TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
  1. Moderator
  2. Vaccines and delivery technologies
  3. Friday, 01 May 2009
Public Sector and Industry: Working Together to Better Meet Developing Country Needsby Debra D. Kristensen, Senior Technical Officer and Policy Advisor, PATH, and Christopher B. Nelson, Senior Director, Medical Affairs and Policy, Merck & Co, Inc. Originally established in 2007 by the GAVI Alliance to provide presentation and packaging guidance for rotavirus and pneumococcal vaccines, the Vaccine Presentation and Packaging Advisory Group (VPPAG), now hosted by the World Health Organization (WHO) and chaired by The United Nations Children's Fund has a broader mandate to discuss preferred product profiles for vaccines currently under development. The revitalized VPPAG has begun the task of developing a generic preferred product profile for new vaccines that are destined for use in public-sector immunization programs inlow-resource settings. The group is also advancing a specific preferred product profile for second-generation human papillomavirus (HPV) vaccines. Ideally, the product profile documents will facilitate the provision of vaccines in packaging and presentations that are appropriate for use in low-resource, public-sector programs. Issues to consider include: type of container, doses per container, packaging and container packed volumes, recommended storage temperatures, and labeling. Until recently, the public sector has not routinely defined the preferred profiles of future vaccine products in a timely way. The group aims to influence the process as early as possible in a vaccine’s development life cycle as it is costly to make substantial changes in vaccine packaging and presentation once the product is beyond preclinical development. For example, including additives to improve the thermostability or to serve as a preservative for multidose formats of a vaccine currently commercialized or in late-stage development would require repeating clinical trials, licensure, and WHO prequalification steps, all of which are time-consuming and can be extremely costly. The VPPAG is the only forum where vaccine industry and immunization program stakeholders interact to discuss details regarding vaccine product characteristics and their impact on immunization programs. The group’s new Terms of Reference, draft HPV vaccine profile, and a profile previously completed for pneumococcal vaccine are available for download on the VPPAG website. We invite you to comment on or post a question relating to this article by clicking the “post reply” button on this page. You will have to log in or register, but the process is very simple. To link back to the Optimize e-newsletter, click here.


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