Pfizer Vaccine Approved for Emergency Use

A panel of Food and Drug Administration (FDA) science advisors approved the Pfizer-BioNTech vaccine on Thursday in a 17-4 vote to proceed to emergency authorization use for distribution in the United States. The approval is the first step to rolling out the COVID-19 vaccine, which is earmarked for frontline healthcare workers and nursing home patients to be vaccinated first, with expectations that could occur as early as Monday or Tuesday of next week.

The committee received guidance from independent health experts in reaching the decision to move forward, approving the vaccine use for those 16 years and older. The federal government has 100 million doses reserved, which would vaccinate 50 million people with a 2-shot regimen. Pfizer-BioNTech currently has 25 million doses ready to dispense to the US and expects to increase overall production by as many as 1.3 billion vaccine doses by the end of next year.

The FDA issued its endorsement after reviewing the trial testing data submitted by Pfizer-BioNTech, saying the vaccine efficacy and safety outweighs the risks, although health experts in the United Kingdom are reviewing two cases of severe reactions, including anaphylaxis which can be life threatening. British health officials have advised those with a history of severe allergic reactions to avoid this particular vaccine while they continue to review the data. The FDA is scheduled to begin reviewing another vaccine produced by Moderna next week, with Johnson & Johnson and AstraZeneca vaccine assessments soon to follow.