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

Global Healthcare Consulting led the development of standardized templates with key considerations for the benefit-risk assessmentĀ of COVID-19 vaccine. 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 in Vaccine. (https://www.sciencedirect.com/science/article/pii/S0264410X20308306?via%3Dihub; https://www.sciencedirect.com/science/article/pii/S0264410X20309440?via%3Dihub; https://www.sciencedirect.com/science/article/pii/S0264410X20307891?via%3Dihub; https://www.sciencedirect.com/science/article/pii/S0264410X20310306, https://brightoncollaboration.us/bravato/).

The templates have been endorsed by the WHO Global Advisory Committee on Vaccine Safety (GACVS) and are being utilized by COVID-19 vaccine developers to evaluate and communicate the benefit-risk of COVID-19 vaccine candidates, pharmacovigilance and risk communication.