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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.
Lancet Infect Dis. 2021 02; 21(2):e26-e35.LI

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?"

Authors+Show Affiliations

The Jenner Institute, University of Oxford, Oxford, UK. Electronic address: susanne.hodgson@ndm.ox.ac.uk.University of Oxford Clinical Medical School, Medical Sciences Division, University of Oxford, Oxford, UK.University of Oxford Clinical Medical School, Medical Sciences Division, University of Oxford, Oxford, UK.Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Oxford, UK.Oxford Vaccine Group, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.Oxford Vaccine Group, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

33125914

Citation

Hodgson, Susanne H., et al. "What Defines an Efficacious COVID-19 Vaccine? a Review of the Challenges Assessing the Clinical Efficacy of Vaccines Against SARS-CoV-2." The Lancet. Infectious Diseases, vol. 21, no. 2, 2021, pp. e26-e35.
Hodgson SH, Mansatta K, Mallett G, et al. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infect Dis. 2021;21(2):e26-e35.
Hodgson, S. H., Mansatta, K., Mallett, G., Harris, V., Emary, K. R. W., & Pollard, A. J. (2021). What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. The Lancet. Infectious Diseases, 21(2), e26-e35. https://doi.org/10.1016/S1473-3099(20)30773-8
Hodgson SH, et al. What Defines an Efficacious COVID-19 Vaccine? a Review of the Challenges Assessing the Clinical Efficacy of Vaccines Against SARS-CoV-2. Lancet Infect Dis. 2021;21(2):e26-e35. PubMed PMID: 33125914.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. AU - Hodgson,Susanne H, AU - Mansatta,Kushal, AU - Mallett,Garry, AU - Harris,Victoria, AU - Emary,Katherine R W, AU - Pollard,Andrew J, Y1 - 2020/10/27/ PY - 2020/08/11/received PY - 2020/09/05/revised PY - 2020/09/14/accepted PY - 2020/10/31/pubmed PY - 2021/2/16/medline PY - 2020/10/30/entrez SP - e26 EP - e35 JF - The Lancet. Infectious diseases JO - Lancet Infect Dis VL - 21 IS - 2 N2 - 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?" SN - 1474-4457 UR - https://www.unboundmedicine.com/medline/citation/33125914/What_defines_an_efficacious_COVID_19_vaccine_A_review_of_the_challenges_assessing_the_clinical_efficacy_of_vaccines_against_SARS_CoV_2_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1473-3099(20)30773-8 DB - PRIME DP - Unbound Medicine ER -