Forbes.com reports that Merck is close to obtaining approval for a vaccine against common viruses that lead to cervical cancer. An FDA advisory committee voted 13-0 to approve Merck’s Gardasil, a vaccine that protects against four types of sexually transmitted viruses– two of which are believed to be responsible for about 70% of cervical cancer cases. According to Merck, approval and widespread use of the vaccine could cut worldwide deaths from the disease by two-thirds.
Amid uncertainties regarding the age group for treatment, the extent of the campaign, and how routine pap smear screening will be affected, are some medical concerns. In particular, the FDA has questioned whether the vaccine could make disease progression worse among women already infected and whether the benefit is partly mooted by the fact that the vaccine does not protect against all viral strains linked to cervical cancer. Of further note, the agency is expected to discuss the five congenital defects of children born to women who were vaccinated with Gardasil around the time of conception.
The good news for Merck is that the FDA usually follows the recommendations of its outside panel of experts, who in this case all support approval of the vaccine. The final decision is expected by June 8. The anticipated cost of treatment, administered in three shots over six months is $300-500. According to analysts, this could translate into over a billion dollars in sales. This may be the break Merck needs– approval could help offset mounting legal costs as the company continues to defend against Vioxx lawsuits.
Merck recommends that the vaccine be used for females aged 9 to 26. The Advisory Committee on Immunization Practices is considering these recommendations and whether routine vaccination should be endorsed. GlaxoSmithKline PLC is working on a similar vaccine, hoping to submit it for approval by the end of the year.
