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Ad26.COV2.S
Ad26.COV2.S is a Viral vector vaccine Biologic drug developed by National Institute of Allergy and Infectious Diseases (NIAID). It is currently in Phase 3 development for COVID-19 prevention in adults. Also known as: Janssen COVID-19 Vaccine, JNJ-78436735, JNJ-78436735, VAC31518, Ad26COVS1.
Ad26.COV2.S is a viral vector vaccine that delivers genetic instructions for the SARS-CoV-2 spike protein to stimulate immune responses against COVID-19.
The Janssen COVID-19 vaccine, also known as Ad26.COV2.S, is a vaccine developed by Janssen Vaccines and Johnson & Johnson for COVID-19, SARS, and other related conditions. It is one of the interventions being studied in clinical trials, including a trial examining its immunogenicity in tuberculosis patients.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Ad26.COV2.S |
|---|---|
| Also known as | Janssen COVID-19 Vaccine, JNJ-78436735, JNJ-78436735, VAC31518, Ad26COVS1, JNJ-78436735, Ad26COVS1 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Drug class | Viral vector vaccine |
| Target | SARS-CoV-2 spike protein |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine uses a replication-incompetent adenovirus serotype 26 (Ad26) as a vector to carry the gene encoding the SARS-CoV-2 spike protein into host cells. Once inside cells, the spike protein is produced and presented to the immune system, triggering both cellular and humoral immune responses. This approach generates antibodies and T-cell responses that protect against SARS-CoV-2 infection.
Approved indications
- COVID-19 prevention in adults
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Fever
Key clinical trials
- Evaluating Safety and Immune Response of Janssen, Moderna, Pfizer/BNT, and Novavax COVID-19 Vaccines for Same and Mixed Boosters in Adolescents and Adults Aged 12-64 With and Without HIV in Kenya, DRC, and Rwanda (PHASE2)
- Janssen Ad26.CoV2.S Vaccine Booster in Kidney Transplant Recipients (PHASE3)
- COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders (PHASE2)
- Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients
- A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults (PHASE3)
- A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19) (PHASE2)
- Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (PHASE1, PHASE2)
- Cohort Assessing the Immunogenicity and the Safety of the COVID-19 Vaccine Janssen in Healthy Volunteers Based on 2 Age Groups: 65 Years or Older - 55 to 65 Years. Covicompare-Janssen (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ad26.COV2.S CI brief — competitive landscape report
- Ad26.COV2.S updates RSS · CI watch RSS
- National Institute of Allergy and Infectious Diseases (NIAID) portfolio CI
Frequently asked questions about Ad26.COV2.S
What is Ad26.COV2.S?
How does Ad26.COV2.S work?
What is Ad26.COV2.S used for?
Who makes Ad26.COV2.S?
Is Ad26.COV2.S also known as anything else?
What drug class is Ad26.COV2.S in?
What development phase is Ad26.COV2.S in?
What are the side effects of Ad26.COV2.S?
What does Ad26.COV2.S target?
Related
- Drug class: All Viral vector vaccine drugs
- Target: All drugs targeting SARS-CoV-2 spike protein
- Manufacturer: National Institute of Allergy and Infectious Diseases (NIAID) — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for COVID-19 prevention in adults
- Also known as: Janssen COVID-19 Vaccine, JNJ-78436735, JNJ-78436735, VAC31518, Ad26COVS1, JNJ-78436735, Ad26COVS1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing