Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Accepted/In Press date: 1 January 2020

e-pub ahead of print date: 8 December 2020

Published date: 9 January 2021

Additional Information: Funding Information: This Article was funded by UK Research and Innovation, NIHR, Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca. The authors dedicate this paper to the many healthcare workers who have lost their lives during the pandemic. This report is independent research funded by the UK National Institute for Health Research, UK Research and Innovation, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D'OR, the Brava and Telles Foundation, and the South African Medical Research Council. We are grateful to the NIHR infrastructure provided through the NIHR Biomedical Research Centres and the NIHR Clinical Research Network at the UK study sites. The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care. PMF received funding from the Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior, Brazil (finance code 001). The authors are grateful to the volunteers who participated in this study. The authors are grateful to the senior management at AstraZeneca for facilitating and funding the manufacture of the AZD1222 vaccine candidate and for financial support for expansion of the Oxford sponsored clinical trials in Brazil. AstraZeneca reviewed the data from the study and the final manuscript prior to submission, but the authors retained editorial control. Funding Information: This Article was funded by UK Research and Innovation, NIHR, Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D’Or, the Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca. The authors dedicate this paper to the many healthcare workers who have lost their lives during the pandemic. This report is independent research funded by the UK National Institute for Health Research, UK Research and Innovation, the Bill & Melinda Gates Foundation, the Lemann Foundation, Rede D’OR, the Brava and Telles Foundation, and the South African Medical Research Council. We are grateful to the NIHR infrastructure provided through the NIHR Biomedical Research Centres and the NIHR Clinical Research Network at the UK study sites. The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health Research or the Department of Health and Social Care. PMF received funding from the Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior, Brazil (finance code 001). The authors are grateful to the volunteers who participated in this study. The authors are grateful to the senior management at AstraZeneca for facilitating and funding the manufacture of the AZD1222 vaccine candidate and for financial support for expansion of the Oxford sponsored clinical trials in Brazil. AstraZeneca reviewed the data from the study and the final manuscript prior to submission, but the authors retained editorial control. Funding Information: Oxford University has entered into a partnership with AstraZeneca for further development of ChAdOx1 nCoV-19. SCG is co-founder of Vaccitech (collaborators in the early development of this vaccine candidate) and named as an inventor on a patent covering use of ChAdOx1-vectored vaccines and a patent application covering this SARS-CoV-2 vaccine (PCT/GB2012/000467). TL is named as an inventor on a patent application covering this SARS-CoV-2 vaccine and was a consultant to Vaccitech for an unrelated project, during the conduct of the study. PMF is a consultant to Vaccitech during the conduct of the study. AJP is chair of the UK Department of Health and Social Care's (DHSC) Joint Committee on Vaccination & Immunisation (JCVI), but does not participate in discussions on COVID-19 vaccines, and is a member of WHO's SAGE. AJP is a National Institute for Health Research (NIHR) Senior Investigator. The views expressed in this Article do not necessarily represent the views of the DHSC, JCVI, NIHR, or WHO. AVSH reports personal fees from Vaccitech, outside of the submitted work, and has a patent on ChAdOx1 licensed to Vaccitech (PCT/GB2012/000467), and might benefit from royalty income to the University of Oxford from sales of this vaccine by AstraZeneca and sublicensees. MS reports grants from NIHR and non-financial support from AstraZeneca, during the conduct of the study; and grants from Janssen, GlaxoSmithKline, Medimmune, Novavax, and MCM and grants and non-financial support from Pfizer, outside of the submitted work. CG reports personal fees from the Duke Human Vaccine Institute, outside of the submitted work. ADD reports grants and personal fees from AstraZeneca, outside of the submitted work. AF is a member of the JCVI and chair of the WHO European Technical Advisory Group of Experts. AF declares research grants from Pfizer, GlaxoSmithKline, Sanofi, Merck Sharp & Dohme, and Valneva, outside of the submitted work. JV, TLV, and IH are employees of AstraZeneca. The other authors declare no competing interests. Publisher Copyright: © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license

Keywords: Adolescent, Adult, Aged, Brazil, COVID-19/prevention & control, COVID-19 Vaccines/adverse effects, Double-Blind Method, Female, Humans, Male, Middle Aged, Single-Blind Method, South Africa, Treatment Outcome, United Kingdom, Young Adult

Local EPrints ID: 446188

URI: http://eprints.soton.ac.uk/id/eprint/446188

DOI: doi:10.1016/S0140-6736(20)32661-1

ISSN: 0140-6736

PURE UUID: 0f6c3d7c-d31a-4970-8fd2-ff0d6f4c73af

ORCID for Saul N. Faust: orcid.org/0000-0003-3410-7642

Date deposited: 27 Jan 2021 17:30

Last modified: 16 Aug 2024 01:41