A Food and Drug Administration panel has recommended GlaxoSmithKline Plc’s vaccine Rotarix for use in infants, U.S. advisers said on Wednesday.

Rotarix is a vaccine for the rotavirus, a common gastrointestinal infection in infants before age 5. Although rotavirus deaths in the U.S. are rare, the infection still causes about 50,000 to 70,000 hospitalizations each year. About 20 to 60 of those infants die, the U.S. Centers for Disease Control and Prevention reported.

The FDA panel voted 11-1 in favor on the question of whether the vaccine was safe, which brings the vaccine closer to final approval in the U.S.

"We have a high level of confidence in the safety of the vaccine," Glaxo's vice president for regulatory affairs Clare Kahn told the panel, according to Reuters.

If the vaccine wins U.S. approval, it will compete against RotaTeq, a similar vaccine manufactured by Merck & Co., which is strongly recommended by the U.S. CDC for all young children in the country. The vaccine that has been on the U.S. market since 2006 brings Merck more than $350 million every year in the U.S. alone.
 
Despite its good welcoming, health officials have been monitoring Merck’s vaccine for links to a rare bowel problem called intussusception. This was the reason for which a Wyeth vaccine was pulled off the market in 1999. However, the CDC later cleared the vaccine saying intussusception rates among vaccinated infants were lower than what would be found in the general population.

Approval of Rotarix in the U.S. could intensify the rivalry between the two drug makers. The vaccine is already approved in many other European countries.

There is no word on when the final approval may come, but now that the FDA panel has backed the drug, it should be closer than ever.