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WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)? The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.
The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.
The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).
https://www.fda.gov/media/144414/download
Moderna's EUA:
"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Moderna COVID-19 Vaccine for the prevention of COVID-19"
Janssens's EUA:
"On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of the Janssen COVID-19 Vaccine for the prevention of COVID-19 for individuals 18 years of age and older pursuant to Section 564 of the Act."
They moved the goalposts, again. The EUA shots were first marketed as preventing covid in most people, like traditional vaccines that confer immunity. Now the talking point is that they “reduce severity and symptoms” but since the CDC isn’t reporting on “breakthrough” cases anymore that claim can’t be easily proven.
And they wonder why many of us are hesitant? This sort of crap breeds mistrust.