GlaxoSmithKline has received a boost on news that US regulators have agreed to review its marketing application for the oral rotavirus vaccine Rotarix.

Rotavirus is particularly virulent, infecting nearly every child around the globe by the age of five, and is the primary cause of severe acute gastroenteritis in infants and young children in the US and worldwide, the group says. In the USA alone, 2.7 million children under five years of age suffer from rotavirus disease every year and, out of these, 55,000 to 70,000 are hospitalised and 20-60 die.

GSK’s rotavirus vaccine, which is already licensed in 99 countries around the world, works by mimicking natural rotavirus infection, and clinical studies have shown this to provide “significant protection from moderate to severe disease, regardless of rotavirus strain,” the firm claims.

Early protection

Around 17% of children hospitalised with rotavirus are aged less than six months old, and GSK’s proposed immunisation schedule would mean that vaccination would be completed by four months of age, thereby offering protection very early on in life.

“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,” commented Barbara Howe, vice president of North American Vaccine Development at GSK. “We also believe it is important to immunise infants against rotavirus as early as possible,” she added.

Rotarix received its first green light in Mexico back in 2004, as GSK took the unusual step of introducing the vaccine in the markets where the need is greatest. The vaccine’s closest competitor is Sanofi-Pasteur MSD’s RotaTeq, which was cleared in the USA and Europe last year.