Cross-posted from the January 2012 issue of GIN with thanks.
31/01/2012 from Madhav Balakrishnan, WHO HQ
The Global Network for Post-marketing Surveillance (PMS) of Vaccines was established by WHO in early 2008 with a primary objective to monitor the safety of WHO prequalified vaccines supplied through UN agencies. By 2011, twelve countries, Albania, Brazil, China, India, Iran, Kazakhstan, Mexico, Senegal, Sri Lanka, Tunisia, Uganda and Vietnam have been included in the network. These countries were trained in Vaccine Pharmacovigilance, on the methods of causality assessment for vaccine Adverse Event Following Immunization (AEFI) classification and the use of Vigiflow© (a software platform to report and upload AEFI cases to the WHO Programme for International Drug Monitoring, which is maintained by the Uppsala Monitoring Centre (UMC) in Sweden).
As of 31 December 2011, eight of the twelve countries in the Global PMS network were uploading AEFI case reports to the Uppsala Monitoring Centre (UMC) in Sweden, using the Vigiflow system. Reports pertaining to 6,099 AEFI have been uploaded into the WHO UMC database. Of these, 2,770 involved multiple vaccines. DTP vaccines were associated to the largest number (3,745) of adverse events. Most events related to DTP were reported from Iran (3,516) and Sri Lanka (187) both of which have well established AEFI surveillance systems.
With one more year for the project, the PMS Network has improved the reporting of AEFI for vaccines in most participating countries. Systems are being established to ensure harmonization of the surveillance and reporting systems, including case report forms, software systems, and type of AEFI reported. The network countries have identified the need for a more simple data processing tool that could be more specific for vaccines and that could be operated off-line given the internet limitations in many countries. Currently the WHO and UMC are exploring the prospects of creating a simpler tool based on the experience gathered.