FDA gives full approval to Pfizer COVID vaccine

By Minna Lee, Countable News

What’s the Story?

• The U.S. Food and Drug Administration (FDA) has granted full approval to the two-dose Pfizer-BioNTech Covid Vaccine for ages 16 and up.
• The vaccine will be branded as Comirnaty (koe-mir'-na-tee).
• Pfizer-BioNTech will still be operating under Emergency Use Authorization for people ages 12-15. 

What's the FDA saying?

• On Monday, the FDA released a statement:

“Today, the US Food and Drug Administration 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.”

Increased vaccination rates?

• Government and health officials hope this development will encourage reluctant individuals to get vaccinated and lead to vaccination mandates in workplaces. 
• In response to the FDA's announcement, President Joe Biden said:

“If you’re one of the millions of Americans who’ve said that they will not get the shot until it has full and final approval of the FDA: it has now happened. The moment you’ve been waiting for is here. It is time for you to go get your vaccination. And get it today.”

How does the FDA approve vaccinations?

• The Pfizer vaccine has been available to the public under Emergency Use Authorization since December 2020 and applied for full approval in May 2021.
• Observations on the benefits and risks of the vaccine were already recorded by the FDA when they granted Emergency Use Authorization, but the full FDA approval process also includes collecting data from people who’ve been fully vaccinated for six months. 
• The study included data from 44,000 people ages 16 and up to detect side effects after six months of vaccination. 
• In the past, vaccination approval has usually taken up to six months. Completing the process for Pfizer within four months makes this the FDA’s fastest vaccine approval.

Will other COVID vaccines receive FDA approval?

• The Moderna and the J&J/Janssen vaccines have been distributed under the FDA’s Emergency Use Authorization. Both have not been granted full approval by the FDA.
• Modern applied for FDA approval in June 2021. 
• Johnson & Johnson has not filed their vaccine for full FDA approval but plans on doing so later this year.