Merck Seeks FDA Approval for Gardasil in Boys

Jonathan D. Rockoff
The Wall Street Journal
January 6, 2009

Merck is asking federal regulators to expand the use of its human papillomavirus vaccine to boys and young men.

The company has asked the FDA to approve the Gardasil vaccine’s use in males ages 9 to 26 years to prevent genital warts and other lesions, CNBC’s Mike Huckman reported. In 2006, the FDA approved giving the vaccine to girls and women of those ages.

We talked with a Merck spokeswoman who pointed to studies showing Gardasil’s effectiveness in young males.

But the request will likely renew questions about Gardasil’s cost-effectiveness, especially with a price tag of $360 for a three-dose regimen. In August, Harvard researchers suggested the vaccine wasn’t worth the cost in older women likely to have been exposed to HPV by the time they were to get vaccinated.

Merck has also asked the FDA to expand Gardasil’s use to women ages 27 to 45 years.

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