Pfizer-BioNTech COVID-19 vaccine gets approval in US; first to gain full FDA approval

The United States Food and Drug Administration (FDA) has approved the Pfizer-BioNTech COVID-19 vaccine. It is the first COVID vaccine to receive full approval from the agency. The coronavirus vaccine will now be marketed as Comirnaty. It has been approved for individuals aged 16 years and above. According to FDA, the vaccine will continue to be available under Emergency Use Authorization (EUA) for individuals aged 12 years to 15 years and can be administered as a third dose in "certain immunocompromised individuals". Acting FDA Commissioner Janet Woodcock in a press release has informed that the approval of the vaccine from the FDA is a "milestone" amid the battle against the COVID-19 pandemic. Woodcock assured the people that the vaccine meets the "high standards for safety and effectiveness needed for the approval from FDA.

"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," said Acting FDA Commissioner Janet Woodcock.

Woodcock added that although millions of people have been vaccinated against COVID-19 but "we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated". He stressed that the approval of Pfizer-BioNTech will put them closer to "altering the course of this pandemic in the US". Peter Marks, director of FDA’s Center for Biologics Evaluation and Research informed that a thorough and thoughtful evaluation of vaccines was conducted by scientific and medical experts. Marks added that scientific data and information that included "hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities".

Image Credit: AP