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The U.S. Food and Drug Administration has fully approved the Pfizer-BionTech COVID-19 vaccine for use in people age 16 and older.
The U.S. Food and Drug Administration has fully approved the Pfizer-BionTech COVID-19 vaccine for use in people age 16 and older, the first COVID vaccine to receive such approval. The drug will be marketed under the name Comirnaty.
In the FDA’s Monday morning announcement, Acting Commissioner Janet Woodcock, M.D., called the agency’s decision to approve the vaccine “a milestone as we continue to battle the COVID-19 pandemic,” one that “puts us one step closer to altering the course of this pandemic in the U.S.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may how install additional confidence to get vaccinated,” Woodcock added.
The Pfizer vaccine, along with one manufactured by Moderna, had been operating under an Emergency Use Authorization (EUA) since December 2020 for people age 16 and older, while Johnson & Johnson’s Jansen vaccine received an EUA in February 2021. The FDA is still reviewing Moderna’s application for full authorization. Johnson & Johnson has not yet applied for full authorization.
The approval comes at a time when the country is experiencing a resurgence of COVID-19 infections, hospitalizations and deaths, due almost entirely to the spread of the Delta variant. Nearly all those contracting the disease now are unvaccinated. As of mid-August, about 72% of adult Americans had received at least one dose of COVID-19 vaccine, although vaccination rates vary substantially by region.
In a June Kaiser Family Foundation poll, about 30% of unvaccinated adults said they would be “more likely” to get vaccinated once a vaccine received full FDA approval.
The announcement is expected to trigger additional vaccination requirements among public and private organizations and institutions. United Airlines had already said it would require its 67,000 employees to get vaccinated by late October or risk losing their jobs. The Pentagon says it will mandate vaccinations for all 1.3 million active duty personnel by mid-September.
The FDA said it based its approval on the results of clinical trials measuring the vaccine’s effectiveness and safety. The agency analyzed data from about 20,000 vaccine and 20,000 placebo recipients age 16 and older who didn’t have evidence of COVID-19 infection within a week of getting the second dose. It found the vaccine was 91% effective in preventing COVID-19.
The agency evaluated safety by following more than half the clinical trial participants for at least four months after getting the second dose of the vaccine. Among the most commonly reported side effects were pain, redness and swelling at the injection site, fatigue, headache and fever.
It also found higher risk of myocarditis and pericarditis, especially within seven days of receiving the second dose. The observed risk is also higher for men under 40 compared to women and older men.
“We have not lost sight that…the public is counting on safe and effective vaccines,” said Peter Marks, M.D., Ph.D. director of the FDA’s Center for Biologics Evaluation and Research. “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.”