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. 2020 Sep 3;38(39):6184-6189.
doi: 10.1016/j.vaccine.2020.07.028. Epub 2020 Jul 31.

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

Sonali Kochhar  1 , Jean-Louis Excler  2 , Denny Kim  3 , James S Robertson  4 , Patricia E Fast  5 , Richard C Condit  6 , Stephen Drew  7 , David Wood  4 , Marc Gurwith  8 , Bettina Klug  9 , Mike Whelan  10 , Najwa Khuri-Bulos  11 , Tamala Mallett Moore  12 , Emily R Smith  8 , Robert T Chen  8 ; Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG). Electronic address: brightoncollaborationv3swg@gmail.com
Affiliations

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

Sonali Kochhar et al. Vaccine. .

Abstract

Inactivated viral vaccines have long been used in humans for diseases of global health threat and are now among the vaccines for COVID-19 under 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 inactivated viral vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of the vaccine platform. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed inactivated viral vaccines.

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

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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.

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