UPDATE 2-Glaxo wins US FDA clearance for rotavirus vaccine
(Recasts; Adds FDA comments, Lancet study on Latin American trial)
WASHINGTON, April 3 (Reuters) - A second oral vaccine to prevent a leading cause of severe diarrhea in infants won approval from U.S. health officials on Thursday.
The GlaxoSmithKline Plc (GSK.L) vaccine Rotarix fights infection with the rotavirus, which causes about 55,000 hospitalizations in U.S. children each year and kills more than 600,000 children worldwide, mostly in developing countries.
Rotarix already is approved in more than 100 other countries throughout the world. The vaccine competes with Merck & Co Inc's (MRK.N) rotavirus vaccine called RotaTeq.
Without vaccination, nearly every child in the United States likely would be infected at least once with rotavirus by age five, the Food and Drug Administration said.
In studies of more than 24,000 infants, Rotarix prevented severe and mild cases of rotavirus-caused diarrhea and vomiting during the first two years of life.
"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," Dr. Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research, said in a statement announcing the Rotarix approval.
The most common reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting, the FDA said.
An earlier oral rotavirus vaccine sold by Wyeth WYE.N was pulled from the market in 1999 after it was linked to a rare, life-threatening type of bowel obstruction known as intussusception.
In a Glaxo study of more than 63,000 infants, there was no increase in the problem compared with a placebo.
Higher rates of convulsion and pneumonia-related deaths were seen in Rotarix patients in that study but not in other Glaxo trials.
"Although the FDA has concluded that the available data do not establish that these events are related to the vaccine, the agency has requested the manufacturer to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information," the FDA said.
Glaxo said Rotarix "will offer protection against the most commonly circulating rotavirus types in the U.S. and allow infants to complete the vaccination series by four months of age."
Rotarix, which is a liquid, is given in two doses to infants from six to 24 weeks of age, the FDA said.
Merck's RotaTeq vaccine is administered in three doses from ages six weeks to 32 weeks. Continued...
