Reilly: COVID vaccines not approved by FDA

Posted 7/20/21

According to an article (“Vaccines get thumbs up,” Sun City West Independent, July 7, 2021), the claim was made that “three vaccines so far approved for use in the U.S. have proved to be effective in keeping people alive and out of the hospital.”

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Reilly: COVID vaccines not approved by FDA

Posted

According to an article (“Vaccines get thumbs up,” Sun City West Independent, July 7, 2021), the claim was made that “three vaccines so far approved for use in the U.S. have proved to be effective in keeping people alive and out of the hospital.”

This statement is misleading because none of the three vaccines have been approved by the Food and Drug Administration and none of the vaccines have been classified by the FDA as “effective.” They have been classified as “may be effective” under an FDA emergency use authorization. According to the FDA website, the three vaccines being used in the United States have been given an EUA classification (not disclosed in the article) and they are not FDA approved vaccines (also not disclosed in the article).

To quote from the FDA fact sheets for the three vaccines we find the following, “Pfizer-BioNTech COVID-19 Vaccine is an unapproved vaccine,” “The Moderna COVID-19 Vaccine is an unapproved vaccine” and “The Janssen COVID-19 Vaccine is an unapproved vaccine.” In all three FDA fact sheets it’s made clear that “There is no FDA approved vaccine to prevent COVID-19.”

The Pfizer BioNTech fact sheet states, “The Pfizer-BioNTech Vaccine has not undergone the same type of review as an FDA-approved and cleared product.” If one goes to the FDA list of Vaccines licensed for use in the United States, one will find that the three COVID-19 shots are not listed, because they have an emergency use authorization and are not FDA approved.

For those who believe they are required to take the COVID vaccination, the FDA fact sheets state, “It is your choice to receive or not to receive [any of the three] COVID-19 Vaccine[s]. Should you decide not to receive it; it will not change your standard of medical care.”

It’s entirely your decision. Not mandated. 

Brian Reilly

Sun City West

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