FDA Approves First COVID-19 Vaccine


On 23 August 2021, the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. 

The terms of the authorization to market the vaccine include requirements that the company conduct active surveillance studies in the U.S. and Europe related to reported cases of myocarditis and pericarditis. The company is also being required to submit prospective studies to assess the incidence of subclinical myocarditis, following administration of a second dose of Comirnaty in participants 5 to 15 years of age, and following administration of a third dose of Comirnaty in a subgroup of participants 16 to 30 years of age.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

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