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Gardisil HPV Vaccine Approved By FDA Panel - May Prevent Cervical Cancer - Approval Could Prevent Most Common Sexual Virus

May 18th 2006

Gardisil HPV Vaccine Approved By FDA Panel - May Prevent Cervical Cancer - Approval Could Prevent Most Common Sexual Virus

HPV Virus

A U.S. Food and Drug Administration advisory panel recommended approval (13 to 0 vote) of the first vaccine to fight cancer.  The vaccine, Gardisil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine), is a vaccine that can be used against the human papilloma virus (HPV) which has been linked to cervical cancer.  The FDA is not required to follow the advice of its panels, but they usually do.  A decision on approval by the FDA is expected by June 8.

Gardisil, manufactured by Merck, is a vaccine that is most effective in women before they become sexually active.  It is hoped the vaccine will help prevent hundreds of thousands of women from dying worldwide of cervical cancer.  According to the University of Alabama at Birmingham, it is estimated that 450,000 women are diagnosed with cervical cancer annually and 200,000 women die each year from the disease.  Other sources say the number of deaths might be as high as 300,000 per year.  In the U.S. approximately 12,000 women are diagnosed with cervical cancer, resulting in 4,500 deaths each year.

 

Merck has already tested the vaccine on 27,000 women and girls in 33 countries.  They found the drug to be safe and 100% effective against two viral strains of the HPV.  This accounts for roughly 10 percent of the HPV infections. 

Richard Haupt, executive director of medical affairs with Merck's Vaccine Division says studies show the vaccine protects women for at least five years, and it is most effective when given to women years before they become sexually active, such as when they are nine or 11 years old. This is according to Kathy Jones of the Food Consumer Organization.

 

Dr. Diane Harper of the Dartmouth-Hitchcock Medical Center says HPV is the most common sexually transmitted infection.  She told ABC News that most women will have a high risk HVP infection before they die. 

Usually the virus is harmless, but sometimes it rages out of control causing cancer, according to ABC News reporter John McKenzie. He reports that 11 percent of  the pediatricians are concerned that the vaccine may encourage more sexual behavior.  CBS reporter, Lisa Daniels, said conservative groups say that giving the vaccine to women could be “harmful”.  It may give women the license to engage in premarital sex. 

 

Some citizens groups worry that it may become a required vaccination.  Lisa Daniels reported that if the vaccine wins approval by the FDA, another panel might recommend that Gardisil vaccinations be mandatory for girls as young as 13.

The vaccine will likely be available this summer.  GlaxoSmithKline (GSK) has also been working on a vaccine called Ceravix.  So far this experimental vaccine has been 100 percent effective against two cancer causing HPV strains.  GSK is expected to seek regulatory approval later this year. 

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Dan Wilson
Best Syndication

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Keywords and misspellings: viris cervacal servical canser gardasil gradisil


Important:  The material on Best Syndication is for informational purposes only and is not a substitute for medical advice or treatment for any medical conditions. You should promptly seek professional medical care if you have any concern about your health, and you should always consult your physician before starting a fitness program.
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Copyright 2005 Best Syndication                   Last Updated Saturday, July 10, 2010 09:51 PM