Sanofi Pasteur MSD won approval in the European Union for its human papillomavirus vaccine Gardasil ahead of the weekend, bringing hope to women across the EU who are at risk of developing cervical cancer.
Gardasil also gains a first-to-market advantage over rival HPV vaccine Cervarix from GlaxoSmithKline, which was submitted in Europe in March but is likely still several months away from approval.
Sanofi Pasteur MSD – a joint venture between Sanofi-Aventis and Merck & Co, said it could be available on the market in some European countries as early as next month. It is already approved in the USA, Canada, Mexico, Australia, New Zealand and Brazil, and has been tipped as a $3 billion product at peak.
Gardasil protects against cervical cancer caused by HPV strains 6, 11, 16 and 18, and also against genital warts. It is estimated that around 80% of sexually active women can expect to have an HPV infection at some point in their lives.
But the new vaccine has caused controversy over plans to give it to girls as young as nine, before they become sexually active. In July, the European Medicines Agency's scientific advisory panel gave the vaccine the thumbs up for use in girls aged nine-15 and women aged 16-26. In the USA, the Centers for Disease Control recommended that Gardasil should be routinely given to girls at the age of 11 or 12, but said the vaccination could be administered as young as nine.
Boys could also be vaccinated in the hope of eradicating HPV and reducing the incidence of genital warts, according to Merck.
In the UK, Gardasil will cost around £65 per dose, with three shots given over six months to provide long-lasting immunity. A decision on whether the vaccine will be available on the National Health Service will be taken on the advice of the Joint Committee on Vaccination and Immunisation later this year.
Commenting on the approval, Prof Margaret Stanley of the University of Cambridge, UK, said: "vaccination should save many women from dying from cervical cancer. But even earlier, a substantial amount of pre-cancerous and potentially pre-cancerous cervical lesions should be prevented."