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Greetings partners and colleagues,
This issue of Rotavirus Update focuses on the recent International Rotavirus Symposium, held in Istanbul, Turkey, earlier this month. The research and experiences presented by some of the world's leading authorities offered an invigorating perspective on the progress and achievements gained in just a few short years. Each element of our partners’ efforts to reduce the deadly toll of rotavirus disease was represented, and each demonstrated impressive advancements—an ever-growing amount of data from surveillance networks reveals rotavirus as a primary cause of gastroenteritis hospitalizations in children around the world; interim data from a clinical trial provide promising evidence of the potential of rotavirus vaccines in impoverished settings in Africa; and experiences of countries that have introduced rotavirus vaccines offer real-world evidence of their impact.
The event's proximity to Eastern Europe allowed for the participation of several GAVI-eligible countries from that region. Decisions on the use of rotavirus vaccines depend heavily on the very type of evidence and information presented at the meeting, creating a particularly poignant confluence of research and policy essential for reducing childhood deaths due to rotavirus in this region and around the world.
Sincerely, John R. Wecker Director, PATH Rotavirus Vaccine Program |
June 2008 In this Issue Rotavirus symposium presents scientific developments with public health perspective Preliminary data reveal high efficacy of rotavirus vaccine in South Africa Lessons learned in Latin America will inform future rotavirus vaccine introduction Study shows rotavirus vaccines are cost-effective in GAVI-eligible countries Partners undertake broad range of activities to address rotavirus research priorities |
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Rotavirus symposium presents scientific developments with public health perspective The 8th International Rotavirus Symposium brought together country leaders and scientific experts to discuss progress and remaining challenges in making rotavirus vaccines accessible to children around the world. The event, convened by the Albert B. Sabin Vaccine Institute, the Fogarty International Center, the Norwegian Institute of Public Health, the US Centers for Disease Control and Prevention (CDC), and PATH, welcomed more than 400 participants from 67 countries—the symposium’s highest-ever participation. Presentations provided scientific and programmatic updates on rotavirus disease surveillance, clinical trials to address vaccine safety and efficacy in developing countries, country experiences with vaccine introduction, development of candidate rotavirus vaccines, and evidence to inform country decision-making. Presentations will soon be available on the symposium’s website. Preliminary data reveal high efficacy of rotavirus vaccine in South Africa Interim results from a clinical trial of rotavirus vaccine in South Africa and Malawi, presented for the first time at the International Rotavirus Symposium, offer a very promising signal about the potential of rotavirus vaccines in the world’s poorest countries. Principal investigator Dr. Shabir Mahdi of Dr. George Mukhari Hospital presented the data, which reveal that Rotarix® manufactured by GlaxoSmithKline was 83 percent efficacious in preventing severe rotavirus gastroenteritis among infants in impoverished populations of South Africa. The full results, which will include data from children in Malawi, will be available in early 2009. While rotavirus vaccines are currently licensed and used in several countries, the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) recommended clinical trials in Asia and Africa where rotavirus disease burden is very high and where oral vaccines have the potential to perform differently. In addition to the Rotarix® trial, PATH is conducting trials of Rotateq® in impoverished populations of five additional countries in Africa and Asia in partnership with manufacturer Merck & Co., Inc, with results expected in late 2009. SAGE will review the evidence from these trials to inform its recommendation on the global use of rotavirus vaccines. Lessons learned in Latin America will inform future rotavirus vaccine introduction Rotavirus vaccine introduction in several countries of Latin America has yielded important lessons learned, as presented at the symposium by Dr. Lucia Helena de Oliviera, regional advisor for new vaccines with the Pan American Health Organization (PAHO). In particular, countries need to address the issue of cold chain storage capacity with new rotavirus vaccines; evaluate systems to monitor immunization coverage; train and supervise vaccine providers; and conduct rotavirus strain surveillance. The experiences of early adopters in considering and implementing these activities will be important for facilitating rotavirus vaccine introduction in other countries, as well as ensuring sustainable programs throughout the region and the world. Dr. Oliviera and collegues further expand upon these issues and experiences (summary only without subscription) in a study recently published in Expert Review of Vaccines. Study shows rotavirus vaccines are cost-effective in GAVI-eligible countries Introducing rotavirus vaccines in developing countries not only has the potential to save millions of lives, but the intervention is also cost-effective. At the recent rotavirus symposium, PATH senior health economist and policy officer Dr. Deborah Atherly reviewed an analysis of the cost-effectiveness and impact of rotavirus vaccines in GAVI-eligible countries. The analysis combined cost-effectiveness results with estimates of vaccine adoption over time. Results indicate that rotavirus vaccination is cost-effective in all GAVI-eligible countries and could avert the deaths of 225,000 children per year at peak adoption and 2.5 million deaths between 2008 and 2025. In addition, cost-effectiveness ratios improve and vaccine impact increases substantially over time, primarily due to adoption in higher-burden countries and estimated price decline. Dr. Atherly noted market-related issues that must be addressed to achieve these significant outcomes. These include improving demand forecasting to assure sustainable supply, understanding and closely monitoring the supplier landscape to ensure that supply matches demand, and continuing to address vaccine affordability so that countries can support sustainable immunization programs. Partners undertake broad range of activities to address rotavirus research priorities While progress continues with the currently available rotavirus vaccines, significant efforts are underway to lay a foundation for future candidates. Dr. Duncan Steele, PATH’s senior advisor on diarrheal disease, discussed research priorities—as recommended by SAGE and the WHO Global Advisory Committee on Vaccine Safety—along with the activities PATH and partners are currently conducting to address them: · Several countries have initiated post-marketing surveillance to assess vaccine safety with respect to intussusception and other potential rare adverse events; · PATH is working closely with emerging manufacturers in India and China to develop the next generation of rotavirus vaccines, providing clinical expertise and an “enabling platform” of technology support to expand the manufacturers’ capacity; and · Surveillance activities continue to monitor strain diversity and genotypes in various global settings. Partner profile: Curatio International Foundation Manana Khotchava, a pediatrician in Georgia, shakes her head sadly when asked about the problem of diarrheal disease in her country. “This is a real issue,” she says. “Many children are suffering, but it is a struggle to get our policymakers to take action because we don’t yet have the information to convince them.” Underreporting and unconfirmed diagnoses of diarrheal disease are common in Georgia, Dr. Khotchava explains. While severe cases are reported as they come across with the health care system, she says, those are just “the tip of the iceberg.” In Georgia, as in other former Soviet countries, the transition to a free-market economy spurred semi-privatization of health care. For many Georgians, though, the introduction of private health care has meant skyrocketing costs, hindering some from seeking care for their children for common illnesses like diarrhea. At the same time, low pay for providers has contributed to underreporting of diarrheal disease. Surveillance and information systems have been strengthened during recent years, explains Ivdity Chikovani, a program manager at the Curatio International Foundation (CIF), a nongovernmental organization created in 1994 to help reform health systems in transition economies. “However, they are far from perfect,” she explains, “and it is important to work on multiple fronts to strengthen policy, information systems, and laboratory procedures.” In January 2008, CIF partnered with PATH to host a regional conference in Tbilisi, Georgia. Bringing together academics, health care workers, and policymakers, the workshop generated significant interest in rotavirus vaccines and broader diarrheal disease control measures. CIF and PATH continue to work with Georgian academics, health care providers, and the Ministry of Health to address barriers to diarrheal disease control. The partnership has resulted in a draft nationwide plan on prevention and treatment interventions, and has facilitated new diarrheal disease management guidelines. The plan aims to facilitate education of clinicians and medical students, assist with the introduction of the new ORS and zinc preparations on the local pharmaceutical market, create standard diagnostic laboratory procedures to improve the disease surveillance system, implement a system for measuring intervention impact, and revise the national multi-year immunization plan to set the stage for introduction of the rotavirus vaccine in the coming years. CIF’s history of strengthening health systems in the region, as well as increasing interest in diarrheal disease control, gives Chikovani and her colleagues hope for progress and scale-up. “We really hope the work we are doing in Georgia will be able to be applied to other countries in the region as well.” Rotavirus Vaccine Program website Enhanced Diarrheal Disease Control Resource Center |
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The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance. |
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Masthead photo by Richard Lord.
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