Gardisil HPV Vaccine
Approved By FDA Panel - May Prevent Cervical Cancer - Approval Could
Prevent Most Common Sexual Virus
May 18th 2006
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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.
Dan Wilson
Best Syndication
Books on Cancer
Keywords and misspellings:
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