Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines
- PMID: 33070999
- PMCID: PMC7563577
- DOI: 10.1016/j.vaccine.2020.09.042
Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines
Abstract
Several live-attenuated viral vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of live-attenuated viral vaccines. This will help key stakeholders assess potential safety issues and understand the benefit-risk of such vaccines. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed live-attenuated viral vaccines.
Keywords: Attenuated; Benefit-risk; Brighton Collaboration; CEPI; COVID-19; Live; Safety; Template; Vaccine; Viral.
Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.
Conflict of interest statement
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
References
-
- Bonhoeffer J., Kohl K., Chen R., Duclos P., Heijbel H., Heininger U., et al. The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI) Vaccine. 2002;21(3–4):298–302. - PubMed
-
- Monath T.P., Seligman S.J., Robertson J.S., Guy B., Hayes E.B., Condit R.C., et al. Live virus vaccines based on a yellow fever vaccine backbone: standardized template with key considerations for a risk/benefit assessment. Vaccine. 2015;33(1):62–72. doi: 10.1016/j.vaccine.2014.10.004. - DOI - PMC - PubMed
-
- Clarke D.K., Hendry R.M., Singh V., Rose J.K., Seligman S.J., Klug B., et al. Live virus vaccines based on a vesicular stomatitis virus (VSV) backbone: Standardized template with key considerations for a risk/benefit assessment. Vaccine. 2016;34(51):6597–6609. doi: 10.1016/j.vaccine.2016.06.071. - DOI - PMC - PubMed
-
- Monath T.P., Fast P.E., Modjarrad K., Clarke D.K., Martin B.K., Fusco J., et al. rVSVΔG-ZEBOV-GP (also designated V920) recombinant vesicular stomatitis virus pseudotyped with Ebola Zaire Glycoprotein: Standardized template with key considerations for a risk/benefit assessment. Vaccine X. 2019;1 doi: 10.1016/j.jvacx.2019.100009. - DOI - PMC - PubMed
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources