FDA Panel Recommends Approval Of HPV Vaccine Cervarix For Women, Gardasil For Male Warts

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals;  Men's health
Article Date: 11 Sep 2009 - 4:00 PDT

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An FDA panel on Wednesday recommended that the agency approve GlaxoSmithKline's human papillomavirus vaccine, Cervarix, to prevent cervical cancer, as well as expand approval of Merck's HPV vaccine, Gardasil, to include use in men ages nine to 26 for the prevention of genital warts, the Wall Street Journal reports. Though FDA is not obligated to follow the panel's guidance, it typically does.

The panel voted 12-1 that Cervarix is safe and effective in preventing the transmission of two strains of HPV that can lead to cervical cancer and that it should be approved for use in women ages 10 to 26 (Corbett Dooren, Wall Street Journal, 9/9). The National Vaccine Information Center's Vicky Debold, a staunch critic of vaccine safety, cast the sole vote against Cervarix (McCullough, Philadelphia Inquirer, 9/10). Both Cervarix and Gardasil protect against HPV strains 16 and 18, which cause about 70% of cervical cancer cases. Gardasil also protects against two other strains that cause genital warts in both men and women. Gardasil is FDA-approved for girls and women ages nine to 26, and the Centers for Disease Control and Prevention recommends routine vaccination for girls ages 11 and 12 (Wall Street Journal, 9/9). The vaccine also is recommended for girls and women ages 13 through 26 who have not yet been vaccinated or who have not received all three doses (Women's Health Policy Report, 9/9). If Cervarix is approved by FDA, the vaccine would later go before a CDC advisory panel, which develops written recommendations for the routine administration of vaccines to children and adults. Private insurers often wait for a CDC panel's endorsement before agreeing to pay for a new vaccine, the Journal reports (Wall Street Journal, 9/9).

The panel voted unanimously, with one abstention, that Gardasil is effective at blocking the strains of HPV that can lead to genital warts in men ages nine to 26. The panel voted 7-1 that the vaccine is safe for the group (AP/Washington Post, 9/10). Merck also sought approval of Gardasil for extremely rare HPV-related penile and anal cancers, but FDA denied the approval (Philadelphia Inquirer, 9/10).

Approval Would Up Rivalry

If FDA approves Cervarix, it would increase U.S. competition for Gardasil, which was first approved in 2006. Cervarix already is approved in about 100 other countries (Wall Street Journal, 9/9). GSK initially sought Cervarix approval more than two years ago, but FDA wanted more information about the drug because of concerns that a chemical in the vaccine triggered autoimmune diseases. In March, GSK submitted data from a 30,000-person trial indicating that the diseases were not more common in vaccinated women than in the control group (Philadelphia Inquirer, 9/10).

NYT Examines Vaccine Market

The New York Times on Thursday examined how GSK and Merck are battling to expand the market for their HPV vaccines. An analyst with Sanford C. Bernstein predicted that in 2015, Gardasil would have 65% of the HPV vaccine market and Cervarix would have the rest. Still, sales of Merck's vaccine are stalling. Gardasil had sales of $363 million in the first half of this year, a decrease of 34% compared with the same period in 2008. Analysts say expanding the market to men could be a challenge because it could be difficult to persuade parents and insurance companies to pay for a vaccine that prevents genital warts, a non-fatal condition (Singer, New York Times, 9/10).

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