Is Gardasil Safe?
Fretting about whether to get your daughter vaccinated against cervical cancer? Or perhaps about getting Gardasil yourself? The federal government has new data that officials say should help calm fears about the safety of the controversial shots.
The analysis of data collected from about 190,000 women and girls who got at least one Gardasil shot found no evidence that the vaccine increased the risk for any serious complications, according to the federal Centers for Disease Control and Prevention in Atlanta.
The CDC and other major medical groups recommend girls get the vaccine before they become sexually active to minimize the chances of getting cervical cancer later in life. The vaccine protects against strains of the human papilloma virus (HPV) that can cause cervical cancer.
But many parents have been reluctant to get their daughters vaccinated. Part of the reluctance is worries that vaccinating girls against a sexually transmitted virus might encourage sexually activity, and part of it is concerns about safety. Vaccine critics cite thousands of reports that the CDC has received about complications among people who got the vaccine, including strokes, blood clots, seizures and even some deaths.
The CDC and the Food and Drug Administration have looked into this before and concluded that it's not surprising that serious problems may have been reported among some recipients, given that doctors have administered more than 20 million doses of the vaccine. There's no convincing evidence that the major complications that have been reported have been actually caused by the vaccine, the agencies said.
To try to explore that further, however, CDC researchers analyzed preliminary data collected by another system specifically set up to better monitor adverse reactions from vaccines known as the Vaccine Safety Datalink. The system collects detailed medical information from seven large health maintenance organizations around the country.
Scientists compared the rate of adverse reactions among girls or young women who received some 375,000 doses of the vaccine in the last two years with that among those who did not get the vaccine or got other vaccines. None of eight serious complications, including seizures, blood clots, strokes or the neurological condition Guillain-Barre syndrome, occurred more frequently among those vaccinated than those who went without it, the CDC reported yesterday to a panel of experts that monitors vaccines for the agency.
The agency said it also carefully analyzed the 27 deaths that have been reported, and found no common pattern that would indicate they were caused by the vaccine.
The shots do cause minor reactions, such as sore arms, dizziness, nausea and mild headaches, and a lot of fainting. But so far that seems to be the worst problems.
Given the level of passion surrounding Gardasil, the new data are unlikely to settle the debate. While CDC officials say they hope the new information will help reassure those who have gotten the vaccine or are considering it, critics say they remain unconvinced.
October 23, 2008; 7:00 AM ET
Categories: Family Health , Teens , Women's Health
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