Pfizer Gets FDA Approved

Posted by @fda on Instagram.

On Monday, Aug. 23, 2021, the Pfizer-BioNTech vaccine for COVID-19 was granted full approval by the U.S. Food and Drug Administration. Prior to this approval, the Pfizer vaccine was granted emergency use authorization (EAU) on Dec. 11, 2020 to help mitigate the effects of the COVID-19 public health crisis.

Now to be marketed as Comirnaty, the Pfizer vaccine has gone through extensive safety checks and clinical trials to earn FDA approval, with 22,000 trial participants receiving the vaccine and 22,000 participants receiving a placebo. From the results of this clinical trial, the vaccine was deemed 91% effective in preventing COVID-19. While the vaccine is only approved for individuals 16 years-of-age or older, an EAU remains in place for those ages 12 to 15. 

Director of FDA’s Center for Biologics Evaluation and Research, Peter Marks, states in a press release that, “the public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.” 

Already, FDA approval of the Pfizer-BioNTech vaccine has triggered a slew of vaccine mandates nationwide. On Tuesday, Aug. 24, only one day after the approval, Ohio State University put a vaccine mandate in place for all students, faculty and staff members in response to news from the FDA. All individuals affiliated with the university are required to have their first dose of a COVID-19 vaccine by Oct. 25, 2021 and their second dose by Nov. 12, 2021. On Thursday, Aug. 26, Governor Pritzker of Illinois issued a state-wide mandate that all eligible students and school employees be fully vaccinated. It’s not just academic institutions — leading investment bank, Goldman Sachs, also announced on Aug. 24 that all people entering their offices, employees and customers alike, must be fully vaccinated against COVID-19 beginning Sept. 7. 

Since Monday, numerous other schools, employers and municipalities have issued vaccine mandates, a trend that will surely continue in the coming weeks. 

Members of the Penn State community, including faculty, students and State College residents continue to push for a vaccine mandate at the university. On Friday, Aug. 27, community members gathered on Old Main lawn to urge the university to take further action against the COVID-19 pandemic. Despite these efforts, Penn State still has not implemented a vaccine mandate on campus. They do, however, strongly encourage all students, faculty and staff to be vaccinated and share their vaccination with the university.

The FDA approval of the Pfizer-BioNTech vaccine will certainly change future responses to the pandemic, hopefully increasing vaccination rates nationwide and giving some peace-of-mind to those wary of the vaccine’s safety. 

As Janet Woodcock, Acting FDA Commissioner, said in a tweet last Monday, “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

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