FDA Panel Backs Glaxo's Rotarix
By JENNIFER CORBETT DOOREN
February 21, 2008; Page D6
A Food and Drug Administration panel of vaccine experts recommended the approval of Rotarix, a GlaxoSmithKline PLC vaccine designed to help protect infants from a gastrointestinal illness caused by rotavirus.
The panel unanimously said it believed the vaccine was effective and voted 11-1 in favor on the question of whether the vaccine was safe. The votes amount to a recommendation that the agency approve the vaccine.
The agency isn't required to follow the advice of its outside panels of medical experts, but usually does. The FDA is expected to decide whether to approve Rotarix by April 3.
Rotavirus infection hits most children before age 5. Although rotavirus deaths in the U.S. are rare, the infection still causes about 50,000 to 70,000 hospitalizations each year. Rotarix, like a similar vaccine by Merck & Co. called RotaTeq, is designed to protect infants against rotavirus during their first two years of life, when the infection's symptoms are most likely to be severe.
Merck's vaccine has been on the U.S. market since 2006, and health officials have been monitoring it for links to a rare bowel problem called intussusception. A Wyeth vaccine was pulled off the market in 1999 after it was linked to the ailment, which is marked by a twisting or obstruction of the intestine that can be fatal.
About a year ago, the FDA issued a public-health advisory discussing 28 reports of intussusception seen among infants who were given Merck's vaccine. The Centers for Disease Control and Prevention later cleared the vaccine, saying intussusception rates among vaccinated infants were lower than what would be found in the general population. Still, federal health officials continue to monitor RotaTeq and would do the same for Rotarix, assuming it is approved.
So far, 11 clinical studies of Glaxo's vaccine, involving more than 75,000 children, don't show 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.
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.
Clare Kahn, Glaxo's North American vice president of regulatory affairs, said, "The risk-benefit ratio is favorable for the intended population."
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