The FDA has authorized the Pfizer vaccine for emergency use only

The Food and Drug Administration has just issued emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine for people aged 16 years and older, to be distributed across the United States.

“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States. With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks.
—Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research.

Some positive news for the worst country to be hit by COVID-19 in the world. COVID-19 has taken 293K American lives in the United States. To read the full statement, please visit the FDA website.

Today, FDA issued the first emergency use authorization (EUA) for a vaccine for the prevention of #COVID19 caused by SARS-CoV-2 in individuals 16 years of age and older. The emergency use authorization allows the vaccine to be distributed in the U.S. https://t.co/1Vu0xQqmCB pic.twitter.com/c8maeePP9O
— U.S. FDA (@US_FDA) December 12, 2020

The FDA has determined that the #COVID19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence it may be effective in preventing COVID-19.
— U.S. FDA (@US_FDA) December 12, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.
— U.S. FDA (@US_FDA) December 12, 2020

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