Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
Open accessAbstract
BACKGROUND: The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. METHODS: viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed. RESULTS: The per-protocol population included 19,630 SARS-CoV-2-negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe-critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe-critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe-critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe-critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19-related), and 16 in the placebo group (5 were Covid-19-related). CONCLUSIONS: A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe-critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.).
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Pfizer and Moderna used nearly identical SAE definitions, consistent with regulatory expectations.
“Pfizer and Moderna used nearly identical definitions, consistent with regulatory expectations.”
From Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults (2022) · cites this paper as [4]
The Methods (Safety Assessments and Statistical Analysis; pages not supplied) describe how the Ad26.COV2.S trial recorded and tabulated serious adverse events. Searches for Pfizer, Moderna, SAE definitions, and regulatory expectations found no passage comparing the two companies’ definitions. (LLM, conf=0.78)
Experimental — accuracy not yet measuredThe interim phase 3 results of other COVID-19 vaccines have shown efficacies ranging from 62.1% to 95%.
“The interim phase 3 results of other COVID-19 vaccines have shown efficacies ranging from 62·1% to 95%.24, 25, 26, 27, 28”
From Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey (2021) · cites this paper as [28]
The Results > Efficacy and Discussion (page unavailable) report efficacy for Ad26.COV2.S, not the interim phase 3 efficacy range for other COVID-19 vaccines. Searches for 62.1%, 95%, and other vaccine trials found no passage in our copy establishing the claimed range. (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn a phase III trial of the Janssen Ad26.COV2.S vaccine, vaccine efficacy in South Africa was 52% and 64% against moderate to severe COVID-19 with onset at least 14 and 28 days after administration, respectively.
“In a phase III trial of the Janssen Ad26.COV2.S vaccine, vaccine efficacy in South Africa was 52% and 64% against moderate to severe COVID-19 with onset at least 14 and 28 days after administration, respectively 225 .”
From The biological and clinical significance of emerging SARS-CoV-2 variants (2021) · cites this paper as [225]
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“8 90 (Astra Zeneca – Oxford) Ad26CoV2S [6] 1.”
- Authors
- Sadoff, J., Gray, G., Vandebosch, A., Cárdenas, V., Shukarev, G., Grinsztejn, B., Goepfert, P. A., Truyers, C., Fennema, H., Spiessens, B., Offergeld, K., Scheper, G., Taylor, K. L., Robb, M. L., Treanor, J., Barouch, D. H., Stoddard, J., Ryser, M. F., Marovich, M. A., Neuzil, K. M., Corey, L., Cauwenberghs, N., Tanner, T., Hardt, K., Ruiz-Guiñazú, J., Le Gars, M., Schuitemaker, H., Van Hoof, J., Struyf, F., & Douoguih, M.
- Affiliations
- Janssen (Belgium) (BE)
- From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J.R.G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases–Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); the National Institute of Allergy and Infectious Diseases, Rockville (K.L.T., M.A.M.), Walter Reed Army Institute of Research, Silver Spring (M.L.R.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) — all in Maryland; Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); Janssen Research and Develo...
- Corresponding author
- Douoguih, Macaya
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-06-10
- Volume
- 384
- Issue
- 23
- Pages
- 2187-2201
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC8220996
- OpenAlex
- W3153508314
- Cited by
- 2,397
- References
- 28
- Citations by year
- 2026: 76 · 2025: 159 · 2024: 253 · 2023: 437 · 2022: 916 · 2021: 555 · 2020: 1
- FWCI
- 171.43
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Arca - Repositório Institucional da Fiocruz (submittedVersion, other-oa)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, other-oa)
- Funders
- HIV Vaccine Trials Network (UM1 AI68618, UM1 AI68614)
- HIV Prevention Trials Network Leadership and Operations Center (UM1 AI68619)
- AIDS Clinical Trials Group Leadership and Operations Center (UM1 AI68636)
- Infectious Diseases Clinical Research Consortium Leadership Group (UM1 AI148684)
- Vaccine and Therapeutic Evaluation Units (UM1 AI148373, UM1 AI148452, UM1 AI148576, UM1 AI148685)
- National Institute of Allergy and Infectious Diseases
- HVTN Statistics and Data Management Center (UM1 AI68635)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Virus-based gene therapy research
- Keywords
- Ad26.COV2-S, COVID-19 vaccines, SARS-CoV-2 spike protein, adenoviral vector, vaccine efficacy, vaccine safety, reactogenicity, breakthrough infection, South Africa
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, COVID-19 Vaccines, Ad26COVS1, Adolescent, Adult, Aged, Double-Blind Method, Female, Hospitalization, Humans, Male, Middle Aged, Incidence, Proportional Hazards Models, Young Adult, Asymptomatic Diseases, Patient Acuity
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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