Implementing the Global Vaccine Safety Blueprint
At the 24th meeting of GACVS, the Global Vaccine Safety Blueprint was presented in order to obtain committee input into this strategic plan. The wide-ranging discussions are documented in previous reports. In September 2011, a number of stakeholders, including GACVS members, met in Geneva to discuss this Blueprint. The purpose of this GACVS session was to review the Global Vaccine Safety meeting and the Blueprint discussions, which occurred at the SAGE meeting. The expected outcome was to clarify the role of GACVS in implementation of the Blueprint through a Global Vaccine Safety Initiative (GVSI).
GACVS members who attended the meeting commented that the Blueprint provides a common platform for all stakeholders and recognized the clear need to strengthen vaccine safety surveillance in low- and middle-income countries. The Blueprint is very ambitious and is likely to be achievable only by step-wise increments and prior-itization of goals. It was thought that developing novel pilot or demonstration projects to achieve surveillance goals may be more achievable in terms of resources and attraction of funding.
GACVS concurs with SAGE in emphasizing the critical importance of country ownership in monitoring vaccine safety and responding to safety concerns. SAGE also suggested focusing the Vision Statement on vaccine pharmacovigilance and listing specific objectives. While this focus was recognized as important in order to provide specific direction to the Blueprint, it would be important that vaccine safety monitoring was not seen in isolation from other surveillance systems and data. There was also general agreement that methods of surveillance that are alternative and complementary to passive surveillance should be evaluated. The importance of surveillance for burden of vaccine-preventable disease is a critical component of a full evaluation of vaccine risks and benefits.
The proposed terms of reference for the management structure of the GVSI were presented. GACVS members recommended that this structure should be designed to deliver the programmatic changes required of the GVSI. In particular, the lines of reporting and evaluation and the relationship with WHO immunization advisory bodies including GACVS and SAGE should be defined such that the proposed structure aligns its efforts with those of other WHO advisory groups. GACVS identifies its main roles in supporting the GVSI in relation to the development of safety communication plans, the deve-lopment of internationally harmonized tools, and the provision of international expert advice. GACVS could also have a role in prioritization of GVSI activities and could also review and guide any demonstration surveillance projects.
WHO and its partners should lead the Blueprint implementation. It should be aligned with other related WHO capacity-building efforts. This includes in particular the strengthening of immunization programmes and national regulatory authorities, together with the deve-lopment of national expert advisory bodies. SAGE suggested that a mechanism be developed to enable prioritization of both activities and countries in the implementation of the Blueprint and SAGE invited the GAVI Alliance and other partners to support this implementation.1
- See No. 1, 2012, pp. 1–16.