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IPFS News Link • Food And Drug Administration / F.D.A

What the FDA and NIH Have to Say About the Vaccine

• http://www.ronpaulinstitute.org by mary l. g. ther

To clarify: The only approved vaccine is COMIRNATY. If this name is not on the vial of the vaccine one is being given, it's not approved. This is important because vaccines provided under Emergency Use Authorization (EUA), including Pfizer's non-COMIRNATY, Johnson & Johnson, and Moderna's, have a liability shield.

The approval letter for COMIRNATY includes the following requirement for additional testing:

Effects on children under 16

Required Pediatric Studies:

Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age.

Final Protocol Submission: October 7, 2020
Study Completion: May 31, 2023
Final Report Submission: October 31, 2023

Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of COMIRNATY in infants and children 6 months to <12 years of age.

Final Protocol Submission: February 8, 2021
Study Completion: November 30, 2023
Final Report Submission: May 31, 2024

Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age.

Final Protocol Submission: January 31, 2022
Study Completion: July 31, 2024
Final Report Submission: October 31, 2024

In other words, the safety for children will be determined over October 31, 2023 – October 31, 2024.


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