The recommendation is based on data presented from phase III clinical trials that evaluated the effects of the drug in 70,000 infants.
The FDA will now consider the committees recommendation when it reviews the biologics license application that Merck submitted for Rotateq in April 2005. The FDA is not bound by the committee’s recommendation but takes its advice into consideration when reviewing investigational vaccines seeking approval.
Rotavirus gastroenteritis causes an estimated 250,000 emergency department visits and 500,000 visits to physicians offices each year in the US.
“We are pleased that the Advisory Committee agreed that the data presented showed that Rotateq reduced the effects of this potentially serious disease,” said Dr Peter Kim, president, Merck Research Laboratories.