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.
Previous safety data on the HPV vaccine has been collected in clinical trials, as well as the Vaccine Adverse Event Reporting System Both have important limitations in assessing the safety profile of the vaccine. Clinical trials often include a highly selected population, with sample sizes too small, and follow up too short, to observe rare safety events such as autoimmune conditions. The VAERS reports are often hard to interpret due to the lack of a proper comparison group and limited ability to determine whether the onset of the condition really preceded vaccination. On the other hand, the present study, conducted at Kaiser Permanente in California employed methods that involved in-depth medical chart review to ensure the accuracy of diagnosis and that onset of disease was after vaccination. In addition, disease incidence in the vaccinated group was compared with a comparable unvaccinated group. As a result, this study offers important complementary safety information for the HPV vaccine.
The study was funded by Merck & Co., which manufactures Gardasil.
Other authors on the study included: Nicola P. Klein, MD, John Hansen, MPH, Kamala Deosaransingh, MPH, and Michael Emery, MS, of the Kaiser Permanente Vaccine Study Center; Christine M. Velicer, PhD, and Kai-Li Liaw, PhD, of the Department of Epidemiology, Merck Research Laboratories; Bradley Ackerson, MD, of the Department of Pediatrics, Kaiser Permanente
|SOURCE Kaiser Permanente|
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