Requiring HPV vaccination for school-age girls for upcoming school year 'too soon,' researcher says

It is premature to require middle-school age girls to receive Merck's human papillomavirus vaccine Gardasil for the upcoming school year, Doug Lowy -- head of the National Cancer Institute's Laboratory of Cellular Oncology and one of the scientists responsible for the development of the vaccine -- said on Wednesday, CQ HealthBeat reports (Bartolf, CQ HealthBeat, 6/20).

Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with HPV strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains. FDA in June 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine, which is given in a three-shot series (Kaiser Daily Women's Health Policy Report, 5/18).

Lowy, referring to opposition from parents and pro-abstinence groups who believe the vaccine could promote sexual promiscuity, said, "We should minimize the degree to which [Gardasil is] politically polarized by giving parents the option of opting out of the vaccine."

He added that mandating the vaccine before a long safety record has been established is a risky move because the current research does not indicate how long the vaccine will remain effective or if women will need to receive booster shots. "We know it will work for five years, but having a longer record of high effectiveness would make it more reasonable to mandate the vaccine," Lowy said (CQ HealthBeat, 6/20).

FDA To Review Merck's Application for Additional Gardasil Uses
Merck on Wednesday announced that FDA has accepted its application to FDA for extended approval of Gardasil to help prevent vaginal and vulvar cancers under a standard review period, Reuters reports (Reuters, 6/20).

A study published last month in the journal Lancet found that after three years of follow-up, Gardasil was 71% effective in preventing vaginal and vulvar cancers related to HPV strains 16 and 18 among women who previously had been exposed to HPV strains 6, 11, 16 and 18. It was 100% effective among women who previously had not been exposed to those strains. The vaccine was not effective in fighting vaginal or vulvar lesions that already had formed, according to the study. According to Merck, vaginal and vulvar cancers account for about 3% and 4% of gynecological cancers, respectively. HPV is present in about 80% of the 6,000 vaginal and vulvar cancers diagnosed annually in the U.S. (Kaiser Daily Women's Health Policy Report, 5/18).

According to the AP/Forbes, the application also includes data on immune memory, or the ability of the immune system to continue fighting off HPV after the vaccination. If approved, Gardasil's label would include the additional information (AP/Forbes, 6/20). A standard review period usually takes about 10 months, Merck said, adding that it expects FDA to decide on the application in the first quarter of 2008 (Reuters, 6/20).

U.K. Recommends Gardasil for Girls Ages 12 to 13
The United Kingdom's Joint Committee on Vaccination and Immunisation on Wednesday recommended that girls ages 12 and 13 in the country receive Gardasil, London's Guardian reports (Sample, Guardian, 6/21). The country's Department of Health said it has agreed "in principle" to accept the committee's advice, subject to an independent review of its cost to the National Health Service, the Press Association reports. According to the health department, the vaccine will be administered in three doses over six months and will cost 300 pounds, or about $600, for the full course of treatment. Public Health Minister Caroline Flint said the government hopes to begin vaccinating girls as early as 2008 (Kirby, Press Association, 6/20).

Gardasil has been approved in the European Union and 76 countries worldwide -- including Australia, Canada, and the U.S. Merck and Sanofi-Aventis on Monday announced that Switzerland has recommended that girls ages 11 to 14 in the country receive Gardasil. The Swiss decision follows similar recommendations in Austria, Belgium, France, Germany, Italy, Luxembourg and Norway. Sanofi Pasteur, a joint company of Merck and Sanofi-Aventis, is funding a campaign advocating for European governments to vaccinate young girls with Gardasil (Kaiser Daily Women's Health Policy Report, 6/20).