Consensus summary report for CEPI/BC March 12–13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines. Issue 31 (26th June 2020)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Vaccine. Volume 38:Issue 31(2020)
• Page Start: 4783
• Page End: 4791
• Publication Date: 2020-06-26
• Subjects: SARS-CoV-2 -- COVID-19 -- Vaccine safety -- MERS-CoV vaccine -- SARS-CoV-1 vaccine -- SARS-CoV-2 vaccine -- Animal models -- Enhanced disease -- Vaccine adjuvants; ACE2 Angiotensin-converting enzyme 2 -- ADE Antibody disease enhancement -- ARDS Acute respiratory distress syndrome -- B/HPIV3 Bovine/human parainfluenza virus type 3 -- BC Brighton Collaboration -- BPL β-Propiolactone -- BtCoV Bat coronavirus -- CEPI Coalition for Epidemic Preparedness Innovations -- CNS Central nervous system -- COVID-19 Coronavirus Disease 2019 -- CRISPR Clustered regularly interspaced short palindromic repeats -- DNA Deoxyribonucleic acid -- DPP4 Dipeptidyl peptidase-4 -- hACE2 Human ACE2 receptor -- HBs Hepatitis B surface antigen -- hDPP4 Human DPP4 -- IHC Immunohistochemistry -- MERS CoV Middle East respiratory syndrome coronavirus -- mRNA Messenger RNA -- MVA Modified Vaccinia Virus Ankara -- NHP Non-human primate -- Non-SPF Non-specific pathogen free -- NTD N terminal domain -- RAG1 Recombination activating gene 1 -- RBD Receptor binding domain -- rMVA Recombinant modified vaccinia virus Ankara -- RNA Ribonucleic acid -- RSV Respiratory syncytial virus -- SARS-CoV-1 Severe acute respiratory syndrome coronavirus 1 -- SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2 -- SPEAC Safety Platform for Emergency vACcines -- TCR T-cell receptor -- Tg Transgenic -- Th1 T-helper cell type 1 -- Th2 T-helper cell type 2 -- VSV Vesicular stomatitis virus -- WHO World Health Organization; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2020.05.064
• Languages: English
• ISSNs: 0264-410X

Abstract

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.