Cited by 1,257SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesVaccine Coverage and Hesitancy

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index; none of the 14 sources its claims cite is checked for support yet.

Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant

Open access

Published version of a preprint

Abstract

BACKGROUND: Assessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in different populations is essential, as is investigation of the efficacy of the vaccines against emerging SARS-CoV-2 variants of concern, including the B.1.351 (501Y.V2) variant first identified in South Africa. METHODS: viral particles or placebo (0.9% sodium chloride solution) 21 to 35 days apart. Serum samples obtained from 25 participants after the second dose were tested by pseudovirus and live-virus neutralization assays against the original D614G virus and the B.1.351 variant. The primary end points were safety and efficacy of the vaccine against laboratory-confirmed symptomatic coronavirus 2019 illness (Covid-19) more than 14 days after the second dose. RESULTS: Between June 24 and November 9, 2020, we enrolled 2026 HIV-negative adults (median age, 30 years); 1010 and 1011 participants received at least one dose of placebo or vaccine, respectively. Both the pseudovirus and the live-virus neutralization assays showed greater resistance to the B.1.351 variant in serum samples obtained from vaccine recipients than in samples from placebo recipients. In the primary end-point analysis, mild-to-moderate Covid-19 developed in 23 of 717 placebo recipients (3.2%) and in 19 of 750 vaccine recipients (2.5%), for an efficacy of 21.9% (95% confidence interval [CI], -49.9 to 59.8). Among the 42 participants with Covid-19, 39 cases (95.1% of 41 with sequencing data) were caused by the B.1.351 variant; vaccine efficacy against this variant, analyzed as a secondary end point, was 10.4% (95% CI, -76.8 to 54.8). The incidence of serious adverse events was balanced between the vaccine and placebo groups. CONCLUSIONS: A two-dose regimen of the ChAdOx1 nCoV-19 vaccine did not show protection against mild-to-moderate Covid-19 due to the B.1.351 variant. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT04444674; Pan African Clinical Trials Registry number, PACTR202006922165132).

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Registry

Crossref · 10.1056/nejmoa2102214

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  • It may state two separate claims as one. 17
  • Probably not a substantial claim. 10
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  • Vaccine and placebo recipient counts are reversed

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    The abstract assigns 1010 recipients to placebo and 1011 to vaccine, while the Results section assigns 1010 to vaccine and 1011 to placebo.

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  1. Pfizer. Pfizer and BioNTech announce vaccine candidate against COVID-19 achieved success in first interim analysis from phase 3 study. November 9 2020 (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against).
  2. Tegally H Wilkinson E Giovanetti M et al. Emergence and rapid spread of a new severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) lineage with multiple spike mutations in South Africa. December 22 2020 (https://www.medrxiv.org/content/10.1101/2020.12.21.20248640v1). preprint. · DOI
  3. Emary KRW Golubchik T Aley PK et al. Efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine against SARS-CoV-2 VOC 202012/01 (B.1.1.7). February 4 2021. preprint.
  4. National Institute for Communicable Diseases. Dominance of the SARS-CoV-2 501Y.V2 lineage in Gauteng. January 28 2021 (https://www.nicd.ac.za/wp-content/uploads/2021/01/Dominance-of-the-SARS-CoV-2-501Y.V2-lineage-in-Gauteng-South-Africa-1.pdf.) preprint.
  5. Amnesty International. COVID-19: Oxford/AstraZeneca vaccine a boost for global access but huge inequality remains. November 23 2020 (https://www.amnesty.org/en/latest/news/2020/11/oxford-astrazeneca-vaccine-a-boost-for-global-access-but-huge-inequality-remains).

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Metadata

Authors
Madhi, S. A., Baillie, V., Cutland, C. L., Voysey, M., Koen, A. L., Fairlie, L., Padayachee, S. D., Dheda, K., Barnabas, S. L., Bhorat, Q. E., Briner, C., Kwatra, G., Ahmed, K., Aley, P., Bhikha, S., Bhiman, J. N., Bhorat, A. E., du Plessis, J., Esmail, A., Groenewald, M., Horne, E., Hwa, S.-H., Jose, A., Lambe, T., Laubscher, M., Malahleha, M., Masenya, M., Masilela, M., McKenzie, S., Molapo, K., Moultrie, A., Oelofse, S., Patel, F., Pillay, S., Rhead, S., Rodel, H., Rossouw, L., Taoushanis, C., Tegally, H., Thombrayil, A., van Eck, S., Wibmer, C. K., Durham, N. M., Kelly, E. J., Villafana, T. L., Gilbert, S., Pollard, A. J., de Oliveira, T., Moore, P. L., Sigal, A., & Izu, A.
Affiliations
  • South African Medical Research Council (ZA)
  • University of the Witwatersrand (ZA)
  • University of Oxford (GB)
  • Setshaba Research Centre (ZA)
  • University of Cape Town (ZA)
  • Stellenbosch University (ZA)
  • Soweto CTC (ZA)
  • National Health Laboratory Service (ZA)
  • Africa Health Research Institute (ZA)
  • Max Planck Institute for Infection Biology (DE)
  • AstraZeneca (United Kingdom) (GB)
  • From the South African Medical Research Council Vaccines and Infectious Diseases Analytics Research Unit (S.A.M., V.B., A.L.K., G.K., S.B., J.P., A.J., M.L., S.M., A.M., C.T., A.T., A.I.), African Leadership in Vaccinology Expertise (C.L.C.), Wits Reproductive Health and HIV Institute (L.F., E.H., M. Masenya, F.P., S.E.), the Antibody Immunity Research Unit, School of Pathology (J.N.B., C.K.W., P.L.M.), and the Perinatal HIV Research Unit (C.B.), Faculty of Health Sciences, and the Department of Science and Innovation/National Research Foundation South African Research Chair Initiative in Vaccine Preventable Diseases Unit (S.A.M., V.B., A.L.K., G.K., S.B., A.I.), University of the Witwatersrand, and the National Institute for Communicable Diseases (NICD) of the National Health Laboratory Service (NHLS) (J.N.B., C.K.W., P.L.M.), Johannesburg, Setshaba Research Centre, Tshwane (S.D.P., K.A., M. Malahleha, M. Masilela, K.M.), the Division of Pulmonology, Groote Schuur Hospital and the University of Cape Town ...
Corresponding author
Madhi, Shabir A.
Venue
New England Journal of Medicine
Published
2021-05-20
Volume
384
Issue
20
Pages
1885-1898
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3139533040
Cited by
1,257
References
23
Citations by year
2026: 9 · 2025: 33 · 2024: 64 · 2023: 135 · 2022: 413 · 2021: 600
FWCI
96.76
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion, cc-by)
  • medRxiv (acceptedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
Funders
  • Bill and Melinda Gates Foundation (INV-017710)
  • South African Medical Research Council (96167)
  • U.K. Research and Innovation (MC_PC_19055)
  • UK National Institute for Health Research
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Social Sciences › Health › Vaccine Coverage and Hesitancy
Keywords
ChAdOx1 nCoV-19 vaccine, COVID-19 vaccine efficacy, B.1.351 variant, SARS-CoV-2 variants of concern, neutralizing antibodies, pseudovirus neutralization, symptomatic COVID-19, vaccine safety, adenovirus vector vaccine
MeSH terms
Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, COVID-19 Serological Testing, ChAdOx1 nCoV-19, Adenoviridae, Adolescent, Adult, Double-Blind Method, Humans, Middle Aged, South Africa, T-Lymphocytes, Treatment Failure, Young Adult, Antibodies, Neutralizing, Vaccine Potency

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