Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Nov 17;38(49):7708-7715.
doi: 10.1016/j.vaccine.2020.08.009. Epub 2020 Sep 6.

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines

Affiliations
Review

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of viral vector vaccines

Richard C Condit et al. Vaccine. .

Abstract

Many of the vaccines under development for COVID-19 involve the use of viral vectors. The Brighton Collaboration Benefit-Risk Assessment of Vaccines by Technology (BRAVATO, formerly the Viral Vector Vaccine Safety Working Group, V3SWG) working group has prepared a standardized template to describe the key considerations for the benefit-risk assessment of viral vector vaccines. This will facilitate key stakeholders to anticipate potential safety issues and interpret or assess safety data. This would also help improve communication and public acceptance of licensed viral vector vaccines.

Keywords: Benefit-risk; Brighton Collaboration; CEPI; COVID-19; Safety; Template; Vaccine; Vector; Viral; Virus.

PubMed Disclaimer

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

    1. Thanh Le T, Andreadakis Z, Kumar A, Gómez Román R, Tollefsen S, Saville M et al. The COVID-19 vaccine development landscape [published online ahead of print, 2020 Apr 9]. Nat Rev Drug Discov. 2020;10.1038/d41573-020-00073-5. doi:10.1038/d41573-020-00073-5 - PubMed
    1. 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. doi.org/10.1016/S0264-410X(02)00449-8. - PubMed
    1. Chen R.T., Carbery B., Mac L., Berns K.I., Chapman L., Condit R.C., et al. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) Vaccine. 2015;33(1):73–75. doi: 10.1016/j.vaccine.2014.09.035. - DOI - PMC - PubMed
    1. 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
    1. 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

Publication types