The US FDA Has Granted the Janssen COVID-19 Vaccine an Emergency Use Authorization (EUA)

The U.S. FDA Has Granted the Janssen COVID‑19 Vaccine an Emergency Use Authorization (EUA)

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.

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The Janssen COVID-19 Vaccine

A non-replicating viral vector vaccine expressing the SARS-CoV-2 spike antigen.

HOW IT'S DESIGNED
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Storage, Dosage and Administration

Stored at 36°F to 46°F and administered intramuscularly as a single 0.5-mL dose.

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Product Use Training Webinars for Vaccinators

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Clinical Data

Review data from the ongoing phase 3 ENSEMBLE safety and efficacy trial as well as from post authorization experience.

READ THE RESULTS
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Reporting Adverse Events

Learn more about the mandatory requirements for administering the Janssen COVID-19 Vaccine under EUA, including adverse event reporting.

SEE THE REQUIREMENTS
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Expiry Information

Learn more about how to look up the expiry date of the Janssen COVID-19 Vaccine.

CHECK EXPIRATION

Ensuring the Authenticity of the Janssen COVID-19 Vaccine

Johnson & Johnson and Janssen Pharmaceuticals are committed to identifying and mitigating the risks of counterfeit healthcare products. Information regarding how we address counterfeiting can be found at healthforhumanityreport.jnj.com

The Janssen COVID-19 Vaccine is to be administered intramuscularly by a healthcare professional.

An authentic Janssen COVID-19 Vaccine includes the Janssen name and logo on the carton. The Janssen COVID-19 Vaccine is supplied in multi-dose vials. The vial stoppers are not made with natural rubber latex.

The Janssen COVID-19 Vaccine is never sold online and is distributed only through government channels. Janssen cannot verify the authenticity of products acquired outside of the legitimate supply chain. If you suspect the Janssen COVID-19 Vaccine you have may be counterfeit, contact us at 1-800-565-40081-800-565-4008 (US Toll Free) or 1-908-455-99221-908-455-9922 (US Toll).

COVID-19=coronavirus disease 2019; EUA=Emergency Use Authorization; FD&C Act=Federal Food, Drug, and Cosmetic Act.

Important safety information

Important safety information