FDA Announces Approval Of HPV Vaccine Gardasil

Main Category: Immune System / Vaccines
Also Included In: Sexual Health / STDs;  Cervical Cancer / HPV Vaccine;  Immune System / Vaccines
Article Date: 13 Jun 2006 - 0:00 PST

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FDA on Thursday announced the approval of Merck's human papillomavirus vaccine Gardasil for sale and marketing to girls and women ages nine to 26, the Washington Post reports (Kaufman, Washington Post, 6/9). 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, 6/8). The trials showed the vaccine -- given in three injections over six months -- also was about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases (Kaiser Daily Women's Health Policy Report, 5/31). Gardasil also protects 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. An FDA advisory panel in May voted that the vaccine is safe and effective for girls and women ages nine to 26 (Kaiser Daily Women's Health Policy Report, 6/5). Gardasil in studies has been shown to be effective for three-and-a-half years, according to Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research. It is unclear if people will need a "booster" shot after that time, according to the San Jose Mercury News (San Jose Mercury News, 6/9). Elaiv Barr, Merck senior director of clinical vaccine and biologics research, said the vaccine "will be available in doctors' offices later this month," adding, "We have the capacity to make millions of doses" (Cohen, Newark Star-Ledger, 6/9). As soon as it is distributed, physicians will be able to administer the vaccine (Washington Post, 6/9).

CDC Advisory Panel To Review Gardasil
CDC's Advisory Committee on Immunization Practices, which drafts recommendations and schedules the administration of vaccines in the U.S., on June 29 is scheduled to review who should receive Gardasil, the Wall Street Journal reports (Coorbett Dooren, Wall Street Journal, 6/9). ACIP's HPV vaccine group has recommended giving the vaccine to girls ages 11 and 12. The 15-member ACIP also will consider recommending Gardasil for girls and women ages 13 to 26. However, ACIP only can recommend who should get the vaccine, and any vaccination requirements would be determined by states (Kaiser Daily Women's Health Policy Report, 5/19). Although ACIP is "likely to be heavily influenced" by FDA's approval recommendations, the panel could decide to recommend that boys also receive the vaccine, according the Journal.

Costs, Insurance Coverage
Merck said the full treatment course will cost $360, the New York Times reports (Harris, New York Times, 6/9). That cost "has raised concerns" that women in developing countries and some women in the U.S. who do not have private health insurance will not be able to obtain the vaccine, the Post reports (Washington Post, 6/9). However, Merck has said it plans to work with government agencies nationwide and globally to make the vaccine affordable for low-income populations (Allday, San Francisco Chronicle, 6/9). Private health insurers in the U.S. are likely to cover Gardasil vaccinations for girls ages 11 and 12, but older women might have to pay for it themselves, the Times reports (New York Times, 6/9). According to the Journal, health insurance companies typically follow CDC recommendations when deciding coverage (Wall Street Journal, 6/9). In addition, there is a federal program that is expected to cover the vaccine for 45% of the U.S. children for whom it is recommended. However, state programs to cover children not covered by the federal program have had difficulties in buying other high-priced vaccines (New York Times, 6/9).

Media Campaign
Merck nearly one year ago launched a media campaign to raise consumer awareness about the vaccine and to alleviate concerns among parents about adding Gardasil to other routine childhood vaccinations, Bloomberg reports. Fewer than 20% of women in the U.S. knew that HPV can cause cervical cancer, according to Merck research that was conducted about 18 months ago, the company said (Zimm/Blum, Bloomberg, 6/9). The company's "Tell Someone" campaign, launched in April, uses paid television advertisements showing actresses, in interview style, expressing surprise about the cause of cervical cancer and promising to tell other women. In addition, Merck last fall funded "Make the Connection," run by the industry-backed not-for-profit Cancer Research and Prevention Foundation and celebrity charity Step Up Women's Network. The campaign includes publicity events, a television public service announcement and cameos by celebrities, such as Maria Shriver and Jessica Alba, wearing beaded bracelets to highlight the link between cervical cancer and HPV. Neither ad campaign mentions Gardasil because Merck could not legally promote the vaccine until receiving an FDA license to do so (Ginsberg, Philadelphia Inquirer, 6/9). Margaret McGlynn, president of Merck's vaccine division, on Thursday said the company now will pursue an "extensive educational campaign" that will "motivate women to get the vaccine" (Newark Star-Ledger, 6/9).

Reaction
"This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers," FDA Acting Commissioner Andrew von Eschenbach said, adding that the vaccine will have a "dramatic effect" on women's health worldwide (Washington Post, 6/8). Goodman said that even with Gardasil's approval, women will need to continue to undergo Pap tests to screen for HPV and cervical cancer because the vaccine does not protect against all of the HPV strains that cause cervical cancer (Rubin, USA Today, 6/9). He added that the vaccine's rapid approval by FDA "underscores [the agency's] commitment to help make safe and effective vaccines available as quickly as possible" (FDA release, 6/8).

Media Coverage
Several broadcast programs reported on the FDA approval of the HPV vaccine:

• ABCNews' "World News Tonight": The segment includes comments from William Schaffner, an infectious disease expert at Vanderbilt University ("World News Tonight," ABCNews, 6/8). A related ABCNews story is available online. Video of the segment is available online.
  


• CBS' "Evening News": The segment includes comments from Ursula Matulonis, a physician at the Dana-Farber Cancer Institute, and a U.S. woman diagnosed with cervical cancer (Kenniff, "Evening News," CBS, 6/8). The complete segment is available online in RealPlayer.
  


• NBC's "Nightly News": Robert Bazell, science correspondent for NBC, discusses the costs and benefits of the vaccine (Bazell, "Nightly News," NBC, 6/8). The complete segment is available online in Windows Media.

"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.