(ABC4) – The Food and Drug Administration has awarded the first full approval of a COVID-19 vaccine. On Monday, August 23, the FDA approved the Pfizer-BioNTech COVID-19 vaccine. According to the FDA, the Pfizer COVID-19 vaccine will now be marketed as Comirnaty, a vaccine for preventing coronavirus, in individuals 16-years-old and older. For those between the ages of 12 and 15, the FDA says the Pfizer vaccine remains available for emergency use authorization. This vaccine is also available under the same authorization for those who are immunocompromised and looking for a third dose.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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 requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D., in a Monday news release. “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. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
The Pfizer COVID-19 vaccine has been available since December 2020 for individuals 16-years-old and older. It became available to those as young as 12 in May 2021.
While reviewing Pfizer’s request for full approval, the FDA says the vaccine was found to be 91% effective in preventing COVID-19 disease. The most common side effects reported with the COVID-19 vaccine were pain, redness, and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, chills, and fever. According to the FDA, the Pfizer vaccine is effective in preventing the virus and “potentially serious outcomes including hospitalization and death.
Full approval for Moderna’s COVID vaccine is likely to follow a few months after Pfizer’s. U.S. health officials Wednesday recommended all Americans get COVID-19 booster shots to shore up their protection amid the surging delta variant and evidence that the vaccines’ effectiveness is falling.
This is a developing story. Refresh for updates
