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. 2020 Jun 26;38(31):4783-4791.
doi: 10.1016/j.vaccine.2020.05.064. Epub 2020 May 25.

Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines

Paul-Henri Lambert  1 , Donna M Ambrosino  2 , Svein R Andersen  3 , Ralph S Baric  4 , Steven B Black  5 , Robert T Chen  5 , Cornelia L Dekker  6 , Arnaud M Didierlaurent  1 , Barney S Graham  7 , Samantha D Martin  8 , Deborah C Molrine  9 , Stanley Perlman  10 , Philip A Picard-Fraser  11 , Andrew J Pollard  12 , Chuan Qin  13 , Kanta Subbarao  14 , Jakob P Cramer  15
Affiliations

Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines

Paul-Henri Lambert et al. Vaccine. .

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.

Keywords: Animal models; COVID-19; Enhanced disease; MERS-CoV vaccine; SARS-CoV-1 vaccine; SARS-CoV-2; SARS-CoV-2 vaccine; Vaccine adjuvants; Vaccine safety.

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Conflict of interest statement

Declaration of Competing Interest RB has collaborations with VaxArt, Takeda, Moderna, Eli Lily, and Pfizer. SB is a consultant for GSK on matters unrelated to the topic of this manuscript. CD is a consultant to Medicago on their vaccine programs; her husband owns stock in Dynavax Technologies Corporation. BSG is a named inventor on patent applications related to coronavirus vaccines and monoclonal antibodies. AJP is Chair of UK Dept. Health and Social Care's (DHSC) Joint Committee on Vaccination & Immunisation (JCVI) and is a member of the WHO's SAGE. AJP is an NIHR Senior Investigator. PL, DA, SRA, RTC, AMD, SDM, DM, SP, PAP, CQ, and KS declare no competing financial interests or personal relationships that could have appeared to influence the work reported in this manuscript.

Figures

Fig. 1
Fig. 1
2P mutation stabilizes MERS and SARS CoV S; improves expression, prefusion structure, and immunogenicity.
See this image and copyright information in PMC

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