A vaccine that has the potential to dramatically reduce the number of cervical cancer cases is set to be released this week.
The potentially groundbreaking vaccine, called Gardisal, was developed at 16 research sites, including the U, and has proven to be 100 percent effective in the prevention of the sexually transmitted disease known as the human papilloma virus (HPV). The new drug proved so effective that test trials ended early.
“The vaccine was highly effective, almost perfectly effective. We have never had this before,” said John Kriesel, an assistant professor of infectious diseases at the U and the principal investigator of the vaccine in Utah.
HPV is responsible for 80 percent of cervical cancer cases and is the most common STD in the United States, infecting as many as 80 percent of sexually active individuals by the time they reach 50. The different subtypes of the virus can cause genital warts and cervical cancer in women, but many times, the virus goes unnoticed without any symptoms.
One of the dangers of HPV is that most people never know they have or have had the STD because some strains go away on their own.
“If people have already begun to have intercourse, their exposure has probably already occurred,” said Karen Zempolich, a gynecologic oncologist who worked on the clinical trial at the Huntsman Cancer Institute.
“I think that teens or college students who are thinking about sex rarely worry about whether or not they are going to get HPV,” Kriesel said.
Cervical cancer is the No. 1 killer of women of reproductive age in the world. Approximately 10,000 new cases of cervical cancer are diagnosed in the United States each year, killing about 3,700 women, Zempolich said.
“There are lots and lots of college-aged women who have cervical dysplasia, which is the pre-cancer,” Zempolich said. “Most cases do not develop into cancer as long as women are able to get treatment. However, the treatment alone can threaten the integrity of a woman’s fertility.”
The FDA advisory committee is recommending the vaccine not only for adult women, but also children ages 9 and older.
“(HPV) affects women, but disproportionately, young women,” Zempolich said. “While they don’t get the cancer, at 20, 21, they get the exposure.”
Katie Larson, who graduated from the U in 2005 in health and sports science, said she did not know what HPV was until a year ago.
“It is scary because guys don’t even know they have it and they give it to women and (it) can cause cervical cancer,” she said.
The U contributed to the development of this vaccine by taking part in a national clinical trial of it.
Scientists hope the vaccine will prevent almost 1 million new STD cases each year in the United States alone, but warn that this isn’t a fail-safe for other diseases.
“I don’t think it is a blank check for going out and having safe sex. There are definitely other sexually transmitted diseases,” Zempolich said.
But scientists and doctors are optimistic that the vaccine can have success similar to the success of the vaccine created for Hepatitis B.
“Hepatitis B used to be a sexually transmitted disease, and now it is virtually gone because we immunized little kids with the Hepatitis B vaccine. This will be a similar situation,” Kriesel said.
The vaccine was unanimously approved by the FDA advisory committee of 13 scientists. It has not yet been approved for use in men even though males are also at risk from HPV, as it also causes anal cancer.
“It is an equal-opportunity virus,” Zempolich said. But, she said, having more women immune to the virus decreases the chances that men will be exposed.
Merck, the pharmaceutical company that produces Gardisal, has already begun shipping the vaccine to physicians. Doctors will pay $360 for a full vaccination, which includes three injections. It is not yet clear how many insurance companies will cover the vaccine.