Pfizer's fully FDA-approved COVID-19 vaccine will now be marketed as Comirnaty for people ages 16 and older. The shot is still available under emergency use authorization for people ages 12 and up.
Four more quick facts:
1. The FDA's decision is based on data from 20,000 vaccine and 20,000 placebo recipients ages 16 and older. The shot was found 91 percent effective at preventing COVID-19 and its potentially serious outcomes, the agency said.
2. About 12,000 vaccine recipients have been monitored for at least six months following their second dose. The most commonly reported side effects observed were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills and fever.
3. The FDA also said it conducted a rigorous evaluation of the risk of myocarditis and pericarditis following vaccination with Pfizer's shot. The agency found the shot causes an increased risk of both, particularly within seven days of the second dose, but didn't specify how much the risk is increased.
4. The FDA is requiring Pfizer to conduct postmarket studies to further assess the risks of myocarditis and pericarditis after vaccination.