Navigation Links
Kaiser Permanente Study Finds Gardasil Does Not Trigger Lupus, Rheumatoid Arthritis or Type 1 Diabetes After Vaccination
Date:1/25/2012

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.

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 South Bay Medical Center; Lina S. Sy, MPH, Jeff M. Slezak, MS, Harpreet Takhar, MPH, T. Craig Cheetham, PharmD, Steven J. Jacobsen, MD, PhD, of the Department of Research & Evaluation, Kaiser Permanente Southern California.

About the Kaiser Permanente Department of Research & Evaluation

The Department of Research & Evaluation (R & E) conducts high quality, innovative research into disease etiology, prevention, treatment and care delivery.  Investigators conduct epidemiology, health sciences, and behavioral research as well as clinical trials. Areas of interest include diabetes and obesity, cancer, HIV/AIDS, cardiovascular disease, aging and cognition, pregnancy outcomes, women's and children's health, quality and safety, and pharmacoepidemiology. Located in Pasadena, Calif., the department focuses on translating research to practice quickly to benefit the health and lives of Kaiser Permanente Southern California members and the general population. Visit www.kp.org/research.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve 8.9 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, visit www.kp.org/newscenter.

For more information
Sandra Hernandez-Millett, sandra.d.hernandez-millett@kp.org 626-405-5384
Emily Schwartz, eschwartz@golinharris.com, 415-318-4371


'/>"/>
SOURCE Kaiser Permanente
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Kaiser Permanente - Group Health Study Shows Depression Worsens HIV Treatment
2. Healthy Bones Program Reduces Hip Fractures by 37 Percent, Kaiser Permanente Study Finds
3. National Institutes of Health Awards More Than $54 Million to Kaiser Permanente to Conduct Health Research
4. Kaiser Foundation Health Plan and Hospitals Report Third Quarter 2009 Financial Results
5. Kaiser Permanente Launches Sustainability Scorecard for Medical Products
6. Home Health Monitoring May Significantly Improve Blood Pressure Control, Kaiser Permanente Study Finds
7. Kaiser Permanente Demonstrates Success of Large-Scale Total Joint Replacement Registry
8. ECRI Institute Names Kaiser Permanente Winner of 5th Annual Health Devices Achievement Award
9. Kaiser Permanente Leads the Nation in 12 Quality Measures
10. Kaiser Permanentes ALL/PHASE Initiative Wins 2010 Care Continuum Alliance Quality Impact Award for Greatest Impact on Health
11. Kaiser Permanente Recognized as a J.D. Power 2011 Customer Service Champion
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... Oasmia Pharmaceutical AB (NASDAQ: ... new generation of drugs within human and veterinary ... Paclical/Apealea in the Phase III study that included ... cancer. These preliminary results showed non-inferiority between the ... versus Taxol in combination with carboplatin. In fact, ...
(Date:4/27/2016)... At the Sachs CEO forum ... Phase 2 clinical study of its lead drug candidate, ... implantation (CI) surgery. This large, placebo-controlled, double-blind, phase 2 ... and France . STR001 ... time of surgery. "Despite advances in cochlear implant technology, ...
(Date:4/26/2016)... April 26, 2016 US demand for ... expand 4.9 percent annually to $27.6 billion in ... facilities to decrease rates of healthcare-associated infections (HAIs) ... equipment, and services.  Although declining, the overall rate ... targeted levels set by the CDC.  Recent statistics ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 30, 2016 , ... World Patent Marketing ... Up Springboard, an automotive invention that improves the storage features of a pick ... billion," says Scott Cooper, CEO and Creative Director of World Patent Marketing. "Over ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... , announces the addition Onnit brand Alpha BRAIN and New Mood Daily-Stress Formula ... brain and mood optimization products to the store is just one more way ...
(Date:4/29/2016)... ... April 29, 2016 , ... The White House announced ... loans, more information about their loan terms and accounts, and more protections for ... including federal and private loans, has reached $1.3 trillion, with 43 million Americans ...
(Date:4/29/2016)... ... April 29, 2016 , ... The Wharton ... $30,000 Perlman Grand Prize of the 2016 Wharton Business Plan Competition —as ... People’s Choice Award, and the Committee Award for Most ‘Wow Factor,’ making them ...
(Date:4/29/2016)... ... April 29, 2016 , ... Dr. Robert Mondavi, one of the ... smiles. Cosmetic dentistry is a fast-growing field as more patients are discovering the many ... learn more about the options currently available to them and which ones might work ...
Breaking Medicine News(10 mins):