Glaxo’s Rotarix: rotavirus vaccine Rotarix is effective against severe gastroenteritis
Glaxo’s Rotarix: rotavirus vaccine Rotarix is effective against severe gastroenteritis
Glaxo’s Rotarix Shows Benefit In Latin American Infants-Study. GlaxoSmithKline PLC’s (GSK) rotavirus vaccine Rotarix is effective against severe gastroenteritis for up to two years when given to infants during their first two years of life, according to a late-stage study published Friday in medical journal The Lancet.
Researchers from the Institute of Biomedical Sciences, Faculty of Medicine, University of Chile, conducted a phase III trial on more than 15,000 healthy infants from ten Latin American countries, who were randomly assigned to receive two oral doses of Rotarix or placebo.
Fewer cases of severe rotavirus gastroenteritis were recorded for the combined two-year period in children who received the vaccine when compared with the placebo group, the researchers found.
Out of 7,025 vaccinated infants, 32 developed gastroenteritis, compared with 161 in the 7,081 infants who received the placebo.
Already available in Europe, Rotarix is awaiting final green light from the U.S. regulator after a panel of Food and Drug Administration experts recommended its approval in February.
The FDA isn’t required to follow the advice of its panels of medical experts, but usually does. The agency is expected to decide whether to approve Rotarix by April 3.
Rotavirus infects nearly every child worldwide by the age of five and is the leading cause of severe gastroenteritis in infants and young children, often resulting in hospitalization. It’s also one of the causes of childhood death in developing countries in Africa and Asia. The U.S. is the only major market that has recommended rotavirus vaccination for all infants, turning it into a key commercial opportunity for both Rotarix and Merck & Co. Inc.’s (MRK) RotaTeq, which has been available since 2006 and is the only rotavirus vaccine on sale in the country.
Glaxo’s Rotarix: rotavirus vaccine Rotarix is effective against severe gastroenteritis
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