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Children's Vaccines Health Center

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Should Your Child Get the HPV Vaccine?

What to know if you're debating the risks and benefits of HPV vaccination for your son or daughter.

HPV Vaccine's Safety Record

Despite a solid safety record for Gardasil and Cervarix, many adverse events have been registered with the Vaccine Adverse Events Reporting System (VAERS).

As of late November 2010, more than 18,000 complaints had been reported. That's twice the number of reports following injection with Menactra, another vaccine for adolescents that protects against meningitis. VAERS, co-sponsored by the CDC and the FDA, collects data on any adverse event that follows a vaccine -- whether or not it's caused by the vaccine. The information helps the agencies analyze and track the most common complaints.

Most VAERS reports on the HPV vaccine are for minor events, such as fainting and/or having pain at the site of the shot. But there are also reports of deep vein thrombosis (blood clotting) and Guillain-Barre Syndrome, a rare neurological disorder.

The CDC is aware, of course, of the reports of illness, and acknowledges that concerns about the vaccine's safety may be keeping people from getting immunized.

However, says Claudia Vellozzi, MD, deputy director of the CDC's Immunization Safety Office, the HPV vaccine has been shown to be as safe as meningitis and Tdap vaccines.

VAERS, Vellozi points out, is a passive reporting system, so there is no way to know if the vaccines caused the adverse events. Also, she says, VAERS is subject to underreporting and simultaneous reporting.

That is, there's no way to know if the vaccines caused the adverse events, or whether the numbers are on point.

"In our review of available vaccine safety data, FDA and CDC have concluded that the benefits of HPV vaccination continue to outweigh its risks and the vaccine is recommended," Vellozzi says.

As of September 2010, about 32 million doses of Gardasil had been distributed in the U.S.

In October, after reviewing reports from managed care organizations that tracked millions of patients who'd received Gardasil -- about 600,000 doses -- the CDC again concluded that Gardasil poses no serious health problems. The analysis looked at side effects within 42 days of the shot.

The Institute of Medicine (IOM) is also reviewing adverse events of several vaccines introduced since 1997, including HPV vaccines. Its findings are due in June.

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