Standardized templates for the benefit-risk assessment of COVID-19 vaccine candidates endorsed by WHO Global Advisory Committee on Vaccine Safety (GACVS)

Dr Sonali Kochhar led the development of standardized templates with key considerations for the benefit-risk assessment of COVID-19 vaccine candidates has been led by. The templates have been developed for all the platforms being utilized for COVID-19 vaccines (including nucleic acid (RNA and DNA), protein, inactivated viral and live attenuated viral vaccines) and been published.

The templates were presented to WHO SAGE and Global Advisory Committee on Vaccine Safety (GACVS) members, and at its May 27-28, 2020 meeting, GACVS recommended that “any review of the safety of new vaccines be based on the appropriate Brighton Collaboration standardized templates for benefit-risk assessment of vaccines (by technology platforms) when available and approved, which offer a structured approach to evaluating safety. GACVS advised that templates be pilot-tested in a number of scenarios and then adapted accordingly.”

 The templates are currently being utilized by vaccine developers, including those funded by  Coalition for Epidemic Preparedness Innovations (CEPI), to evaluate and communicate the benefit-risk of COVID-19 vaccine candidates.