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news.An advisory committee to the US Centers for Disease Control and Prevention has unanimously voted to recommend that all infants should be vaccinated with Merck & Co's Rotateq to prevent rotavirus gastroenteritis.
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The advisory committee recommended that the oral, three-dose vaccine be given during the current routine ‘well-baby’ visits at two, four, and six months of age.
On February 3, 2006, the FDA approved Rotateq, now the only vaccine available in the US to prevent this serious and unpredictable disease, for use in infants between the ages of six to 32 weeks. The FDA approval was largely based on the results of phase III trials in which the drug prevented 98% of severe cases of rotavirus gastroenteritis.
“With about 2.7 million episodes of rotavirus occurring each year among children under age five in the US, this decision highlights the importance of rotavirus disease prevention and adds this needed vaccine to the current pediatric immunization schedule,” said Dr Mark Feinberg, vice president of policy, public health and medical affairs at Merck Vaccines.
In addition to filing for licensure in more than 50 countries in 2005, Merck is working to conduct clinical studies of Rotateq in Africa and Asia. The trials are an important step in the process of making a rotavirus vaccine available in these regions.