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Consensus summary report for CEPI/BC March 12–13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines
Open accessAbstract
A novel coronavirus (CoV), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in late 2019 in Wuhan, China and has since spread as a global pandemic. Safe and effective vaccines are thus urgently needed to reduce the significant morbidity and mortality of Coronavirus Disease 2019 (COVID-19) disease and ease the major economic impact. There has been an unprecedented rapid response by vaccine developers with now over one hundred vaccine candidates in development and at least six having reached clinical trials. However, a major challenge during rapid development is to avoid safety issues both by thoughtful vaccine design and by thorough evaluation in a timely manner. A syndrome of "disease enhancement" has been reported in the past for a few viral vaccines where those immunized suffered increased severity or death when they later encountered the virus or were found to have an increased frequency of infection. Animal models allowed scientists to determine the underlying mechanism for the former in the case of Respiratory syncytial virus (RSV) vaccine and have been utilized to design and screen new RSV vaccine candidates. Because some Middle East respiratory syndrome (MERS) and SARS-CoV-1 vaccines have shown evidence of disease enhancement in some animal models, this is a particular concern for SARS-CoV-2 vaccines. To address this challenge, the Coalition for Epidemic Preparedness Innovations (CEPI) and the Brighton Collaboration (BC) Safety Platform for Emergency vACcines (SPEAC) convened a scientific working meeting on March 12 and 13, 2020 of experts in the field of vaccine immunology and coronaviruses to consider what vaccine designs could reduce safety concerns and how animal models and immunological assessments in early clinical trials can help to assess the risk. This report summarizes the evidence presented and provides considerations for safety assessment of COVID-19 vaccine candidates in accelerated vaccine development.
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“In animal models of infections with other coronaviruses and for previous whole-cell inactivated vaccines developed for respiratory syncytial virus and measles virus, VAERD has usually been associated with the development of T helper 2 cell (TH2 cell)-biased CD4+ T cell responses, with significantly increased levels of interleukin-4 (IL-4), IL-5 and/or IL-13 (refs12,126,165–174).”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [172]
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“Moreover, in contrast to these few studies involving VAERD, many other studies us-ing similar vaccine platforms and animal challenge models report protection without immunopathologic outcomes [3,88].”
Influential
Metadata
- Authors
- Lambert, P.-H., Ambrosino, D. M., Andersen, S. R., Baric, R. S., Black, S. B., Chen, R. T., Dekker, C. L., Didierlaurent, A. M., Graham, B. S., Martin, S. D., Molrine, D. C., Perlman, S., Picard-Fraser, P. A., Pollard, A. J., Qin, C., Subbarao, K., & Cramer, J. P.
- Affiliations
- University of Geneva (CH)
- Coalition for Epidemic Preparedness Innovations (NO)
- University of North Carolina at Chapel Hill (US)
- The Task Force for Global Health (US)
- National Institutes of Health (US)
- University of Iowa (US)
- University of Oxford (GB)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Peter Doherty Institute (AU)
- Coalition for Epidemic Preparedness Innovations (US)
- Corresponding author
- Dekker, Cornelia L.
- ORCID
- Venue
- Vaccine
- Publisher
- Elsevier BV
- Published
- 2020-06
- Volume
- 38
- Issue
- 31
- Pages
- 4783-4791
- ISSN
- 0264-410X (ISSN-L)
- PMC
- PMC7247514
- OpenAlex
- W3031777395
- Cited by
- 119
- References
- 59
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 6 · 2023: 8 · 2022: 24 · 2021: 40 · 2020: 36
- FWCI
- 3.43
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Vaccine (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Archive ouverte UNIGE (University of Geneva) (publishedVersion)
- Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
- Oxford University Research Archive (ORA) (University of Oxford) (submittedVersion, cc-by-nc-nd)
- Archive ouverte UNIGE (University of Geneva) (submittedVersion, cc-by)
- UNC Libraries
- Funders
- Coalition for Epidemic Preparedness Innovations
- National Institute of Allergy and Infectious Diseases (P01AI060699, R01AI129269)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Immunology and Microbiology › Immunology › Immune responses and vaccinations
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- COVID-19 vaccines, SARS-CoV-2, disease enhancement, vaccine safety, vaccine design, animal models, RSV vaccine, vaccine immunology
- MeSH terms
- Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Vaccines, Animals, Antibodies, Viral, Clinical Trials as Topic, Disease Models, Animal, Humans, Pneumonia, Viral, Viral Vaccines, Coronavirus Infections, Risk Assessment, Severe Acute Respiratory Syndrome, Pandemics
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