Janssen COVID-19 Vaccine
On May 22, 2023, Janssen Biotech, Inc. requested the voluntary withdrawal of the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government have expired, there is no demand for new lots of the vaccine in the U.S., and they do not intend to update the strain composition of this vaccine to address emerging variants. On June 1, 2023, FDA revoked the EUA for this vaccine.
- Emergency Use Authorization Status:
- Revoked (June 1, 2023)
- Name:
- Janssen COVID-19 Vaccine
- Manufacturer:
- Janssen Biotech Inc.,
a Janssen Pharmaceutical Company of Johnson & Johnson
Fact Sheets (English)
| Information | Last Updated |
|---|---|
| Fact Sheet for Healthcare Providers Administering Vaccine | March 13, 2023 |
| Fact Sheet for Recipients and Caregivers | March 13, 2023 |
Regulatory Information (Emergency Use Authorization)
| Information | Date |
|---|---|
| Review Memorandum | June 1, 2023 |
| Revocation of EUA 27205 | June 1, 2023 |
| Letter of Authorization (Reissued) | March 13, 2023 |
Federal Register Notices
| Title | Date |
|---|---|
| Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic; Availability | May 27, 2021 |