The U.S. Food and Drug Administration (FDA) has issued full approval of the COVID-19 vaccine. The Pfizer-BioNTech COVID-19 was previously granted emergency use authorization. The full FDA approval was announced in August 2021.
Healthcare providers across the nation are hoping this step will increase confidence in the vaccines and that the FDA approval will put us one step closer to ending the pandemic. Based on the updated clinical trial results, the vaccine is 91% effective in preventing COVID-19 disease and potentially serious outcomes including hospitalization and death.1
What does FDA Approval of the COVID-19 Vaccine Mean?
Full approval means that the FDA has reviewed additional, updated data about the safety of the vaccine in a larger group of clinical-trial participants for six months, compared with two months for the earlier emergency authorization.
Public health officials believe that this approval means that our communities can be confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. FDA approval will allow doctors to prescribe extra Pfizer-BioNTech shots (booster shots) to anyone they think should get one.
The FDA decision also clears the way for Pfizer to market their vaccine, which is not permitted without full approval. As part of their marketing efforts, Pfizer has announced a brand name for the vaccine, which is Comirnaty.
Does This Mean That the COVID-19 Vaccine is Safe?
Millions of people have already safely received the COVID-19 vaccine. The FDA says that approval means, “the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
Among people who are unvaccinated and have been hesitant to get the vaccine, surveys show that 3 out of 10 have said they would be more likely to get vaccinated if the vaccines have full approval, rather than an emergency use authorization. Health officials are hopeful that this approval will motivate more people to get vaccinated and help end the pandemic.
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If you would like to learn if you are eligible for the vaccine, would like to know where to get vaccinated in Miami or South Florida, or if you have any questions about vaccination safety, please contact us.
1 The U.S. Food and Drug Administration. FDA Approves First COVID-19 Vaccine. Available: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine Accessed September 7, 2021