FDA Advisory Committee Recommends US Approval of Rotavirus Vaccine

Vaccine has the Potential to Save Thousands of Lives in Poor Countries

Feb 20, 2008, 00:00 ET from PATH

    GAITHERSBURG, Md., Feb. 20 /PRNewswire-USNewswire/ -- The US Advisory
 Committee on Vaccines and Related Biological Products issued a positive
 recommendation today on the use of rotavirus vaccines, potentially bringing
 greater protection to children in the US from this common and sometimes
 fatal cause of severe diarrhea. After reviewing data from clinical trials
 on the safety and efficacy of Rotarix(R), manufactured by GlaxoSmithKline
 Biologicals (GSK), the committee recommended that the US Food and Drug
 Administration (FDA) approve the company's application for licensure. The
 FDA should make its ultimate decision on Rotarix(R) licensure in the US
 within the coming weeks. Another rotavirus vaccine, RotaTeq(R) manufactured
 by Merck & Co., Inc., received FDA approval in 2006.
     Globally, rotavirus accounts for more than 500,000 deaths and two
 million hospitalizations annually. Ready access to good medical care means
 that children in industrialized countries rarely die from rotavirus
 infection. Children in the poorest countries, however, suffer the greatest
 burden: more than 90 percent of deaths due to rotavirus occur in the
 developing world, where access to simple, lifesaving treatment is severely
     "Vaccines against rotavirus remain the most effective way to prevent
 this deadly disease," notes Dr. John Wecker, director of PATH's Rotavirus
 Vaccine Program. "Making rotavirus vaccines available to the children in
 poor countries who face the greatest risk of dying must be a high
     Every child in the world will contract rotavirus at least once before
 the age of three, regardless of income level or geographic location.
 Because vaccination is the only way to prevent hospitalizations from severe
 rotavirus infection in industrialized countries and the mortality it causes
 in low-resource settings, the World Health Organization (WHO) strongly
 recommends the inclusion of rotavirus vaccination into the national
 immunization programs of countries where clinical trials have shown
 rotavirus vaccines to be safe and effective. In January 2007, the WHO
 granted "prequalification" to Rotarix(R), allowing it to be purchased
 through United Nations procurement systems.
     Because rotavirus vaccines represent the best hope to save thousands of
 children's lives in poor countries, PATH's Rotavirus Vaccine Program is
 working in partnership with Merck and GSK to conduct large-scale clinical
 trials of their vaccines in Africa and Asia. These data will provide
 valuable information for developing countries considering the use of
 rotavirus vaccines to reduce rotavirus mortality.
     PATH is an international nonprofit organization that creates
 sustainable, culturally relevant solutions enabling communities worldwide
 to break longstanding cycles of poor health. By collaborating with diverse
 public- and private-sector partners, PATH helps provide appropriate health
 technologies and vital strategies that change the way people think and act.
 PATH's work improves global health and well-being. For more information,
 please visit http://www.path.org.
     The PATH Rotavirus Vaccine Program is working with the GAVI Alliance,
 the World Health Organization, and the US Centers for Disease Control and
 Prevention to help countries make informed decisions about the use of
 rotavirus vaccines, and to access and afford the currently licensed
Contact: Eileen Quinn, 202-631-9294 equinn@path.org Deborah Phillips, 206-788-2449 dphillips@path.org