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Dear partners and colleagues, Welcome to the September issue of Rotavirus Update. This summer was marked by exciting developments in our work with partners to bring rotavirus vaccines to developing countries. For the first time, the GAVI Alliance invited eligible countries in the Latin America and European regions to apply for support to introduce rotavirus vaccines. And studies to evaluate safety and efficacy in Africa and Asia are well underway: several African sites have completed enrollment, and additional sites in Africa and Asia are making steady progress recruiting participants. It is indeed heartening to see how the vision of GAVI’s Accelerated Development and Introduction Plans is becoming a reality. We look forward to a productive time ahead, working with our many partners, including national governments considering rotavirus vaccine introduction, clinical trial investigators, and strategic partners at the World Health Organization (WHO) and US Centers for Disease Control and Prevention (CDC).Together, we will continue to accelerate access to this lifesaving intervention. Sincerely, John R. Wecker, PhD Director, PATH Rotavirus Vaccine Program |
September 2007 In this Issue WHO updates position paper on rotavirus vaccines Updates to GAVI guidelines advance introduction planning for rotavirus vaccines First participant enrolled in Kenya vaccine trial PATH hosts experts to catalyze renewed interest in diarrheal disease control |
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WHO updates position paper on rotavirus vaccines Taking into account the latest disease burden estimates and country experiences, WHO recently published an important position paper on rotavirus disease and vaccines. While recommending introduction in regions where vaccine efficacy data has demonstrated the public health value of rotavirus vaccines, WHO also noted the need for studies on safety and efficacy in Africa and Asia—which PATH is conducting in partnership with Merck & Co., Inc., and GSK Biologicals—before issuing a global recommendation. The updated position paper also encourages an integrated approach to diarrheal disease control in developing countries, in which rotavirus vaccines will play an essential role. Updates to GAVI guidelines advance introduction planning for rotavirus vaccines With a recent revision to guidelines for country support, the GAVI Alliance officially added rotavirus vaccines to the list of interventions available for eligible countries in Latin America and Europe. Rotavirus has also been added to the Vaccine Product Selection Menu, a guide for national immunization managers, on GAVI’s website. Formalizing the availability of rotavirus vaccines is a significant milestone toward introduction in some of the world’s poorest countries. Application materials on the GAVI website also provide guidance on calculating vaccine co-financing rates for both RotaTeq® and Rotarix®. Though RotaTeq® is administered in three doses as compared to the two-dose series for Rotarix®, GAVI will apply an adjustment factor when a country chooses to introduce RotaTeq® so that co-pay amounts for the two vaccines are the same. First participant enrolled in Kenya vaccine trial Kenyan investigators participating in the Phase 3 clinical trial to study safety and efficacy of RotaTeq® enrolled their first participant in July, and more than 200 infants have since been entered into the study. With this milestone, all three African countries participating in the trial—Ghana, Mali, and Kenya—have sites up and running. Data from these studies and others that PATH and rotavirus vaccine manufacturers are carrying out in Asia and additional African countries will inform WHO’s position on global rotavirus vaccine introduction and will set the stage for future GAVI support. Enrollment is now complete for the Phase 3 safety and efficacy trial of GSK’s Rotarix® vaccine in Africa. Investigators will follow participants through one year of age to assess the occurrence of severe rotavirus gastroenteritis episodes; extended followup past one year of age will determine how well the vaccine continues to protect. Later this month, partners will come together for investigators’ meetings in South Africa and Malawi to review plans for extended follow-up and train field staff. PATH hosts experts to catalyze renewed interest in diarrheal disease control Global experts considered strategies to generate awareness and resources to re-prioritize diarrheal disease control at a July 24 meeting hosted by PATH. Representatives from the Bill & Melinda Gates Foundation, USAID, UNICEF, PATH, and others engaged in a robust discussion about proven approaches, new interventions, and opportunities to re-invigorate interest in diarrheal disease programs at both the global and national levels. The group pledged to identify future opportunities for collaboration and to work together on education and outreach at both the country and global levels. PATH forges new partnerships to advance rotavirus vaccine development In parallel to the Rotavirus Vaccine Program’s efforts to increase access to current rotavirus vaccines, PATH recently initiated new partnerships with Shantha Biotech in India and the Wuhan Institute of Biological Products in China to accelerate development and clinical trials of an additional vaccine against rotavirus. This human bovine reassortant vaccine contains components developed by the US National Institutes of Health and is designed to protect against rotavirus strains typically found in Asia and Africa. Click here to learn more about PATH’s work in rotavirus vaccine development. · A new page on the website for the WHO’s Global Advisory Committee on Vaccine Safety consolidates recommendations and reviews of safety data on rotavirus vaccines. · The US Food and Drug Administration has accepted GSK’s application for review of the Rotarix® vaccine. · The European Medicines Agency granted market authorization for the concomitant administration of RotaTeq and oral polio vaccine. RotaTeq® is manufactured by Merck & Co., Inc. · Russian-language materials now available within the PATH/UNICEF Enhanced Diarrheal Disease Control Resource Center. · African rotavirus surveillance newsletter provides update on strain surveillance and preliminary country data. Rotavirus Vaccine Program website |
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The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance. |
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Questions or comments about the PATH Rotavirus Vaccine Program? Contact us at rvpinfo@path.org.
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