Cervical cancer vaccine wins approval in U.S.
Thu. June. 8 2006 10:21 PM ET
For the first time since the discovery of cervical cancer, women will have the option to take a vaccine that will protect themselves from the deadly illness.
The Food and Drug Administration (FDA) approved the vaccine Gardasil Thursday for girls and women ages 9 to 26.
Gardasil prevents infection from the two strains of human papillomavirus, or HPV, which is responsible for approximately 70 per cent of cervical cancer cases.
"This marks an unprecedented advance in preventing diseases that affect millions of women," Alex Azar from the U.S. Department of Health said in a press conference.
Analysts believe the vaccine will soon be available in Canada as well.
Cervical cancer kills 290,000 women worldwide each year. HPV is the most prevalent virus among sexually transmitted diseases (STDs).
Gardasil will also protect against two other strains of HPV that are responsible for 90 per cent of genital wart cases.
However, Merck & Co. Inc., the drug's manufacturers, is expected to market the vaccine for cancer, rather than STDs.
Merck's Canadian subsidiary plans to bring the vaccine to market in Canada. Approximately 1,350 women will be diagnosed with cervical cancer this year and nearly 400 will die from the disease.
Although pap-smear tests for early detection have drastically reduced cervical cancer deaths, this is the first form of actual prevention.
"This is an incredible news and incredible breakthrough...this is the first time in history that we have a safe and effective treatment against cancer," McMaster University Professor Janusz Kaczorowski told CTV.
However, with the three-shot series costing approximately $360 US, it is unclear how widespread the use of the vaccine will be.
In addition to the cost barrier, conservative groups in the U.S. have also rallied against making the vaccine mandatory for school attendance.
Gardasil is targeting girls and young women because the vaccine works best when given to females before they engage in sexual relations.
"Most girls, women in Canada, are sexually active at 14, 15, 16...you would probably want to administer the vaccine prior to that," Kaczorowski said.
According to the FDA, the vaccine may not protect women who are already infected and may even increase their risk of lesions that can lead to cervical cancer.
On June 29, the U.S. national Advisory Committee on Immunization Practices will decide whether to endorse Gardasil as a routine vaccination.
If the vaccine is endorsed, it will be up to each individual state to decide whether to add Gardasil to the list of required vaccines to attend public schools.
Conservative groups, like Focus on the Family, oppose making the vaccine mandatory. They argue that the child's parents or guardian should make the decision.
More than half of sexually active adults will be affected by HPV at some point in their lives.
So far, clinical trials have demonstrated Gardasil prevents 100 per cent of cervical cancer related to HPV in women who had not been previously infected. The vaccine also prevented 99 per cent of the cases of genital warts caused by the two other types of HPV.
However, it is still not known how long the effects of the vaccine will last or whether women will have to receive multiple shots throughout their lives.
Analysts predict Gardasil sales could be more than $1 billion US a year in the United States alone.
Merck is seeking to license the virus in 50 other countries.
With a report from CTV's Avis Favaro