Gardasil is the new cervical vaccine developed by Sanofi Pasteur and Merck and found to be effective in its phase III trial, the vaccine is given in three doses over 6 months which has shown 100% successful. The company is to apply for a license this year. The vaccine protects against Human Papilloma virus infection and also genital warts, which infects both men and women. The Gardasil vaccines may hit the market early next year and the profits would be great, and it is estimated that Gardasil sales could be worth $1 billion (Ģ567 million) a year. Physicians want it to be part of a national program and say it should be given to boys as well as girls between the ages of nine and 11 before they start any sexual activity.
Cervical cancer is caused by human Papilloma Virus (HPV) and the vaccine protects against two types of HPV which are present in 70 per cent of cervical cancers. The study was conducted in 12,167 women within the age group of 16 to 23 from 13 countries. Half the study recruits were given Gardasil and the other half were given placebo (dummy injection with no vaccine) and the recruits were followed for 2 years, the follow up showed that the vaccinated women did not develop any cancer or pre cancer. None of the women had HPV when they were enrolled.
The vaccine acts against HPV types 16 and 18, which are present in 70 per cent of cervical cancers, as well as HPV types six and 11, present in genital warts. The study, called Future II, is part of a continuing phase three trial involving more than 25,000 patients in 33 countries. Similar results were previously seen in a much smaller trial involving only 277 women.
Dr Charles Lacey, now of York University but a member of the British arm of the trial at St Mary's Hospital, London, said, "The work has been going on for 15 years and this is a breakthrough. This is crossing the high pass. We can now see the Promised Land on the other side and we would have to give the vaccine before the onset of sexual activity. This would vary from country to country but in Britain this could be girls and boys between the ages of nine and 11."
Prof Margaret Stanley, of Cambridge University, an expert on HPV, said, "We now have evidence that Gardasil is effective against the advanced-stage abnormalities of the cervix, called lesions, which lead to invasive cervical cancer. The smaller-scale preliminary HPV vaccine trials published to date have only indicated that this may be the case but this study gives us very solid evidence. The results are so exciting because of the sheer size of the trial and the fact that it demonstrated 100 per cent efficacy."
The Department of Health said, "We have met the company and it has shared with us the latest information on the development of this vaccine."