FDA Approves First COVID-19 Vaccine from Pfizer-BioNTech

On August 23, 2021, FDA approved the first COVID-19 vaccine: the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty. Comirnaty is indicated for the prevention of COVID-19 disease in individuals 16 years of age and older. This vaccine will continue to be available under Emergency Use Authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

The Pfizer-BioNTech COVID-19 vaccine has been available under EUA since December 11, 2020 for individuals 16 years of age and older. On May 10, 2021, the authorization was expanded to include those 12 through 15 years of age.

Comirnaty contains messenger RNA (mRNA), which makes a mimic of one of the proteins in the virus that causes COVID-19. As a result, the immune system of the individual receiving this vaccine will react defensively to the virus that causes COVID-19. The mRNA is present in the body for a short time and is not incorporated into nor does it alter an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered in two doses that are three weeks apart.

“[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 [FDA’s] rigorous scientific standards for [E]mergency [U]se [A]uthorization, 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 [FDA] requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, in an agency press release. “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 [United States].”

“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 Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, in the press release. “We have not lost sight that the COVID-19 public health crisis continues in the US 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 US."

Source: FDA