Experimental HPV Vaccine Also Protects Against Vaginal, Vulvar Cancers, Study Says

Main Category: Immune System / Vaccines
Also Included In: Women's Health / Gynecology;  Sexual Health / STDs;  Cervical Cancer / HPV Vaccine
Article Date: 06 Jun 2006 - 18:00 PDT

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Merck's experimental human papillomavirus vaccine Gardasil, which an FDA advisory committee last month voted is safe and effective for girls and women ages nine to 26, also prevents against vaginal and vulvar cancers, two other gynecological cancers that also are linked to HPV, according to a study presented on Sunday in Atlanta at a meeting of the American Society of Clinical Oncology, the AP/Houston Chronicle reports (Marchione/Stobbe, AP/Houston Chronicle, 6/4). About 80% of people with vaginal and vulvar cancer also test positive for HPV, USA Today reports (Szabo, USA Today, 6/5). Merck in October 2005 announced that Gardasil in clinical trials was 100% effective in preventing infection with HPV strains 16 and 18. Trials also have shown that the vaccine -- given in three injections over six months -- is about 99% effective in preventing HPV strains 6 and 11 (Kaiser Daily Women's Health Policy Report, 5/31). Jorma Paavonen of the University of Helsinki in Finland on Sunday said that physicians randomly assigned 18,000 women to receive the vaccine or a placebo and monitored them over the next two years. Twenty-four women who received the placebo after two years developed vaginal or vulvar cancer, but no vaccinated women did, according to Paavonen (USA Today, 6/5).

Wall Street Journal, Minneapolis Star Tribune Examine HPV Vaccine Approval
The Wall Street Journal and the Minneapolis Star Tribune on Monday examined the possible effects of FDA approving Gardasil. The FDA advisory committee's vote earlier this month effectively recommends that the agency approve the vaccine for sale and marketing to girls and women ages nine to 26. Although FDA is not required to agree with the advisory panel's recommendations, it often follows them (Kaiser Daily Women's Health Policy Report, 5/31). However, FDA approval of the vaccine "also would mark the beginning of another daunting process: trying to convince regulators, parents and politicians that every middle-school girl in the nation should receive a vaccination against a sexually transmitted [infection]," according to the Journal (McDermott, Wall Street Journal, 6/3). Physicians are concerned about an "uphill battle convincing some parents" that the vaccine is right for their daughters because some parents might feel that vaccinating children might send conflicting messages regarding sex before marriage, according to the Tribune (Marcotty, Minneapolis Star Tribune, 6/3). If Merck's application for Gardasil receives FDA approval, it also must be examined by CDC's Advisory Committee on Immunization Practices, which drafts recommendations and schedules for the administration of vaccines in the U.S. (Kaiser Daily Women's Health Policy Report, 5/19). ACIP on June 29 will meet to "combine the FDA's conclusions with its own analysis of factors such as the vaccine's price ... in issuing guidelines for state regulators and pediatricians," after which the "battle moves to the states," which set immunization requirements, the Journal reports (Wall Street Journal, 6/3). Some groups that promote abstinence support the approval of Gardasil, while some groups, such as Focus on the Family and the Christian Medical & Dental Associations, say they support availability of the vaccine but do not want to make it mandatory because they would prefer that parents choose whether to vaccinate their children, according to the Star Tribune (Minneapolis Star Tribune, 6/3). Thursday is FDA's deadline for ruling on the vaccine, the Journal reports (Wall Street Journal, 6/3).

Boston Globe Examines How HPV Vaccine Development Depended on Public-Private Partnership
The Boston Globe on Monday examined how the development of Gardasil and of GlaxoSmithKline's experimental HPV vaccine, Cervarix, "depended on a kind of public-private partnership that is revolutionizing the way scientific discoveries are brought to market" (Henderson, Boston Globe, 6/5). Cervarix, which has been shown in studies to be 100% effective in preventing infection with HPV strains 16 and 18, also has been shown to have high levels of antibodies against the strains in those who receive the vaccine for up to four-and-a-half years after receiving the drug, according to a study published in the April 6 online edition of the journal Lancet (Kaiser Daily Women's Health Policy Report, 4/6). According to the Globe, the public-private partnership occurs when early research is funded by federal money, after which private companies use existing marketing and manufacturing infrastructures to sell the developed products. The public research facilities that are involved in the work also receive a percentage of the profit after the product is available on the market, the Globe reports. For example, for the two experimental HPV vaccines, federal researchers discovered the "basic science" upon which Gardasil and Cervarix are based, but Merck and GSK will market their respective vaccines (Boston Globe, 6/5).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . � 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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