The FDA has given full approval to the COVID-19 vaccine manufactured by Pfizer.
On Monday, the FDA announced that they had approved the mRNA vaccine for individuals over the age of 16. The vaccine is still under emergency use authorization for individuals from 12 to 15 years of age.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Acting FDA Commissioner Dr. Janet Woodcock said.
The vaccine, whose brand name is Comirnaty, was first introduced under emergency authorization on Dec. 11, 2020. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. In order to get FDA approval, Pfizer’s vaccination was reviewed in 44,000 individuals, half of which received a placebo, according to the FDA.
The full approval of the Pfizer shot may now pave the way for employers, colleges, and the military to make the vaccine mandatory. There is also hope that full approval will win over skeptical unvaccinated Americans whose main hesitance was that the vaccine only had emergency use authorization.
According to the CDC, so far the majority of vaccinated adults have received the Pfizer brand with its competitor, Moderna, coming in second place. So far, over 170 million adults are fully vaccinated and over 200 million have received at least one dose.
Pfizer initially submitted its application for approval in May. Moderna submitted its application in July and is expected to receive full approval soon. Johnson & Johnson, whose shot has been mired in bad publicity due to potentially deadly side effects, plans to submit its application later this year.