According to the Centers for Disease Control, Advisory Committee on Immunization and Practices, Resolution 6/06-2 the administration of the quadrivalent Human Papilloma Virus vaccination is suggested for administration to girls as young as 9 but preferably in the age set of 11-12, and as a catch up vaccination for girls aged 13-18. The vaccination is to be given in three staggered doses with the second dose given 2 months from the first and the third 6 months after the first dose. This is based on the positive research findings of both non-profit research groups and pharmaceutical companies developing preventative HPV vaccinations. This work addresses the validity of mandating this vaccine in Solano County California, upon these age guidelines as a prophylactic measure to decrease the incidence of the specific HPV types (6,11,16,18) associated with the vaccination, namely the Merck vaccination trade name Gardasil. In addition to this informative resolution the California Department of Health Services has obtained the vaccination and has made compatible resolutions to vaccinate girls according to the national recommendations, either through private physicians or through state and local agency immunization programs, (California Vaccines for Children (VFC) Program Providers) such as those found in Solano County.
Background/Review of Literature:
HPV types 6 and 11 are responsible for 90% of the cases of genital warts and types 16 and 18 are responsible for 70% of all incidences of cervical cancer, the second most common cancer among women accounting for 10% of all cancer deaths in women worldwide.
The promising test results, for both safety and effectiveness, with regard to this vaccination are foundationally valid up to the long-term testing of up to 3.5 years, providing a high incidence of protection from these types of HPV, and long-term studies will continue to determine the need for booster protection based on the length of serum protection indicated in human trials. "The burden of HPV-related diseases, recent scientific discoveries of viral etiology of several anogenital cancer types, and the development of prophylactic vaccines together present an unprecedented opportunity for global cervical cancer prevention."
Long-term results of widespread vaccination will likely not be felt for many years, as the incidence of cancer occurrence increases with age and rarely effects the younger demographic, owing to the long growth nature of the disease, which can take up to 10 years to develop into cancerous lesions, where most women effected with potentially life threatening cancerous lesions caused by these virus types are over the age of 40. Though the potential long-term benefits are substantial
Genital HPV infection is believed to be the most common sexually transmitted viral infection, with an estimated prevalence of about 20-40% among sexually active 20-year-old women, an estimated 3-year cumulative incidence of more than 40% in studies of college women in the United States, and an estimated lifetime risk for women of at least 75% for one or more genital HPV infections.
Due to the relatively common incidence of infection and the resulting cancer deaths a prophylactic vaccination is a viable and cost effective measure to reduce incidence of morbidity and mortality as well as community cost of treatment for this group of diseases. It is also important to note that while the quadrivalent vaccination does effectively stop infection from these four types of HPV it does not provide protection from all known HPV viruses and therefore regular recommended screening utilizing PAP exams and other screening elements is still recommended even for those vaccinated with Gardasil.
If duration of immunity is substantial or can be extended adequately through booster vaccinations, the high vaccine efficacy observed in Phase II and III studies suggests that female populations receiving prophylactic immunization will experience a reduction in the morbidity and mortality associated with HPV-related anogenital diseases. The promise of prophylactic vaccines from a broad public health perspective, however, can be realized only if vaccination can be achieved for those groups of women for whom access to cervical cancer screening services is most problematic. The protective effect of vaccination that is successfully provided to adolescent and young women who are unlikely to undergo regular Pap screening will be of greater magnitude than that provided to women who will undergo regular screening regardless. Even as HPV vaccination for the prevention of cervical cancer is introduced and promoted, it remains critical that women undergo regular screening regardless of whether they have been vaccinated.
As the potential positive effects in prevention of this classification of diseases is significant the recommendations of the federal and state agencies should be heeded, regardless of the long-term nature of eventual outcomes. Additionally, due to the nature of the concern, the scope of which is significant with a high incidence of infection that is not effectively avoided with traditional barrier methods of STD and pregnancy protection, such as condoms, these recommendations should be heeded by the community.
At least one state has taken steps to mandate the utilization of the vaccination and though there is a great deal of controversy associated with this move, Texas is implementing a mandate of the immunization for all sixth grade girls by 2008. The reasons for this are many, and far reaching as the effectiveness of the vaccination is statistically significant with reported protection in the 100% range in the studies conducted thus far.
Discussion/Recommendations for Further Study:
Though the initial results of research have been extremely promising with regard to vaccination there are several areas of needs associated with the treatment plan for any individual woman, including the education of the continued need for routine screening for cervical cancer, as the HPV vaccinations available today do not prevent all types of HPV or all related and non-related incidence of cancer. In consideration must be an emphasis of the need to not obtain a false sense of security after vaccination that results in stopping of routine gynecological exams and PAP testing. Additionally, some parents are concerned with the administration of the vaccination to young girls, as they see the potential for early entrance into sexual activity as a possible outcome, though most scientists disagree, it is still a topic for ethical debate as many parents do not even like the idea of thinking of their 9- to 12-year-old girls as potentially sexual active. Another potential concern is cost as the per shot administration of the current FDA approved shot can be as high as $220 dollars and with three to be administered there is concern about its affordability. It is also likely that many insurance companies will not cover the medication or its administration without it being mandated and that the burden to taxpayers would be initially large if it was offered as a routine immunization, in company with those that are already required, but there is no question that the immunization will prevent infections, and reduce long-term burden associated with treatment for these strains of the HPV virus as well as reduce cancer deaths among women.
Mandating immunization, may seem extreme but in Solano County the recommendation to do so is well founded, as the long-term benefit, is great and risks are minimal, though many questions are still left to be answered, the more widespread the utilization of the immunization the greater the total potential for effect.
Further research will be required, in long-term studies to determine the long-term efficacy of the vaccination as well as the length of protection it offers, to determine the need for boosters. Cost will likely be a significant barrier to the wide spread implementation of the immunization mandates and there is a disproportionate representation of need for immunization in economically stable areas, where routine screening for cervical cancer is already prevalent, making it most important to reach disenfranchised groups both in the U.S. And worldwide, but especially racial minorities. Future research will likely be the best possible answer to the questions, on an ethical, biological level and there is a fruitful opportunity here for research and potential social and systems benefits.
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Lowy & Schiller,…