First cervical cancer vaccine is approved

Scruff

from New Scientist

The first vaccine against cervical cancer has been fast-tracked to approval by US drug regulators. The disease kills 233,000 women worldwide each year.
The Food and Drug Administration approved the sale of Gardasil, produced by US pharmaceutical firm Merck, 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. 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 trials involving 21,000 women around the world demonstrated Gardasil was "nearly 100% effective" in preventing HPV-caused precancerous cervical, vaginal and vulvar lesions. It also prevented genital warts effectively, 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. The vaccine is approved for use in females of 9 to 26 years of age and involves three injections over a six-month period.
Common infection

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. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research, said the vaccine was the first of its type and warranted the speeded-up review.
Officials say HPV is the most common sexually transmitted infection in the US. 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 Centers for Disease Control and Prevention.
On average, there are 9710 new cases of cervical cancer and 3700 deaths attributed to it in the US each year. Around the world, there are an estimated 470,000 new cases every year, and around 233,000 deaths as a result of the disease.
Bill Gates

Merck, based in New Jersey, US, has agreed to conduct several further studies following the approval, 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 men.
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.
The effort will be backed by a $27.8 million grant from the Bill and Melinda Gates Foundation, with the support of Merck and GlaxoSmithKline. Glaxo announced in 2004 that it too had developed an HPV vaccine (see Vaccine may protect against cervical cancer) and is seeking a green light from the FDA to begin distribution.

Thats great news. wonder when it will be approved this side of the pond. Could go a long way towards decreasing the incidences of cancer and the std, especially given the recent report of incidences of cancer doubling in the next 10-25 years. Not to mention save lives!


wonder if it would be as effective at preventing hpv and warts in men as well seeing as a woman may be vaccined but a man could still be carrying it .

DrIndy

Men carry it asymptomatically, but just like Rubella (german measles), it is pointless just vaccinating women to prevent the spread of HPV. An effective vaccine is one which covers a very significant body of the population in such a way that not only are most people immune and cannot catch the disease, but those who are not immune are surrounded by so many immune people, that they cannot spread the disease to other, non-immune people.

It is an exciting development and would be very beneficial. The difficulty is uptake - the catholic heirarchy may well mow in and cause trouble as the alternative prevention to infection is celibacy.

Deer

It's absolutley fantastic news but I presume it won't work on people who already have HPV?