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What Does Full FDA Approval of a Vaccine Do If It’s Already Authorized for Emergency Use?  


Author:  Jennifer Girotto.


Source: Volume 22, Number 04, Fall 2021 , pp.78-78(1)




Correctional Health Care Report

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Abstract: 

Thirty percent of unvaccinated American adults said they were waiting for the COVID-19 vaccines currently authorized for emergency use to be officially approved by the U.S. Food and Drug Administration. The FDA has since granted that approval for those age 16 and older for the Pfizer-BioNTech vaccine. What had to happen for the FDA to advance from emergency use authorization, or EUA, to full approval? The author, a pharmacist who trains other pharmacists, health care providers and students on why, when and how to administer vaccines, explains why emergency use authorization, while streamlining the regulatory process so the vaccine is more quickly available to the public, still follows a rigorous process the FDA requires to ensure vaccine safety and effectiveness. The difference between emergency use authorization and full approval is that more time has passed and more safety and efficacy data is now available for review.

Keywords: Emergency Authorization

Affiliations:  1: University of Connecticut.

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