Now called Comirnaty, the vaccine is approved for those 16 years and older.
The FDA’s full approval of Pfizer and BioNTech’s COVID-19 vaccine is expected to boost vaccination rates in the United States, health care groups say.
In a joint statement, the American Medical Association, the American Hospital Association, and the American Nurses Association lauded the approval of the vaccine, now called Comirnaty, to prevent COVID-19 in people 16 and older.
The vaccine also continues to be available under emergency use authorization (EUA), including for adolescents 12 through 15 years of age, as well as for a third dose in certain immunocompromised individuals, the FDA said in a press release.
“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,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement.
According to recent polling, 30% of unvaccinated people said they were waiting for vaccines to receive full approval before getting vaccinate.
“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,” Woodcock said
The FDA’s full approval is the result of “many months of work, robust data evaluation, and a thorough, comprehensive review process” and is a “major step forward in the worldwide effort to end this pandemic,” AHA, ANA and AMA said.
“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,” the health organizations said. “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. With millions of data points on the vaccine’s safety and efficacy over nearly nine months of vaccinations, every ‘i’ is dotted and every ‘t’ is crossed. This vaccine is safe, it prevents severe COVID-19, hospitalization, and deaths, and it will save your life.”
FDA’s approval also should further reinforce efforts in the health care field to urge vaccination, and to “deploy all reasonable tools to achieve high levels of vaccination, including mandatory vaccination policies,” AMA, AHA and AHA said.
Diego R. Hijano, MD, a pediatric infectious disease specialist at St. Jude Children’s Research Hospital in Memphis, is also encouraging all parents and eligible children to get the vaccine.
“As the Delta variant continues to surge, America’s children are in a very dangerous situation, with record numbers being hospitalized around the country,” Hijano said in a press release. Received it via email. “With the FDA’s full approval of the Pfizer COVID vaccine today, it should give hesitant parents more confidence in the safety and effectiveness of the vaccine; there is no reason not to get yourself and your child vaccinated against the COVID virus.”