FDA Grants Full Approval to Comirnaty, Pfizer’s COVID-19 Vaccine

The Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s COVID-19 vaccine – now called Comirnaty – for individuals aged 16 and older. The vaccine will also be available via Emergency Use Authorization (EUA) for people between the ages of 12 and 15.

“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 Dr. Janet Woodcock, in a statement.

The vaccine was originally granted an EUA in December, allowing it to be used during a public health emergency — the COVID-19 pandemic — to prevent infection. To be granted full approval, the pharmaceutical companies had to submit a biologics license application, which provides extensive data on how well the vaccine works, how it is manufactured — including inspection of the sites — and, importantly, the safety of the drug.

“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 U.S.,” Woodcock said.

Comirnaty is an mRNA vaccine. When people receive it, their immune system will produce proteins that mimic the virus that causes COVID-19. As a result, their immune system will react defensively if it encounters the virus in the future. The vaccine is given via two shots, administered three weeks apart.

“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 Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."

Oncologists expressed their support of the full approval on social media.

“Outstanding news to start the day! Full approval will make many things easier and accepted,” tweeted Dr. Toni Choueiri, director of the Lank Center for Genitourinary Oncology and director of the Kidney Cancer Center at Dana-Farber Cancer Institute in Boston.

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