San Francisco Chronicle, June 30, 2006
Cervical cancer vaccine due soon; Federal panel urges it go to all girls, 11-12
Author: Erin Allday
A new vaccine that prevents most forms of cervical cancer will be widely available as early as this fall after a federal advisory panel recommended Thursday that all 11- and 12-year-old girls receive the immunization.
The Advisory Committee on Immunization Practices stopped short of recommending that states make the vaccine, called Gardasil, mandatory for admission to school. But the panel advised that the vaccine should be included in the federal Vaccines for Children program, which offers free immunizations to about 45 percent of children nationwide.
The vaccine ideally is given before a girl has had sex and is exposed to the sexually transmitted virus that causes cervical cancer, which is why the panel recommended it for preteen girls. The panel suggested the vaccine is acceptable for girls as young as 9.
"It's an incredible development that we have a vaccine that helps prevent cancer. It's fabulous, and it's something that should be offered to all women," said Dr. Ruth Shaber, director of women's health services for Kaiser Permanente in Northern California.
Because Gardasil is aimed at stopping a sexually transmitted disease, conservative groups, while supporting the vaccine, have asked that state governments not make immunization mandatory for school attendance. And some parents have said they would be reluctant to give the vaccine to their young daughters.
Janice Crouse, a spokeswoman for the Abstinence Clearinghouse and Concerned Women for America, two conservative organizations, said she "applauds" the vaccine but added that making it mandatory would "fly in the face of a lot of people's beliefs and values."
In San Francisco, mom Maxine Prestwich said she would not want to give the vaccine to her two daughters, ages 5 and 7, when they reach adolescence.
"I would be opposed to making it mandatory. They need to give people the choice to do it or not, not force it on us," Prestwich said. "I don't live my life in such a way that I am concerned about STDs. And I don't worry about it for my daughters."
Gardasil won approval from the Food and Drug Administration on June 8 and was then sent to the advisory panel for consideration. The panel's recommendation now goes to the head of the Centers for Disease Control and Prevention, who will decide within months whether to make it an official standard of care for physicians nationwide. CDC recommendations are not mandatory, but physicians usually add them to their standard practices.
With just the advisory panel's recommendation, at least two major insurance plans -- Kaiser Permanente and WellPoint -- announced Thursday that they would cover Gardasil and offer it as a standard vaccination for preteen girls. Kaiser officials said they hoped to have a supply of the vaccine by fall. The vaccine costs $360, which includes three injections over six months, although most patients won't pay that amount if it is covered by insurance.
Whether the vaccine becomes a school-attendance requirement in California is up to the state Legislature, said Michelle Mussuto, a spokeswoman for the Department of Health Services. Immunizations also can be made mandatory through a change in government regulations, but that process is rare, Mussuto said.
California has six required immunizations now, all of which must be completed before kindergarten. Two more immunizations are recommended, but not required, for children about to enter seventh grade. Part of the reason the advisory panel recommended that girls receive the Gardasil vaccine at age 11 or 12 is that they are likely to get other immunizations at the same time.
In clinical studies, Gardasil, which is made by pharmaceutical giant Merck & Co., prevented infections from two strains of human papilloma virus that cause 70 percent of cervical cancer cases. It also prevented infection from two additional strains that cause 90 percent of cases of genital warts.
Cervical cancer is the second-most common cancer among women worldwide and the third-most fatal, causing 290,000 deaths a year.
The disease is rare in the United States, where regular screening for adult women catches most precancerous cases; about 3,700 American women die of cervical cancer every year. But the virus that causes the cancer, the human papilloma virus, is the most common sexually transmitted disease in the United States by far. The CDC reports that the virus infects at least 80 percent of women by the age of 50.
Because the virus is so common, it's important for girls to be immunized before they become sexually active, doctors said. The clinical studies focused on women and girls ages 9 to 26. Merck is currently conducting studies on boys and men, who can become infected with the virus and pass it on to women and who also can contract a rare form of penile cancer from the virus.
The federal advisory panel recommended that all women up to age 26 be vaccinated against the virus, though it is still unclear whether the vaccine is effective in women who have been exposed to the virus. Kaiser said it will not cover the vaccine for women who already have had sex.
Doctors noted Thursday that the vaccine will not pre-empt the need for regular screening for the virus and cervical cancer, including annual Pap smears. The vaccine does not prevent all forms of the virus, for starters, and there also is no evidence yet of how long the vaccine lasts. It's possible young women will need a booster shot in their late teens or early 20s.
In fact, Shaber said she isn't certain that all girls need to be immunized at age 11 or 12. Some families might want to wait a year or two to give their daughters the maximum protection. If a girl is immunized at age 11 and the vaccine only lasts five years, she said, that could leave her vulnerable as a teenager.
"Depending on the family, it's OK to wait a couple years," Shaber said. "The grim fact is a lot of girls are starting to have sexual activity in their mid-teen years. You want to catch them before they're exposed."
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