Pfizer becomes first Covid vaccine globally to get full USFDA approval

Aditi Tandon

Tribune News Service

New Delhi, August 23

American drug regulator, the US Food and Drug Administration, on Monday granted full approval to the Pfizer vaccine for the prevention of Covid 19 in individuals 16 years of age and older.

The vaccine will, however, be available under emergency use authorisation (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals, the FDA said.

So far, the Pfizer-BioNTech Covid-19 vaccine had only the emergency use authorisation approval for all categories of people.

“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 authorisation, 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.

He said while millions of people have already safely received Covid-19 vaccines, the FDA recognised that for some, its approval 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, the FDA chief added. 

Since December 11, 2020, the Pfizer-BioNTech Covid-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021.

EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research.