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First cervical cancer vaccine approved in US

The US medicines watchdog today granted a licence for the first vaccine against cervical cancer, which kills around 240,000 women worldwide a year.
  
  


The US medicines watchdog today granted a licence for the first vaccine against cervical cancer, which kills around 240,000 women worldwide a year.

The Food and Drug Administration licensed the drug Gardasil for use in girls and women from the ages of nine to 26.

The vaccine works by preventing infection by four of the dozens of strains of the human papilloma virus (HPV), the most common sexually transmitted disease, including the two most common types responsible for about 70% of cervical cancer cases. The drug also blocks infection by two other strains of the virus, which are responsible for 90% of genital wart cases.

Dr Carolyn Runowicz, president of the American Cancer Society, said: "Approval of the HPV vaccine, the first vaccine targeted specifically [at] preventing cancer, is one of the most important advances in women's health in recent years."

Alex Azar, deputy secretary of the US department of health and human services, said: "Fortunately, we can now include the worst types of HPV and most cervical cancer in the list of diseases that no one need suffer or die from ever again."

The vaccine, which costs $360 (£195) for a course of three injections, will be available across the US later this month. But whether its use becomes routine depends on the recommendations of the national Advisory Committee on Immunisation Practices, which it is expected to deliver at the end of June.

Clinical trials showed Gardasil prevented cervical cancer caused by the two most common strains of HPV in all women who had not been previously infected, according to its manufacturer, Merck & Co. The pharmaceutical company added that the drug also prevented 99% of genital wart cases caused by the two HPV strains responsible for most genital warts.

The trials showed Gardasil to work best when given to girls before they began having sex and ran the risk of HPV infection. The vaccine does not protect people already infected. By the age of 50, around 80% of women have been infected with the human papilloma virus. In most cases, the body clears the virus itself.

Gardasil has already been granted a licence in Mexico. Medicines regulators across the world, including the European Medicines Agency, are currently reviewing applications to grant a licence for the drug. About 2,800 women are diagnosed with cervical cancer each year in the UK, with fewer than 1,000 dying from the disease.

Healthcare analysts believe US sales of Gardasil could top $1bn a year for Merck. But it could face competition from GlaxoSmithKline, which is developing its own HPV vaccine.

 

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