US Advisors Back Wyeth
Vaccine for Ear Infections
Tue May 21, 2:58 PM ET
SILVER SPRING, Md. (Reuters) - A U.S. advisory panel on Tuesday
recommended approval of Wyeth's Prevnar pneumonia vaccine for preventing
some ear infections in children.
Prevnar hit the U.S. market in 2000 for combating seven strains of
bacteria that cause pneumonia.
Already given routinely to U.S. infants, winning Food and Drug
Administration (news
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web sites) approval for ear infections would allow Wyeth to promote
Prevnar for the common childhood malady.
The FDA usually follows the advice of its advisory panels.
Ear infections are common in U.S. children, occurring in more than 60
percent in their first year of life and about 90 percent by age 5.
Pneumococcus is the bacteria most often reported as responsible for ear
infections, but they also can be caused by other bacteria or viruses.
The advisors voted 13-3 to recommend Prevnar for ear infections, despite
concern by some panel members that the drug has limited effectiveness.
In one study, Prevnar showed a 57 percent reduction in episodes of ear
infections caused by the seven strains of pneumococcus the vaccine targets
but reduced ear infections from any cause by only six percent.
"We're not talking about huge efficacy rates here," said panel member
Gary Overturf, from the University of New Mexico School of Medicine.
But Michael Decker, a committee member and scientist at Aventis SA unit
Aventis Pasteur, said limited efficacy was better than none. "If you turn
down every partial solution, you never have a solution," he said.
Wyeth estimates Prevnar could eliminate 1 million to 1.5 million doctor
visits a year and cut ear-tube placements, a treatment for recurrent ear
infections, by 60,000 a year.
Shares of Wyeth fell $1.12, or 1.9 percent, to $27.12, in afternoon trade
on the New York Stock Exchange (news
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web sites). |