RICHMOND, Va. — On Oct. 1, Virginia will become the first state to require 11- and 12-year-old girls to be vaccinated for a sexually transmitted infection.

The controversial legislation, requiring vaccinations against the human papillomavirus in order for girls to remain in school, comes on the heels of news that the vaccine may be linked to serious side effects.

Marketed as Gardasil, the vaccine fights two strains of HPV, believed to cause 70% of cervical cancers.

As of June 30, 2008, the U.S. Food and Drug Administration and Centers for Disease Control and Prevention had received 9,749 reports of potential adverse reactions to the vaccine. The 6% said to be “serious” included paralysis, seizures, strokes and 20 deaths.

In June 2006, the vaccine was approved by the FDA for girls and women 9 to 26. But when the FDA fast-tracked Gardasil, it was on the condition that the manufacturer, New Jersey-based Merck & Co., Inc., do more safety studies. Those won’t be completed until June 30, 2009.

Merck said the company has “analyzed the adverse events” and “believes that no safety issue related to the vaccine has been identified.”

FDA and CDC officials also called the vaccine “safe and effective,” stating that an adverse-event report “does not mean there is a connection between the vaccine and the event.”

But Virginia mother Barbara Loe Fisher, who heads the National Vaccine Information Center, believes the vaccine could be dangerous. “Merck studied fewer than 1,200 girls under age 16 — and now all little girls in Virginia are supposed to get this vaccine? That’s just shoddy science. Where’s the proof this vaccine won’t do any harm?” Fisher asked.

One of the vaccine’s developers, Dartmouth Medical School professor and HPV specialist Dr. Diane Harper, said all of the adverse effects being reported happened, but no one really knows how many more adverse effects will happen “because the vaccine hasn’t been studied long enough. Nor do we know whether these adverse effects will happen more frequently if more than one vaccine — for example, Menactra [for meningitis] and Gardasil — are given at the same office visit.”

Last month a series of New York Post stories told of:

• a 14-year-old Nevada girl who developed paralyzing Guillain-Barré Syndrome after her second Gardasil shot,

• a 13-year-old who suffered post-Gardasil headaches, lethargy and paralysis in her left leg, and

• an upstate New York honor student, 17, received her third Gardasil shot and dropped dead two days later in the bathroom of her home.

Such anecdotal evidence, however, doesn’t prove cause and effect.

Meanwhile, the drive is on to get as many 11- and 12-year-old girls vaccinated as quickly as possible. In 2007, at least 24 states and the District of Columbia introduced legislation to make the HPV vaccine mandatory for school attendance, but most of them were not enacted or were stalled in committee. California and Maryland withdrew their bills. After heated protests from parents, Texas Gov. Rick Perry’s executive order requiring the vaccine for all girls entering sixth grade was overturned by the state legislature.

Because the school year starts before Oct. 1, most Virginia sixth-grade girls won’t be affected by the law until 2009.

“Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children,” concluded a June report by Judicial Watch, a D.C.-based public-interest group.

A senior health policy analyst for Virginia’s Joint Commission on Health Care, Michele Chesser, believed the vaccine poses no public danger. The reactions are “few and far between,” most are “relatively mild” and “all vaccines come with possible side effects,” Chesser said.

But Gardasil researcher Harper has repeatedly called the push to mandate Gardasil for little girls “a great, big public health experiment.”

“The vaccine has been tested for only six years. So we don’t know if it will protect an 11- or 12-year-old from cancer 25 years down the road,” Harper said.

Further, Harper said that governmental haste to vaccinate girls is fueled by misunderstandings. Myth has it that once a woman becomes sexually active, Gardasil will no longer work, or at least won’t work as well. But, in fact, Harper explained, “The studies show girls will be just as protected [from cervical cancer] if they get the shots at age 15, 18, 22, or 26 — even if they’ve been exposed to HPV. There’s no reason to push this on 12-year-olds.”

“School requirements have proven effective in preventing infectious disease, by improving access to vaccines, reducing ethnic and racial disparities, providing vaccines to the underinsured and by providing funding to public health officials to help purchase vaccines and implement vaccine programs,” said Merck spokeswoman Amy Rose.

Rose added, however, that Merck has stopped lobbying for mandates. “Decisions to support school requirements are up to the individual states, not Merck,” Rose said.

At $500 for a series of three shots, Gardasil is the most expensive vaccine the FDA has ever approved. “By mandating this vaccine, states are telling parents that unless they provide $500 to Merck, they cannot send their child to public school,” Harper said. “Why the rush to get everybody vaccinated?”

Although some parents have reportedly opposed Gardasil for little girls on the grounds it might encourage promiscuity, Fisher believes framing the Gardasil debate as part of the “culture wars” misdirects the public dialogue. “This isn’t about sex. This about product safety,” Fisher said.

Dr. Gary Rose, president of the Medical Institute for Sexual Health in Austin, Texas, called the sexual morality issue a red herring. Rose said, “There are 25 other sexually transmitted diseases. So just because a girl gets the HPV vaccine doesn’t give her permission to have premarital sex. If I have a gun with 26 bullets in it, and I take one bullet out, I’m still not going to aim it at my head.”

With approximately 6.2 million Americans infected annually, HPV is the most common sexually transmitted infection in the U.S. But 90% of the infections clear up without treatment. A rare few go on to trigger cervical cancer.

About 11,000 American women – fewer than one-hundredth of 1% of the female population — get cervical cancer each year, and about 4,000 die from it. Ten times that many women die each year from breast cancer.

Because Gardasil protects against only 70% of cervical cancers, vaccinated women will still need regular pap smears. Therefore, Harper said, “The most likely benefit of Gardasil for the vast majority of American women is that it will give them a greater reassurance that every pap they get will be normal.”

The likeliest benefit for most women is anxiety reduction? “That’s exactly right,” Harper replied. “So do we really need to give this vaccine to every 12-year-old? To me, that’s a silly use of state resources.”

Even if Gardasil turns out to be safe, states like Virginia may face trouble down the road. Already, attorneys are lining up on the Internet to advertise themselves as “Gardasil lawyers.”

Sue Ellin Browder is based in

Willits, California