GSK annouces that Rotarix could be added to routine infant vaccines, pending FDA approval

CHICAGO GlaxoSmithKline has announced that their drug Rotarix, an oral vaccine for infants to prevent rotavirus gastroenteritis, has a chance of being co-administered with routine infant vaccines, if the Food and Drug Administration approves it.

The news data showed that the vaccine does not interfere with immune responses to other vaccines currently included in the Centers for Disease Control and Prevention’s schedule of recommended immunizations for infants. The information is from a Phase III clinical trial that was presented at a conference in Chicago.

“These co-administration data indicate that GSK’s rotavirus candidate vaccine could be integrated into the current infant immunization schedule in the U.S.,” said Remon Abu-Elyazeed, M.D., Ph.D., Director, Clinical Development, Vaccines for Virus Diseases, GlaxoSmithKline Biologicals. “If the candidate vaccine is approved, infants could complete the rotavirus vaccine series by four months of age.”

In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency room visits.  In addition, between 55,000 and 70,000 children are hospitalized each year and 20-60 die.