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In separate votes Wednesday, FDA's panel ruled that Gardasil successfully prevents genital warts in boys and men ages 9 to 26.
While an approval decision from the FDA could theoretically double the market opportunity for Gardasil, analysts don't expect much use among males.
"If it's not preventing something serious like cervical cancer and there are questions about safety, I think a parents' acceptance of the vaccine in young boys might be less urgent than for their girls," Fernandez said in an interview last week.
Gardasil became an early success story for Merck after its launch, with sales growing to over $1.4 billion last year.
But momentum has slowed amid questions about the longevity of the vaccine's effect and its cost effectiveness, considering its price tag of nearly $400.
Merck has tracked HPV immunity out to five years in women, and just three years in boys and men. Public health advocates argued Gardasil should not be approved for boys without evidence of its long-term effectiveness.
"The boys of America are not facing an epidemic of genital warts," said Diana Zuckerman, of the National Research Center for Women and Families in Washington, during a public comment period. "We have time to wait for better data before approval."
Dr. Richard Haupt, Whitehouse Station, N.J.-based Merck's head researcher for Gardasil, said the company plans long term studies to track the vaccine's effectiveness over time.
"Our long-term evaluations will look at immune response, but more importantly they will look at disease prevention over time," said Haupt.
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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