The vaccination efforts in the United States just got a much a needed boost.
On Monday, the Food and Drug Administration (FDA) granted the Pfizer-BioNTech COVID-19 vaccine full approval to be used for the vaccination program against COVID-19.
Sources said the approval of the Pfizer COVID-19 vaccine is considered a milestone since it is the first complete authorization for a COVID-19 vaccine after an approximately three-month review of Pfizer and its German partner BioNTech’s application to the FDA for full approval.
In a press release statement, the FDA said the Pfizer vaccine will be commercially sold as Comirnaty, with the full authorization applying to vaccine recipients age 16 and older.
It was learned that FDA’s emergency use authorization will remain in place for those between the ages of 12 and 15.
The emergency use authorization also still applies to the third dose for immunocompromised people.
Acting FDA Commissioner Janet Woodcock is very happy with their move since it is a big step in stopping COVID-19 in the US.
“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,” Woodcock said.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Woodcock added.
Moreover, sources said that the Pfizer-BioNTech vaccine, like the other two available in the U.S., had been given emergency use authorization, allowing it to be administered only during a public health emergency.
But under a full authorization, the FDA is permitting patients to get the shots once the public health emergency is declared over.