TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
  1. Optimize.WHO
  2. Vaccines and delivery technologies
  3. Wednesday, 06 February 2013
by Osman Mansoor, UNICEF, and Debra Kristensen, PATH As newer vaccines are introduced in low-income countries, immunization programs are facing difficult challenges related to proper storage, transport, tracking, and delivery of vaccines. While some of these challenges are not new, the importance of addressing them has become critical in recent years, given the increased volume of vaccines that must now be distributed and managed by logisticians and health workers. Some problems can be addressed by purchasing additional, high-quality, cold chain equipment. Other problems can be addressed by adding immunization personnel to payrolls and providing them with opportunities for supplementary training. However, such remedies are expensive and some issues can be best addressed at the earliest stages of vaccine development, where decisions relating to packaging, formulation, labeling, and presentation can make vaccines much better suited for travel and delivery in low-resource environments. The Vaccine Presentation and Packaging Advisory Group (VPPAG) was founded in 2007 and has become an important forum for discussion about how vaccine products can be designed to suit the needs of developing countries. The VPPAG includes industry representatives from the International Federation of Pharmaceutical Manufacturers and Associations and Developing Country Vaccine Manufacturers’ Network as well as experts from the World Health Organization’s Expanded Programme on Immunization and Quality, Safety, and Standards groups; PATH; John Snow, Inc; the US Centers for Disease Control and Prevention; the United Nations Children’s Fund’s Supply and Program divisions; and the GAVI Alliance. To inform decisions, data are gathered and analyzed to create draft specifications for vaccine presentations and packaging. Then the group moves toward consensus on the specifications via written feedback and monthly telephone conference calls. Discussions within the VPPAG have resulted in meaningful changes in the way vaccines are made and packaged, making them more suited for developing-country settings. For example, after learning more about cold chain storage space limitations, a rotavirus vaccine manufacturer reformulated the vaccine to require 83 percent less storage space per dose. The most significant changes in vaccine products, however, are less visible because they are happening earlier in the vaccine development process, which is when a series of important decisions are made before vaccines are tested in trials and approved by regulatory agencies. For both vaccine manufacturers and public health experts, this early focus has been a relief, as it allows time for ample dialogue and discussion. In just five years, the VPPAG has provided technical input into a target product profile for pneumococcal conjugate vaccines and is working on a similar target product profile for human papillomavirus vaccine. The group has also published its first generic preferred product profile (gPPP) for vaccines intended for use in public-sector immunization programs in low-resource settings. The gPPP provides guidance on key manufacturing decisions in four domains: formulation, presentation, labeling, and packaging. The gPPP also highlights areas of interest that lack adequate data and require further investigation. The gPPP has helped shape policy as well. Drawing on the gPPP, WHO developed a set of guidelines called the Programmatic Suitability of Vaccines Candidates for WHO Prequalification (PSPQ). The PSPQ guidelines help the international community assess whether a new vaccine product satisfies the mandatory and critical requirements for programmatic suitability and defines the preferred characteristics of future vaccines. WHO has been using the PSPQ guidelines in the prequalification process since January 2012. The gPPP is updated regularly as new information and research is available. Other activities are discussed as needs arise. The VPPAG is currently examining how to best use limited space on vaccine labels, for example, and looking into optimal packaging sizes. To help improve vaccine products for developing-country use, the VPPAG is interested in hearing from newsletter readers and TechNet subscribers what kind of packaging and presentation challenges are being encountered in developing countries. To participate in this conversation, respond to this forum post, or if you are reading a PDF copy of this newsletter, please go to TechNet 21.org and visit the Vaccine presentation, packaging and wastage forum. Note: To submit a post on TechNet you need to be logged in. If you do not have one already, it’s easy tocreate an account. You can learn more about the VPPAG by reading the following article in the January 2013 edition of the WHO Bulletin: http://www.who.int/bulletin/volumes/91/1/12-110700.pdf


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