Gardasil gets FDA nod for cervical cancer

USA-based pharmaceutical major Merck & Co's cervical cancer vaccine Gardasil (recombinant quadrivalent human papillomavirus; Types 6, 11, 16, 18 is one step closer to approval after the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee unanimously voted that it is safe and effective.

The FDA committee agreed that Phase II and III trial data supports the agent's approval for the prevention of precancers and other cervical, vulvar and vaginal lesions caused by HPV types 6, 11, 16 and 18, including genital warts. Its guidance will be considered by the agency in its review of Merck's December 2005 Biologics License Application, with a June 8 action date. The firm noted that the agency will consider the committee's opinion but is not bound by it.

The investigational vaccine targets the world's most prevalent sexually-transmitted disease and has an annual US market potential of $2.0 billion. It is a key product for the firm, which is facing law suits over its withdrawn painkiller Vioxx (rofecoxib). However, industry observers fear that Merck's plan to have Gardasil made mandatory for school admission will be opposed by America's conservative Right. Christian lobby groups, in particular, believe that the STD vaccine could create a false sense of security and lead to promiscuity.