FDA grants full approval to Pfizer vaccine

The Food and Drug Administration has granted full approval to the Pfizer-BioNTech COVID-19 vaccine for people ages 16 and older. 

The vaccine, which will be marketed as Comirnaty, remains unchanged from when it was first approved for emergency use in the United States last December for people 16 and older. It is the first COVID-19 vaccine to be granted full approval.

The clinical trials for the vaccine show the vaccine was 91% effective in preventing infection. The Biologics License Application was submitted to the FDA to secure full approval on May 7 for patients ages 16 and up. The application requires a review of preclinical and clinical data, details of the vaccine’s manufacturing process, testing results for quality and inspections of the sites where the vaccine is made.

The vaccine remains available for people ages 12-15 through emergency use authorization. Immunocompromised people can get a third dose of the vaccine through emergency use authorization as well.

The vaccine contains a messenger mRNA, which is used by the body to make a mimic of one of the proteins in the coronavirus to help their immune system reach defensively to the virus. The mRNA is only present in the body for a short time and is not incorporated into or alters genetic material. 

“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 said in a statement.

“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.,” Woodlock said.

The FDA noted myocarditis and pericarditis, which is related to heart inflammation, as potential side effects of the vaccine. The risk for the side effect is higher among males under 40 compared to females and older males and highest in males 12-17. The symptoms remain rare, however, as only 1,306 reports of myocarditis or pericarditis among people ages 30 and younger who received an mRNA COVID-19 vaccine (Pfizer and Moderna) have been reported, according to the CDC. The FDA is requiring that Pfizer monitor the long term effects of myocarditis after authorization. 

Pfizer is also voluntarily committed to conducting safety studies on the vaccine during pregnancy. A CDC analysis of the effects of COVID-19 vaccines on pregnant women show that there are no safety concerns.

The announcement may trigger an increase in vaccination rates. A Kaiser Family Foundation poll in June showed that 31% of unvaccinated adults would be more likely to get a coronavirus vaccine if it has full FDA approval. The full approval also makes it easier for employers to mandate vaccinations for their employees across the country.

66.1% of New York’s adult population has at least one dose of a coronavirus vaccine. 62.8% of people in Riverhead, and 58% of people in Calverton, have at least one dose, according to state data by zip code.