Monitoring vaccine safety
At previous meetings(1, 2), 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 data transmission by countries, assurance of data quality, and the processing and analysis of data, including timely signal detection and action. As a result of the above-mentioned request, a subgroup of 6 GACVS members 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 was presented to the full committee. The specific terms of reference of this subgroup are: to advise WHO regarding the development of a high-quality system for reporting, detecting, analysing and communicating adverse events following immunization (AEFI) at a global level; and to advise WHO, the WHO Collaborating Centre for International Drug Monitoring based in Uppsala, Sweden, (known as the Uppsala Monitoring Centre or UMC) and Member States on specific issues relating to implementing activities aimed at achieving the first goal. To achieve this goal, specific objectives and deliverables have been agreed upon, and these will be undertaken by the subgroup over the next couple of years. A high priority will be to raise the profile and awareness of pharmacovigilance within the immunization community using existing WHO networks and other means.
A report on a visit to Uppsala by representatives of the secretariat and subgroup was presented. Key areas for action include: (i) increasing vaccine-specific expertise at the UMC through the creation of a position dedicated to vaccine safety; (ii) assisting in the recruitment of additional volunteer expert reviewers who can assess potential vaccine safety signals; and (iii) engaging scientific experts to consider what types of methods are best for detecting vaccine safety signals. Deficiencies with respect to vaccines in the anatomical therapeutic chemical and defined daily dose (ATC/DDD) classification and WHO’s Drug Dictionary need to be addressed. A programme of work is planned to review and propose modifications appropriate to vaccines to the ATC/DDD; these proposals will be presented to the WHO Collaborating Centre for Drug Statistics Methodology, Oslo, Norway, at its forthcoming meeting.
- See No. 28, 2005, pp. 242-247
- See No. 28, 2006, pp. 273-278