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FDA Grants Full Approval To Pfizer COVID-19 Vaccine

Pfizer COVID-19 vaccine
Jeff Chen
/
Alaska Public Media

The U.S. Food and Drug Administration has granted full approval to the Pfizer COVID-19 vaccine to everyone age 16 and older. It’s the first COVID-19 vaccine to receive this designation. 

The FDA had previously issued an emergency use authorization for the Pfizer vaccine for everyone age 12 and up. The emergency use authorization will remain in place for children ages 12 to 15. The emergency use authorization also allows third, booster doses for immunocompromised individuals.

You might start hearing the Pfizer COVID-19 vaccine being referred to by another name. The company announced that it’ll begin marketing the vaccine as Comirnaty, pronouced koe-mir’-na-tee.

“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,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement announcing the decision on Aug. 23. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Following the approval, the Alaska Department of Health and Social Services released a statement saying that getting vaccinated is “the single most important action Alaskans can take to help stop the pandemic and save lives.” The department hopes that the FDA’s full approval of the Pfizer vaccine will encourage more people to get the shots.

Statewide, 54% of eligible Alaskans are fully vaccinated against COVID-19. In the Yukon-Kuskokwim Delta, the percentage is higher, at 71%.

The FDA approval comes as COVID-19 cases surge across the state and the region. The Yukon-Kuskokwim Health Corporation classifies the entire Yukon-Kuskokwim Delta as undergoing high transmission of the virus. The region is seeing its highest daily case rates since January, and hospitalizations are increasing. Current patients are younger and sicker than during the previous surge, and most of those who have been hospitalized have not been fully vaccinated.

“The difference between this surge and the surge that we experienced last winter, with our main bulk of our cases, is many of the patients who are testing positive now are unvaccinated. They have not received the vaccination or they're not fully vaccinated,” YKHC Chief of Staff Dr. Ellen Hodges said.

Children too young for vaccination also make up a larger share of people testing positive. Hodges encourages everyone who’s eligible to get the vaccine.

“The vaccine is highly, highly effective in preventing infection, and it's very safe. And I encourage anyone who's listening to this to please go get vaccinated as soon as you can, if you're not already vaccinated,” Hodges said.

COVID-19 vaccines are available at the YKHC Bethel hospital and village health clinics.

The FDA has also granted emergency use authorization to two other COVID-19 vaccines in the U.S., from companies Moderna and Johnson & Johnson.

Anna Rose MacArthur served as KYUK's News Director from 2015-2022.
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