Gardasil Linked to More Allergic ReactionsSep 3, 2008 | Parker Waichman LLP
Gardasil, the Merck and Co. vaccine approved to target the human papillomavirus (HPV), is again at the epicenter of controversy. Australian researchers are reporting that young women in Australia who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer rare and severe allergic reaction versus other girls who received other vaccines in comparable school-based vaccination programs. The researchers reported that the Gardasil reactions were unusual and manageable.
The researchers were led by Dr. Julia Brotherton of The Children's Hospital at Westmead and studied 114,000 young women vaccinated with Gardasil as part of a 2007 vaccination program in New South Wales. Of the girls vaccinated, 12 experienced suspected cases of anaphylaxis. Anaphylaxis is a potentially life-threatening allergic reaction that can cause difficulty breathing, nausea, and rashes. Eight of the 12 experienced “an estimated rate of reaction of 2.6 per 100,000 doses administered” as compared with “a rate of 0.1 per 100,000 doses in a 2003 school-based meningitis vaccination program.” In a commentary on the study, Dr. Neal Halsey of Johns Hopkins University in Baltimore wrote, "It's just a reminder that there are rare adverse effects. It doesn't change the strong recommendations for all adolescent girls to get this vaccine but we just have to watch them to make sure they don't have this allergic reaction," he added.
Gardasil was approved by the US Food and Drug Administration (FDA) two years ago for girls aged nine-26 and protects against sexually transmitted diseases caused by four particularly dangerous HPV strains in women that are responsible for 70 percent of cervical cancers and 90 percent of genital warts. Merck & Company—Gardasil’s maker—said 16 million doses have been administered since its approval. Last May, the U.S. Centers for Disease Control and Prevention (CDC) said Gardasil is linked with a higher risk of fainting that, in some cases, resulted in injury. In July, Gardasil was criticized for possible links to a 20-year-old woman who suffered a stroke after receiving a second Gardasil injection. In June, Merck added more possible adverse reactions to Gardasil’s growing list, including fatigue, weakness, and muscle pain; however, many feel this is not enough.
Since its approval, 18 women who received the Gardasil vaccine died; blood clots were responsible for four, according to a report released by watchdog group Judicial Watch. We reported on the deaths of two women oversees apparently linked to Gardasil and which followed the deaths of three other young women—ages 12, 19, and 22—who died in the U.S. days after Gardasil was administered. A 14-year-old girl experienced debilitating headaches, fainting spells, and arthritis-like stiffness and became so dizzy she could barely walk, was hospitalized, missed nearly one month of school, and suffered a seizure. Recently, 13-year-old, who was seemingly healthy 15 months prior to receiving her third Gardasil shot began showing signs of having been stricken with a degenerative muscle disease; she is now almost completely paralyzed.
U.S. News & World Report says there are other possible adverse side effects linked to Gardasil and the New York Post reports Gardasil has been associated to medical problems. Meanwhile, researchers and Merck are collecting data to consider whether boys should receive Gardasil as well.