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This COVID-19 vaccine safety surveillance manual has been developed upon recommendation and guidance of Global Advisory Committee on Vaccine Safety (GACVS) members, as well as by experts incorporating current and available information critical to all stakeholders when COVID-19 vaccines will be introduced.
This manual provides relevant guidance prior to, during and after COVID-19 vaccine introduction for governments, global, regional and national staff from immunization programmes, regulatory authorities, partners and pharmacovigilance centres as well as marketing authorisation holders.
The manual comprises the following modules:
- COVID-19 vaccines: description and general safety considerations for implementation
This module outlines the different COVID-19 vaccines that are being developed, their platforms, technologies, development and licensing status, and their unique safety features and potential risks. It also highlights the safety implications for implementing immunization programmes for priority target populations. - Stakeholders for safety surveillance of COVID-19 vaccines
This module lists the various stakeholders, their roles and responsibilities in COVID-19 vaccine safety surveillance and pharmacovigilance, at the global, regional and national levels. It also provides guidance on how the stakeholders could collaborate to ensure the efficient handling of COVID-19 vaccine safety surveillance and pharmacovigilance. - Establishing COVID-19 vaccine safety surveillance systems
This module provides a list of the minimum requirements that should be in place to effectively monitor and manage COVID-19 vaccine safety issues and the resources required at global, regional and national levels in terms of tools, techniques, technologies and guidance. It defines what is meant by pharmacovigilance preparedness, and provides guidance for the measurement of preparedness, planning and prioritization. - Responding to adverse events following immunization This module outlines the minimum approaches that countries should have in place for responding to adverse events following COVID-19 immunization also the additional approaches that countries with more resources can undertake. It describes the practical differences for establishing COVID-19 vaccine safety surveillance system based on the types of vaccine platforms, different population profiles, handling high levels of reporting and the need to anticipate new events.
- Responding to adverse events of special interest
This module introduces the concept of adverse events of special interest which is a novel entity for many countries and regulatory agencies. It provides guidance on the selection and definition of these events. The need to prepare data on background rates of adverse events of special interest is emphasized. - Data management systems for COVID-19 vaccine safety surveillance
The module describes the different approaches and options available to collect data using the tools available (some of which are still under development), the routing, timelines and the activities to be done at various levels when processing the data and generating information for action. It presents an overview of the approaches undertaken by countries and their efforts to share vaccine safety and pharmacovigilance data. Guidance is provided to show how indicators to measure the functionality of data management systems and the quality of the pharmacovigilance could help programme managers at national, province and district levels. - Engaging with the pharmaceutical industry on COVID-19 vaccine safety
This module describes the essential role played by the private sector, particularly the pharmaceutical industry, in the development and introduction of vaccines, as well as in on-going pharmacovigilance activities to ensure efficacy, quality and safety throughout the vaccines’ life cycle. The module will provide guidance on transparent collaboration between the public and private sectors to ensure the safe and effective deployment of COVID-19 vaccines. - Regulatory reliance and work-sharing
This module provides definitions of regulatory reliance and work-sharing and presents some examples of how these approaches have been used. How these approaches could be used for developing COVID-19 vaccine safety surveillance systems, particularly in resource-poor settings, are outlined. - COVID-19 vaccine safety communication
This module provides guidance on communicating about COVID-19 vaccine safety from a programme perspective. It includes a description of factors that influence people's perceptions of vaccine safety; case studies of past experiences with previous pandemics or vaccine safety issues; a synthesis of evidence and recommendations for communication from risk communication; hypothetical scenarios that apply these recommendations to the COVID-19 vaccine context; and criteria for prioritising responses to vaccine safety issues.