As a member of the WHO Global Advisory Committee on Vaccine Safety (GACVS) Working Group on COVID-19 Vaccines Safety Preparedness, Dr Sonali Kochhar from Global Healthcare Consulting helped to develop the WHO Covid-19 vaccines: safety surveillance manual (https://www.who.int/publications/i/item/10665338400). This provides safety surveillance guidance for COVID-19 vaccine introduction for governments, global, regional and national staff from immunization programmes, regulatory authorities, ministries of health, pharmacovigilance centres and vaccine manufacturers. The manual is being utilized globally for COVID-19 vaccine deployment.
Global Healthcare Consulting led the development of standardized templates with key considerations for the benefit-risk assessment 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.