The FDA-Approved Vaccine: Comirnaty

The FDA-approved, COVID vaccine produced by BioNTech, named “COMIRNATY”, is a U.S. licensed product. This product is legally subject to liability protection laws in the case of vaccine injury or death.

From the FDA:

Pfizer-BioNTech COVID-19 Vaccine EUA Letter of Authorization, reissued August 23, 2021.

Issuance of Authorization:

C. There is no adequate, approved, and available­9 alternative to the emergency use of Pfizer-BioNTech COVID‑19 Vaccine to prevent COVID-19.

9: Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. (emphasis ours)


In other words, all vaccines presently available on the U.S. market i.e. Pfizer-BioNTech, Moderna and Johnson & Johnson, are experimental, unlicensed products often referred to as “FDA-authorized” or EUA products.

If you plan to get a vaccine, you may consider asking to see the vial. Only if the vial is labeled as “Comirnaty”, is it a licensed, FDA-approved product. That means it is subject to liability laws if you are injured. Additionally, you may also want to ask for the insert included with the vial to view the list of FDA-approved vaccine ingredients before receiving an injection.

If you or a loved one experiences an adverse reaction to a vaccine, we can help.