On August 23, the U.S. Food and Drug Administration granted full approval of the Pfizer vaccine for anyone 16 or older. The vaccine, also known as the Pfizer- BioNTech COVID-19 Vaccine, will now be marketed as Comirnaty for individuals ages 16 and up and will continue to be available under emergency use authorization (EUA) for individuals 12 to 15. If you or your loved ones are still considering vaccination, now is the time to act.
Acting FDA Commissioner Janet Woodcock, M.D. says “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.”
Approval of the vaccine came with rigorous testing for efficacy and long-term effects. The safety of Comirnaty (Pfizer) was evaluated in approximately 22,000 people, 16 years and older, who received the vaccine and 22,000 people in the same age range who received a placebo. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 among participants. To ensure participant safety, more than half of the trial participants were monitored for at least four months after the second dose, and approximately 12,000 participants were followed for 6 months after the trial. The FDA and CDC have extensive monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated.
Common side effects of the Comirnaty vaccine are usually mild, and severe side effects are extremely rare. The most reported side effects by clinical trial participants were pain, redness and swelling at the injection side; fatigue; headache; muscle or joint pain; chills and fever. However, side effects tended to dissipate within 48 hours, and the risk of remaining unvaccinated is a greater risk than experiencing side effects.
Pfizer has also proven to be effective and safe for children aged 5 to 11 after a trial with thousands of participants revealed conclusive data. In the trial, which included 2,268 participants between 5 and 12 years old, the vaccine was found to be safe and effective, eliciting a robust antibody response using a two-dose regiment of 10 ug doses. These results were comparable to those recorded in a previous Pfizer- BioNTech study with people aged 16 to 25, who were immunized with 30 ug doses. The 10 ug dose was carefully selected as the preferred dose for safety, tolerability and efficacy in children aged 5 to 12. This data has been shared with the FDA for initial review, and a formal request for Emergency Use Authorization (EUA) of the companies’ COVID-19 vaccine for children aged 5 to 12 was submitted on October 7, 2021.
The best way to protect yourself, your family and your community is by getting vaccinated. Vaccination brings us one step closer to ending the COVID-19 pandemic. Sign up for your vaccine today by visiting https://vaccinelocator.doh.wa.gov/.
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