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The FDA Approves Use of HPV Vaccine

On June 8, the Food and Drug Administration (FDA) voted 13-0 to approve sales of Gardasil, a vaccine designed to prevent certain strains of the Human Papillomavirus (HPV) known to cause genital warts and/or cervical cancer.1 HPV is the most common sexually transmitted disease (STD) in the U.S. ; an estimated 20 million people in this country become infected with HPV every year. More than half of Americans will be infected at some point in their lives, and by the time women in the U.S. reach age 50, approximately 80 percent of them have been infected with HPV.2

Now that Gardasil has approval, Merck (the manufacturer) and the FDA will be monitoring the effectiveness of the vaccine over the years to determine if boosters will be needed, and to look for side effects that might have gone unnoticed during clinical testing. As of now, studies have shown very few side effects for the vaccine, and the FDA's approval of Gardasil was, as the Washington Post pointed out, “almost universally hailed.”3

There are still approximately 9,700 cases of cervical cancer a year in the U.S., though the growing use of pap smears has helped dramatically lower the number of yearly cases. With the arrival of Gardasil, some health officials worry that women will see the vaccine as a replacement for regular Pap tests which screen for cancerous and pre-cancerous changes in the cervix. Given that widespread distribution could take time and the length of effectiveness of the vaccine will probably not be known for years, health officials warn that the vaccine cannot replace regular screenings.4

Health officials are encouraging the researchers who tested this drug to determine the best means of distribution. Widespread access to the vaccine is vital because it will only prevent the virus in women who have not yet been exposed to HPV; given that the median age at which women become sexually active is 155, access for young people will be essential. An independent panel (the Advisory Committee on Immunization Practices) formed by the Centers for Disease Control and Prevention (CDC) voted unanimously on June 29 to recommend that all women between the ages of 11 and 26 receive the vaccine.6 Many public health groups are also advocating that vaccinations be “early and mandatory,” as wider distribution of the vaccine could save more lives. The senior director for clinical affairs for Planned Parenthood Federation of America, Jeffrey Waldman, stated that “to have the greatest benefit, this vaccine would be given to all girls—and in the future, maybe boys—before they become sexually active.”7

Some health experts are concerned that the expensive vaccine, which will cost between $300 and $500 for three doses given over six months, might not reach the young and low-income women who need it most. As John Schiller of the National Institute for Health (NIH) said, “[n]one of us [is] going to be happy if the only women who get the vaccine are the same women who are already getting regular screens for cervical cancer.”8 Showing similar concern, the program director of the National Women's Health Network, Amy Allina, stated, “the potential of this technology will only be realized if it is made accessible to the women who are at greatest risk for cervical cancer.”9

The Advisory Committee on Immunization Practices does not make recommendations on whether an immunization should be mandatory in public schools—such a decision is left to the states to decide—but some experts say it is unlikely that the vaccine will be mandatory in most states because the “target” age group of girls will already be in school.10 If Health and Human Services (HHS) confirms the recommendations made by the Committee, which it likely will, then most health insurers will cover the cost of the vaccination for low-income girls, and the federal government will have to provide vaccinations for as many as seven million girls through Vaccines for Children, a federal entitlement program that provides about half of all vaccines to low-income children.11

Though the issue of whether the vaccine will be mandatory is left to the states, some socially conservative groups still oppose mandatory vaccinations saying that the vaccine might increase promiscuity among young people. As Linda Klepacki of Focus on the Family put it “[w]e can prevent [HPV] by the best public health method, and that's not having sex before marriage.”12 Leslie Unruh of the Abstinence Clearinghouse also opposes the vaccine, saying, “I personally object to vaccinating children against a disease that is 100% preventable with proper sexual behavior.”13

While the prospect of eliminating the two strains of HPV that cause about 70 percent of cervical cancer and the two strains of HPV that cause about 90 percent of genital warts is a positive step for protecting women's health, many advocates worry that the HPV vaccine will get caught in the crossfire of current debates in the U.S. around abstinence promotion and abstinence-only-until-marriage programs. As one survivor of cervical cancer stated, “[t]his vaccine should not lead to an argument about when girls have sex…It's about saving the lives of women in their child-bearing years, letting them have children or take care of the children they already have.”14

Outside of the U.S., cervical cancer is an even larger public health problem; approximately 250,000 women, about 85% of whom live in developing countries, die each year from cervical cancer, making it the second-leading cause of death in women worldwide. Many of these women, like poor women in the U.S., do not have access to preventive healthcare, such as pap smears, putting them at a higher risk of developing cervical cancer.15

The Seattle-based international health non-profit, PATH, recently received a 27.8 million dollar grant from the Bill & Melinda Gates Foundation to conduct research regarding distribution of the vaccine in developing countries. The grant will allow PATH to identify key obstacles to distribution and look into the best means of distribution in countries that already lack the resources for providing preventative healthcare.16

PATH, which is collaborating with Merck and GlaxoSmithKline Biologicals (manufacturers of a similar vaccine), as well as other international agencies such as the World Health Organization (WHO), will focus on India, Peru, Uganda and Vietnam. One of the goals of this research is to identify what distribution methods do or do not work in these four countries, and then to apply that knowledge to other countries with similar social and economic structures. The director of infectious diseases at the Gates Foundation, Dr. Regina Rabinovich, summarized this plan, saying “PATH will help determine how to deliver these vaccines in developing countries, where systems to reach young women with health services are fragile, and cervical cancer may not be seen as a problem because so few women are screened.”17

References

  1. Gardiner Harris, “U.S. Approves Use of Vaccine for Cervical Cancer,” New York Times, 9 June 2006, accessed 13 June 2006, <http://www.nytimes.com/2006/06/09/health/09vaccine.html>.
  2. Ibid.
  3. Marc Kaufman, “FDA Approves Vaccine That Should Prevent Most Cervical Cancers,” Washington Post, 9 June 2006, accessed 13 June 2006, <http://www.washingtonpost.com/wp-dyn/content
    /article/2006/06/08/AR2006060800865.html
    >.
  4. Ibid.
  5. Harris, “ U.S. Approves Use of Vaccine for Cervical Cancer.”
  6. Gardiner Harris, “Panel Unanimously Recommends Cervical Cancer Vaccine for Girls 11 and Up,” New York Times, 30 June 2006, accessed 6 July 2006, <http://www.nytimes.com/2006/06/30/health/30vaccine.html>.
  7. Harris, “ U.S. Approves Use of Vaccine for Cervical Cancer.”
  8. Arthur Allen, “And Now, the HPV Vaccine,” Slate, 8 June 2006, accessed 13 June 2006, <http://www.slate.com/id/2143304>.
  9. Kaufman.
  10. David Brown, “HPV Vaccine Advised for Girls,” Washington Post, 30 June 2006, accessed 6 July 2006 <http://www.washingtonpost.com/wp-dyn/content/
    article/2006/06/29/AR2006062901900.html
    >.
  11. Harris, “Panel Unanimously Recommends Cervical Cancer Vaccine for Girls 11 and Up.”
  12. Harris, “ U.S. Approves Use of Vaccine for Cervical Cancer.”
  13. Janet Guyon, “The Coming Storm Over a Cancer Vaccine,” Fortune Magazine, 31 October 2005, accessed 22 June 2005 <http://money.cnn.com/magazines/fortune/fortune_archive/2005/10/31/8359188/index.htm>.
  14. Harris, “ U.S. Approves Use of Vaccine for Cervical Cancer.”
  15. Reuters, “Gates Cash Backs Cervical Cancer Shots for Poor,” 6 June 2006, accessed 26 June 2006, <http://go.reuters.com/newsArticle.jhtml?type=healthNews&storyID=12438055&src=rss/healthNews>.
  16. Ibid.
  17. “PATH to Pave the way for Cervical Cancer Vaccines in the Developing World,” GlaxoSmithKline, 6 June 2006, accessed 26 June 2006, <http://us.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=912#>.

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