GlaxoSmithKline’s second oral vaccine for the prevention of rotavirus, an infection that causes vomiting and diarrhea in infants and children has got green signal from the US drug regulator, FDA. Rotarix vaccine is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.

According to the FDA, Rotavirus causes an estimated 2.7 million cases of gastroenteritis in children, and it sends 55,000 to 70,000 children to hospitals every year. It is responsible for 20 and 60 deaths yearly. Without treatment nearly every child in the United States would likely be infected at least once with rotavirus by age 5. Rotavirus has many strains. The new vaccine guards against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains.

In a press release on Thursday night, Dr. Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research, said "This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children."
The US drug regulator reported that Rotarix was proven effective in preventing both severe and mild cases of gastroenteritis caused by rotavirus during the first two years of life in studies involving more than 24,000 infants. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting.

Rotarix is manufactured by GlaxoSmithKline Biologicals, of Rixensart, Belgium. GlaxoSmithKline head of vaccines in the US, David Pernock, said: "We are thrilledl. We think Rotarix will be a significant product in the US."

The approval means GlaxoSmithKline will now be competing with Merck in providing the vaccine against the childhood disease Rotavirus. The $1bn (£501m) market is presently dominated by Merck's RotaReq vaccine. GlaxoSmithKline could see sales of £400m by 2012 with its Rotarix product now, predict the ING analysts.