to begin receiving the COVID-19 vaccine as soon as next week. Federal officials are prepared to distribute 6.4 million doses within 24 hours of the authorization.
According to an FDA statement, the agency is rapidly working toward finalizing this authorization.
An Emergency Use Authorization (EUA) would not be a full approval, and the FDA would continue to collect safety data before issuing a full approval.
COVID-19 Vaccine Approval and Distribution
The endorsement for authorization comes from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), composed of independent doctors, scientists and experts. The panel voted 17-4 in favor of the recommendation, with one vote abstaining.
This endorsement follows a recommendation from the Centers for Disease Control and Prevention (CDC) for a COVID-19 vaccine distribution plan, which would prioritize vaccine distribution for health care workers and long-term care residents before making the vaccine available to the general public.
As Pfizer Inc.’s vaccine advances through required steps for approval, drugmaker Moderna Inc. has also applied for EUA for its COVID-19 vaccine and continues through the approval process.
At minimum, an approved COVID-19 vaccine would likely still require months before distribution to the general public. Organizations should plan for the coronavirus pandemic to continue, and await more guidance for what a COVID-19 vaccine authorization will mean for workplaces.