Janssen COVID-19 Vaccine FDA Approval Status
Last updated by Judith Stewart, BPharm on June 6, 2023.
FDA Approved: No (Discontinued)
Brand name: Janssen COVID-19 Vaccine
Generic name: SARS-CoV-2 vaccine
Dosage form: Injection
Previous Name: Ad26.COV2-S
Company: Johnson & Johnson Innovative Medicine
Treatment for: Prevention of COVID-19
The Janssen COVID-19 Vaccine (Ad26.COV2-S) was an investigational vaccine against SARS-CoV-2 for the prevention of COVID-19.
- The Janssen COVID-19 Vaccine (Ad26.COV2-S) was a monovalent vaccine composed of a recombinant, replication incompetent adenovirus serotype 26 (Ad26) vector, constructed to encode the SARS-CoV-2 virus spike (S) protein.
- Efficacy and safety data from the Phase 3 ENSEMBLE clinical trial demonstrated that the investigational single-dose COVID-19 vaccine was 72% effective in the U.S. and 66% effective overall at preventing moderate to severe COVID-19, 28 days after vaccination.
- On February 27, 2021, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the single-dose Janssen COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.
- On May 22, 2023 Janssen Biotech Inc. requested the voluntary withdrawal of the EUA for Janssen COVID-19 Vaccine. Janssen Biotech, Inc. informed the FDA that the last lots of the vaccine purchased by the U.S. Government had expired, there was no demand for new lots of the vaccine in the U.S., and they did not intend to update the strain composition of the vaccine to address emerging variants.
- On June 1, 2023, the FDA revoked the emergency use authorization (EUA) of the Janssen COVID-19 Vaccine.
Development timeline for Janssen COVID-19 Vaccine
Further information
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