International drug monitoring

The report ³ of the WHO Consultation on global monitoring of adverse events following immunization (AEFI) held in Geneva on 9–10 January 2006 at the request of the GACVS ⁴ was presented and discussed by the Committee. The recommendations were endorsed, with emphasis placed on ensuring that vaccine pharmacovigilance is strengthened within the WHO Programme for International Drug Monitoring with respect to data transmission by countries, assurance of data quality, and the processing and analysis of data, including timely signal detection and action. A working subgroup of 6 GACVS members was formed to ensure that the initiative continues to move forward in a timely fashion. Terms of reference and an action plan will be developed and initiated by the working group in conjunction with the WHO secretariat in the coming months and a progress report submitted to GACVS at its November 2006 meeting.

³ See No. 27, 2006, pp. 261-265.

⁴ See No. 28, 2005, pp. 242-247.

Full report of GACVS meeting of 6-7 June 2006, published in the WHO Weekly Epidemiological Record on 14 July 2006

The Committee considered a presentation of the work of the Uppsala Monitoring Centre (UMC) in Sweden, a WHO Collaborating Centre for International Drug Monitoring, given by the Director of the UMC. Although the UMC had made much progress in analysing drug-related adverse events, there are limitations in the UMC programme with respect to vaccine-related reports. These limitations include the comparatively small number of and generally limited information in the reports reaching the UMC, difficulties inherent in dealing with signals using tools developed to address non-vaccine drug-related issues, and the problems that have been experienced in communicating signals to national vaccine authorities.

GACVS proposed that WHO consider the need for improved monitoring and analysis of vaccine-related adverse events globally. The Committee suggested that WHO convene an in-depth consultation with a view to developing the current system further for detecting, reporting, analysing and communicating vaccine-related adverse events. The consultation would include international experts in drug safety, drug regulation and vaccine safety, including scientists from industry.

Full report of GACVS meeting of 9-10 June 2005, published in the WHO Weekly Epidemiological Record on 15 July 2005