Ad26.COV2-S FDA Approval Status
FDA Approved: No (Emergency Use Authorization)
Brand name: Ad26.COV2-S
Generic name: SARS-CoV-2 vaccine
Dosage form: Injection
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Prevention of COVID-19
Ad26.COV2-S is an investigational vaccine against SARS-CoV-2 in development for the prevention of COVID-19.
- Ad26.COV2-S is 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.
- The U.S. Food and Drug Administration (FDA) issued 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 February 27, 2021.
Development Timeline for Ad26.COV2-S
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.