Abstract
Through its Global Action Plan for Influenza Vaccines (GAP), the World Health Organization (WHO) in collaboration with the United States Department of Health and Human Services has produced a checklist to support policy-makers and influenza vaccine manufacturers in identifying key technological, political, financial, and logistical issues affecting the sustainability of influenza vaccine production. This checklist highlights actions in five key areas that are beneficial for establishing successful local vaccine manufacturing. These five areas comprise: (1) the policy environment and health-care systems; (2) surveillance systems and influenza evidence; (3) product development and manufacturing; (4) product approval and regulation; and (5) communication to support influenza vaccination. Incorporating the checklist into national vaccine production programmes has identified the policy gaps and next steps for countries involved in GAP’s Technology Transfer Initiative. Lessons learnt from country experiences provide context and insight that complement the checklist’s goal of simplifying the complexities of influenza prevention, preparedness, and vaccine manufacturing.
Highlights
The World Health Organization (WHO) Global Action Plan for Influenza Vaccines (GAP) was developed in order to address challenges to sustainable influenza vaccine production and uptake in developing countries
WHO directly supports 14 developing countries to establish or expand influenza vaccine manufacturing. This support is provided as part of a larger WHO mandate born within the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI) [1], approved in 2008 by Member States
The use of the checklist has proven useful in the identification of policy gaps and opportunities for better coherence of policies, as a tool for policy-makers and manufacturers to address the complexities of influenza prevention and preparedness and vaccine manufacturing
Summary
Over the last 10 years, through the implementation of GAP, WHO has distilled expertise and experiences into a checklist designed to support policy-makers and manufacturers in developing countries who are seeking to improve influenza vaccine sustainability. This checklist addresses the following areas: (1) the policy environment and health-care systems; (2) surveillance systems and influenza evidence; (3) product development and manufacturing; (4) product approval and regulation; and (5) communication to support influenza vaccination. These conditions are outlined below (see Annex 1: Supplementary material)
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