FDA Approves COVID-19 Pfizer Vaccine, Now to be Marketed as Comirnaty

The US Food and Drug Administration today approved the first COVID-19 vaccine. The Pfizer-BioNTech COVID-19 Vaccine, will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.

The vaccine also continues to be available under emergency use authorization, including for individuals 12 through 15 years of age, and for the administration of a third dose in certain immunocompromised individuals.  

Based on results from the clinical trial, the FDA says the vaccine was 91% effective in preventing COVID-19 disease. 

According to the FDA description, Comirnaty contains messenger RNA (mRNA), a kind of genetic material that is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19.

“The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material,” the FDA states.

Comirnaty has the same formulation as the Emergency Use Authorization vaccine and is administered as a series of two doses, three weeks apart.