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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
Open accessAbstract
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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“the long-term risks and benefits of a SARS-CoV-2 vaccine will take a long time to fully evaluate in adults33 while the public health needs of a vaccine are pressing.”
From SARS-CoV-2 vaccine testing and trials in the pediatric population: biologic, ethical, research, and implementation challenges (2021) · cites this paper as [33]
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Fatima, M., Cheema, H. A., Khan, M. H. A., Shahid, H., Ali, M. S., Hassan, U., Murad, M. W., Rehman, M. A. U., & Farooq, H. (2022) · Annals of Medicine and Surgery · doi:10.1016/j.amsu.2022.103486 · Cited by 47
Kantarcıoğlu, B., Iqbal, O., Walenga, J. M., Lewis, B., Lewis, J., Carter, C. A., Singh, M., Lievano, F. A., Tafur, A. J., Ramacciotti, E., et al. (2021) · Clinical and Applied Thrombosis/Hemostasis · doi:10.1177/10760296211021498 · Cited by 45
Identification of Vitamin K3 and its analogues as covalent inhibitors of SARS-CoV-2 3CLpro
Wang, R., Hu, Q., Wang, H., Zhu, G., Wang, M., Zhang, Q., Zhao, Y., Li, C., Zhang, Y., Ge, G., et al. (2021) · International Journal of Biological Macromolecules · doi:10.1016/j.ijbiomac.2021.04.129 · Cited by 44
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COVID-19 Vaccination Efficacy and Safety Literature Review
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Understanding the Challenges and Uncertainties of Seroprevalence Studies for SARS-CoV-2
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RETRACTED: Why are we vaccinating children against COVID-19?
Kostoff, R. N., Călina, D. C., Kanduc, D., Briggs, M. B., Vlachoyiannopoulos, P. G., Svistunov, A. А., & Tsatsakis, A. M. (2021) · Toxicology Reports · doi:10.1016/j.toxrep.2021.08.010 · Cited by 39
Retractedde Castro, J. T., de Azevedo, P. O., Fumagalli, M. J., Hojo-Souza, N. S., Salazar, N., Almeida, G. G., Oliveira, L. I., Faustino, L., Antonelli, L. R. D. V., Marçal, T. G., et al. (2022) · Nature Communications · doi:10.1038/s41467-022-32547-y · Cited by 37
Therapeutic Potential of Exploiting Autophagy Cascade Against Coronavirus Infection
Maity, S., & Saha, A. (2021) · Frontiers in Microbiology · doi:10.3389/fmicb.2021.675419 · Cited by 35
Iguacel, I., Maldonado, A. L., Ruíz-Cabello, A. L., Samatán, E., Alarcón, J., Orte, M. Á., Mateos, S. S., & Martínez‐Jarreta, B. (2021) · Frontiers in Public Health · doi:10.3389/fpubh.2021.739003 · Cited by 33
Porru, S., Spiteri, G., Monaco, M. G. L., Valotti, A., Carta, A., Lotti, V., Diani, E., Lippi, G., Gibellini, D., & Verlato, G. (2022) · Vaccines · doi:10.3390/vaccines10020272 · Cited by 33
Lanini, S., Capone, S., Antinori, A., Milleri, S., Nicastri, E., Camerini, R., Agrati, C., Castilletti, C., Mori, F., Sacchi, A., et al. (2021) · Science Translational Medicine · doi:10.1126/scitranslmed.abj1996 · Cited by 34
Potential of Microneedle Systems for COVID-19 Vaccination: Current Trends and Challenges
Hassan, J., Haigh, C., Ahmed, T., Uddin, M. J., & Das, D. B. (2022) · Pharmaceutics · doi:10.3390/pharmaceutics14051066 · Cited by 36
Metadata
- 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
- Venue
- The Lancet Infectious Diseases
- Publisher
- Elsevier BV
- Published
- 2021-02
- Volume
- 21
- Issue
- 2
- Pages
- e26-e35
- ISSN
- 1473-3099 (ISSN-L)
- 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
- 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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