HPV Vaccine Cervarix 100% Effective In Preventing Precancerous Lesions

Human Papillomavirus Vaccine Cervarix

GlaxoSmithKline'sexperimental human papillomavirus vaccine Cervarix has shown as much as100% effective in preventing advanced precancerous lesions caused byHPV strains 16 and 18, according to preliminary data of a phase IIIpublished in the online edition of the journal Lancet, the Wall Street Journal reports (Wall Street Journal, 6/28).

Cervarix and Merck'sHPV vaccine Gardasil have been shown to be 100% effective in preventinginfection with HPV strains 16 and 18, which together cause about 70% ofcervical cancer cases. Researchers in a 2006 study published in theonline edition of the Lancet also found that Cervarixprevented infection with HPV strains 31 and 45, which together withstrains 16 and 18 cause more than 80% of cervical cancer cases (Kaiser Daily Women's Health Policy Report, 6/7).

For the study, Jorma Paavonen of Helsinki UniversityCentral Hospital in Finland and colleagues examined 18,644 women ages15 to 25 in the U.S., Latin America, Europe and Asia to determine theefficacy of the vaccine (Ricks, Long Island Newsday, 6/28).

Thestudy found that Cervarix was 90.4% effective in preventing lesionscaused by HPV strains 16 and 18, based on an analysis that onlyrequired detection of the virus in the lesion, Reuters reports.However, researchers found most of the lesions contained multiple HPVstrains known to cause cancer, and GSK said the data showed Cervarixwas 100% effective in preventing lesions caused by strains 16 and 18.According to the study, the vaccine also provided significantprotection against HPV strains 31, 45 and 52, which together accountfor about 12% of cervical cancer cases.

In an accompanying editorial in the Lancet, Jessica Kahn of the University of Cincinnati College of Medicine and Robert Burk of the Albert Einstein College of Medicineat Yeshiva University said the results were encouraging but it is tooearly to assess the vaccine's efficacy because cervical cancer canevolve over several decades. The authors also underscore the adversereactions among women vaccinated with Cervarix, including generalsymptoms and injection site symptoms (Hirschler, Reuters, 6/27).

The Australian Therapeutic Goods Administration last month granted the first major market license for Cervarix, approving the vaccine for girls and women ages 10 to 45. The European Medicines Agencycould recommend the vaccine this month. FDA has granted a standard10-month review of Cervarix and will most likely take action on GSK's application in January 2008, according to analysts at Evolution Securities (Kaiser Daily Women's Health Policy Report, 6/7).

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