The HPV Vaccine and Autoimmunity: Reviewing the Research

Editor's Note: Medscape asked Paul Offit, MD, to provide more detailed commentary in response to the letter to the editor he wrote, Paul Offit Responds to News About HPV Vaccine 'Syndrome'. Our goal is to offer more information to health professionals about what the evidence says regarding human papillomavirus (HPV), vaccine safety, and adverse events.

HPV Vaccine and Adverse Effects: A Focus on the Research

In 2006, the Centers for Disease Control and Prevention (CDC) recommended the HPV vaccine for girls aged 11-13 years. In 2010, the CDC extended its recommendation to include adolescent boys. Since licensure, more than 200 million doses of the vaccine have been distributed globally. Because the vaccine has been given to millions of people, strokes, anaphylaxis, autoimmune diseases, venous thromboembolism, and adverse pregnancy outcomes have, on rare occasion, occurred following vaccination. To determine whether these events are causally or coincidentally associated with receipt of the HPV vaccine, investigators have studied large numbers of people who did or did not receive the vaccine.

To determine whether these events are causally or coincidentally associated with receipt of the HPV vaccine, investigators have studied large numbers of people who did or did not receive the vaccine.

To address concerns over news reports or published case series of autoimmune disorders appearing after HPV immunization, I will focus on studies related to the association between HPV vaccine and autoimmune disorders in this review.

In 2011, Chao and colleagues^[1] at the Kaiser Permanente Vaccine Study Center in Oakland, California, evaluated 189,629 women of all ages who had received at least one dose of the quadrivalent HPV vaccine (HPV4) between 2006 and 2008 and compared the incidence of autoimmune diseases in these women vs the incidence in women who hadn't received the vaccine. Investigators found no statistically significant differences between the vaccinated and unvaccinated groups in the incidence of immune thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis, type 1 diabetes, Hashimoto disease, Graves disease, multiple sclerosis, acute disseminated encephalomyelitis, Guillain-Barré Syndrome (GBS), neuromyelitis optica, optic neuritis, or uveitis.^[1]

In 2013, Arnheim-Dahlström and coworkers^[2] from the Department of Medical Epidemiology and Biostatistics at the Karolinska Institutet in Sweden and the Statens Serum Institut in Denmark prospectively evaluated 997,585 girls aged 10-17 years, 296,826 of whom had received HPV4. As in the California study, investigators found no differences between the vaccinated and unvaccinated groups in the incidence of thyroid, gastrointestinal, musculoskeletal, systemic, hematologic, dermatologic, or neurologic autoimmune events.^[2]

In 2014, Grimaldi-Bensouda at the Institut Pasteur, in collaboration with investigators from 113 medical centers throughout Europe,^[3] performed a case-control study matching 211 cases of autoimmune diseases among females aged 14-26 years to 875 controls. Investigators found no evidence for an increased risk for idiopathic thrombocytopenic purpura, multiple sclerosis, GBS, connective tissue disorders (SLE, rheumatoid arthritis, or juvenile arthritis), type 1 diabetes, or autoimmune thyroiditis following vaccination with HPV4.^[3]

To date, researchers have not found evidence that meets any of the four operational criteria necessary to prove that HPV vaccines induce autoimmunity.

Most recently, in 2015, Vichnin and colleagues^[4] from the United States and Europe evaluated 9 years of HPV vaccine safety data from 15 studies that included more than 1 million preadolescents, adolescents, and adults. Again, investigators found no differences in the incidence of such autoimmune diseases as GBS and multiple sclerosis in vaccinated people compared with background rates of these diseases.^[4]

These data shouldn't be surprising. To date, researchers have not found evidence that meets any of the four operational criteria necessary to prove that HPV vaccines induce autoimmunity.

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