Another Study Brought to You by Merck & Co.
Two-Year Study Tracked Results for 190,000 girls and women
Wednesday, January 25, 2012
PASADENA, Calif., Jan. 25, 2012 — /PRNewswire/ — Gardasil, the human papillomavirus vaccine that is now recommended for male and female adolescents and young adults, does not trigger autoimmune conditions such as lupus, rheumatoid arthritis, type 1 diabetes or multiple sclerosis after vaccination in young women, according to a new study in the Journal of Internal Medicine.
Kaiser Permanente researchers used electronic health records to conduct an observational safety study of 189,629 females aged 9 to 26 years old in California who were followed for six months after receiving each dose of the quadrivalent HPV vaccine in 2006-2008. Researchers found no increase in 16 pre-specified autoimmune conditions in the vaccinated population compared to a matched group of unvaccinated girls and women.
The quadrivalent HPV vaccine was licensed by the U.S. Food and Drug Administration in 2006 and recommended for young women and girls to protect against genital warts, which infects 6.2 million people annually, is the most common sexually transmitted infection in the United States, and can lead to cervical cancer in women. But autoimmune reactions have been a long-standing concern surrounding vaccination and many parents withhold the vaccine from their children because of perceived safety concerns. However, most speculated associations have stemmed from case reports that have not been confirmed by large, controlled epidemiologic studies. This study presents findings from a well-designed, post-licensure safety study of the vaccine on a large, ethnically diverse population, researchers said.
“This kind of safety information may help parents with vaccination decisions,” said study lead author Chun Chao, PhD, a research scientist at the Kaiser Permanente Department of Research & Evaluation in Pasadena, Calif. “These findings offer some assurance that among a large and generalizable female population, no safety signal for autoimmune conditions was found following HPV4 vaccination in routine clinical use.”
The study looked for autoimmune conditions such as immune thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, type 1 diabetes, Hashimoto’s disease, Graves’ disease, multiple sclerosis, acute disseminated encephalomyelitis, other demyelinating diseases of the central nervous system, vaccine-associated demyelination, Guillain-Barre syndrome, neuromyelitis optica, optic neuritis and uveitis.