Health @ Heart
Vaccine for Cervical Cancer
Last of two parts
What is this new wonder drug?
The vaccine, which is genetically engineered, is Gardasil, which blocks infection caused by two of the more than 100 types of human papilloma virus (HPV), strains 16 and 18. These two sexually transmitted viruses are responsible for about 70% of cervical cancers. HPV, in one form or the other, afflicts about 20 million Americans. The other strains of the virus cause painful genital warts, and sometimes, cervical cancers too. Part III clinical trials in 225,000 women worldwide are underway
How good is the study?
Excellent. The final stage investigation on Gardasil involved 10,559 sexually active women (ages 16 to 26 in the United States and in 12 other countries) who did NOT have HPV 16 or 18 infection. One half of the subjects were given 3 vaccine shots over 6 months, while the other half (control group) received the placebo (dummy) shots. Among those who got Gardasil were still virus-free after 6 months and none of them developed cervical cancer or precancerous lesions over the 2 year follow-up. Twenty one in the control group had precancerous lesions and cervical cancers." To have 100 percent efficacy is something that you have very rarely," Dr. Eliav Barr, Merck's head of clinical development for Gardasil, told The Associated Press.
How early should the vaccine be given?
Students in grammar school, middle school and high school should be vaccinated before they become sexually active, because once they catch HPV infection, there is no cure; herpes is for life. This was the recommendation of Dr. Gloria Bachmann, director of The Women's Health Institute at Robert Wood Johnson Medical School in Brunswick, NJ., who said this vaccine is a "phenomenal breakthrough." Prophylaxis Gardasil vaccination comprehensively eliminates HPV 16 and 18 associated non-invasive and invasive cervical cancer. The vaccine also cuts down infection with HPV 6 and 11, the causes of 90% of genital warts.
When will the vaccine be available?
The US Food and Drug Administration has already approved Merck's application for the distribution and sale of Gardasil for young girls and women. This vaccine is in head-to-head competition with a rival (Cervarix) from GlaxoSmithKline, a UK-based company. As the good old cliché goes "an ounce of prevention is better than a pound of cure."
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