BETHESDA, Md., Dec. 14 (UPI) -- A panel of Food and Drug Administration experts on Wednesday voted unanimously to recommend approval of Merck & Co.'s RotaTeq, a rotavirus vaccine.
The panel voted 10-0 that the vaccine was safe and backed efficacy by an equal measure.
The FDA is not bound to follow its panels' advice, but it does so in most cases.
The panel's main concern was safety. The only other approved rotavirus vaccine, Wyeth's RotaShield, was recalled in 1999, nine months after its launch. The vaccine was linked to an increased risk of intussusception, an intestinal blockage that can be fatal.
The FDA advisers said that Merck showed that RotaTeq did not seem to increase the risk of that side effect.
"The data as presented to me are very reassuring with regard to intussusception -- I don't know how you could do better," said Gary Overturf, the panel's chairman and a professor of pediatrics at the University of New Mexico Medical Center in Albuquerque.
Committee members supported Merck's plan to monitor that condition through a large post-marketing study at a managed-care organization.
They also asked the company to more closely study the vaccine's impact on infants who have lowered immunity and whether the product is less effective when given with other common childhood vaccines or, conversely, if it reduces protection from those shots.
If approved, RotaTeq would be given orally to infants age 6-12 weeks, followed by two more doses, given 4-10 weeks after the previous dose.
In Merck's main trial, the vaccine protected 74 percent of children from the vomiting and diarrhea that accompanies infection, and almost 95 percent from more severe infection.
The vaccine also substantially reduced hospitalizations, emergency department and doctors' office visits, said Merck.
The day before the panel meeting, the FDA had said it needed more data before deciding whether Merck's vaccine should be approved.
In light of the lingering safety concerns with the rotavirus vaccine, Merck conducted trials of its product that enrolled 70,000 children in the United States and overseas.
However, it remains unclear whether pediatricians will embrace RotaTeq if it is approved, given the disastrous experience of the Wyeth vaccine.
"I think a lot of pediatricians are going to be cautious and want to see the data," said Penny Dennehy, division director for pediatric infectious diseases at Hasbro Children's Hospital in Providence, R.I., and a member of the American Academy of Pediatrics Committee on Infectious Diseases.
However, Dennehy acknowledged the need for a rotavirus vaccine, noting that, while it is only associated with 20 to 70 deaths each year in the United States, it is the cause of 50,000 hospitalizations and huge numbers of visits to emergency rooms and physicians' offices over the winter months when the virus is at its peak.
Rotavirus is much more devastating in developing countries where healthcare is harder to access and scores of children die from dehydration. Worldwide, 350,000 to 590,000 children, mostly under age 5, perish from rotavirus each year.
In a small survey of pediatricians published in 2003, 94 percent said they would use a new rotavirus vaccine if it proved to be safer than the Wyeth vaccine and if the American Academy of Pediatrics and the CDC's Advisory Committee on Immunization Practices recommended it.
The survey was conducted by researchers at the Rollins School of Public Health at Emory University in Atlanta.
Merck's rival GlaxoSmithKline launched its rotavirus vaccine Rotarix in January in Mexico but has not indicated if or when it will seek U.S. approval.
