FDA Says First Authorized COVID-19 Vaccine's Benefits 'Outweigh Its Risks'

The Food and Drug Administration (FDA) officially authorized the Pfizer and BioNTech COVID-19 vaccine for public use, announcing Saturday morning its “known and potential benefits outweigh its known and potential risks.”

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Dr. Stephen Hahn, FDA commissioner, and Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said the emergency use authorization (EUA) of the country’s first coronavirus vaccine is a continuing process, but they have “complete trust and confidence” in the expedited work of the agency’s scientists. Hahn noted “thousands of people are dying every day,” and the EUA could not have come at a better time.

Hahn said the agency “overwhelmingly agreed the vaccine benefits outweigh its risks” and urged everyone to take both doses of the vaccination.

Both doctors cautioned that “inoculation will take time,” and Americans should “remain vigilant” as they maintain social distance and wear masks in public places.

Marks noted that people who experience a “severe allergic reaction” should inform FDA tracking teams.

Normally the review process takes months, but Marks said the agency conducted this review “in just a few weeks.”

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Pregnant women and any individuals with severe allergies are advised to use caution should they choose to get the vaccination.

Marks noted that as of right now, the vaccine is not technically an “FDA-approved” vaccine, but is authorized for public use.

The emergency use authorization (EUA) of Pfizer and BioNTech’s Covid-19 vaccine is a “significant milestone” in the fight against the pandemic, Hahn said in a Friday statement. During the Saturday briefing both said threats of losing their jobs were not a factor behind the success of the expedited vaccine process.

The Centers for Disease Control and Prevention (CDC) vaccine advisory committee scheduled a Saturday morning meeting because it must vote to recommend the vaccine in order for vaccinations to officially start. The FDA then must accept that recommendation from the CDC. The CDC is assisting with the rollout of the vaccines.

Instructions for use and the the full text outlining the basis for their decision will be posted on the FDA.gov website.

This is a developing story and will be updated.

FDA Commissioner Stephen Hahn addresses the media during a press conference at the White House on on August 23, 2020 in Washington, DC. The agency’s chief spokesperson has been fired after the FDA controversially endorsed blood plasma treatment for COVID-19. Peter Marovich/Stringer

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