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FDA Approves First COVID-19 Vaccine

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

a medical professional holds a syringe containing the pfizer covid nineteen vaccine and a proof of vaccine card before it is administered to a medical professional at mount sinai hospital in new york new york on december fifteenth twenty twenty

Anthony Behar/Sipa USA/via AP Images

En español | The U.S. Food and Drug Administration (FDA) has granted official approval 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 emergency use authorization (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.


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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.

"If we look at a more conservative estimate — if we can get 10 percent more of the eligible population vaccinated against COVID — that's going to make a huge difference with regards to community transmission,” Limaye says. Nearly 90 percent of U.S. counties are experiencing high levels of virus transmission, according to the CDC.

The approval process for Pfizer's vaccine, which will now be marketed as Comirnaty, was based on safety and effectiveness data from a large clinical trial population. More than half of the trial participants were monitored for safety for at least four months after the second dose; about 12,000 recipients have been followed for at least six months.

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.

Pfizer's approval could also spur vaccine mandates at more businesses and organizations throughout the U.S., which could drive up vaccinations. So far about 51 percent of the total U.S. population is fully vaccinated.


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Vaccines are still ‘highly effective’ in fight against virus

Reports of breakthrough infections 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 green-light booster shots 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.

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