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Just two months in, the new year has already brought historical milestones in the effort to bring rotavirus vaccines to the developing world. Building off the momentum of last years’ unprecedented advances, the first-ever prequalification of a rotavirus vaccine tops the list. Last month, the World Health Organization announced “acceptability in principle” of GlaxoSmithKline’s Rotarix®. Coupled with the GAVI Alliance Board’s decision in late 2006 to include rotavirus vaccine in its portfolio of subsidized vaccines for eligible countries, this designation is a significant step toward introducing these lifesaving drops in the world’s poorest communities.
In the broader global vaccine agenda, PATH applauds the governments of Italy, Canada, Russia, the United Kingdom, and Norway; and the Bill & Melinda Gates Foundation for their support of an Advanced Market Commitment to support the development and affordable pricing of a vaccine against pneumococcal disease. Such new financial solutions, along with the foresight of these innovative funders, are encouraging indicators of the global community’s commitment to realizing the promise of new vaccines.
Best wishes for a productive new year,
John R. Wecker, PhD Director, PATH Rotavirus Vaccine Program |
February 2007 In this Issue GlaxoSmithKline’s Rotarix vaccine earns WHO prequalification FDA updates prescribing information on RotaTeq® vaccine Innovative investment accelerates global access to pneumococcal vaccines Investigators’ meeting in London kicks off key clinical trials Update on rotavirus surveillance Vaccination may be factor in reduced seasonal rotavirus incidence in El Salvador PATH featured in BBC series on vaccine innovations and challenges |
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GlaxoSmithKline’s Rotarix® vaccine earns WHO prequalification On January 30, 2007, WHO announced prequalification of the Rotarix® vaccine manufactured by GlaxoSmithKline (GSK), marking the first time in history that a rotavirus vaccine has been prequalified. This designation of “acceptability in principle” will allow for purchase of the vaccine by United Nations agencies and is a significant advance in the accessibility of rotavirus vaccine for developing countries that depend on agencies like UNICEF for drug procurement. In issuing its decision, WHO noted the need for data on the vaccine’s safety and efficacy in Africa and Asia before the product will be prequalified for use in these regions. GSK is partnering with PATH to generate important clinical data in trials conducted in Bangladesh, Malawi, and South Africa. For further details, including provisions on Rotarix® packaging and presentation, please see the notes on Rotarix® within WHO’s list of prequalified vaccines. |
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FDA updates prescribing information on RotaTeq® vaccine In a public health notification issued February 13, the US Food and Drug Administration (FDA) provided updated prescribing information for the RotaTeq® vaccine manufactured by Merck & Co., Inc. The update noted 28 reported cases of intussusception identified through the US Vaccine Adverse Event Reporting System, but clarified that “the number of intussusception cases reported to date after RotaTeq administration does not exceed expected background rates among unvaccinated children of the same age.” In an update to its website posted February 14, the US CDC affirmed its continued support for use of the vaccine: “This notice does not mean there is a problem with the RotaTeq® vaccine. CDC is not changing its policy at this time. CDC continues to support the Advisory Committee on Immunization Practices’ [ACIP] recommendation for routine immunization of all U.S. infants with three doses of RotaTeq® administered orally at ages 2, 4 and 6 months.” The ACIP will conduct a regularly-scheduled review of the safety tracking data during its upcoming meeting on February 21, and the CDC stated that it will continue to monitor reports of possible adverse effects of the vaccine in partnership with the FDA. Media reports of the FDA notice implied a link between the vaccine and intussusception that is not supported by the current data. To avoid further misperceptions, PATH is reaching out to key audiences, including the investigators with whom we are collaborating to conduct clinical trials of RotaTeq® in Africa and Asia, as well as our partners in the global health community. |
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Innovative investment accelerates global access to pneumococcal vaccines The governments of Italy, Canada, Russia, the United Kingdom, and Norway; and the Bill & Melinda Gates Foundation recently announced their decision to financially support an Advance Market Commitment (AMC) for the purchase of pneumococcal vaccines for developing countries. Pneumococcus, a bacterium that is one of the most common causes of pneumonia, kills about one million children under age five each year. By creating incentives for companies to invest in vaccines for diseases that disproportionately affect developing countries, an AMC can help create more predictable markets and accelerate research and development. Click here to learn more. Investigators’ meeting in London kicks off key clinical trials At an investigators’ meeting in London last month, PATH and partners met to finalize plans to launch Phase 3 clinical trials of RotaTeq, the rotavirus vaccine manufactured by Merck & Co., Inc. PATH and Merck are partnering with leading researchers in Asia and Africa to conduct efficacy trials in five countries: Bangladesh, Vietnam, Kenya, Ghana, and Mali. Enrollment at some study sites will be initiated as early as this month, and results are anticipated by mid-2009. Meeting participants, including leading rotavirus experts from NIH and WHO, reviewed the study protocol for the study to ensure adherence, scientific rigor, and regulatory compliance. Update on rotavirus surveillance Routine surveillance is revealing significant rates of rotavirus among children suffering from diarrheal disease in Pakistan, where two sites recorded rates of 20 and 38 percent, respectively. The data were generated through hospital-based rotavirus surveillance supported by the WHO Eastern Mediterranean Regional Office and were presented at the Third Annual Symposium on Neonatal and Child Health organized by the country’s National Insititute of Child Health. Sentinel hospital-based surveillance supported by PATH, CDC, and WHO recently begun in several countries of the European (EURO) and African (AFRO) WHO regions. In EURO, surveillance was initiated in December 2006 at six hospitals in Azerbaijan, Republic of Georgia, Tajikistan, and Ukraine. AFRO surveillance is ongoing at six hospitals in Cameroon, Ghana, Kenya, Uganda, and Zambia. Both networks are coordinated by the respective regional WHO offices and follow WHO protocol. With the launch of these new networks, global rotavirus surveillance is ongoing in a total of 40 countries in all five WHO regions. These surveillance activities will provide valuable data to inform decisions regarding the introduction of rotavirus vaccines. Click here for additional information on the regional rotavirus surveillance networks supported by PATH’s Rotavirus Vaccine Program. Vaccination may be factor in reduced seasonal rotavirus incidence in El Salvador The current rotavirus season in El Salvador is providing insight into the real-world impact of vaccine introduction as well as the disease’s epidemiology in the country. Often mislabeled in the local media as a result of “outbreaks,” cases of rotavirus routinely increase in the region during the winter months due to natural epidemiological patterns. But vaccination against rotavirus, initiated in El Salvador last October, is already helping to reduce this burden. To date, more than 20,000 infants in El Salvador have been fully immunized, and an impact can be seen in the latest surveillance figures. In January 2006, 164 cases including 15 deaths were confirmed among children between 7 and 14 months of age. By comparison, 114 rotavirus cases and four deaths were confirmed among unvaccinated children during the same period this year, and no reports of rotavirus have been recorded among vaccinated children. El Salvador is one of several countries in Latin America that report monthly rotavirus surveillance data to the Pan American Health Organization. Click here for further details on PAHO’s support of these activities. PATH featured in BBC series on vaccine innovations and challenges A new four-part documentary series by the BBC looks at the scientific advances and real-world challenges of delivering life-saving vaccines to children in the developing world. From the hunt within research labs to harness new technologies to the clinics in remote villages where the vaccines are given to children, the series looks at the promise of and the progress on making vaccines affordable and accessible to the countries where they are needed most. PATH’s work on the development of new vaccines and helping to accelerate the use of rotavirus vaccines are featured in this compelling narrative. BBC World programs may be viewed in more than 200 countries, but do not air in the US or UK. The “Vaccine Hunters” series began airing February 4, 2007, over the BBC World Service; see http://www.bbcworld.com/ for viewing times. |
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PATH Rotavirus resource library Rotavirus Vaccine Program website PATH/UNICEF 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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Questions or comments about PATH's rotavirus vaccine program? Contact us at rvpinfo@path.org.
© 2004-2007, PATH