UNITED STATES: The U.S. Food and Drug Administration (FDA) on 23 August approved the Pfizer/BioNTech COVID-19 vaccine as the first to be licensed by the federal agency.
The Pfizer vaccine, and will now be marketed as ‘Comirnaty’ (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material that is used by the body to replicate one of the proteins in the virus that causes COVID-19. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of the third dose in certain immunocompromised individuals. The approval comes amid lingering vaccine hesitancy among many Americans.
The FDA said its review for approval included data from approximately 44,000 people.
Acting FDA Commissioner Janet Woodcock said: “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.”
“Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S,” she said.
The FDA initially gave Pfizer temporary authorisation – so as to determine if the benefits of a product outweigh potential risks during a public health emergency.
This full approval is essentially permanent. The licensing process requires companies to provide the FDA with information on how and where the product is made, as well as other clinical testing data.
Critics had been calling on the FDA to speed up this approval process as the nation struggled with dropping vaccination rates earlier this year.
Soon after the announcement, the U.S. military said they would officially require all 1.3m active duty U.S. troops to get the jab. The vaccinations are being provided at no cost to Americans.