The FDA has approved the first COVID-19 vaccine, Comirnaty, for individuals 16 years of age and older. The vaccine was previously available under emergency use authorization and has been shown to be 91% effective in preventing COVID-19 disease. The approval is based on a thorough evaluation of the vaccine's safety and effectiveness, including data from a large clinical trial. The vaccine will continue to be available under emergency use authorization for individuals 12 through 15 years of age and for certain immunocompromised individuals.