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Authorized, Not Approved: The Pfizer COVID Vaccine

Sunday, December 13, 2020 15:29

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In the public announcement of the United States public distribution start for the Pfizer developed COVID vaccine, the FDA was very careful in their wording.

The FDA has authorized the distribution of the Pfizer developed COVID vaccine, they have NOT approved the Pfizer developed COVID vaccine.

What does this subtle wording difference really mean? Here is the FDA definition, taken from the government website.

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against Chemical, Biological, Radiological and Nuclear (CBRN) threats by facilitating the availability and use of MCMs (Medical Countermeasures) needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved and available alternatives.

The FDA issued EUA letter to Pfizer was sent by RADM Denise M. Hinton, Chief Scientist, Food and Drug Administration (PDF here) on 11 December 2020. This section relates to the authorization.

https://www.youtube.com/embed/iGkwaESsGBQ

References

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

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

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Total 1 comment

tonyw

in this case it is not a “serious” life threatening disease.. it is no more deadly than the flu we get every year.. Just keep pushing the fear which is what its all about

Dec 13, 2020, 10:56 pm 0 Reply

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