Merck gets approval for “first and only” US cervical cancer vaccine

Merck has announced that the FDA has concluded that its cervical cancer vaccine, Gardasil, is both effective and safe to use.

Gardasil is a vaccine that targets two types of the human papillomavirus (HPV), which scientists believe is the most significant cause of cervical cancer. Merck says the vaccine prevented 100 per cent of cervical cancers caused by the HPV strains 16 and 18 – the most common cervical cancer-causing strains – in women aged between 16 and 26 years of age. It also added that it was 95.2 per cent successful in preventing cervical cancer when including two other strains of the virus, six and 11.

Additionally, the drug was also found to prevent 99.1 per cent of external genital lesions caused by the HPV, such as genital warts, caused by HPV virus strains six, 11, 16 and 18.

Peter S Kim, president of Merck Research Laboratories, said: “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.”

He added: “If approved, Gardasil will be the first and only vaccine to prevent cervical cancer and other serious HPV-related diseases.”

However, GlaxoSmithKline’s Cervarix, another HPV vaccine, is currently undergoing phase III trials and it has also shown a high level of effectiveness. In the company’s 2005 annual review, chief executive JP Garnier said that of Glaxo’s five “major” vaccine launches, “perhaps most exciting is Cervarix for cervical cancer”. He commented that he expects both EU and US approval to be complete by the end of the year.

According to Cancer Research, there are almost 3,000 new cases of cervical cancer each year and it is the second most common cancer for women under 35-years-old.

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