US approves first cervical cancer vaccine

10-Jun-2006 Intellasia | 09/Jun/2006 AFP | FDA (press release) | 10:13 AM Print This Post

US drug regulators approved the first vaccine against cervical cancer, which kills some 233,000 women worldwide each year.
The Food and Drug Administration (FDA) approved the sale of Gardasil, produced by US pharmaceutical firm Merck and Co., after a six-month fast-track clinical test.
The vaccine protects against the human papillomavirus (HPV), which causes genital warts that can lead to cancer, an FDA spokeswoman said, reading a statement.
HPV infections are responsible for 70% of cervical cancer, which is the second most common cancer among women worldwide.
The vaccine is effective against four key types of the virus.
Four different clinical tests involving 21,000 women around the world demonstrated Gardasil was “nearly 100% effective” in preventing HPV-caused precancerous cervical, vaginal and vulvar lesions as well as genital warts, the FDA said.
“While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers,” the FDA said.
Involving just three injections over a six-month period, the vaccine is approved for use in females nine to 26 years of age.
Gardasil was evaluated and approved in six months under FDA’s priority review process, for products with potential to provide significant health benefits, the agency said.
“Today is an important day for public health and for women’s health, and for our continued fight against serious life-threatening diseases like cervical cancer,” said Alex Azar, deputy secretary of the US
Department of Health and Human Services.
Jesse Goodman, director of FDA’s Centre for Biologics Evaluation and Research, said the vaccine was the first of its kind and warranted the speeded-up review.
“Its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible,” Goodman said.
Officials say HPV is the most common sexually transmitted infection in the United States. About 6.2 million Americans become infected with genital HPV each year and over half of all sexually active men and women become infected at some time in their lives, according to estimates by the Centres for Disease Control and Prevention.
On average, there are 9,710 new cases of cervical cancer and 3,700 deaths attributed to it in the United States each year, while worldwide, cervical cancer is estimated to cause over 470,000 new cases and 233,000 deaths each year.
“This vaccine is a significant advance in the protection of women’s health in that it strikes at the infections that are the root cause of many cervical cancers,” said Andrew von Eschenbach, acting FDA commissioner.
Merck, based in Whitehouse Station, New Jersey, has agreed to conduct several studies following licensure, including additional studies to further evaluate general safety and long-term effectiveness, the FDA said.
Merck is also undertaking a study on the safety and effectiveness of Gardasil in males.
Meanwhile, the non-profit international health group PATH, supported by the charitable foundation of Microsoft founder
Bill Gates, will begin exploring the possibilities for distributing Gardasil to women in the developing world.
PATH will launch a five-year effort to investigate how such distribution can be undertaken, starting in India, Uganda, Peru and Vietnam, according to a spokesman.
The effort will be backed by a 27.8 million-dollar grant from the Bill and Melinda Gates Foundation, with the support of Merck and GlaxoSmithKline.
Glaxo recently announced that it too had developed an HPV vaccine and would seek a green light from the FDA to begin distributing it.

 


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