http://health.msn.com/centers/cancer/articlepage.aspx?cp-documentid=100136070&GT1=8199

Cervical Cancer Vaccine Gets FDA Panel's OK
Advisory committee recommends agency approve Gardasil
By Amanda Gardner, HealthDay Reporter


THURSDAY, May 18 (HealthDay News) -- A vaccine that protects against the
virus known to cause most cervical cancers was given the blessing of a
U.S. Food and Drug Administration advisory panel Thursday.

The vaccine, Gardasil, is expected to get full FDA approval on June 8,
and the national Advisory Committee on Immunization Practices will then
decide whether to include the vaccine in routine vaccination schedules.
Gardasil, which is manufactured by Merck & Co., would then become the
first vaccine to be approved for the prevention of cervical cancer.

Experts noted the development of this type of vaccine is unquestionably
a good thing.

"This will be a very important advance for public health for women,"
said Dr. Jay Brooks, chairman of hematology/oncology at the Ochsner
Clinic Foundation, in Baton Rouge, La.

"It's a very positive thing. There's no negative that I can think of,"
echoed Dr. Nicholas Klein, director of obstetrics and gynecology at
Nyack Hospital, in Nyack, N.Y. "It's a great step forward in possibly
preventing cervical cancer."

There are, however, some important remaining questions.

"This can have a tremendous effect on women's health," said Dr. Daniel
H. Smith, chief of the gynecologic oncology division at Hackensack
University Medical Center's Cancer Center, in New Jersey. "Having said
that, to me, the real issue is who should be treated, and when."

At Thursday's hearing, Merck officials told members of the FDA's
Vaccines and Related Biological Products advisory committee that the
vaccine could be used for females between 9 and 26 years old but would
work best when given to girls before they become sexually active.

"It will be most effective when administered prior to entry in the risk
period, and that is the age group 15 and below," Merck's Dr. Eliav Barr
told the panel, according to an Associated Press report.

The FDA panel voted 13-0 to recommend the vaccine, AP reported.

The main cause of cervical cancer is continuous infection with human
papilloma viruses (HPV), especially HPV 16 and 18, which are spread by
sexual contact. The virus also causes precancerous and benign cervical
lesions and genital warts, and may be implicated in some anal and oral
cancers. An estimated 20 million men and women in the United States are
infected with HPV but, for most, the virus shows no symptoms and goes
away on its own.

Cervical cancer is the second most common malignant disease in women
globally, causing an estimated 290,000 deaths worldwide each year. In
the United States, some 10,400 new cases will be diagnosed this year,
and 3,700 women will die from the disease.

In a two-year study involving more than 12,000 women, the vaccine was
found to be 100 percent effective against four types of human papilloma
virus: 16 and 18, which are responsible for about 70 percent of cervical
cancer cases, and 6 and 11, which cause 90 percent of genital wart
cases.

Merck has said the vaccine has the potential to reduce the annual number
of new cervical cancer cases around the world from 500,000 to about
150,000, and cut deaths by more than two-thirds, to about 90,000.

The vaccination will require three shots over six months, which experts
said is normal.

"Polio, for example, has to be taken more than once. Some other vaccines
have a limited lifespan and they have to be renewed every 10 years or
so. That's not something new; I believe that it's very positive for
women's health," Klein said.

And many experts agreed that the earlier the vaccine is given, the
better.

"There is a potential that individuals will feel that taking this shot
means that the recipient will be sexually active," Brooks said. "We
should completely remove that stigma, and we should simply vaccinate
like we would against any other diseases. We're not making any moral
judgments as to individuals being vaccinated."

"If you vaccinate early enough and widely enough, you would cut down on
the ravages of HPV," he added. "It should be done before sexual activity
begins."

Experts also felt the vaccine should eventually be given to boys as well
as girls, given that boys transmit the virus.

"Why don't we give it to boys?" Smith asked.

Even with the vaccine, women would still need to be screened for
cervical cancer caused by other types of HPV, experts noted.

And, according to an AP report, FDA reviewer Dr. Nancy Miller told panel
members that Gardasil would not necessarily protect against any of the
four viruses in people who already have been infected and even increases
their risk for precursors to cancer.

A second experimental cervical cancer vaccine, Cervarix, which would
protect against HPV 16 and 18, is being developed by GlaxoSmithKline.

/end


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