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MERCK VREA SA VACCINEZE CU GARDASIL COPIII SI BARBATII TINERI > Merck Seeks FDA Approval for Gardasil in Boys

January
23

11:17 am Atentie !, GARDASIL, Important, Info, Realitatea adevarata, Reflectati !, Utile

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Posted by Jonathan D. Rockoff

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Boys may soon get Gardasil, too, if FDA approves an expansion of use for the Merck vaccine.

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.

The vaccine is a key product for Merck, which estimates sales this year of as much as $1.6 billion. But sales have slowed, down 4% in the third quarter compared to a year earlier.

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