Literature review of vaccine-related adverse events reported from HPV vaccination in randomized controlled trials

Background: The human papilloma virus (HPV) infections were addressed with two FDA-approved HPV vaccines: quadrivalent and bivalent vaccine. The objective of this manuscript is to determine the safety of the HPV vaccine. Results: A search of PubMed articles for "human papillomavirus vaccine" was used to identify all-type HPV clinical studies prior to October 2014. A refined search of clinical trials, multicenter studies, and randomized studies were screened for only randomized controlled trials comparing HPV vaccine to controls (saline placebo or aluminum derivatives). Studies were limited to the two FDA-approved vaccines. Following PRISMA guidelines, the literature review rendered 13 publications that met inclusion/ exclusion criteria. Gender was limited to females in 10 studies and males in 1 study. Two studies included both males and females. Of the 11,189 individuals in 7 publications reporting cumulative, all-type adverse events (AE), the AE incidence of 76.52% (n=4544) in the vaccinated group was statistically significantly higher than 67.57% (n=3548) in the control group (p<0.001). The most common AE were injection-site reactions. On the other hand, systemic symptoms did not statistically significantly differ between the vaccination cohort (35.28%, n=3351) and the control cohort (36.14%, n=3198) (p=0.223). The pregnancy/ perinatal outcomes rendered no statistically significant difference between the vaccine group and control group. Conclusion: Because the statistically significantly higher incidence of AE in the HPV vaccine group was primarily limited to injection-site reactions, the vaccinations are safe preventative measures in both males and females. © 2016 The Author(s).