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

Mohamed Macki,Ali A. Dabaja

doi:10.1186/s12610-016-0042-7

Abstract

BackgroundThe 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.ResultsA 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.ConclusionBecause 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.

Highlights

The human papilloma virus (HPV) infections were addressed with two Food and Drug Administration (FDA)-approved HPV vaccines: quadrivalent and bivalent vaccine
The National Cancer Institute independently developed the HPV vaccine, which was subsequently sold to Merek & Co and GlaxoSmithKline for randomized controlled trials (RCTs)
Years of clinical trials by the pharmaceutical companies have materialized into two Food and Drug Administration (FDA)-approved HPV vaccine

Summary

Introduction

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. Studies were limited to the two FDA-approved vaccines. 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). 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. While the efficacy of both vaccines has been verified in randomized control studies (RCT) [2,3,4], the safety of these prophylactic interventions has been strongly contested in the outpatient settings

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