Pfizer vaccine receives full FDA approval

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The Food and Drug Administration has given full approval to the Pfizer/BioNTech COVID-19 vaccine, the FDA announced Monday morning.

“We hope full approval of the vaccine will instill more confidence in anyone who has been hesitant about receiving the life-saving COVID-19 vaccine. This means the Pfizer vaccine has the same approval as the rest of the standard vaccines on the market which we rely on to keep ourselves protected from other diseases,” said Sarah Poe, Malheur County Health Department Director.

This is the first vaccine against the novel coronavirus to receive full approval, though it is still under emergency use authorization for adolescents age 12-15. Even without full approval, Poe said, “the great news is that Pfizer is available to anyone age 12 and up and can be received at the same time as other vaccines. Now is the time to act as cases are going up and kids are going back to school.”

The vaccine has been under an EUA since Dec. 11, 2020 for individuals age 16 and older, but the full approval comes from expanded safety and efficacy data released by the manufacturer this April. An analysis of 927 confirmed cases found that the vaccine had 91.3 percent efficacy against symptomatic disease up through six months after the second dose. In addition, the vaccine was 100 percent effective in preventing severe disease, as defined by the CDC, Pfizer said.

The vaccine will be marketed as Comirnaty. The Pfizer vaccine uses mRNA technology, and does not contain live virus.

 “Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and research, in a statement.

 “I read an article about a poll conducted by the Kaiser Family Foundation which said 31 percent of unvaccinated people would be more likely to get a COVID-19 vaccine once one of them received full approval from the FDA,” said Health Department Nursing Supervisor Rebecca Stricker. “My hope is that this approval will give people the confidence they need to get the vaccine. I would give anything to put an end to this pandemic, and if this change encourages people to get vaccinated, we are that much closer to keeping our public safe and healthy.” In Malheur County, most physician’s offices and clinics provide vaccines, so call your provider to schedule an appointment. Vaccines are also available at the Health Department. To schedule an appointment, call 541-889-7279.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

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