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An experimental vaccine against cervical cancer has moved a step closer toward becoming the first cancer vaccine of any kind on the market.
Scientists are reporting today that the vaccine was 100% effective in preventing cervical cancer and precancerous changes tied to two types of a common sexually transmitted virus.
"It's a very impressive finding," Christopher Crum, director of women's and perinatology pathology at the Brigham and Women's Hospital in Boston, said Thursday.
The report is the first from a large-scale trial of a cancer vaccine. In April, researchers published similarly encouraging results from a smaller study of the Merck vaccine.
Spokeswoman Janet Skidmore said Thursday that Merck plans to apply to the Food and Drug Administration by year's end for permission to sell the vaccine. "There is the potential it could be available late next year, assuming all goes well," she said.
The vaccine, called Gardasil, targets human papillomavirus (HPV) types 16 and 18, thought to cause 70% of cervical cancers, and HPV types 6 and 11, associated with 90% of genital warts cases. Up to 70% of sexually active women will become infected with HPV, which clears up on its own more than nine times out of 10. Lasting infection causes virtually all cervical cancers.
In April, the researchers suggested that the vaccine might be most effective in 10- to 13-year-olds, who are not likely to be infected with HPV.
Preteens and adolescents, sexually active or not, could receive the HPV vaccine along with the other shots they're required to get, said co-investigator Kevin Ault, an Emory University obstetrician/gynecologist who did his research when at the University of Iowa.
It would be just as important to vaccinate boys as girls, Ault said. He cited the rubella vaccine to illustrate his point. All babies are immunized against rubella to prevent them from spreading the disease to pregnant women, because it can cause birth defects.
Skidmore says Merck is testing the vaccine in girls and boys as young as 9. The FDA will decide whether it should be sold for use in preteens, she says.
The latest findings from the company-funded study, being presented at the Infectious Diseases Society of America meeting in San Francisco, involved more than 12,000 females, ages 16 to 23. They were randomly assigned to receive either the three-shot vaccine or dummy shots.
The analysis began a month after they received their last shot and continued for an average of 16 months. None of the females who received the vaccine was found to have precancerous changes or cervical cancer, compared with 21 of those who received the dummy shots.
GlaxoSmithKline also is testing a vaccine against cervical cancer but has not yet reported results.
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