QDIS Blog

A blog about chemistry, drug development, science, and technology

May 19, 2006

Gardasil recommend for approval

by @ 11:54 am.  Filed under FDA, Pharma News

Yesterday, the FDA Advisory committee for vaccines met and recommended 13-0 to approve Gardasil, Merck’s vaccine against human papillomavirus virus (HPV) which can lead to cervical cancer in women. It is good to see the FDA coming down on the side of good science again and not giving in to political pressure. It is estimated that this vaccine could save many of the almost 300,000 lives of women who die world-wide annually, including 3,500 each year in the US.

One aspect which may limit wide-spread use is the cost estimated to be $300-500 and the fact that it is three shots administered over six months. Merck is seeking approval for use in children as young as 9 whereas the panel recommended children as young as 11. It is important to administer the shots before they are sexually active.

It should be noted that Gardasil does not protect against all forms of HPV, but is effective against the ones primarily responsible for cervical cancer.

Other links:
• Washington Post: FDA Panel Endorses Cervical Cancer Vaccine
• Yahoo Finance: FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of GARDASIL(R), Merck’s Investigational Cervical Cancer Vaccine
Yahoo News results for Gardasil

You can hear more of my comments on Gardasil in the Bicyclemark Audio Communique #128

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Email Ed Vawter



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  • Gardasil Not Readily Available?

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    One Response to “Gardasil recommend for approval”

    1. QDIS Blog » Blog Archive » CDC Recommends Gardasil vaccination Bloomberg.com: Worldwide Says:

      […] I’ve posted before about Merck’s cancer vaccine Gardasil. You can see my other posts for further details. The final step after the FDA approval was whether or not the CDC would recommend it be used generally for young girls. […]

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