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news.The FDA has accepted GlaxoSmithKline's Rotarix drug, an oral candidate vaccine for rotavirus gastroenteritis in infants, for a biologics license application review.
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GSK says severe, dehydrating gastroenteritis occurs primarily among children aged three to 35 months. Of children hospitalized with rotavirus, approximately 17% are younger than six months old. If approved, the GSK candidate vaccine could offer completion of the rotavirus vaccination series by four months of age.
The rotavirus candidate vaccine is a live-attenuated vaccine derived from the most common human rotavirus strain. Published data show that immunity resulting from natural human rotavirus infection provides significant protection against moderate to severe disease, regardless of rotavirus strain, the company says.
The BLA for the GSK rotavirus candidate vaccine is based on what GSK claims is one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants. These clinical trials were conducted in the Americas, Europe, Asia and Africa and reflect an ethnically diverse population.
“This vaccine, which is designed to protect in a manner similar to natural human infection, could make a considerable contribution in protecting very young infants from rotavirus disease, a significant burden on families and the healthcare system in the US,” said Barbara Howe, vice president, North American vaccine development, GlaxoSmithKline. “We also believe it is important to immunize infants against rotavirus as early as possible.”