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Medical Inquiries

Medical Inquiries

The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older. The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.


Report adverse events using one of the following:

www.vaers.hhs.gov/reportevent.html

Call FDA 1-800-822-79671-800-822-7967 or

Call Janssen 1-800-565-40081-800-565-4008 (US Toll Free) or 1-908-455-99221-908-455-9922 (US Toll)

Important safety information

Important safety information