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Dear partners and colleagues, This month's issue of Rotavirus Update brings you news on important advances as we work with our partners to accelerate access to rotavirus vaccines around the world. One of the most exciting developments in recent months is the encouraging response to the GAVI Alliance's invitations to countries eligible to receive support for rotavirus vaccine introduction. Several countries expressed interest in bringing these vaccines to their public sectors in partnership with GAVI as soon as 2008. With clinical trials underway to study rotavirus vaccines' safety and efficacy in the regions of the world that carry the greatest disease burden, the stage is being set for informed decision-making in Africa and Asia. Promising research is demonstrating the feasibility of including rotavirus vaccines in routine programs, and the global community is seeking creative approaches to meet the unique needs of developing countries who aim to introduce. The fruitful alliance of national governments, international donors, nongovernmental organizations, and vaccine manufacturers continues to move the rotavirus agenda forward with unprecedented speed. Sincerely, John R. Wecker, PhD Director, PATH Rotavirus Vaccine Program |
July 2007 In this Issue Eligible nations voice support for rotavirus vaccine introduction Information on Kawasaki disease added to RotaTeq® product label Oral polio vaccine retains immunogenicity when administered with RotaTeq® Rotarix® submitted for FDA approval Clinical trials expand to Mali WHO Bulletin outlines progress and promise of rotavirus vaccines |
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Eligible nations voice support for rotavirus vaccine introduction Several countries recently expressed interest in rotavirus vaccine introduction, responding to formal invitation letters issued by the GAVI Alliance. Ministers of Health were asked to signify their level of interest with regard to the potential health impact of preventing rotavirus, operational implications of the current vaccine presentation, and the expected level of co-financing needed through GAVI support. Early responders included Bolivia, Guyana, Honduras, Nicaragua, and Uzbekistan, where GAVI-subsidized rotavirus vaccines may be introduced in the public sectors as early as 2008. Following its November 2006 review of the investment case for rotavirus vaccines developed by PATH, the US Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO), the GAVI Alliance Board of Directors approved plans to provide financial support in two phases for rotavirus vaccine procurement in eligible countries. The first phase will allow for support to GAVI-eligible countries in the Latin American and European regions, where clinical trials have demonstrated rotavirus vaccines' safety and efficacy. GAVI's second phase of financing will apply to African and Asian countries beginning in 2010, following the results of large-scale efficacy trials currently underway in those regions. Reflecting a commitment to reduce rotavirus mortality in their respective countries and recognizing the potential impact of rotavirus vaccines, Djibouti and Sudan also communicated interest to GAVI-well ahead of the second phase of financing, in which these and other countries in the region will become eligible for support. Responses at this stage are nonbinding, and the first deadline for country applications is set for late September 2007. Information on Kawasaki disease added to RotaTeq® product label A new update to the label for Merck's RotaTeq® vaccine advises health care practitioners on three cases of Kawasaki disease recorded through the US Vaccine Adverse Events Reporting System and one unconfirmed case identified through the Vaccine Safety Datalink Project. Kawasaki disease is a rare condition in young children involving inflammation of the blood vessels. Its cause is unknown, and the disease impacts approximately 4,000 children in the US each year, the majority under five years old. In its approval of the product label revision, the US Food and Drug Administration (FDA) noted that the cases reported to date are not more frequent than what could be expected to occur by coincidence, and there is no known cause and effect between receiving RotaTeq® or any other vaccine and the occurrence of Kawasaki disease. Health care practitioners and parents should remain confident in using RotaTeq®. Click here to read the FDA's official statement. The US CDC also updated its online information on RotaTeq® to reflect the label change. Oral polio vaccine retains immunogenicity when administered with RotaTeq® Evidence to support the inclusion of rotavirus vaccines in routine EPI schedules received a boost in May, with the presentation of study results at the 25th annual meeting of the European Society for Pediatric Infectious Diseases in Porto, Portugal. Merck's RotaTeq® vaccine proved to be appropriate for co-administration with oral polio vaccine (OPV), demonstrating no interference with the immunogenicity of OPV when the vaccines were given concomitantly. RotaTeq® also retained high efficacy (93 percent) when administered with OPV. The study was presented as a poster session, and its abstract is listed here. Rotarix®, the rotavirus vaccine manufactured by GlaxoSmithKline, achieved similar results in a Phase 2 trial conducted at the International Center for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), and supported by PATH. Polio immune responses among infants were not reduced when Rotarix® was administered with OPV. Rotarix® submitted for FDA approval Earlier this month, GSK filed a marketing application with the US FDA for approval of Rotarix®. To date, the vaccine has been approved for use in more than 90 countries worldwide, including the European Union. Click here for more details from GSK's partner Avant Immunotherapeutics, Inc. Clinical trials expand to Mali Earlier this month, sites in Mali enrolled the first patients in a trial to study the safety and efficacy of the RotaTeq® vaccine manufactured by Merck, and sites in Kenya are scheduled to begin enrollment in July. These are the latest in a series of clinical trials that PATH is conducting in partnership with manufacturers to determine the appropriateness of new rotavirus vaccines for use in developing countries. Previous clinical trials of these vaccines, conducted in Europe and in North and South America, found them to be highly efficacious and safe, and they are now licensed and used in several countries. Because oral vaccines have historically performed differently in different regions of the world, the Strategic Advisory Group of Experts on Immunization of the World Health Organization (WHO) recommended that the new, orally administered rotavirus vaccines be tested for efficacy in Asia and Africa where disease burden is very high. WHO Bulletin outlines progress and promise of rotavirus vaccines New rotavirus vaccines and their availability in the developing world were highlighted in the June issue of the Bulletin of the World Health Organization. The article highlighted advances and partnerships that have made recent progress possible, along with the next steps needed to bring the vaccines to the world's children at highest risk for severe diarrheal disease. Rotavirus vaccines are increasingly becoming a crucial component of strategies to control diarrheal disease in low-resource countries, alongside proven interventions such as handwashing, use of oral rehydration solution, and exclusive breastfeeding. Click here to read the full article. PATH JE project seeks new director PATH is seeking qualified candidates in our search for a new director of the Japanese encephalitis (JE) project. JE is a viral neurological disease spread by mosquitoes and is little known outside of Asia. The virus primarily strikes the rural poor and kills at least 10,000 people-most of them children-every year. In endemic countries, PATH supports national programs in establishing JE surveillance and considering introduction of JE vaccines. Leading and managing a global team, the JE project director will be responsible for achieving project milestones and representing the JE project to the donor, international partners, and representatives of government agencies. As a member of PATH's Immunization Solutions Leadership Team, the JE project director also actively contributes to the overall strategic direction and programmatic priorities toward supporting the integration of vaccines for public health impact and disease control in developing countries. Please visit PATH's employment page to learn more about this and other positions, or send your resume or inquiry in confidence directly to Dorothy Culjat, SPHR, senior recruiter. Rotavirus Vaccine Program website | |
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The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance. | |
Questions or comments about the PATH Rotavirus Vaccine Program? Contact us at rvpinfo@path.org.
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