Cited by 633SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesCOVID-19 epidemiological studies

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What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2

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Hodgson, Susanne H, Mansatta, Kushal, Mallett, Garry, Harris, Victoria, Emary, Katherine R W, Pollard, Andrew J·2021·The Lancet Infectious Diseases

DOI 10.1016/s1473-3099(20)30773-8PMC PMC7837315

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Abstract

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused more than 1 million deaths in the first 6 months of the pandemic and huge economic and social upheaval internationally. An efficacious vaccine is essential to prevent further morbidity and mortality. Although some countries might deploy COVID-19 vaccines on the strength of safety and immunogenicity data alone, the goal of vaccine development is to gain direct evidence of vaccine efficacy in protecting humans against SARS-CoV-2 infection and COVID-19 so that manufacture of efficacious vaccines can be selectively upscaled. A candidate vaccine against SARS-CoV-2 might act against infection, disease, or transmission, and a vaccine capable of reducing any of these elements could contribute to disease control. However, the most important efficacy endpoint, protection against severe disease and death, is difficult to assess in phase 3 clinical trials. In this Review, we explore the challenges in assessing the efficacy of candidate SARS-CoV-2 vaccines, discuss the caveats needed to interpret reported efficacy endpoints, and provide insight into answering the seemingly simple question, "Does this COVID-19 vaccine work?"

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Authors: Hodgson, S. H., Mansatta, K., Mallett, G., Harris, V., Emary, K. R. W., & Pollard, A. J.
Affiliations: University of Oxford (GB)
Corresponding author: Hodgson, Susanne H
ORCID: Hodgson, Susanne H
Mansatta, Kushal
Mallett, Garry
Harris, Victoria
Emary, Katherine R W
Pollard, Andrew J
Venue: The Lancet Infectious Diseases
Publisher: Elsevier BV
Published: 2021-02
Volume: 21
Issue: 2
Pages: e26-e35
ISSN: 1473-3099 (ISSN-L)
DOI: 10.1016/s1473-3099(20)30773-8
PMC: PMC7837315
OpenAlex: W3088489318
Cited by: 633
References: 79
Citations by year: 2026: 11 · 2025: 14 · 2024: 52 · 2023: 99 · 2022: 221 · 2021: 221
FWCI: 6.56
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Infectious Diseases (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Funders: UK Research and Innovation (MC_PC_19055)
Coalition for Epidemic Preparedness Innovations
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
Physical Sciences › Mathematics › Modeling and Simulation › COVID-19 epidemiological studies
Keywords: COVID-19 vaccines, SARS-CoV-2, vaccine efficacy, efficacy endpoints, vaccine development
MeSH terms: Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, Clinical Trials as Topic, Humans, Research Design, Vaccination, Treatment Outcome, Outcome Assessment, Health Care

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What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2

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