Pfizer-BioNTech COVID-19 Vaccine Gets Full FDA Approval Javascript must be enabled to use this site. Please enable Javascript in your browser and try again. × Search search POPULAR SEARCHES SUGGESTED LINKS Join AARP for just $9 per year when you sign up for a 5-year term. Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. Leaving AARP.org Website You are now leaving AARP.org and going to a website that is not operated by AARP. A different privacy policy and terms of service will apply.

FDA Approves First COVID-19 Vaccine

Pfizer shot gets official stamp of approval from regulators for Americans 16 and older

Anthony Behar/Sipa USA/via AP Images The U.S. Food and Drug Administration (FDA) has to the Pfizer-BioNTech vaccine for individuals 16 and older, making it the first fully approved vaccination in the fight against COVID-19. Acting FDA Commissioner Janet Woodcock, M.D., called the agency's Aug. 23 announcement a “milestone” in the ongoing pandemic and said in a statement that 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.” For the last eight months, Pfizer's two-dose regimen has been administered under (EUA) — a designation that allows access to treatments and other medical tools that are not yet fully approved but whose benefits have been shown to outweigh risks. It will continue to be available under its EUA for people ages 12 to 15 and for certain immunocompromised individuals seeking a recommended third dose. Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine.

Approval could offer assurance to millions

More than 92 million Americans have so far been fully vaccinated with Pfizer's two-dose regimen, federal data shows — that's about 54 percent of the fully vaccinated population. And health experts are hopeful that official approval will sway millions more to do the same, especially as COVID-19 cases, hospitalizations and deaths driven by the highly contagious delta variant are surging throughout the U.S. A Kaiser Family Foundation survey found that about 30 percent of unvaccinated people said they would be more likely to get the vaccine if it was fully approved; many of those holding out cited safety concerns without the FDA's official endorsement. If the FDA's approval nudges this population to get the vaccine, it could help shift the direction of the pandemic, says Rupali Limaye, director of behavioral and implementation science at the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. AARP Membership — $12 for your first year when you sign up for Automatic Renewal Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. Entertainment $3 off popcorn and soft drink combos See more Entertainment offers > Overall, the vaccine was found to be 91 percent effective in preventing COVID-19 disease in the population studied, and the most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever. Safety monitoring will continue, the FDA says, including for risk of myocarditis and pericarditis following vaccine administration. In addition to evaluating “hundreds of thousands of pages” of data, FDA officials also “performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” as part of the approval process, Peter Marks, M.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "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.,” he added. AARP Membership — $12 for your first year when you sign up for Automatic Renewal Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. are on the rise, but Limaye says that should not dissuade people from getting vaccinated. Health officials maintain that all three vaccines available to the public — from Pfizer-BioNTech, Moderna and Johnson & Johnson — are still “highly effective” at preventing severe illness and death from the coronavirus, including from the delta variant. "What we want to do is we want to prevent deaths from happening,” Limaye says. “So we need to keep our eyes focused on that number. And the fact that all of our products that we have in the U.S. that are [authorized] are still holding up quite well is really quite something.” Nearly all of COVID-19-related hospitalizations and deaths are occurring in unvaccinated people, experts stress. Less than 1 percent of fully vaccinated people have had a breakthrough infection that has resulted in hospitalization or death, CDC data shows. Next up: Moderna applied for FDA approval for its two-dose vaccine in June and is awaiting the agency's decision; Johnson & Johnson is expected to submit its application for the company's one-dose shot soon. These two vaccines still remain available under emergency use authorization, and all three vaccines continue to be free to the public. Federal officials are also expected to for vaccinated Americans next month. Rachel Nania writes about health care and health policy for AARP. Previously she was a reporter and editor for WTOP Radio in Washington, D.C. A recipient of a Gracie Award and a regional Edward R. Murrow Award, she also participated in a dementia fellowship with the National Press Foundation. More on health AARP Membership — $12 for your first year when you sign up for Automatic Renewal Get instant access to members-only products and hundreds of discounts, a free second membership, and a subscription to AARP the Magazine. AARP VALUE & MEMBER BENEFITS See more Health & Wellness offers > See more Flights & Vacation Packages offers > See more Finances offers > See more Health & Wellness offers > SAVE MONEY WITH THESE LIMITED-TIME OFFERS