The committee's guidance will be considered by the FDA as it decides whether or not to approve the vaccine. The FDA is not bound by the committee's guidance, but will take its advice into consideration. A final decision is expected to be made by June 8, 2006.
The vaccine protects against two types of human papillomavirus (HPV) estimated to cause an estimated 70% of cervical cancer cases and can lead to vulvar and vaginal cancers.
In addition, the vaccine protects against two further strains of HPV estimated to cause 90% of genital wart cases. According to the company, HPV-related diseases cost about $5 billion per year in the US.
“Merck is thrilled that the advisory committee has agreed that the extensive data from our decade-long, 27,000-patient clinical trial program support the use of Gardasil to reduce the burden of cervical cancer and other diseases caused by HPV,” said Dr Peter Kim, president of Merck Research Laboratories.