Background: In the literature conflicting opinions are detectable on the onset of adverse events as autoimmune disease post HPV vaccine and often case reports describes the onset of one of these events, but don't emerge a clear relationship and we don't have data to support it.
Methods: We carried out a systematic review to identify all scientific publications dealing with the correlation between vaccine anti-papillomavirus and new onset of autoimmune diseases. We searched the main scientific databases (PubMed, Sciverse Scopus, Web of knowledge and Cochrane Central Register of Controlled Clinical Trials) for the following search terms: "vaccine"; "anti-papillomavirus"; "autoimmune"; "disease"; "disorder". To evaluate the safety of HPV vaccines, the dichotomous data on the number of subjects experiencing an autoimmune disorder in the study vaccine group and the placebo group were extracted from each study with subsequent determination of the risk ratios and their 95% confidence intervals. We combined data statistically using a random effects model.
Results: We conduct a meta-analysis on six studies on bivalent and quadrivalent HPV vaccine. The total number of subjects included in the meta-analysis comprised 243,289 in the vaccine group and 248,820 in control groups. Four of the six trials had a Jadad score of 3 or 4 indicating an adequate trial quality. The most frequent autoimmune disease observed across the six studies were musculoskeletal,CNS conditions and endocrinological conditions . The results of the meta-analysis demonstrated no correlation between autoimmune disorders and HPV vaccines (pooled OR 1.038, 95% CI 0.689-1.562).
Conclusions: No correlation was identified for bivalent and quadrivalent HPV vaccines. It's therefore essential to correctly inform the general population in order to try to increase both Italian and international vaccination coverage.
Keywords: Autoimmune diseases; HPV vaccine; Meta-analysis; Sistematic review.