After almost nine months under an emergency use authorization, the Pfizer-BioNTech COVID-19 vaccine earned full approval from the U.S. Food and Drug Administration.
The vaccine now will be marketed as Comirnaty, the FDA announced Monday, Aug. 23. It is the only vaccine of the three granted emergency use authorization to receive full approval. The other two are Moderna and Johnson & Johnson.
The FDA issued the emergency use authorization for the Pfizer vaccine on Dec. 11, 2020. The vaccine is still available under emergency use authorization for youths 12 to 15 years old and as a third-dose booster for certain immunocompromised people.
The approval could encourage people who were hesitant to now get the vaccine, according to a June 30 Kaiser Family Foundation vaccine monitor survey. Thirty-one percent of unvaccinated adults said they would be more likely to be vaccinated if fully authorized vaccines were available, according to the study.
“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,” said acting FDA Commissioner Dr. Janet Woodcock. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
All three of the vaccines have met “rigorous, scientific standards for emergency use authorization,” Woodcock continued.
The effectiveness and safety of the Comirnaty vaccine was evaluated among 22,000 people who received the vaccine and 22,000 who got the placebo.
The FDA determined the Comirnaty vaccine was 91 percent effective in preventing COVID-19. The administration reported some common side effects were redness and swelling at the injection site, fatigue, headache, muscle and joint pain, chills, and fever.
The vaccine as administered under the Pfizer name, according to the FDA, does increase the risk of myocarditis (inflammation of heart muscle) and pericarditis (inflammation of membrane enclosing the heart) in some individuals, with the highest observed risk in males 12 to 17 years of age. The FDA review found that most individuals who have those side affects recover, although a few required intensive care support.
Comirnaty is the same formulation as the Pfizer vaccine that was initially granted an emergency use authorization and is administered with two doses given three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Dr. Peter Marks, the director of the 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.”