Human Papilloma Virus Vaccine Human Papilloma Virus

Human Papilloma Virus Vaccine

Human Papilloma Virus

The paper deals with HPV epidemiology and associated diseases, the licensed HPV vaccines, recommendations of ACIP, concerns on mandating the HPV vaccine among young girls and the personal perspective on HPV vaccination issue. The Human Papilloma Virus infection is incredibly high and almost 80% of the population is expected to get infected with the virus at any stage of life. The virus is normally cleared by the immune system quite easily but persistent infection may lead to various types of cancers. Since the development of HPV vaccine, a lot of research, media coverage, and policies have been made to deal with. In U.S., only one-third of the pre-adolescent girls have acquired the three dose HPV vaccine. Thus, the question of its mandate arises. ACIP's provided recommendations are a big step towards the increased awareness and implementation of HPV vaccine program.

All the latest private insurance plans are required to implement ACIP recommended vaccinations under the Affordable Care Act.

The high risk and low risk HPV serotypes are prevented through vaccination against HPV. HPV 16 and 18 are responsible for 72% of anal cancers and 70% of cervical cancers. Low risk serotypes usually lead to genital warts. A number of other cancers can also be prevented from HPV vaccination like vulvar, oropharyngeal and penile cancers. HPV infection is most probably acquired through sexual intercourse and in lesser cases, through non-sexual means. There is no cure to the disease. Only the symptoms can be managed through several treatment strategies.

However, vaccination would be a suitable choice that could save millions of lives of women around the world and protect them from chronic infection. Parents are usually concerned about safety and other social issues related to their young girls. Thus, they may show reluctance towards getting their young girls vaccinated. Therefore, proper awareness should be provided in this regard which is even more important than mandating the vaccine.

Human Papilloma Virus

Human Papilloma Virus (HPV) is one of the most common sexually transmitted infections in the United States. Annually, approximately 6.2 million people get infected with the virus (Weinstock et al., 2000). Most of the HPV infections are asymptomatic and restrained but persistent infection can lead to cervical cancer in women (Castellsague, 2008). Other than that, papilloma warts and other types of cancers may also occur with an equal prevalence in both men and women. Nearly100 HPV serotypes have been discovered out of which 40 cause genital infections. The genital HPV serotypes are classified on the basis of their epidemiological relationship with cervical cancer. There are a few serotypes that are high risk and lead to cervical cancer such as HPV 16 and 18. Other than cervical cancers, various anogenital cancers like that of vulva, vagina, anus and penis may also be associated with HPV. All these types of cancers are rarer than cervical cancer. The HPV and anogenital cancer association is not well studied; however studies have proved that HPV is linked to oral cavity and pharyngeal cancers.

Gardasiltm is a quadrivalent HPV vaccine manufactured by Merck and Co., Inc. which prevents HPV infections from the serotypes 6,11,16,18. This vaccine was licensed in June 2006 for females between 9-26 years of old and was targeted to prevent vaccine HPV-type -- related cervical cancer and anogenital warts. The cervical cancer prevention and control programs operating in the United States have decreased the cervical cancer cases and deaths. It has been achieved through cervical cytology screening that can detect precancerous lesions or warts. The cervical cancer screening will still be required in the presence of quadrivalent HPV vaccine in the United States because this vaccine only prevents the infection by four HPV types. Other types of HPV cannot be prevented by it.

The HPV infection is acquired through genital contact which generally occurs during sexual intercourse. Other type of genital contacts like oral genital, manual-genital and genital-genital have also been studied in association with HPV infection but the most common is the sexual intercourse. Other risk factors for females include partner sexual behavior and immune status. The nonsexual routes may also lead to HPV infection like mother to fetal transmission (Centre for Disease Control and Prevention, 2007).

A study carried out in U.S. during 2004-2008 encompassed whole U.S. population and it was estimated that almost 33,000 HPV-associated cancers occur on annual basis. In females, the number of HPV-associated cancers per year is 21,300 while in males the number reaches to 12,000 annually. The most prevalent HPV associated cancer among women is cervical cancer while oropharyngeal cancers are more prevalent among men. The extent and stage of HPV associated cancers in the United States was estimated in the study through the examination of cancers in different body parts and cancer cell types associated with HPV. Generally, HPV is known to cause 90% of anal, 50% of vulvar, 35% of penile and 65% of vaginal cancers ("HPV-Associated Cancers Statistics," 2012).

The only way through which HPV can be prevented is to avoid all types of contacts with other persons like skin-skin, oral or genital. For sexually active individuals, a long-term monogamous relationship is the most suitable strategy to prevent HPV infection. However, being asymptomatic it is difficult to predict whether a sexually active person is infected with HPV in past (Division of STD Prevention, 1999).

It has been proved through research that appropriate and continuous use of condoms reduces the chances of HPV transmission between sexual partners. However, condoms do not provide complete protection as the areas that are not covered by condoms may get infected by the virus.

Both Gardasil and Cervarix have been approved by FDA for the prevention f HPV associated cancers like cervical, vaginal or vulvar. Furthermore, the precancerous lesions and genital warts can also be prevented. Both vaccines are efficient enough to prevent infections cause by HPV 16 and 18. However, for prevention of oropharyngeal cancers, these vaccines have not been approved.

Presently, there is no medical treatment available for HPV infections. However, precancerous lesions or genital warts acquired through HPV infection are treatable. The techniques available to treat precancerous cervical lesions include cryosurgery, surgical conization etc.

Other alternative options can be topical drugs, excisional surgery, laser surgery etc. The same treatment is given to HPV infected individuals that develop cancer as the patients having non-HPV tumors ("STD Treatment Guidelines," 2010).

HPV Vaccines

Merck and Co. Inc. was the first one to bring the vaccine in the U.S. market that prevents HPV infection. GlaxoSmithKline PLC (GSK) is also not lagging behind in this arena and has a similar efficacy to the Merck vaccine. As the HPV infection is affecting millions of people, the industrialists believe that the market for HPV vaccine will reach multi-billion Dollar range (Arvis, 2005).

Gardasil and Cervarix manufacured by Merck and GlaxoSmithKline Plc (GSK) respectively are the two U.S. approved vaccines to combat HPV infection. Both the vaccines protect against the HPV types 16 and 18 that account for 70% of the cases of cervical cancers. During the last year, Gardasil generated $1.2 billion in revenue while Cervarix was able to bring $812 million (Edney, 2012).

Merck's vaccine was brought to the market in 2006 while Glaxo's vaccine was approved in 2009. Both vaccines prevent the HPV strains that are associated with cancers of the anus, vulva, pharynx, vagina and cervix. The shots are recommended by U.S. For boys and girls of age 11-12. During 2010, one third of girls in the age group 13-17 were vaccinated. According to epidemiologists, a rate below 80% is required to reduce the HPV prevalence to a significant level (Pettypiece, 2013).

As per the recent data published in British Medical Journal, Gardasil is more cost effective than Cervarix. Cervarix has to be £19-£35 cheaper than Gardasil to be equally cost effective to its competitor. However, according to researchers from the Health Protection Agency, differential benefits of both the vaccines are not quite clear (World News, 2011).

Advisory Committee on Immunization Practices (ACIP)

The Advisory Committee on Immunization practices (ACIP) was developed under Section 222 of the Public Health Service Act. The committee is administrated by the provisions of the Federal Advisory Committee Act (Department of Health and Human Service, 2012).

The committee consists of 15 members including the Chair. The committee members and the Chair is selected by the Secretary, Human Health Services through approval by who that are knowledgeable in the fields of immunization practices and public health, who have expertise in vaccine use and use of other immune-biological agents in clinical practice. The committee comprises of people that are aware of the consumers' perspectives and social aspects of the immunization programs.

ACIP was established to assist states and their political subdivisions to prevent and control the communicable diseases. It could advise the state on issues related to the improvement and preservation of public health. It can make grants to states and can assist the states in overcoming the costs of communicable disease control programs in consultation with state health authorities.

The HPV work group of ACIP first met in 2004 to review the data associated with the quadrivalent vaccine. Monthly teleconferences and meetings were held by the workgroup thrice a year to review published as well as unpublished data related to HPV vaccine clinical trials along with data on efficacy, immunogenicity and safety of the vaccine. Moreover, data on HPV epidemiology, natural history and sexual behavior in the United States was also reviewed. Economic and cost effective analyses were carried out. During ACIP meetings in 2005 and 2006, presentation on these topics were held. The ACIP HPV vaccine group devised and discussed the recommendation options. The expert opinion of the workgroup for the recommendations was taken when there was a lack of evidence. The recommendations were approved in 2006 ACIP meeting.

For effective control of vaccine-preventable diseases among the population, ACIP provides advice and guidance to the Secretary (HHS) and Director (CDC) for the best selection of vaccines and related products. It may also provide advice for disease control for which a U.S. licensed vaccine is present. This guidance encompasses right use of vaccine and might include recommendations for administration of antibody preparations or anti-microbial therapy that prove effective for controlling the same disease. Unlicensed vaccines may be employed in some circumstances. For every vaccine being recommended, the committee shall review the population groups and circumstances under which the vaccine is recommended. Guidance is developed by the committee on correct route, vaccine dose and frequency of administration, relevant antibody or antimicrobial agent.

Recommendations on precautions and side effects related to the vaccines are also be provided by the committee. Consideration of population-based studies like risk, efficacy and cost, are included in the committee deliberations on appropriate vaccine use. As new information comes or the disease risk varies, the committee withdraws or modifies their recommendations related to the particular vaccine. The committee also provides recommendations regarding the general use of vaccines and antibodies as a category of biological agents. These recommendations govern factors like administration method, dose and dosage interval, adverse effects, storage, handling and special conditions or populations requiring modifications in recommendations. The committee also produces a periodical review and revises the list of vaccines aimed at children or adolescents who are eligible to get vaccination through Vaccines for Children Program (Department of Health and Human Service, 2012).

The Vaccines for Children (VFC) program is the supplier of vaccines to all states and territories. These vaccines are delivered to the children free of cost. This program provides all the vaccines recommended by ACIP. The program has reduced the vaccine prices to a great extent and it guarantees that all the states pay the same contract prices for the vaccines (Centre for Disease Control and Prevention, 2007).

State's Role

There is a great debate on whether girls should be vaccinated against Human Papilloma virus (HPV) that is the root cause of cervical cancer and genital warts. This sequence of events branched from the June 2006 ACIP recommendations on routine vaccination of girls in the age group 11-12. This vaccine is now recommended for males as well (National Conference of State Legislatures, 2009).

The Michigan Senate was the first one to introduce legislation for HPV vaccination for girls entering sixth grade. However, the law was not enacted. In late 2006, Ohio also recommended legislation but that also failed. Since 2006, legislation to make the vaccine mandatory, funding and educating the public about HPV vaccine was introduced by 41 states along with Washington D.C. Almost 21 states like Louisiana, Maryland, Minnesota, New York etc. have enacted legislation.

CDC announced in 2006 that The New Hampshire Health Department would provide the vaccine free of costs to girls less than 18 years of age. It was reported that the department distributed almost 14,000 doses in the state. The Governor of South Dakota also announced a relevant plan that incorporated $7.5 million in federal vaccine funds and $1.7 million from the state's general fund. About 20, 000 doses of vaccines were distributed. In 2007, Texas also enacted a mandate by executive order with some exceptions that vaccine be received by girls entering sixth grade.

The Virginia legislature also passed a school vaccine requirement in 2007. In the same year, almost 24 states and Washington introduced legislation to mandate the HPV vaccines for school. The bill was enacted later. California and Maryland were among those who withdrew their bills.

State

Legislations

Florida

SB116 demands from the Department of Health to adopt a rule for adding HPV to the list of communicable diseases having immunization recommendations, it requires that disease awareness and vaccine availability may be ensured by the schools to the parents and guardians of the school students. Died in committee in September, 2012).

Hawaii

HCR 71 would ask the Department of Health to make HPV vaccination accessible to the natives through the teen VAX program. It also urges the insurers to provide HPV immunization to female policy holders of the ages 11-26. The bill was deferred in committee in January, 2011.

Iowa

SSB 3097 will develop a study bill for HPV public awareness program and enable provisions of vaccinations and cervical cancer screenings through this program.

Kentucky

HR80 would persuade females aging 9-26 and males of the age group 11-26 to acquire HPV vaccinations and all citizens to get awareness related to HPV vaccination benefits. The bill was passed in February, 2012.

Table. Legislations introduced in 2011-2012 at the state level (National Conference of State Legislatures, 2009).

Reasons why HPV vaccination should be mandatory for young girls

HPV infection is the leading cause of cervical cancer. In 2007, some 11,150 cases of invasive cervical cancer were reported out which some 3670 were chronic (Tamaki, 2007).

Prevention is better than care. HPV vaccine can prevent the disease which is preferable to treating the disease. By vaccinating young adolescents, thousands of them will be saved from hospitalization, surgery or premature death. According to CDC, cost per life saved by vaccinating against high risk HPV types 16 and 18 is almost $25,000 which is reasonable if other preventive interventions are compared. For example, cost saved by hypertension screening in 40-year-old men is almost $28,000.

Safety is the main concern for the use of vaccine. The studies conducted on the Gardasil's safety have guaranteed that it is safe to use. There is no potentially infectious live virus or active viral DNA in the vaccine. Also, other Gardasil components are used in some other vaccines.