Update: Target Product Profile (TPP) for the Pneumococcal AMC endorsed by the Independent Assessment Committee (IAC)
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The Target Product Profile (TPP) for the Pneumococcal Advanced Market Commitment (AMC) was developed by the World Health Organization at the request of the AMC Secretariat. On December 11, 2008 the Independent Assessment Committee (IAC) officially endorsed the TPP, making it the definitive guidelines for determining the characteristics of AMC-eligible pneumococcal conjugate vaccines. The TPP sets out the standards a vaccine must meet in order to be eligible for sale under the AMC program and the IAC determines whether a candidate vaccine meets the TPP specifications. To meet the TPP, a vaccine must meet or exceed 13 requirements. Specific requirements in the TPP relate to the projected public health impact, vaccine safety, and suitability of the product for use in developing country health systems. Vaccine manufacturers should use the TPP to guide their decisions in relation to vaccine eligibility. The AMC will be operative when all relevant legal agreements have been signed with AMC donors; at which time the IAC will be legally mandated to oversee various aspects of the AMC. A central component of the TPP conveys the serotype formulations for pneumococcal conjugate vaccines. A “codebook” of serotype information is provided in support of this requirement. This codebook was developed through the Pneumococcal Global Serotype Project (GSP) a project sponsored by the GAVI Alliance and conducted by PneumoADIP at the Johns Hopkins Bloomberg School of Public Health. Version 1 of the GSP was presented to the TPP in September 2007. Version 2 of the GSP forms the definitive metrics to assess whether a pneumococcal vaccine meets the pneumococcal AMC TTP for regional vaccine serotype coverage. Briefings by the PneumoADIP for manufacturers and contributors are being planned for early 2009. If you wish to take part please contact Dr. Hope Johnson at hjohnson@jhsph.edu. |
