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Contact: Paul Quirk, 202.572.2879, Paul.Quirk@gmmb.com.

Seattle, WA, March 31, 2009—Rotavirus vaccines have the potential to save more than 2.5 million lives by 2025, according to a briefing paper released today by PATH. The vaccines are already in use in North America, Latin America, and Europe, and are urgently needed in Africa and Asia—where the disease burden is greatest. The briefing paper underscores the burden of rotavirus and highlights the promise of vaccines to combat the virus as the global health community prepares for worldwide introduction.

Key points in the briefing paper indicate that:

  • Rotavirus is a major global health threat. Every child in the world, regardless of socio-economic status or country of origin, will likely contract rotavirus by age three. Rotavirus causes the most common and deadly form of diarrhea among young children, and is responsible for more than 500,000 deaths and two million hospitalizations annually. More than 85 percent of these deaths occur in developing countries in Africa and Asia, where access to simple, lifesaving treatments can be severely limited.
  • Rotavirus is preventable through vaccination. Vaccines are the best way to prevent hospitalizations due to rotavirus in industrialized countries and death in places where access to medical care is limited. In the United States alone, rotavirus vaccinations have lead to a reduction in hospitalizations and emergency room visits by as much as 80 percent. Interventions to improve water supply and sanitation—although effective in preventing other types of diarrhea—do not reduce rotavirus incidence.
  • Saving children’s lives is possible now. Widespread introduction of rotavirus vaccines has the potential to bring substantial health benefits, especially to low-income countries in Africa and Asia. Rotavirus vaccines are already in use in North America, Latin America, and Europe. In early April 2009, the World Health Organization (WHO) will review data from studies of rotavirus vaccines from around the world, including a large-scale clinical trial in Africa, and will consider a recommendation that all countries in the world introduce rotavirus vaccines.

“Rotavirus is one of the most deadly diseases children in the developing world face. Vaccination holds the key to making this disease one of the most preventable,” said Dr. John Wecker, director of Immunization Solutions at PATH. “We need to stand ready to deliver vaccines to children in Africa and Asia, where most rotavirus deaths occur.”

In 2006, two orally administered rotavirus vaccines—RotarixTM, manufactured by GlaxoSmithKline (GSK), and RotaTeq®, manufactured by Merck and Co., Inc.—were demonstrated to be safe and effective in large-scale clinical trials in Europe, Latin America, and the United States. The WHO has recommended inclusion of rotavirus vaccines in national immunization programs of countries where clinical trials demonstrated that the vaccines were safe and effective.

In order to make possible a worldwide push against rotavirus, additional clinical trials were necessary in impoverished populations in Africa and Asia because orally administered vaccines historically perform differently in various populations of the world. In 2004, the PATH Rotavirus Vaccine Program (a partnership between PATH, the US CDC, and the WHO with funding from the GAVI Alliance) took the unprecedented step of partnering with rotavirus vaccine manufacturers, GSK and Merck, to conduct rigorous clinical trials to determine the vaccines’ efficacy in those continents.

In April, the WHO will review results from a large-scale clinical trial in Africa of the GSK vaccine. Findings from similar trials of Merck’s RotaTeq® conducted in Africa and Asia will be available later in fall 2009. These rotavirus vaccine trials provide critical evidence on vaccine performance in real-world settings.

“Global and national leaders are ready to accelerate wider access to these lifesaving vaccines as soon as they are recommended for use in other regions of the world,” Dr. Wecker said. “Preventing rotavirus-related deaths is a global health imperative.”

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