Janssen COVID-19 Vaccine
(Ad26.COV2.S)
Janssen COVID-19 Vaccine (Ad26.COV2.S)
The Janssen COVID-19 Vaccine has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA). The Janssen COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA for active immunization to prevent Coronavirus Disease 2019 (COVID-19) in individuals 18 years of age and older for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and in individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act unless the declaration is terminated or authorization revoked sooner.
Vaccine Expiration Date
Information on How to Obtain the Expiration Date on vaxcheck.jnj
Report an Adverse Event
- Report an Adverse Event to FDA VAERS at www.vaers.hhs.gov/reportevent.html or call the FDA at 1-800-822-7967
- Report an Adverse Event to Janssen at 1-800-JANSSEN
Report a Product Quality Complaint
- Report a Product Quality Complaint to Janssen at 1-800-JANSSEN
Stability, Storage, and Dosing Administration
Centers for Disease Control & Prevention (CDC)
American Society of Hematology (ASH) Resources
Janssen Global Trial Finder
Clinical Trials
Phase 3
COV3001 (ENSEMBLE)
- Publication - Sadoff J, Gray G, Vandebosch A, et al. Final analysis of efficacy and safety of single-dose Ad26.COV2.S. [published online ahead of print February 09, 2022]. N Eng J Med. doi:10.1056/NEJMoa2117608.
- ClinicalTrials.gov - A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)
- Protocol - https://www.jnj.com/coronavirus/ensemble-1-study-protocol
COV3009 (ENSEMBLE2)
- Publication - Hardt K, Vandebosch A, Sadoff J, et al. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial [published online ahead of print September 13, 2022]. Lancet Infect Dis
- ClinicalTrials.gov - A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults (ENSEMBLE 2)
- Protocol - https://www.jnj.com/coronavirus/ensemble-2-study-protocol
COV3012
- Publication - Bekker LG, Garrett N, Goga A, et al. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3b, implementation study. Lancet. 2022;399(10330):1141-1153
- Publication - Takuva S, Takalani A Garrett N, et al. Thromboembolic Events in the South African Ad26.COV2.S Vaccine Study. [published online ahead of print June 2, 2021] N Engl J Med.
- Publication - Takuva S, Takalani A, Seocharan I, Yende-Zuma N, Reddy T, Engelbrecht I, et al. (2022) Safety evaluation of the single-dose Ad26.COV2.S vaccine among healthcare workers in the Sisonke study in South Africa: A phase 3b implementation trial. PLoS Med 19(6): e1004024
- Publication - Goga A, et al. Breakthrough SARS-CoV-2 infections during periods of delta and omicron predominance, South Africa. Lancet 2022; 400(10348): 269-271
- ClinicalTrials.gov - Sisonke (Together): Open Label Trial COVID-19 (Sisonke)
COV3021
- Preprint - Gray G, et al. Vaccine effectiveness against hospital admission in South African health care workers who received a homologous booster of Ad26.COV2 during an Omicron COVID19 wave: Preliminary Results of the Sisonke 2 Study. medRxiv. 2021.12.28.21268436v1
- ClinicalTrials.gov - Sisonke 2 - A COVID-19 Vaccine Boost Open Label Study. (Sisonke Boost)
Phase 2/3
COV3006
- ClinicalTrials.gov - A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive (HORIZON 2)
Phase 2
COV2001
- Publication - J Sadoff, M. Le Gars, B. Brandenburg et al., Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials, Vaccine
- ClinicalTrials.gov - A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents
COV2004
- ClinicalTrials.gov - A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19) (HORIZON 1)
COV2008
- ClinicalTrials.gov - A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
Phase 1 / 2
COV1001
- Publication - J Sadoff, M. Le Gars, B. Brandenburg et al., Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials, Vaccine
- Publication - Sadoff J, Le Gars M, Shukarev G, et al. Interim results of a phase 1–2a trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. (2021)
- Publication - Barouch DH, Stephenson KE, Sadoff J, et al. Durable Humoral and Cellular Immune Responses 8 Months after Ad26.COV2.S Vaccination. N Engl J Med. (2021)
- Publication - Stephenson K.E, M Le Gars, Sadoff J, et al. Immunogenicity of the Ad26.COV2.S vaccine for COVID-19 [published online ahead of print March 11, 2021]. JAMA. doi:10.1001/jama.2021.3645
- Publication - Alter G, Yu J, Liu J, et al. Immunogenicity of Ad26.COV2.S vaccine against SARS-CoV-2 variants in humans. Nature (2021)
- ClinicalTrials.gov - A Study of Ad26.COV2.S in Adults
- Protocol - Sadoff J, Le Gars M, Shukarev G, et al. Interim results of a phase 1–2a trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. (2021)
Phase 1
COV1002
- ClinicalTrials.gov - A Study of Ad26.COV2.S in Adults