On Monday, the U.S. Food and Drug Administration granted the Pfizer/BioNtech COVID-19 vaccine full approval, a milestone in the continued fight against the virus.
Here’s what you need to know about the decision:
Why is the decision important?
While all COVID-19 vaccines currently in use have met FDA’s stringent standards for emergency use authorization, full approval means the Pfizer/BioNtech vaccine has earned the FDA’s strongest endorsement for safety and effectiveness.
Who does it apply to?
The vaccine has been fully approved for the prevention of COVID-19 in individuals 16 and older. The vaccine also continues to be available under emergency use authorization for individuals ages 12-15 and for a third dose in certain immunocompromised individuals. The FDA is expected to authorize a third dose for everyone 12 and older in September.
How did the FDA reach its decision?
FDA experts conducted an extremely thorough evaluation of the Pfizer/BioNtech vaccine. The agency evaluated scientific data and information included in hundreds of thousands of pages of documents, conducted independent analyses of the vaccine’s safety and effectiveness and performed a detailed assessment of manufacturing processes, including inspections of vaccine manufacturing facilities.
How many people have received the vaccine in the U.S.?
More than 170 million Americans are fully vaccinated against COVID-19. Of those, more than 92 million people have received the Pfizer/BioNtech vaccine, which Pfizer has named Comirnaty.
How effective is the vaccine?
As part of the FDA’s review, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older. The vaccine was 91 percent effective at preventing COVID-19 disease.
What about the other vaccines?
The Moderna and Janssen Johnson & Johnson vaccines continue to be available under FDA emergency use authorizations. Moderna has started to apply for full approval for its COVID-19 vaccine in people 18 and older. Johnson & Johnson has not yet filed for full FDA approval of its vaccine. Public health experts recommend receiving whichever vaccine is available to you.
How can I receive the vaccine?
There is no out-of-pocket cost or health insurance required to receive the vaccine. Tidelands Health offers walk-in vaccination at three regional sites:
Tidelands Georgetown Memorial Hospital Harris Medical Pavilion entrance, 606 Black River Road, Georgetown every Monday, Tuesday and Friday, 9 a.m-4 p.m.
Waccamaw Medical Park West 4040 Highway 17, Suite 204, Murrells Inlet Monday-Thursday, 9 a.m.-4 p.m.
Tidelands Health Medical Park at The Market Common 2200 Crow Lane, Myrtle Beach Tuesday-Friday, 9 a.m.-4 p.m.