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Challenges in evaluating SARS-CoV-2 vaccines during the pandemic Abu-Raya, Bahaa; Gantt, Soren; Sadarangani, Manish

Abstract

Key points: - Challenges to the evaluation of SARS-CoV-2 candidate vaccines prior to approval or licensure during the ongoing pandemic include rapidly changing levels of exposure to the virus and population immunity, social distancing practices, and the possibility of antibody-dependent enhancement of disease. - In order to measure vaccine efficacy accurately, researchers should account for these factors in sample size calculations and also carefully consider selection of trial endpoints. - SARS-CoV-2 vaccines must also be evaluated in populations known to be at increased risk for severe COVID-19, such as older adults, people of African descent, and people with multiple comorbidities. - Given the speed of SARS-CoV-2 vaccine development careful attention must be paid to post-licensure assessment of vaccines, including the risk of antibody dependent enhancement of disease, which must be actively monitored closely over multiple years after vaccination.

Item Metadata

Title
Challenges in evaluating SARS-CoV-2 vaccines during the pandemic
Creator
Abu-Raya, Bahaa; Gantt, Soren; Sadarangani, Manish
Contributor
Children's Hospital (Vancouver, B.C.). Research Institute; Children's Hospital (Vancouver, B.C.). Vaccine Evaluation Center
Publisher
Canadian Medical Association Journal
Date Issued
2020-08-24
Description
Key points: - Challenges to the evaluation of SARS-CoV-2 candidate vaccines prior to approval or licensure during the ongoing pandemic include rapidly changing levels of exposure to the virus and population immunity, social distancing practices, and the possibility of antibody-dependent enhancement of disease. - In order to measure vaccine efficacy accurately, researchers should account for these factors in sample size calculations and also carefully consider selection of trial endpoints. - SARS-CoV-2 vaccines must also be evaluated in populations known to be at increased risk for severe COVID-19, such as older adults, people of African descent, and people with multiple comorbidities. - Given the speed of SARS-CoV-2 vaccine development careful attention must be paid to post-licensure assessment of vaccines, including the risk of antibody dependent enhancement of disease, which must be actively monitored closely over multiple years after vaccination.
Subject
COVID-19 (Disease)
Genre
Article; Postprint
Type
Text
Language
eng
Date Available
2020-12-14
Provider
Vancouver : University of British Columbia Library
Rights
Attribution-NonCommercial-NoDerivatives 4.0 International
DOI
10.14288/1.0395298
URI
http://hdl.handle.net/2429/76795
Affiliation
Medicine, Faculty of; Infectious Diseases, Division of; Pediatrics, Department of
Citation
Abu-Raya, B., Gantt, S., & 20 Sadarangani, M. (2020). Challenges in evaluating SARS-CoV-2 vaccines during the COVID-19 21 pandemic. Canadian Medical Association Journal (CMAJ), 192(34), E982-E985.
Publisher DOI
10.1503/cmaj.201237
Peer Review Status
Reviewed
Scholarly Level
Faculty; Postdoctoral
Rights URI
http://creativecommons.org/licenses/by-nc-nd/4.0/
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Attribution-NonCommercial-NoDerivatives 4.0 International