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 Jul 31;38(35):5734-5739.
doi: 10.1016/j.vaccine.2020.06.044. Epub 2020 Jul 9.

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

Sonali Kochhar  1 , Denny Kim  2 , Jean-Louis Excler  3 , Richard C Condit  4 , James S Robertson  5 , Stephen Drew  6 , Mike Whelan  7 , David Wood  5 , Patricia E Fast  8 , Marc Gurwith  9 , Bettina Klug  10 , Najwa Khuri-Bulos  11 , Emily R Smith  12 , Robert T Chen  9 ; Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG)
Affiliations
Review

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

Sonali Kochhar et al. Vaccine. .

Abstract

Several protein 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 protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines.

Keywords: Benefit-risk; Brighton Collaboration; CEPI; COVID-19; Peptide; Protein; Recombinant; Safety; Template; Vaccine.

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. 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: 10.1016/S0264-410X(02)00449-8. - DOI - 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
    1. 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;1:100009. doi: 10.1016/j.jvacx.2019.100009. - DOI - PMC - PubMed

Publication types

MeSH terms