It's a big development on the COVID vaccine front: The FDA on Monday gave full approval to the Pfizer shots, reports the AP. The vaccine had previously been granted an emergency-use waiver, and winning full approval—it's the first vaccine to do so—could have wide-ranging implications.
- New name: "The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older," says the FDA statement. The vaccine will continue to be available under emergency use authorization (EUA) for those ages 12 to 15.
- More mandates: Full approval is expected to encourage more employers and institutions to require vaccinations, reports CNN. Of the 172 million in the US who are fully vaccinated, more than 92 million have the Pfizer shots.
- Booster shots: As USA Today notes, the development also could pave the way for booster shots, because doctors would be able to prescribe such shots in "off label" fashion.
- Skeptics: The development may encourage those who've been reluctant to get the shots before now to roll up their sleeves."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," says acting FDA chief Dr. Janet Woodcock, per the New York Times.
- What's next: The FDA also is reviewing the Moderna vaccine for full approval, and that decision is expected in weeks. Johnson & Johnson is expected to apply for full approval soon.
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