Global network for post-marketing surveillance and AEFI monitoring
GACVS was presented with an update on the progress of the global network for post-marketing surveillance (PMS Network) of adverse events following immunization (AEFI), a WHO-led pilot project aimed at enhancing the monitoring, reporting and sharing of vaccine safety data for countries introducing new prequalified vaccines.
Started in 2007, the aim of the project was to establish a network of at least 20 countries that have introduced newly prequalified vaccines, to stimulate the reporting of AEFI to a central database (Vigibase) located at the WHO Collaborating Centre for international drug monitoring (Uppsala Monitoring Centre; UMC), in Sweden. By 2011, 12 countries had been included in the network: Albania, Brazil, China, India, Islamic Republic of Iran, Kazakhstan, Mexico, Senegal, Sri Lanka, Tunisia, Uganda, and Viet Nam. Countries enrolled in the network have had a baseline evaluation of their national vaccine regulatory process and their AEFI surveillance system capability. In addition, countries were trained in the use of Vigiflow, a software platform to report and upload AEFI cases to UMC, and on the methods of causality assessment for vaccine AEFI classification.
The PMS Network has improved the reporting of AEFI for vaccines in most participating countries. Participating countries have recognized the need for and benefits of the network, but operational challenges exist. Due to lack of harmonization of current surveillance and reporting systems, including case report forms, software systems, and type of AEFI reported, the heterogeneous data accumulated at UMC is likely to provide only limited vaccine safety signals globally. Even though the network primarily focused on newly prequalified vaccines, data collected relates mainly to other, more traditional, vaccines prequalified or not. In addition, the network countries have identified the need for a simpler data processing tool that could be more specific for vaccines and that could be operated offline given the internet connectivity limitations in most countries. GACVS also recognized the limited value of spontaneous reports to generate comprehensive data that can later be used to determine vaccine safety/risk profiles via standard methods. Nevertheless, spontaneous reports of AEFI are important to generate signals for vaccine safety monitoring systems and can inform the design and conduct of careful epidemiological studies to assess potential risks.
GACVS also acknowledges the importance of a global and centralized database for all drugs and vaccines. A more comprehensive and active database for vaccines could allow countries, regions, and investigators to detect global vaccine safety signals that could go unrecognized at a country level, as well as provide background data on common and uncommon adverse events. UMC has the capability and know-how to provide the data infrastructure needed for such an endeavour. UMC could develop a simple data entry tool, based on a minimal dataset, to serve the perceived needs of lower and middle income countries.
As part of the PMS Network activities, a dictionary for prequalified vaccines has been developed. This vaccine dictionary is considered an essential tool for the countries and AEFI systems to determine the components of vaccines that could be implicated in serious or relevant adverse events. It is therefore paramount to expand this dictionary to ensure the inclusion of other licensed vaccines in use, transparent participation from manufacturers, and free availability to countries that need it most.
GACVS also emphasized the need for strengthening AEFI surveillance systems at country and regional levels to improve the current reporting of safety signals following immunization. The development of regional networks could be the next step towards improving the reporting of AEFI and vaccine safety signals at the global level.