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.
Lingering Safety Concerns continued...
And, she adds, "It won't hurt matters that there will be a couple more years of research."
But Linda May, who lives in suburban Indiana, wonders if changes her daughter Laura has experienced since getting her first Gardasil shot in February 2010 are from the vaccine.
May says Laura, a former athlete and star pupil, is fatigued and always achy. Her menstrual cycle is irregular.
Laura doesn't complain, Linda says, but the family can see she is not herself. The Mays have spent countless hours talking to doctors. No diagnosis has been made, but a few have theorized that the vaccine triggered an autoimmune response, she says.
The family plans to file a claim with the Department of Health and Human Services' National Vaccine Injury Compensation Program, which has recorded 88 injury and 8 death claims related to the HPV vaccines and two legal settlements.
May is not against the HPV vaccine. But she wants to see it taken off the market until more safety reviews are done. "I know many girls who've had (the vaccine) and are fine," May says. "It needs to be looked at."
Gardasil is made by the drug company Merck. Richard Haupt, MD, who heads Merck's adult clinical vaccine research group, says clinical trials and post-licensure trials of Gardasil showed no increase in the rate of autoimmune conditions in vaccine recipients -- and Merck has looked for them.
In one surveillance study, Merck pre-specified 16 autoimmune conditions to look for in 200,000 women patients who had received one dose of Gardasil. "We saw no signal of an increase rate of autoimmune conditions," Haupt says.
Gardasil, he says, has been shown to be safe in repeated trials."The benefits of vaccination clearly outweigh any risks," Haupt says.
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.