FDA Approves HPV Vaccines Cervarix for Women, Gardasil for Men

October 19, 2009 — FDA on Friday approved GlaxoSmithKline's human papillomavirus vaccine Cervarix for use in girls and women ages 10 through 25 to prevent cervical cancer, and it expanded approval of Merck's HPV vaccine Gardasil to include boys and men ages nine through 26 for protection against genital warts, Reuters reports (Richwine, Reuters, 10/16).

Gardasil has been approved for use in girls and women since 2006 to prevent two strains of HPV that cause about 70% of cervical cancer. Both Gardasil and Cervarix protect against these two strains of HPV that cause cervical cancer. Gardasil also protects against two other strains of HPV that cause 90% of genital warts. There is evidence showing that Cervarix protects against another HPV strain closely related to types 16 and 18, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 10/16).

Cervarix is already available in Europe and other parts of the world (Perrone, AP/Boston Globe, 10/16). GSK first sought U.S. approval in 2007, but FDA said it needed more information, and the drugmaker refiled for approval in March. In September, an FDA advisory panel said Cervarix was safe and effective at preventing cervical cancer (Wall Street Journal, 10/16).

CDC To Consider Recommendations

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is scheduled to vote next Wednesday on whether the agency will recommend routine vaccination of boys with Gardasil (Reuters, 10/16). CDC currently recommends that girls receive Gardasil vaccinations at age 11 or 12 (Wall Street Journal, 10/16). A CDC recommendation would make it more likely that states would require inoculation and that insurance companies would cover the cost of the $390 vaccine, according to the Wall Street Journal.

The Journal reports that use of Gardasil in boys and men could be controversial because male genital warts are rare -- affecting only 1% of the population -- and not life threatening. Male vaccination could possibly benefit women if it prevents their sexual partners from spreading the virus. However, physicians expect it will be a challenge to convince parents to have their sons vaccinated in the absence of compelling evidence of direct benefits, the Journal reports. Northwestern University sociologist Steven Epstein said, "Are boys -- or their parents, more to the point -- going to be altruistic and get a vaccine so it benefits somebody else?" A study published earlier this month in the British Medical Journal found that vaccinating men against HPV is not cost effective, even when considering its benefit to women. However, Merck's own studies have found it would be cost-effective to vaccinate boys (Rockoff, Wall Street Journal, 10/17).