Comirnaty

...and the legal maze.

This is a quick story to help a curious mind walk through the maze that was the FDA approval of Comirnaty.

SUMMARY OF THE PLOT AND TECHNICAL CAVEATS

On August 23, the FDA approved Comirnaty. Their Comirnaty webpage says the following:

On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, 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 (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

There are two technical caveats to pay attention to in the initial approval:

Caveat One: When the FDA approved the Pfizer v-e recently, they approved the version that is not yet in production (“Comirnaty”)—while the one that is currently in production is still technically under the …