April 13, 2021: Out of an abundance of caution, the FDA and CDC recommended a pause in the use of the Johnson & Johnson (Janssen) COVID-19 vaccine while we review data from six reported cases in the U.S. of a rare and severe type of blood clot in people who received the vaccine. View frequently asked questions…
Report vaccine side effects toll-free at 1-800-822-7967 or online to FDA/CDC Vaccine Adverse Event Reporting System (VAERS).
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). 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:
- Janssen COVID-19 Vaccine
- Janssen Biotech Inc.,
a Janssen Pharmaceutical Company of Johnson & Johnson
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.
|Letter of Authorization||English|
|Letter Granting EUA Amendment (03/29/2021)||English|
|Fact Sheet for Healthcare Providers Administering Vaccine||English|
|Fact Sheet for Recipients and Caregivers||English|
|FDA Decision Memorandum||English|
|Frequently Asked Questions on the Janssen COVID-19 Vaccine||English|
|Press Release (02/27/2021)||English|
|Joint CDC and FDA Statement (04/13/2021)||English|
|02/26/2021 Advisory Committee Meeting Information||English|