The FDA has granted Pfizer Full Approval for their Coronavirus Vaccine as the Delta Variant sends thousand of Unvaccinated Americans to the Hospital, leaving hundreds in critical condition.
On Monday, Pfizer got the news from the FDA that their Vaccine -BioNTech COVID-19 vaccine would get a FULL approval from the FDA in a highly anticipated move.
The FDA reached its decision three months after Pfizer and its partner BioNTech from Germany filed to get approved.
In a release, the FDA announced the Vaccine would be marketed as Comirnaty. This will be the new brand name for Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty mashes up community, immunity, mRNA, and COVID— and will be safe to administer to patients 16 and older.
The FDA also said that the emergency authorization order would remain so kids as young as 12 could get the Pfizer Coronavirus vaccine and immunocompromized people to get a third shot or booster shot.
FDA Acting Commissioner Janet Woodcock said in a statement: “This holds the promise of altering the course of the pandemic in the United States.”
“This is an unprecedented timeline given the volume of review and the meticulous manner in which it was done,” she went on to say “But we want to underscore that our efforts to move as quickly as possible have in no way sacrifice scientific standards for the integrity of our process.”
“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.”
Pfizer CEO said in a statement: “this affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed.”
“I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity,”
THIS STORY IS BREAKING RIGHT NOW CHECK BACK FOR UPDATES