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  1. Coronavirus Disease 2019 (COVID-19)

Janssen COVID-19 Vaccine

Janssen COVID-19 Vaccine is available under EUA as a single primary vaccination dose for individuals 18 years of age and older and as a single booster dose for individuals 18 years of age and older at least two months after completing primary vaccination with the vaccine.

The Janssen COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Janssen COVID-19 Vaccine. View COVID-19 vaccine booster eligibility.


Emergency Use Authorization Status:
Authorized
Name:
Janssen COVID-19 Vaccine
Manufacturer:
Janssen Biotech Inc.,
a Janssen Pharmaceutical Company of Johnson & Johnson

Authorized Use

For the prevention of coronavirus disease 2019 (COVID-19) for individuals 18 years of age and older

Common Side Effects

The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects occurred within 1-2 days following vaccination and were mild to moderate in severity and lasted 1-2 days. Learn more.

Fact Sheets (English) and FAQs

Regulatory Information

Information Date
Letter Granting EUA Amendment January 11, 2022
Addendum to Jan 7, 2022 Review Memorandum January 7, 2022
Review Memorandum January 7, 2022
Decision Memorandum Addendum January 6, 2021
Decision Memorandum Addendum December 30, 2021
Addendum to Dec. 22, 2021 Review Memorandum December 22, 2021
Review Memorandum December 22, 2021
Letter Granting EUA Amendment December 14, 2021
Letter of Authorization (Reissued) November 19, 2021
Decision Memorandum Addendum November 18, 2021
FDA Decision Memorandum Addendum November 5, 2021
Concurrence Letter November 5, 2021
Memorandum to the File October 20, 2021
Decision Memorandum October 20, 2021
Advisory Committee Meeting Information October 15, 2021
FDA Decision Memorandum Addendum September 29, 2021
Concurrence Letter September 29, 2021
FDA Decision Memorandum Addendum September 14, 2021
Concurrence Letter September 14, 2021
FDA Decision Memorandum Addendum September 8, 2021
Concurrence Letter September 8, 2021
Letter Granting EUA Amendment August 30, 2021
Concurrence Letter (shelf life extension to 6 months) July 28, 2021
FDA Decision Memorandum Addendum July 13, 2021
Concurrence Letter  July 13, 2021
Letter Granting EUA Amendment July 12, 2021
Concurrence Letter (Reissued) July 2, 2021
Concurrence Letter (Reissued) July 2, 2021
Concurrence Letter July 2, 2021
FDA Decision Memorandum Addendum July 1, 2021
FDA Decision Memorandum Addendum June 15, 2021
FDA Decision Memorandum June 11, 2021
Concurrence Letter (concurring with the extension of the shelf-life of Janssen COVID-19 Vaccine stored at 2-8oC, from 3 months to 4.5 months) June 10, 2021
Letter Granting EUA Amendment April 23, 2021
Letter Granting EUA Amendment March 29, 2021
FDA Decision Memorandum February 27, 2021
Advisory Committee Meeting Information February 26, 2021
 

Media Materials and Webcasts

Information Date
Press Release October 20, 2021
Media Call October 20, 2021
Advisory Committee Meeting Webcast October 15, 2021
Press Release April 23, 2021
Joint FDA and CDC Press Conference April 23, 2021
Joint CDC and FDA Statement April 13, 2021
Joint FDA and CDC Media Call April 13, 2021
Media Call February 27, 2021
Press Release February 27, 2021
Advisory Committee Meeting Webcast February 26, 2021

 

Translations of the Fact Sheet for Recipients and Caregivers
 

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