FDA officially approves nation’s first Covid-19 vaccine

FDA approved the Pfizer-BioNTech mRNA Covid-19 vaccine today, marking the first jab in the US to receive full clearance. It will be marketed as Comirnaty, for the use in people 16 years of age and older. The vaccine, given in a series of two doses, three weeks apart, is also still available under emergency use authorization (EUA), even for individuals 12 through 15 years of age and for the administration of a third dose in specific people who are immunocompromised.

“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,” says Acting FDA Commissioner Janet Woodcock, MD. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the US.”

FDA-approved vaccines go through the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the typical protocol involves the FDA evaluating data and information included in the manufacturer’s submission of a biologics license application (BLA), which is a comprehensive document that is submitted to the agency providing very specific requirements.