In a joint statement issued Thursday, officials from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention said the benefits of the cervical-cancer vaccine Gardasil continue to outweigh its risks, according to published reports.
The statement followed by two days the publication of a study by both agencies in the Journal of the American Medical Association that found the vaccine to be safe, despite side effects that include fainting and blood clots. For every 100,000 doses of Gardasil distributed, the study found 8.2 episodes of fainting and 0.2 episodes involving blood clotting.
"Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks," the agencies said in the statement posted on the FDA Web site.
In June 2006, Gardasil was licensed for use in girls older than 9 years to prevent infection from four types of a virus called HPV. HPV is a virus known to cause genital warts and cervical cancer. Two types of HPV covered by the vaccine, HPV-16 and HPV-18, cause about 70 percent of cervical cancers. The vaccine is given in three doses.
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.
Merck & Co., the maker of Gardasil, has insisted the vaccine is safe and effective.