FDA Issues Emergency Use Authorization for First COVID-19 Va
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FDA issued the first emergency use authorization (EUA) for a Covid-19 vaccine in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA and available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19.

The study included 37,586 of the participants, 18,801 of whom received the vaccine and 18,785 of whom received saline placebo, they followed for a median of two months after receiving the second dose. Most common side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever.

The vaccine was 95% effective in preventing COVID-19 disease. EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

Source:
https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19
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