On Aug. 23, 2021, The U.S. Food & Drug Administration granted full approval to the COVID-19 Pfizer BioNTech vaccine for individuals 16 and older. The vaccine will now be marketed to individuals 16 and older under the brand name COMIRNATY (Koe-mir-na-tee).

The FDA based its approval on Pfizer’s Biologics License Application (BLA), and its updated analysis of the safety and effectiveness of the vaccine in people aged 16 and older. The analysis studied 20,000 individuals who received the vaccine and 20,000 individuals who received a placebo and found that the vaccine is 91 percent effective in preventing COVID-19.  The FDA found the most common side effects to be pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever.

The FDA did find that the vaccine does present a higher risk of myocarditis and pericarditis in males under the age of 40, the highest risk being for males ages 12 to 17. Myocarditis is inflammation of the heart muscle and pericarditis is inflammation of the outside lining of the heart. Symptoms include chest pain, shortness of breath, and a fast-beating heart. Individuals with symptoms should seek medical attention.  The FDA is requiring Pfizer to continue post-marketing studies.

The Pfizer BioNTech vaccine, as well as the vaccine under its new name COMIRNATY, will continue to be available to individuals requiring a third dose of the vaccine due to a compromised immune system and for individuals between the ages of 12 and 15 under the FDA’s Emergency Use Authorization (EUA). The Pfizer BioNTech vaccine has not been granted EUA for children under the age of 12 yet.  The Pfizer and COMIRNATY vaccines are the same.  They have the same formula