Cited by 121SARS-CoV-2 and COVID-19 ResearchImmune responses and vaccinationsCOVID-19 Clinical Research Studies

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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

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Lambert, Paul-Henri, Ambrosino, Donna M., Andersen, Svein R., Baric, Ralph S., Black, Steven B., Chen, Robert T., Dekker, Cornelia L., Didierlaurent, Arnaud M., Graham, Barney S., Martin, Samantha D., Molrine, Deborah C., Perlman, Stanley, Picard-Fraser, Philip A., Pollard, Andrew J., Qin, Chuan, Subbarao, Kanta, Cramer, Jakob P.·2020·Vaccine

DOI 10.1016/j.vaccine.2020.05.064PMC PMC7247514

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Abstract

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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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: Andersen, Svein R.
Baric, Ralph S.
Black, Steven B.
Chen, Robert T.
Dekker, Cornelia L.
Didierlaurent, Arnaud M.
Graham, Barney S.
Martin, Samantha D.
Perlman, Stanley
Pollard, Andrew J.
Qin, Chuan
Subbarao, Kanta
Cramer, Jakob P.
Venue: Vaccine
Publisher: Elsevier BV
Published: 2020-06
Volume: 38
Issue: 31
Pages: 4783-4791
ISSN: 0264-410X (ISSN-L)
DOI: 10.1016/j.vaccine.2020.05.064
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
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
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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Consensus summary report for CEPI/BC March 12–13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines

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