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  1. Coronavirus Disease 2019 (COVID-19)

Janssen COVID-19 Vaccine

October 20, 2021: The FDA expands authorizations for COVID-19 vaccine booster doses for eligible populations who received the Pfizer-BioNTech or Moderna COVID-19 Vaccine and for Janssen COVID-19 Vaccine recipients 18 and older.  View more information and listen to the media call.

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). On April 23, 2021, the FDA amended the EUA to include information about a very rare and serious type of blood clot in people who receive the vaccine.

On October 20, 2021, the FDA authorized a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older. Also on October 20, 2021, the FDA authorized the use of a heterologous (or “mix and match”) booster dose for currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. Therefore, Janssen COVID-19 Vaccine recipients 18 years of age and older may receive a single booster dose of Janssen COVID-19 Vaccine, Moderna COVID-19 Vaccine (half dose) or Pfizer-BioNTech COVID-19 Vaccine at least two months after receiving their Janssen COVID-19 Vaccine primary vaccination.

The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.


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 of Authorization (Reissued) October 20, 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
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

At this time, the FDA is able to provide translations of the Janessen COVID-19 Vaccine Fact Sheets for Recipients and Caregivers in the languages below. If you have a special language request, please contact: fdaoma@fda.hhs.gov

接受者和护理者须知
(August 27, 2021)
中文 (Chinese, Simplified)
환자와 의료진을 위한 정보지
(August 27, 2021)
한국어 (Korean)
HOJA INFORMATIVA PARA RECEPTORES Y PROVEEDORES DE CUIDADO
(August 27, 2021)
Español (Spanish)
FACT SHEET PARA SA MGA TATANGGAP AT MGA TAGAPAG-ALAGA
(August 27, 2021)
Tagalog (Tagalog)
TỜ THÔNG TIN CHO NGƯỜI NHẬN VÀ NHỮNG NGƯỜI CHĂM SÓC
(August 27, 2021)
Tiếng Việt (Vietnamese)
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