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  1. MCM Legal, Regulatory and Policy Framework

Janssen COVID-19 Vaccine Frequently Asked Questions

On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.

Janssen 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. It is administered as a single-dose.

The FDA evaluated and analyzed the safety and effectiveness data from clinical trials conducted in over 40,000 thousand study participants and manufacturing information submitted by Janssen Biotech, Inc. The FDA has determined that the totality of the available data provides clear evidence that Janssen 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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