Pfizer COVID-19 Vaccine Gains Full FDA Approval

This article has been updated.

The FDA has granted full approval to Pfizer/BioNTech’s COVID-19 vaccine, marking the first time such a vaccine has been granted this status since the pandemic began.

The vaccine will now be marketed as Comirnaty to prevent COVID-19 disease in individuals 16 years and older. Under the FDA's initial emergency use authorization (EUA), the vaccine is still available for individuals aged 12 through 15, while a third dose is also currently authorized for immunocompromised individuals.

The Moderna and Johnson & Johnson COVID-19 vaccines are still available under EUAs from the FDA.

"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, MD.

"This step is one more milestone in a rigorous, independent process that holds vaccines to the highest of standards. Americans now have one more reason to get vaccinated," tweeted Surgeon General Vivek Murthy MD, MBA.

Experts hope this new authorization will help convince vaccine holdouts to get the immunization while, according to The New York Times, hospitals, colleges, and corporations will likely take advantage of full approval to mandate vaccinations.

New York City has now mandated vaccines for all education staff, requiring employees to have at least 1 dose of a COVID-19 vaccine by September 27, and scrapping the option for weekly testing.

The Pfizer vaccine was first made available on December 11, 2020.

“Final FDA approval should further assure people that the Pfizer-BioNTech COVID-19 vaccine is safe and effective," said Paul W. Abramowitz, CEO of the American Society of Health-System Pharmacists, in a statement to The American Journal of Managed Care^® (AJMC^®).

"After FDA’s thorough and transparent review, it is clear that the benefits of this vaccine in helping to prevent COVID-19 far outweigh the risks. Anyone who still has concerns or questions about the vaccine should consult a pharmacist, physician, nurse, or another trusted health care professional to discuss their personal risks and benefits.”

The news comes as the United States continues to combat the Delta variant of COVID-19, which has become the dominant strain of the disease in recent months and has led to increases in deaths and hospitalizations, largely among unvaccinated populations.

The approval is based on additional data provided in the companies' biologics license application (BLA). The data expanded on the initial data submitted for the EUA, and included longer follow-up information in a larger clinical trial population.

Specifically, safety was evaluated in approximately 44,000 individuals aged 16 and older, half of whom received a placebo. Results showed the vaccine was 91% effective in preventing COVID-19 and the most common side effects reported included injection site pain, fatigue, headache, muscle or joint pain, fever and chills.

Post-authorization safety surveillance data also showed increased risks of myocarditis and pericarditis following administration of the vaccine, particularly within 7 days following the second dose.

"The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes," the FDA statement reads. The vaccine's prescribing information includes a warning related to this risk.

Pfizer and BioNTech are required to conduct additional postmarketing studies regarding these risks, and will also be evaluating pregnancy and infant outcomes after receipt of the vaccine during pregnancy.

Approximately 85 million eligible Americans remain unvaccinated against COVID-19, while this new approval permits Pfizer/BioNTech to market the vaccine to the population for which it is approved. The companies cannot, however, advertise to individuals in the 12 to 15 year old age group, for whom an EUA is issued.

The majority of fully vaccinated Americans (54%) received the Pfizer vaccine and FDA regulators are expected to make a decision in the coming weeks regarding the authorization of booster shots for those who received either a Pfizer or Moderna mRNA vaccine.

"The vaccines to prevent COVID-19 are effective; we have known that for months as health care professionals were among the first to get vaccinated and have advocated for our patients to get vaccinated to save lives. But today’s news marks a critical moment for people who were concerned about getting vaccinated due to the vaccines being authorized for emergency use," reads a joint statement from the American Medical Association, American Hospital Association, and American Nurses Association.

"If uncertainty was holding you back, now is the time to act. And if you still have questions about the vaccines or about COVID-19, please consult your health care professional."