Janssen COVID-19 Vaccine
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. 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
| Information | Last Updated |
|---|---|
| Fact Sheet for Healthcare Providers Administering Vaccine | August 27, 2021 |
| Fact Sheet for Recipients and Caregivers | August 27, 2021 |
| Frequently Asked Questions on the Janssen COVID-19 Vaccine | April 27, 2021 |
Regulatory Information
| Information | Date |
|---|---|
| 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 |
| Letter of Authorization (Reissued) | June 10, 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 | 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 |