FDA Panel Endorses Cervical Cancer Vaccine

An unidentified man leaves Merck & Co. headquarters in Whitehouse Station, N.J. in this Thursday, Sept. 30, 2004 file photo. A vaccine with the potential to slash worldwide deaths from cervical cancer, the No. 2 cancer killer in women, should be approved for sales in the United States, a federal panel said Thursday. A Food and Drug Administration advisory committee voted 13-0 to endorse the safety and effectiveness of Merck & Co.'s Gardasil, which blocks viruses that cause cervical cancer. The company said the vaccine could cut worldwide deaths from the disease by two-thirds. (AP Photo/Daniel Hulshizer, FILE) (Daniel Hulshizer - AP)

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.

The company is seeking to license Gardasil in more than 50 countries, said Dr. Eliav Barr, who headed the vaccine program at Merck.

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. Merck seeks use of the vaccine in girls as young as 9.

Dr. Nancy Miller, an FDA reviewer, cautioned that 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, FDA staff highlighted in briefing documents five cases where children with birth defects were born to women who received the vaccine around the time of conception. Merck said it was "highly unlikely" they were related to Gardasil.

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.

The anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500. That could pose a barrier to widespread vaccination campaigns.

"The vaccine community will see this as an opportunity to prevent cancer. They will also see issues of availability and cost," said Dr. Bruce Gellin, a committee member and head of the federal vaccine policy office.

Analysts believe Gardasil sales could top $1 billion a year for Merck, which is battling thousands of lawsuits over its withdrawn painkiller Vioxx.

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