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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.
Vaccine. 2020 06 26; 38(31):4783-4791.V

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.

Authors+Show Affiliations

Centre of Vaccinology, University of Geneva, Switzerland.Independent Advisor, Stuart, FL, USA.Coalition for Epidemic Preparedness Innovations, Oslo, Norway.Department of Epidemiology, Gillings School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.Brighton Collaboration, Task Force for Global Health, Decatur, GA, USA.Brighton Collaboration, Task Force for Global Health, Decatur, GA, USA.Brighton Collaboration, Task Force for Global Health, Decatur, GA, USA. Electronic address: cdekker@stanford.edu.Centre of Vaccinology, University of Geneva, Switzerland.Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.Independent Advisor, Boston, MA, USA.Independent Advisor, Newton, MA, USA.Department of Microbiology and Immunology, University of Iowa, Iowa City, IA, USA.Independent Advisor, Worcester, MA, USA.Department of Paediatrics, University of Oxford, United Kingdom.Institute of Laboratory Animal Science, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.WHO Collaborating Centre for Reference and Research on Influenza, Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.Coalition for Epidemic Preparedness Innovations, London, United Kingdom.

Pub Type(s)

Consensus Development Conference
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32507409

Citation

Lambert, Paul-Henri, et al. "Consensus Summary Report for CEPI/BC March 12-13, 2020 Meeting: Assessment of Risk of Disease Enhancement With COVID-19 Vaccines." Vaccine, vol. 38, no. 31, 2020, pp. 4783-4791.
Lambert PH, Ambrosino DM, Andersen SR, et al. Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines. Vaccine. 2020;38(31):4783-4791.
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. (2020). Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines. Vaccine, 38(31), 4783-4791. https://doi.org/10.1016/j.vaccine.2020.05.064
Lambert PH, et al. Consensus Summary Report for CEPI/BC March 12-13, 2020 Meeting: Assessment of Risk of Disease Enhancement With COVID-19 Vaccines. Vaccine. 2020 06 26;38(31):4783-4791. PubMed PMID: 32507409.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines. AU - Lambert,Paul-Henri, AU - Ambrosino,Donna M, AU - Andersen,Svein R, AU - Baric,Ralph S, AU - Black,Steven B, AU - Chen,Robert T, AU - Dekker,Cornelia L, AU - Didierlaurent,Arnaud M, AU - Graham,Barney S, AU - Martin,Samantha D, AU - Molrine,Deborah C, AU - Perlman,Stanley, AU - Picard-Fraser,Philip A, AU - Pollard,Andrew J, AU - Qin,Chuan, AU - Subbarao,Kanta, AU - Cramer,Jakob P, Y1 - 2020/05/25/ PY - 2020/05/05/received PY - 2020/05/18/revised PY - 2020/05/21/accepted PY - 2020/6/9/pubmed PY - 2020/6/23/medline PY - 2020/6/9/entrez KW - Animal models KW - COVID-19 KW - Enhanced disease KW - MERS-CoV vaccine KW - SARS-CoV-1 vaccine KW - SARS-CoV-2 KW - SARS-CoV-2 vaccine KW - Vaccine adjuvants KW - Vaccine safety SP - 4783 EP - 4791 JF - Vaccine JO - Vaccine VL - 38 IS - 31 N2 - 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/32507409/Consensus_summary_report_for_CEPI/BC_March_12_13_2020_meeting:_Assessment_of_risk_of_disease_enhancement_with_COVID_19_vaccines_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(20)30709-X DB - PRIME DP - Unbound Medicine ER -