August 23, 2021
The U.S. Food and Drug Administration approved its first COVID-19 vaccine Monday, a move that public health officials hope will spur vaccinations among hesitant people. It also may prompt more employers to adopt vaccine mandates.
The Pfizer-BioNTech vaccine, which will be marketed as Comirnaty, was approved for people ages 16 and older. It will be continue to be administered as a series of two doses given three weeks apart. The shot was first made available on an emergency basis last December.
The vaccine will remain available to children ages 12-15 under an emergency use authorization. The administration of a third dose for certain immunocompromised Americans also will continue under the EUA.
"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 said.
"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."
The hope is that full approval will reassure people who have hesitations about the vaccine.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN that he believes full FDA approval could encourage as many as "20 to 30%" of unvaccinated people to get inoculated. He said it also will lead to more employers and universities imposing vaccine requirements.
An emergency use authorization is used by the FDA to provide quick access to medical products, such as vaccines, that can be used when there are no other adequate, approved or available options during a public health emergency.
The FDA will make a product available based upon the best available evidence, without waiting for all of the data to be processed, if the product's benefits outweigh the risks.
An emergency use authorization only remains in effect until the end of the public health emergency. Products approved under it would not be allowed on the market once the public health emergency ended.
To be considered for full FDA approval, Pfizer submitted a biologics license application, which adds to the data and information previously submitted for the EUA. It includes preclinical and clinical and information on the manufacturing process and vaccine testing results. Inspections also were made at the manufacturing sites to ensure vaccine quality. All clinical trials must be completed for the FDA to grant approval.
Pfizer's vaccine uses messenger RNA technology to trigger the creation of a protein from the virus that the body's immune system recognizes as an invader. The mRNA in the vaccine is only circulating in the body for a short period of time and doesn't alter the recipient's genetic material, the FDA emphasized.
Based on clinical trials, the vaccine based is 91% effective in preventing COVID-19. The FDA's approval was based on data from almost 40,000 study participants ages 16 and older.
Those studies wrapped up before the delta variant sent coronavirus cases skyrocketing in the United States. Last week, federal officials unveiled a plan to give booster shots to people who received the Pfizer and Moderna vaccines, noting that the vaccines were about 80% effective against symptomatic infection and at least 90% effective at preventing hospitalization.
"There is real world evidence that are emerging here that suggests that the vaccine is still effective agains the delta variant," Dr. Peter Marks, the FDA's director for the Center of Biologics Evaluation and Research said during a press conference. "Obviously, data coming out of Israel seems to suggest that, with time, immunity from the vaccine does tend to wane. So that's something we'll be following closely."
Woodcock said the FDA will make a decision on boosters based on an examination of safety and efficacy data.
"We would emphasize that the most important thing is that people who are unvaccinated get vaccinated," Woodcock said during the press conference. "We hope that this approval would bolster confidence in those who are wavering. However, giving an additional dose of the vaccine ... the FDA will need to review the data and (that) is not part of this approval."
The most common side effects in the clinical trials were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever.
The vaccine's prescribing information will include a warning about the increased risk of myocarditis and pericarditis after the second dose in men under age 40. Boys ages 12-17 years have the highest risk.
Short-term data shows that most of these more serious adverse reactions are resolved, but more long-term data is needed, the FDA reported.