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Moderna COVID-19 Vaccine Frequently Asked Questions

On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

A: Moderna COVID-19 Vaccine is authorized to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

The FDA evaluated and analyzed the safety and effectiveness data from clinical trials conducted in tens of thousands of study participants and manufacturing information submitted by ModernaTX, Inc. The FDA has determined that the totality of the available data provides clear evidence that Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that that the known and potential benefits outweigh the known and potential risks of the vaccine’s use in millions of people 18 years of age and older, including healthy individuals.

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