Protein Vaccines: Standardized Template for Collection of Key Information for Benefit-Risk Assessment

Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration’s Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO), as part of the Safety Platform for Emergency vACcines (SPEAC) project, has therefore prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will facilitate key stakeholders to anticipate potential safety issues and interpret or assess safety data. This would help improve communication and public acceptance when the protein vaccines are licensed. The Coalition for Epidemic Preparedness Innovations (CEPI) and other key stakeholders could use the template to evaluate and communicate the benefit-risk of vaccines using these protein vaccine platforms. 

BRAVATO (formerly V3SWG) had earlier published a standardized template describing the key considerations for a risk-benefit assessment of new viral vaccines and their vectors. The template has been used for the standardized risk-assessment of several new viral vector vaccines, including some targeting EbolaThe WHO Global Advisory Committee on Vaccine Safety (GACVS) endorsed the use of the template for other new candidate Ebola vaccines “as it is a structured approach to vaccine safety”.

Individuals who are interested in joining BRAVATO or participating in affiliated activities are welcome to contact for possible membership.

Below are links to the latest versions of the protein template, in two forms: 1) the full “publication version”, including all introductory text and formatted for publication; and 2) the shorter and more easily updatable “website version”, formatted for easy completion and with extraneous text removed.

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