Vaccines Get New Scrutiny

Might Gardasil be to blame for Sara Austin's severe headaches?

When Julie Austin decided to give her daughter the Gardasil vaccine, she desperately wanted to protect Sara, then 15, from the human papillomavirus that had caused abnormal Pap smears in other family members. A day after the shot, however, Sara complained that she was dizzy and her head was pounding. "Her doctor said the migraine—the first one Sara ever experienced—could have been caused by Gardasil, but it faded the next day, so I didn't worry," says Austin, of Westfield, Mass. But the headache struck again after Sara's second shot—and again after her third. Then, the crushing pain became constant, causing Sara to miss school, quit the soccer team, and spend weekends in bed.

Her mom now wonders if she made the right decision to vaccinate, even though the Food and Drug Administration insists there's no reason to be worried about Gardasil. "We're monitoring the safety of the HPV vaccine very carefully, and the only adverse event that causes some concern is syncope or fainting," says Robert Ball, director of the FDA's office of biostatistics and epidemiology. And Gardasil's benefits can't be ignored: It protects against several dangerous HPV strains, including those responsible for the bulk of cervical cancers. But others in the medical establishment believe Gardasil's safety hasn't yet been proven and question why it's being recommended for girls as young as 9. "I certainly think it's wrong to give [Gardasil] to young teenage girls," contends pediatrician Catherine DeAngelis, editor in chief of the Journal of the American Medical Association. "What are the risks? We won't know until it's given to millions of women." Karameh Hawash, the pediatric neurologist who recently treated Sara Austin with a prescription migraine drug, says she has seen two other girls stricken by daily headaches after receiving Gardasil shots.

Such uncertainty explains the decibel level of the battle cries both defending and attacking vaccines, which has risen in recent years along with the number of immunizations children face: 38 shots against 15 diseases before kindergarten, compared with 11 shots against eight diseases 15 years ago. There's no question that vaccines have been lifesaving: If every American child followed the recommended schedule, some 33,000 lives would be saved, 14 million infections prevented, and $10 billion slashed from healthcare costs every year, according to the Centers for Disease Control and Prevention. But plenty of parents are unconvinced by the public-health mission, given other data—also from the CDC—showing that about 30,000 "adverse events" are reported every year by doctors and patients, of which 3,000 to 4,500 are serious enough to cause hospitalization, life-threatening illness, or even death. While the CDC's associate director for immunization safety, John Iskander, insists that "vaccines are extraordinarily safe medical products," he also acknowledges that the "trade-off between risks and benefits can be very difficult for parents."

Certainly, the government has taken steps through the years to make vaccines safer, replacing the live pertussis component of the diphtheria-tetanus-pertussis vaccine, which caused high fevers and seizures in some children, with the inactive virus, for example. At the same time, though, officials are targeting an ever-expanding array of diseases. Some parents, fighting against the more-is-better philosophy, have gone so far as to organize chickenpox parties in the belief that infecting their kids the "natural way" is safer than vaccination with a weakened form of the virus; others, fearful that vaccines have led to the rise in autism, choose not to vaccinate at all. Alarmed, the American Academy of Pediatrics in September formed an "immunization alliance" with other medical groups to push for kids to get all recommended vaccines on time. Public schools are pushing harder, too; one Maryland school district threatened to bring criminal charges against noncompliant parents.

Call for study. Far more quietly, the government is acknowledging that, at the moment, science doesn't know much about how many shots a kid can safely get at once and which children will be harmed. Last March, the family of 9-year-old Hannah Poling won a claim in the federal Vaccine Court (created to protect manufacturers from ruinous lawsuits) that the autism she developed as a toddler was most likely triggered by receiving five shots against nine diseases in one day; all told, the government has paid out more than $900 million for vaccine injuries over the past two decades. Since the Poling verdict, the government has called for new safety studies—to evaluate, say, whether gene variations may make some kids more susceptible to vaccine injury. "If we can show that individuals of a certain genetic profile have a greater propensity for developing adverse events, we may want to screen everyone prior to vaccination," says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, a key partner in the new initiative.