Gardasil does not trigger autoimmune conditions; study

US drug giant Merck & Co’s (NYSE: MRK) Gardasil ([human papillomavirus quadrivalent [types 6, 11, 16, and 18]), 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 from Kaiser Permanente published 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 study was funded by Merck.

The quadrivalent HPV vaccine was licensed by the US 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 USA, 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.