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).
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.