Covid-19 vaccines: safety surveillance manual
Overview
The 42nd Global Advisory Committee on Vaccine Safety (GACVS) virtual meeting in May 2020 addressed pharmacovigilance preparedness for the launch of the future COVID-19 vaccines. One of their recommendations was that infrastructure and capacity for surveillance of the safety of COVID-19 vaccines should be in place in all countries and existing infrastructure be reactivated and engaged before a vaccine is introduced. This will require local, national, regional and global collaboration. Countries should include preparedness plans for COVID-19 vaccine safety in their overall plans for vaccine introduction, building on WHO guidance. The COVID-19 vaccine safety guidance manual has been developed upon recommendation and guidance of GACVS members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
Second edition. Updated to include the module on COVID-19 vaccines in pregnant and breastfeeding women.
For ease of use, the manual is available in a compiled form and in several separate modules that can be consulted individually. For each module, specific training material is also available to facilitate implementation.
Annexes
COVID-19 Vaccines: safety surveillance manual_Executive summary
COVID-19 Vaccines: safety surveillance manual_Introduction
COVID-19 Vaccines: safety surveillance manual_ AEFIs
COVID-19 Vaccines: safety surveillance manual_AESIs
COVID-19 Vaccines: safety surveillance manual_Communication
COVID-19 Vaccines: safety surveillance manual_Data management
COVID-19 Vaccines: safety surveillance manual_Description
COVID-19 Vaccines: safety surveillance manual_Pharmaceutical industry
COVID-19 Vaccines: safety surveillance manual_Regulatory reliance
COVID-19 Vaccines: safety surveillance manual_Stakeholders
COVID-19 Vaccines: safety surveillance manual_Surveillance systems
COVID-19 Vaccines: safety surveillance manual_COVID-19 vaccines in pregnant and breastfeeding women
Training material
Training material_COVID-19 vaccines safety surveillance manual_ AEFI
Training material_COVID-19 vaccines safety surveillance manual_ AESI
Training material_COVID-19 vaccines safety surveillance manual_ Communication
Training material_COVID-19 vaccines safety surveillance manual_ Data management
Training material_COVID-19 vaccines safety surveillance manual_ Description
Training material_COVID-19 vaccines safety surveillance manual_ Pharmaceutical industry
Training material_COVID-19 vaccines safety surveillance manual_ Regulatory reliance
Training material_COVID-19 vaccines safety surveillance manual_ Stakeholders
Training material_COVID-19 vaccines safety surveillance manual_ Surveillance systems
