Facts about the FDAʼs full approval of the Pfizer-BioNTech COVID-19 vaccine

The FDA granted full approval of the Pfizer-BioNTech COVID-19 vaccine on August 23, 2021, for individuals ages 16 and older. This vaccine is approved for adolescents 12-15 under an emergency use authorization.
The vaccine's formal name is Comirnaty (koe-mir’-na-tee), which is a combination of “COVID-19 immunity” and “mRNA,” and is meant to evoke the term “community.”
FDA scientists examined thousands of pages of evidence on more than 40,000 trial participants. Of those, 12,000 people were followed for at least 6 months.
The most common side effects were pain at the injection site, fatigue, headache, muscle or joint pain, fever, and chills. These side effects appear within hours or days — and disappear just as quickly.
The risk for myocarditis and pericarditis after vaccination is real but very rare. Adolescents between the ages of 12 and 17 are most at risk, usually in the days after the second dose. There have been 1,377 reports — and 798 conﬁrmed cases — of myocarditis and pericarditis among 369 million doses of vaccines administered in the U.S. Most patients with myocarditis or pericarditis who received care responded well to medicine and rest and felt better quickly.
In the history of vaccines, there has never been a side effect that didn't appear within 8 weeks. This includes well-known but exceedingly rare side effects from the polio and swine ﬂu vaccines.
The mRNA used in the vaccine is present in the body for a short time only. It is not incorporated into nor does it alter an individual’s genetic makeup.
mRNA vaccines are not new. Research has been ongoing since the early 1990s on mRNA vaccines for ﬂu, Zika, rabies, and cytomegalovirus (CMV).