In clinical trials conducted before licensing, researchers found that the rates of adverse events were similar in girls and young women who received the vaccine compared with those who received a placebo injection.
For the new study, researchers from the CDC and the U.S. Food and Drug Administration reviewed data from VAERS, the voluntary system that enables anyone to report a vaccine-related side effect. Slightly more than two-thirds of the information on Gardasil was provided to VAERS by the drug's manufacturer, Merck & Co.
The researchers reviewed data from the time Gardasil was approved in 2006 through December 2008. During that time, 23 million doses of Gardasil were distributed throughout the United States, Merck said.
More than 12,000 reports of adverse events after vaccination were reported to VAERS. Of those, 772 were described as serious, including 32 deaths, the study found.
Slade said that when the researchers reviewed the deaths, they couldn't discern any pattern. Those who died were of different ages, there wasn't a common cause of death, and there wasn't a consistent time after vaccination that these deaths occurred.
"While this is heart-rending for the family involved because you don't expect deaths in this age group, our general feeling is that they're not vaccine-related," she said.
Other reported adverse events included local reactions, such as redness, swelling or pain at the injection site, dizziness, nausea, headache, allergic reactions and autoimmune disorders.
"We're pleased with the JAMA paper as it confirms the safety profile of Gardasil," said Dr. Richard Haupt, executive director of clinical research at Merck Research Laboratories. "The benefit-to-risk profile is very favorable," he added.
Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, said it won't be making any changes to its re
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