April 4, 2008

Rotarix® rotavirus vaccine receives US FDA approval

On April 3, 2008, the US Food and Drug Administration (FDA) approved GlaxoSmithKline's (GSK's) Rotarix® vaccine for prevention of rotavirus in infants, providing an additional option for protecting American children against this severe diarrheal disease. Data from large-scale clinical trials conducted in the US, Europe, and Latin America informed the FDA's decision. Another rotavirus vaccine, RotaTeq®, manufactured by Merck & Co., Inc., received FDA approval in 2006.

Rotavirus causes more than half a million childhood deaths every year, but fatalities are rare in the US and other industrialized countries, where acute medical care is readily accessible. The developing world, however, carries a far greater burden of disease. Nearly 90 percent of all rotavirus-related deaths occur in the world's poorest countries, making rotavirus vaccination an imperative public health intervention.

PATH's Rotavirus Vaccine Program is working in partnership with GSK and Merck on clinical trials of their respective vaccines in Africa and Asia. These trials will generate valuable data for developing countries considering the use of vaccines to reduce rotavirus mortality. They are a pivotal element of a broad range of activities that PATH and its partners are conducting to lay the foundation for accelerated introduction of rotavirus vaccines in the developing world.

Click here to read the FDA announcement.

 The PATH Rotavirus Vaccine Program is supported by the GAVI Alliance.