Will This Vaccine Contain Mercury?

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Panel Recommends Cervical Cancer Vaccine

By ANDREW BRIDGES, AP

WASHINGTON (May 18) - A vaccine that blocks viruses that cause most cervical

cancer is safe and effective and should be approved, a federal panel

recommended Thursday. The drug maker said the vaccine could slash global deaths

from

the No. 2 cancer in women by more than two-thirds.

A Food and Drug Administration advisory committee voted 13-0 on five separate

times to endorse Merck and Co.'s Gardasil. The anticipated cost of the

vaccine, administered in three shots over six months, is $300 to $500 - a

possible

impediment to widespread vaccination campaigns.

The drug protects against the two types of human papillomavirus (HPV)

believed responsible for about 70 percent of cervical cancer cases. The vaccine

also

protects against two other virus types that cause 90 percent of genital wart

cases. All four virus types are sexually transmitted.

The FDA is not required to follow the recommendations of its outside panels

of experts, but usually does. An agency decision is expected by June 8.

HPV is the most common sexually transmitted disease. It affects more than 50

percent of sexually active adults. The cervical cancer it can cause kills each

year about 290,000 women worldwide, including 3,500 women in the United

States, where regular pap smears often detect precancerous lesions and early

cancer.

" This is certainly a wonderful, good step in addition to our screening

processes " in helping eradicate cervical cancer, said Dr. Farley, who

heads

the advisory panel. She is a bacterial infectious disease expert at the Emory

University School of Medicine.

Making their case for approval, Merck officials suggested that development

could make Gardasil the biggest advance in preventing cervical cancer since the

pap test.

" Gardasil has the potential to meet an unmet medical need as the first

vaccine to prevent cervical cancer, " Merck's Dr. Brill- told the

Vaccine and Related Biological Products advisory committee.

Several speakers said the vaccine should not replace screening. Merck said

the drug is not intended to do that.

" We would like to see the FDA mandate some sort of labeling or other

mechanism to communicate to health care providers and patients the continued

need for

regular cervical screening, " said Amy Allina, program director of the National

Women's Health Network.

Merck said the vaccine could be used in females age 9 to 26, but would work

best when given to girls before they begin having sex.

Pending action by the FDA, the national Advisory Committee on Immunization

Practices will decide in June whether to endorse routine vaccination with the

vaccine.

The committee's HPV vaccine group is recommending giving the vaccine to girls

11 and 12. The 15-member committee of experts who advise the government will

consider recommendations for females 13 to 26.

The committee's HPV vaccine workgroup is recommending the vaccine be given to

girls 11 and 12, and the committee will consider recommendations for females

13 to 26.

Early opposition to Gardasil was based on concerns it could encourage sexual

activity in the young. But that largely faded away because of vaccine's

potential for reducing cancer.

FDA reviewers said Gardasil appears safe and effective, according to agency

documents. One agency reviewer, Dr. , told the advisory committee

that Merck submitted data to support the use of the vaccine in females 9 to 26.

said Gardasil does not necessarily protect against one or more of the

four viruses in people already infected before they get the vaccine, and can

increase their risk for precursors to cervical cancer.

Also, the drug does not protect against infection from the many other virus

strains not included in the vaccine. In addition, the FDA staff highlighted

five cases where children with birth defects were born to women who received the

vaccine around the time of conception.

Merck, based in Whitehouse Station, N.J., developed the vaccine and tested it

in more than 27,000 females and males.

Thursday's discussion focused on its use in preventing HPV-related disease in

girls and women, including those as young as 9. But only 250 9-year-old girls

and boys received Gardasil in trials.