VPPAG consultation on Generic Preferred Product Profile for new vaccines: comments invited

Generic Preferred Product Profile for Vaccinesby Osman David Mansoor, UNICEF, and Souleymane Kone, WHO In June, the Vaccine Presentation and Packaging Advisory Group (VPPAG) completed a draft generic preferred product profile (gPPP) for vaccines. The VPPAG developed the document to be a reference for vaccines in the early stages of development, providing recommendations on formulation, presentation, labeling, and packaging to vaccine producers. In cases where evidence is insufficient to make a recommendation, the VPPAG outlines the work required to gather the evidence. The latest version of the gPPP is available on the VPPAG’s website. The document is currently being reviewed by the Technologies and Logistics Advisory Committee (TLAC) to the World Health Organization (WHO) for further review and consultation with industry and national and regional immunization officials. The need for a gPPP stems in part from the rich vaccine research and development pipeline and increasing availability of and financing for new vaccines that may result in a variety of products that could be administered via novel routes and delivery devices. The value of these future novel products will need to be weighed against the added complexity that they pose for national immunization programs. Many of the new vaccines now supported by the Global Alliance for Vaccines and Immunization were not developed specifically for developing country markets and come in new containers that have much higher packed volumes than the previous generation of vaccines—putting pressure on an already strained logistics and supply chain system and stretching the capacity of health workers who often receive little training, insufficient supervision, and unreliable compensation. In such an environment, products that are well-labeled, have inherent safety features, and are intuitive and easy to prepare and administer are far likelier to reach target populations. The gPPP is meant to be a starting point for discussion between industry and public health agencies in early phases of product development. As such, the generic profile does not replace preferred product profiles for specific vaccines. The VPPAG is also available as a resource for development of specific product profiles—to help weigh the trade-offs between product features taking into account the immunization program context and manufacturing constraints. To link back to the Optimize e-newsletter, click here.

Following a month long public consultation process, the Vaccine Presentation and Packaging Advisory Group (VPPAG) has released version 2.1 of the Generic Preferred Product Profile (gPPP). This version incorporates all comments received to date from a wide range of partners and stakeholders, including industry, NGOs, UN agencies and public health experts. The gPPP outlines a set of generic recommendations for future vaccines. The gPPP also includes a work programme which identifies areas in which more information is needed prior to a recommendation being made. VPPAG will now focus its efforts on gathering the necessary data to be able to make recommendations in these areas. As such, the gPPP remains in draft form, with a new version expected in 2010 as progress on the work programme is made. Simona Zipursky ##text##