US licenses new cervical cancer vaccine
The US Food and Drug Administration has announced the approval of Gardasil, a vaccine developed to prevent cervical cancer caused by a virus. According to the European Cervical Cancer Association, around 33,000 women develop cervical cancer every year in the EU, and 15,000 women die from it. Worldwide it is the second most common cancer in women after breast cancer. The most common cause of cervical cancer is the Human Papillomavirus (HPV), and Gardasil provides protection against HPV types 16 and 18, which cause approximately 70 per cent of cervical cancers and against HPV types 6 and 11, which cause approximately 90 per cent of genital warts. Gardasil, which is manufactured by US pharmaceutical company Merck, is a recombinant vaccine (contains no live virus) that is given as three injections over a six month period. Four studies, involving 21,000 women, showed that where women had not already been infected with HPV, the vaccine was nearly 100 per cent effective in preventing precancerous lesions caused by infection with the HPV types which it targets. While the study period was not long enough for cervical cancer to develop, the FDA believes that the prevention of these precancerous lesions is highly likely to result in the prevention of those cancers. However, the studies also showed that the vaccine is only effective when given prior to infection. This, combined with the fact that the vaccine is not effective against all cancer-causing viruses, means women will still need to undergo regular screening to detect precancerous changes in the cervix. Merck will carry out further studies to determine the long term effectiveness of the vaccine. Gardasil has already been licensed for use in Mexico, and Merck has applied for approval in the European Union and a number of other countries.
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