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FDA Grants First COVID-19 Vaccine Approval to Pfizer-BioNTech




The first COVID-19 vaccine with full Food and Drug Administration (FDA) approval was awarded to Pfizer-BioNTech for individuals 16 and older on Aug. 23, 2021. Pfizer is in league with other vaccines as the first COVID-19 vaccine subjected to a full review by the United States regulator; it will be marketed as Comirnaty (Koe-mir’-na-tee).

Health officials believe full approval of the Pfizer vaccine might convince people who are hesitant about being vaccinated. In June, the results of a Kaiser Family Foundation poll indicated that 31 percent of unvaccinated people would be more likely to get the shot once one is fully approved by the FDA.

FDAActing FDA Commissioner Janet Woodcock explained, “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA require of an approved product.”

Pfizer-BioNTech remains available for youth 12-15 under emergency use authorization (EUA) and, as of August 12, for a third dose “in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise,” according to the FDA. While the agency approved Moderna as the third dose for these individuals, the evaluators determined there is no need for others to need a booster shot at this time.

As of 6 a.m. EDT on August 22, 171 million Americans had been fully vaccinated — 51.5 percent.

Written by Cathy Milne-Ware

U.S. Food & Drug Administration: Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals
U.S. Food & Drug Administration: FDA Approves First COVID-19 Vaccine
NPR: Pfizer’s COVID Vaccine Gets Full Approval From The FDA; by Scott Hensley
Beckers Hospital Review: States ranked by percentage of population fully vaccinated: Aug. 23; by Katie Adams

Featured and Top Image Courtesy of Jamie Bernstein’s Flickr Page – Creative Commons License
Inset Image by Edwin J. Torres/ NJ Governor’s Office Courtesy of Phil Murphy’s Flickr Page – Creative Commons License

Cathy Milne-Ware is a seasoned writer and editor. Her background: Journalism for online and print newspapers, new website content from the about page to blog posts, newsletters, book reviews, and social media content. She enjoys writing Health, Entertainment, and Political news stories.

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