FDA panel recommends Rotarix, despite pneumonia worries

WASHINGTON A panel of vaccine experts for the Food and Drug Administration has recommended the approval of Rotarix, a GlaxoSmithKline vaccine designed to help protect infants from a gastrointestinal illness caused by rotavirus, according to the Wall Street Journal. Rotavirus is the most common cause of severe diarrhea and dehydration among infants and young children.

The panel unanimously said it believed the vaccine was effective and voted 11-1 in favor of whether the vaccine was safe or not.

So far, 11 clinical studies of the vaccine, involving more than 75,000 children, hasn’t shown an increased risk of intussusception, with six cases reported among children receiving the vaccine in clinical studies compared with seven cases seen among patients receiving a placebo. Intussusception has been linked to other rotavirus drugs from Merck and Wyeth. In fact, Wyeth’s drug was pulled off the market in 1999 after being linked to the ailment, which is a rare bowel problem characterized by a twisting or obstruction of the intestine.

However, Steven Rosenthal, an FDA medical officer who presented the agency’s review of the vaccine, said there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies. The overall death rate from any cause, however, was similar between infants given the vaccine and those in placebo groups. In total, there were 118 deaths among all infants in the studies, with 19 pneumonia related-deaths among those receiving the vaccine and 10 among those not receiving it.

The FDA is expected to decide whether to approve Rotarix by April 3.

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