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FDA Approves HPV Vaccine to Prevent Genital Warts in Boys and Young Men

On October 16, 2009, the Food and Drug Administration (FDA) approved the vaccine Gardasil to help prevent genital warts caused by human papillomavirus (HPV) in boys and young men ages nine through 26. Gardasil was originally approved for use among females in the same age-range on June 8, 2006.  

The vaccine has proven to be safe and effective, and in the three years since Gardasil was approved for girls and young women, over 26 million doses have been distributed in the United States.[i] The drug has been proven to prevent four of the estimated 40 sexually transmitted strains of HPV known to cause genital warts and/or cervical cancer in women. Two of the HPV strains Gardasil is intended to combat, types 16 and 18, cause approximately 70 percent of cervical cancer cases, while the other two HPV types covered, 6 and 11, cause approximately 90 percent of cases of genital warts.[ii] On September 12, 2008, the FDA also expanded Gardasil’s indication for women to “include prevention of vulvar and vaginal cancer,” which can also be caused by HPV types 16 and 18.[iii]
 
HPV is the most common sexually transmitted disease (STD) in the United States. The Centers for Disease Control and Prevention (CDC) estimate that at least half of all sexually active men and women will acquire some form of genital HPV in their lifetimes.[iv] While most cases of HPV cause no serious health complications and often resolve on their own, several types of HPV can cause cervical cancer in women, affecting over 10,000 newly diagnosed American women each year and killing about 3,700. 
 
For males, the vaccine is aimed at protecting against genital warts and less common malignancies that HPV can cause, such as penile and anal cancer, as well as cancer of the mouth and throat. The virus causes at least 250,000 new cases of genital warts and an estimated 7,500 cancers in males each year, causing perhaps about 1,000 deaths.[v]
 
The FDA’s indication for the use of Gardasil in males only includes the prevention of genital warts, and in a follow-up decision, the Advisory Committee on Immunization Practices of the CDC voted against recommending the “routine vaccination of boys against HPV.”[vi] Some public health professionals have argued that the routine vaccination of boys and young men would also help curb the spread of the virus to their female sexual partners. Critics, however, complained that the three years of clinical trials proving Gardasil’s efficacy among males was insufficient evidence of its efficacy in preventing the transmission of HPV to female partners.[vii] And, some experts questioned whether young men, or their parents, would seriously consider vaccination because far fewer males than females develop genital warts, and the risk of developing cancer cannot be determined. In the end, the Committee was skeptical that inoculating males would be a cost-effective way to prevent the spread of HPV to females.[viii]  
 
Many health advocates, however, feel strongly that the reasons for males to receive the vaccine are compelling. In addition to preventing the transmission of the strains of HPV that cause cervical cancer in women, gay and bisexual males as well as those who have been diagnosed with HIV/AIDS, who are at a higher risk of contracting HPV, would be protected.  Health advocates feel that gay, bisexual, and heterosexual males would all benefit if they and their partners are vaccinated as, although the risk of males developing cancer is undetermined, men are not routinely tested for penile and anal cancer as women are for cervical cancer and cancer caused by HPV could remain undetected for long periods of time.   
 
“The FDA’s expansion of Gardasil for use in males as well as females is an important step in reducing HPV infection and transmission, as well as the genital warts and cancers that are caused by HPV,” said William Smith, vice president for public policy at SIECUS, adding that, “Vaccinating all young people prior to the onset of sexual activity could have a tremendous positive impact on the health of our nation’s young people.”

 

Click here to view all October 2009 Policy Updates

 



[i] U.S. Centers for Disease Control and Prevention, “Reports of Health Concerns Following HPV Vaccination,” Updated 30 September 2009, accessed 21 October 2009 <http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm>.
[ii] U.S. Food and Drug Administration, “FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus,” News Release published 8 June 2006, accessed 19 October 2009 <http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm>. 
[iii] U.S. Food and Drug Administration, Center for Biologics Evaluation and Research “September 12, 2008 Approval Letter – Gardasil,” 12 September 2008, accessed 19 October 2009 <http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm111270.htm>.
[iv] U.S. Centers for Disease Control and Prevention, “Genital HPV Infection—CDC Fact Sheet,” Updated December 2007, accessed 19 October 2009 <http://www.cdc.gov/std/HPV/hpv-fact-sheet.pdf>.
[v] Rob Stein, “A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market,” Washington Post, 26 March 2009, accessed 9 November 2009, <http://www.washingtonpost.com/wp-dyn/content/article/2009/03/25/AR2009032503682.html>.
[vi] Mike Stobby, “Panel backs vaccine as cervical cancer alternative,” The Washington Post, 21 October 2009, accessed 22 October 2009 <http://www.washingtonpost.com/wp-dyn/content/article/2009/10/21/AR2009102101268.html>.
[vii] Matthew Perricone, “FDA approves Merck’s Gardasil for boys,” The Washington Post, 16 October 2009, accessed 18 October 2009 <http://www.washingtonpost.com/wp-dyn/content/article/2009/10/16/AR2009101602048.html>.
[viii] Natasha Singer, “Vaccine Against Virus in Girls May Be Given to Boys,” New York Times, 21 October 2009, accessed 10 November 2009 <http://www.nytimes.com/2009/10/22/health/policy/22vaccine.html?_r=1&scp=3&sq=gardasil&st=cse>.

 

 

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