FDA Panel Expected To Recommend Whether HPV Vaccine Should Be Approved; Agency Raises Concern About Risks In Women Already Exposed To Virus

Main Category: Sexual Health / STDs
Also Included In: Cervical Cancer / HPV Vaccine;  Women's Health / Gynecology
Article Date: 21 May 2006 - 16:00 PDT

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An FDA advisory panel on Thursday is expected to recommend whether the agency should approve Merck's experimental human papillomavirus vaccine Gardasil for sale in the U.S. and whether it should be given to girls as young as age nine, the Boston Globe reports (Henderson, Boston Globe, 5/18). Although FDA is not required to agree with the advisory panel's recommendations, it often follows them. Merck in October 2005 announced that Gardasil in clinical trials was 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases (Kaiser Daily Women's Health Policy Report, 5/17). The agency in documents posted on its Web site ahead of Thursday's meeting said Gardasil likely would have a "significant impact" in decreasing cervical cases. The documents also raised some concern about the vaccine, including whether its efficacy might be "offset" by the fact that it does not protect against all strains of HPV that are linked to cervical cancer (Corbett Dooren, Wall Street Journal, 5/18). In addition, the agency said there was "compelling evidence" that Gardasil's effect is lessened in women who already have been exposed to HPV and could exacerbate cervical cancer in women already diagnosed with the disease (Boston Globe, 5/18). FDA also asked panel members to consider whether women in the clinical trials who previously had tested positive for HPV strains 16 or 18 who received Gardasil have an increased risk for developing precancerous cells compared with women who tested positive for the strains and who received a placebo vaccine. The agency also asked the panel to question whether five congenital abnormalities among infants born to women who gave birth within a month of being vaccinated with Gardasil were linked to the vaccine (Rubin, USA Today, 5/18).

Next Steps, Reaction
Merck in February announced that FDA had granted priority review for Gardasil (Kaiser Daily Women's Health Policy Report, 5/17). Priority review means that the agency has six months from the time of the company's application to make a decision on the vaccine's approval. The six month period ends June 8, according to USA Today (USA Today, 5/18). FDA has indicated that it is likely to approve Gardasil, the Journal reports (Wall Street Journal, 5/18). 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, 5/17).

NPR's "Morning Edition" on Thursday reported on the FDA panel's review of the vaccine. The segment includes comments from Christopher Crum, a pathologist at Brigham and Women's Hospital in Boston; Gary Rose, president and CEO of the Austin, Texas-based Medical Institute for Sexual Health, which advises conservative groups on medical issues; and Connie Trimble, director of the Cervical Dysplasia Center at Johns Hopkins School of Medicine (Silberner, "Morning Edition," NPR, 5/18). A transcript of the segment is available online. The complete segment is available online in RealPlayer.

"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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