Nearly a year in the making, the US Food and Drug Administration has just officially approved the COVID-19 vaccine. The Pfizer-BioNTech COVID-19 Vaccine, which is now officially called “Comirnaty,” according to the FDA, is now approved for age 16 and up for the prevention of COVID-19. This offers a great relief to many Americans hesitant to take the vaccine without approval.
The vaccine has yet to be officially approved in those under the age of 16 but remains available under emergency use for children aged 12-15.
“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 an FDA media release put out on August 23, 2021.
“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.”
Based on a recent clinical trial of the vaccine, the FDA announced in the release, it has proven 91 percent effective against COVID-19. The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
As of August 23, 2021, more than 80 million Americans have still not received the vaccine. Millions of Americans who have been holding off on taking the vaccine until it received full approval, will ideally now look into getting the vaccine based on this approval.
The FDA is assuring the public that, although the initial emergency use of the vaccine was approved expeditiously, rigorous standards were and are in place at all times.
As always, NAHA Health believes in keeping our readers informed. Should you decide to get the vaccine based on this new FDA approval, we encourage you to talk with your doctor about any risks you may face – whether you would be safer getting vaccinated or not.
Anyone can find a location to receive the free vaccine (whether they have insurance or not) by visiting https://www.vaccines.gov/.