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

Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) 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. 

The V3SWG had earlier published a standardized template describing the key considerations for a risk-benefit assessment of new viral vectors or their vaccines. The template has been used for the standardized risk-assessment of several new viral vector vaccines, including some targeting Ebola (1567). The 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” (89).

Please note that Version 2, an update from the original Version 1 of the V3SWG viral vector template, is now available; as is a translation document listing changes between Version 1 and Version 2 of the template and the rationale for the changes.

Individuals who are interested in joining the V3SWG or participating in affiliated activities are welcome to contact the working group secretariat (brightoncollaborationv3swg@gmail.com) for possible membership in the V3SWG.

Below are links to the latest versions of the 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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