Evaluation of the Human Papillomavirus (HPV) Vaccine Utilization, Benefits, and Risks

Abstract

The Food and Drug Administration (FDA) licensed the first two human papillomavirus (HPV) vaccines, Gardasil and Cervarix, for routine use among adolescent girls and young adult females in United States (U.S.). According to the manufacturers, both vaccines were developed to prevent cervical cancer. However, in the long history of the fight against diseases and since vaccines were developed as primary disease prevention tools, no vaccines have been more controversial than these vaccines. Millions of doses of the HPV vaccines were distributed, however, the number of dose that have already been used is currently unknown; the characteristics of healthcare providers administering the vaccines, and the demographics of females who started or completed the three-dose series are not well described. Additionally, shortly after the commencement of population-based vaccination, questions arose as to whether these vaccines are effective in preventing cervical cancer. Also, major concerns about their safety, duration of protection, benefits, and cost-effectiveness were increasingly raised. This research evaluated serious adverse events following vaccination with Gardasil, analyzed the characteristics of those who received the vaccine, and provided a thorough and objective assessment of the value such vaccine may add to the fight against cervical cancer. Extensive data mining, review and analyses of negative health events reported to the Vaccine Adverse Events System (VAERS) and several other large databases were performed on a weekly basis during the three-year study period from November 2006 to November 2009. The disproportionate number of negative adverse events associated with Gardasil was significant when compared to other vaccines. Under the current safety profile, it seems that the benefits of vaccination for an almost always harmless virus such as HPV do not outweigh the risks, and even rare adverse events in a perfectly healthy young girl may be too much of a risk. The results of this study highlighted increasing rates of serious risks and negative health outcomes associated with HPV vaccination. Moreover, it also emphasized that immediate and long-term benefits of the vaccine seemed insignificant. Currently, the HPV vaccine is underutilized, has a questionable safety record, and is of unproven effectiveness, especially when compared to regular cervical cancer screening. However, even if Gardasil turned out to be less risky and more effective, this vaccine is very costly and will not reduce the risk of exposure to or contracting HPV infections. Additionally, it will not reduce the need for routine life-long cervical cancer screening and Papanicolaou (Pap) testing. Furthermore, its use will not impact the incidence or deaths associated with cervical cancer even if the protection against HPV genotypes included in the vaccine would outlast the decades-long latency period of invasive cervical cancer.