Monitoring vaccine safety
At previous meetings1, 2, 3 the GACVS requested that global vaccine pharmacovigilance be strengthened, particularly within the context of the WHO Programme for International Drug Monitoring. Aspects in particular need of attention include prompt data transmission by countries, assurance of data quality, and the processing and analysis of data, including timely signal detection and action. As a result, a GACVS subgroup was formed to work closely with the secretariat to ensure that the initiative continues to move forward in a timely fashion.2 A report of the subgroup’s activities and the outcome of its 11 June 2007 meeting were presented to the full Committee. Most of the subgroup meeting was spent reviewing issues raised by the secretariat (emergency response to crises involving adverse events following immunization (AEFI); potential utility of invoking the International Health Regulations (IHR) as a way to facilitate WHO investigation of serious AEFI in different settings; and an initiative to develop a Global Vaccine Safety Datalink project). It was agreed that development of an emergency response protocol should be pursued, but that invoking the IHR to investigate AEFI should probably be employed only in rare and special circumstances; WHO will further deliberate on how this might be implemented before a final decision is made. Enthusiastic support was expressed for WHO participation in the Global Vaccine Safety Datalink project. The inclusion of vaccine pharmacovigilance sessions at 2 international meetings – the 4th Biennial Conference on Signal Detection and Interpretation in Pharmacovigilance (London, UK, 14–15 June 2007) and the 7th International Society of Pharmacovigilance (Bournemouth, UK, 21–24 October 2007) – was also highlighted.
- See No. 28, 2005, pp. 242–247.
- See No. 28, 2006 pp. 273–278.
- See No 3, 2007, pp. 18–24.