FDA approves Pfizer vaccine
September 11, 2021
On Aug. 23, the U.S. Food and Drug Administration approved the first COVID-19 vaccine, Pfizer-BioNTech. The vaccine was originally rolled out for emergency-use only, but will now be marketed as Comirnaty for the prevention of COVID-19 for individuals 16 and older.
The vaccine is still available for Emergency Use Authorization (EUA) for individuals 12 through 15 and for administration of a third dose for certain immunocompromised individuals.
Pfizer became available for EUA on Dec. 11, 2020, and the authorization for people between the ages of 12 through 15 came on May 10, 2021. EUAs can be used during public health emergencies, provided that the FDA can determine the known and potential benefits of a product outweigh the known and potential risks of the product.
For full FDA approval, the FDA requires six months of follow-up data, FDA inspectors to visit plants where the vaccine is made, and review each step of the process to assure the vaccine is made under safe conditions.
As of Aug. 30, according to the Mayo Clinic, only 52.6% of Americans are vaccinated. With this, public health experts now hope that it will convince more unvaccinated people to go out and get the vaccine.
“If you’re one of the million of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened,” President Biden said on Monday, Aug. 23.
Now as the FDA has approved it, the many corporations that were hesitant to create a mandate for the vaccine, may have a change of heart. Many expect the approval from Aug. 23 to cause a flood of mandates from a variety of businesses.
CVS Health, which has administered more than 30 million vaccines themselves, will now require employees who interact with patients to be vaccinated by Oct. 31. New hires must also be vaccinated before their first day with CVS.
Following Pfizer’s path, Moderna has already applied for full FDA approval and Johnson & Johnson hopes to apply later this year. But, with the rise of the Delta variant, Pfizer is now also seeking approval for their booster shot, which would be the third dose of the vaccine, for everyone ages 16 and older. The company said they hope to have the application submitted by the end of the Aug. 23 week.
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