Pandemic Timeline

Moderna COVID-19 Vaccine receives Emergency Use Authorization from FDA

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize 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 certain criteria are met, including there are no adequate, approved, and available alternatives.

FDA statement on EAUs

In other words, if there is a viable option, an EAU should not be granted.

Safety and efficacy testing is still ongoing for this product.  Details are in the Review Memorandum found in the FDA’s main page for this product.  Therefore, no advertising for this product may legally use the terms “safe and effective”.

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