Developing a global strategy for enhancing vaccine safety

The need for effective systems to monitor the safety of vaccines and to respond to safety issues in low-income and middle-income countries has been broadly recognized. ³ To respond to this demand, WHO is coordinating the development of a strategic plan. An early version of this plan, the “global vaccine safety blueprint,” was discussed by GACVS. The plan will: (i) assist all low-income and middle-income countries in developing at least a minimal capacity to effectively monitor vaccine safety and respond to safety signals, (ii) enhance the level of active surveillance of vaccine safety in countries that introduce new vaccines, and (iii) foster international collaboration and encourage strategic planning so that all vaccines receive adequate safety surveillance and that safety information is shared internationally.

GACVS identified several elements of the blueprint that could be strengthened. It is important that vaccine programmes evaluate vaccine safety as part of their assessments of benefits and risks. Therefore, developing the capacity to monitor the effectiveness of vaccines in preventing targeted diseases should also be a high priority. A monitoring system for vaccine safety should be designed to detect potential safety problems and respond to them rapidly. It is necessary to create and coordinate the capacity for appropriate epidemiological investigations to be undertaken in response to potential safety signals at country level or intercountry level. Several networks with the relevant capacities exist, and WHO will have a critical role in convening and coordinating these groups. In addition, because investigating safety issues requires close interaction with manufacturers, the blueprint should include a code of conduct to be followed during interactions with the pharmaceutical industry. It will also be important to ensure that a proportion of national budgets for vaccines include funding for assessing and investigating safety because these duties will be fundamental to sustaining the development of safety systems. Finally, because many advanced monitoring and investigational activities require access to patients’ information, the blueprint should promote implementation of regulations on data protection that will allow for secondary use of health-care data for public health purposes, including the sharing of data among countries.

The WHO Secretariat and collaborating experts are preparing a version of the draft strategic plan that will be available to all who are considered stakeholders in global vaccine safety and will take into account advice received from GACVS and other stakeholders. It is planned to release this draft during the second half of 2011.

³Global Advisory Committee on Vaccine Safety (GACVS), WHO secretariat. Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS. Expert Review of Vaccines, 2009, 8:705-716.

Full report of GACVS meeting of 15-16 June 2011, published in the WHO Weekly Epidemiological Record on 22 July 2011