HPV vaccine a suggestion, not mandate, in U.S.

updated 1:30 p.m. ET Aug. 31, 2009

RICHMOND, Va. - Only Virginia and the District of Columbia have moved toward requiring sixth-grade girls to get vaccinated for a potentially cancerous sexually transmitted disease, three years after federal health officials recommended the shots.

About two dozen states considered requiring the vaccine, but balked amid funding woes and parents' concerns it wasn't safe and would promote promiscuity. Publicity that a massive pharmaceutical company bankrolled the lobbying effort didn't help.

Virginia and the District of Columbia allow parents to opt out of the "requirement" for any reason, making the vaccine for human papillomavirus, or HPV, more of a suggestion than a mandate. Both passed laws in 2007, but pushed back their start dates to this year to allow more study of the vaccine.

In the nation's capital, where students started school a week ago, girls will be held out of classes after Friday if they haven't either gotten the shot or turned in a form saying their parents opted out.

Virginia rules are more lax. Girls were being asked to bring in documentation if they got the vaccine. If not, officials assumed parents chose not to get the vaccination.

Health officials said they expect as many as half of parents to opt out.

There are more than 44,000 girls expected to enter sixth grade in Virginia's public schools and about 2,300 in D.C.

"Any time you have a first-year requirement, it takes a while for things to catch on," said Tia Campbell, Virginia schools health specialist.

Vaccine recommendations
Heather Renehan of Henrico County near Richmond is a former pharmaceutical sales representative for Merck & Co., maker of the only federally approved HPV vaccine, Gardasil. Renehan got the three-shot series for her 14-year-old daughter Jessi, who is entering high school. But she said she will not get the vaccine for Ally, who is entering the sixth grade, or her younger sister until they get older.

"I think parents can judge their children and judge when they need it," she said. "... I will definitely vaccinate them, though. I think it's critically important."

States’ legislation on an HPV vaccine A look at legislation passed or introduced by states and the District of Columbia since 2007 regarding the HPV vaccine. Several other states provided money for girls to receive the vaccine, either through legislation or the budgeting process. Schools — Virginia and the District of Columbia passed legislation in 2007 that requires girls entering the sixth grade beginning this year to receive the HPV vaccine unless their parents or guardians opt out. — Mandates were proposed in the following states but failed: Kentucky, New Mexico, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Maryland, Massachusetts, Michigan, Missouri, Minnesota, Mississippi, New York, Ohio, Oklahoma, South Carolina, Texas, Vermont and West Virginia. Insurance coverage — The following states passed legislation requiring health insurers to provide coverage for the vaccine: Oregon, Iowa, Colorado, Illinois, Nevada, New Mexico and Rhode Island. Education — The following states require schools or health departments to provide HPV and vaccination information, and in some cases provide the vaccine: Louisiana, Michigan, Colorado, Indiana, Iowa, New Jersey, North Carolina, Maine, North Dakota, Texas and Washington. Utah passed legislation in 2007 establishing an awareness campaign on the causes, prevention and risks of cervical cancer. Study — In Maryland, Minnesota and New Mexico, lawmakers ordered further study of the vaccine.

A U.S. Centers for Disease Control and Prevention advisory committee recommended in 2006 that the vaccine be given to all 11- and 12-year-old girls, and it is approved for girls as young as 9.

"I know that's not what parents really want to think about, but in the United States 70 percent of females have had sexual intercourse by the age of 18," said Virginia Department of Health epidemiologist Laura Ann Nicolai.

HPV, the most common sexually transmitted virus, often is harmless but it can cause cervical cancer, which kills about 3,700 of the 10,000 women who get it each year.

Since Gardasil's approval, more than 40 states have proposed legislation requiring education or insurance coverage of the vaccine or mandating it for girls. About half have approved some sort of legislation.

Texas Gov. Rick Perry sidestepped the legislature in 2007 and ordered a mandate, but lawmakers overturned his executive decree. New Mexico lawmakers passed a mandate that same year, but Gov. Bill Richardson vetoed it.

Several other states set aside money to provide the costly vaccine — the series runs about $360 — but scaled back as the bad economy ate away at budgets.

Side effects
Proposals also lost steam because Merck paid for the lobbying efforts nationwide. The company suspended its efforts in February 2007 "so that there would be no misperception" about its intentions, said Pam Eisele, a spokeswoman for the New Jersey-based company.

Merck stood to make billions because its rival, London-based GlaxoSmithKline PLC, has yet to get U.S. approval for its HPV vaccine, Cervarix. So far, Merck has sold about 26 million doses of Gardasil in the U.S. and 50 million worldwide, with more than $1.4 billion in sales last year.

As far as the vaccine's safety is concerned, two recent studies by federal and academic researchers have found low rates of side effects.

From June 2006 through December 2008, the federal government's voluntary reporting system had received more than 12,000 reports of side effects, or 54 reports per 100,000 doses given. Most were for things such as fainting, dizziness, headaches and nausea.

There were also 32 reported deaths — or one per 1 million girls vaccinated — but it is unclear whether the vaccine was to blame.

Health officials said the benefits outweigh the risks.

"Not all parents may choose to have their children vaccinated, but we certainly hope that all parents will review the educational materials and make an educated and informed decision," said Nicolai, of the Virginia health department.

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