New vaccine introductions: assessing the impact and the opportunities for immunization and health systems strengthening.

In 2010, global immunization partners posed the question, "Do new vaccine introductions (NVIs) have positive or negative impacts on immunization and health systems of countries?" An Ad-hoc Working Group was formed for WHO's Strategic Advisory Group of Experts on immunization (SAGE) to examine this question through five approaches: a published literature review, a grey literature review, in-depth interviews with regional and country immunization staff, in-depth studies of recent NVIs in 3 countries, and a statistical analysis of the impact of NVI on DTP3 coverage in 176 countries. The WHO Health System Framework of building blocks was used to organize the analysis of these data to assess potential areas of impact of NVI on health systems. In April 2012, the Ad-hoc Working Group presented its findings to SAGE. While reductions in disease burden and improvements in disease and adverse events surveillance, training, cold chain and logistics capacity and injection safety were commonly documented as beneficial impacts, opportunities for strengthening the broader health system were consistently missed during NVI. Weaknesses in planning for human and financial resource needs were highlighted as a concern. Where positive impacts on health systems following NVI occurred, these were often in areas where detailed technical guidance or tools and adequate financing were available. SAGE supported the Ad-hoc Working Group's conclusion that future NVI should explicitly plan to optimize and document the impact of NVI on broader health systems. Furthermore, opportunities for improving integration of delivery of immunization services, commodities, and messages with other parts of the health system should be actively sought with the recognition that integration is a bidirectional process. To avoid the gaps in planning for NVI that can compromise existing immunization and health systems, donors and partners should provide sufficient and timely support to facilitate country planning. Areas for future research were also identified. Finally, to support countries in using NVI as an opportunity to strengthen immunization and health systems, the WHO guidance for countries on new vaccine introduction is being updated to reflect ways this might be accomplished. Published by Elsevier Ltd.