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  • Robert Alongi

FDA Approves Emergency Use Authorization for COVID-19 Vaccine

Dear Pharmacists,


This past week, the FDA has approved the Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine which will allow the vaccine to be given in the U.S. FDA Commissioner Stephen M. Hahn, M.D stated “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.”


According to their announcement, the vaccine met all the criteria needed for the issuance of the EUA, and the data that available showed effectiveness in preventing COVID-19 in patients. They also concluded that the known potential benefits outweighed the potential risks and approved the use for it in people aged 16 years or older. Unfortunately, the duration of how long a person is immunized after vaccine administration is still to be determined.


It might take some time before the vaccine is distributed to the public for administration. Healthcare workers (specifically those in hospitals) and high-risk individuals will be given priority on the vaccine. As pharmacists, it is important to be prepared for when this two-dose vaccine is available to community pharmacies, including taking all required CE credits that are needed to give the COVID-19 vaccine.


For more information:

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


https://www.fda.gov/media/144412/download


https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization


https://www.nytimes.com/2020/12/11/health/pfizer-vaccine-authorized.html


https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-pfizer-biontech-etr.html


https://www.hhs.gov/about/news/2020/09/09/trump-administration-takes-action-to-expand-access-to-covid-19-vaccines.html#:~:text=%E2%80%A2%20The%20vaccine%20must%20be,%2D19%20vaccine%20recommendation.




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