Study Finds HPV Vaccine Gardasil Safe

Source: Wall Street Journal | Page: D2

By: Dooren, Jennifer Corbett


A new study of Merck’s Gardasil found no safety concerns for the human papillomavirus (HPV) vaccine. The Kaiser Permanente Vaccine Study Center in Oakland, Calif., led the study, which noted only rare occurrences of fainting and skin infections—known side effects of Gardasil. The vaccine protects against four strains of HPV, including two that account for about 70 percent of cervical-cancer cases in women. The U.S. Food and Drug Administration and the European Medicines Agency sought an additional look at the vaccine’s safety in a large group of people. The study, published in the Archives of Pediatrics & Adolescent Medicine, involved about 190,000 females who received at least one dose of the HPV vaccine between August 2006 and March 2008. Approximately 44,000 of the women received all three recommended doses of the vaccine. The researchers looked at emergency room visits and hospitalizations following each vaccine dose, reviewing more than 200 categories of illnesses to see if there might be a link, and found that in most cases the condition existed prior to vaccination. Gardasil was first approved in 2006 for girls and women ages 9 to 26 years old before later being approved for use in males, but HPV immunization rates lag those of other vaccines partly due to concerns about safety, according to doctors. “This is very reassuring,” said Mary Anne Jackson, section chief, infectious disease at Children’s Mercy Hospitals and Clinics in Kansas City, Mo. The “bottom line is it’s a very safe vaccine.”

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