Merck's rotavirus vaccine, RotaTeq™, was approved by the US Food and Drug Administration (FDA) on February 3, 2006, making RotaTeq™ the only rotavirus vaccine approved for use in the United States. This landmark approval brings added momentum to our efforts in working to reduce rotavirus-related deaths worldwide.

Many children in the US are hospitalized each year due to the severe dehydration rotavirus can cause, but deaths in the industrialized world are rare. In the developing world, however, children often do not have access to hospital care, and rotavirus claims up to 600,000 lives annually.

While the FDA's approval will soon bring this important new public health intervention to children in the US, the safety and efficacy of RotaTeq™ are not yet proven in the world's poorest countries, and clinical trials are urgently needed. Last December, Merck and PATH announced a partnership to design and conduct these critical studies in Africa and Asia, and initiation of clinical trials is expected later this year.

The FDA approval of RotaTeq™, along with the recent publication of successful studies of rotavirus vaccines, continues to raise awareness and shed light on an often neglected and misunderstood disease. Progress such as we have seen in the last few months offers further reason to strengthen our commitment to advocating for interventions that can reduce rotavirus infection and save countless lives in developing countries.

To read the official FDA announcement on the approval of RotaTeq™, click here.