1. Group 3 – Michael, Elani, Golshan, Sarah, Joseph, Nana
The HPV Vaccine
To vaccinate or not to vaccinate...that is the question...
(technically that’s a statement)
Group 3 – Michael, Elani, Golshan, Sarah, Joseph, Nana

2. The Scenario
You are at your neighbour’s party one evening when he approaches you and asks for your opinion on something he read in the news. He has a 16 year old daughter who was told about ‘Gardasil®’ at school. He was reluctant to allow her to have it as he felt that it would only encourage sexual practice.After reading this article he is now concerned that his 19 year old son may be at risk and wonders if he should be getting everyone vaccinated.

3. The ABC News - Call to extend HPV vaccine to boys (by Lindy Kerin)
HPV virus → Cervical cancer in females → Oral cancer in younger males Currently subsidised for women. Should it be subsidised for men? Need to consider → Cost effectiveness → Sufficient evidence?
Oral cancer has traditionally been associated with smoking and drinking alcohol however in younger people it is associated with the HPV virus, as many as 50% of cancers are from this cause.
Professors state that we need to consider the cost effectiveness in males before mass distribution.
HPV = Human Papilloma Virus

4. Cancer, Warts and HPV in Men
Genital warts prevalence is highest among men aged between years and decrease with age
The HPV virus is responsible for:
And about 85% of anal canal cancer is caused by HPV.
About 33-72% of oropharyngeal cancers and 10% of cancers of the larynx are associated with HPV infection.
A recent report has stated that about 50.5% of men are positive for at least one known oncogenic or nononcogenic HPV type. HPV 16 appears to be the most common type detected.

5. Impact of HPV on Women
Almost 300 million women carry HPV DNA, one third carry HPV 16/18 (oncogenic) types. Cervical cancer accounts for 6% of all female malignancies worldwide. Show the second youtube clip from Joseph’s page (bottom). Increased risk of cervical disease in Females with HPV-infected male partners (1)(2)(3)
Reiter PL, McRee A-L, Gottlieb SL, Brewer NT. HPV vaccine for adolescent males: Acceptability to parents post-vaccine licensure. Vaccine. [doi: DOI: /j.vaccine ].In Press, Corrected Proof.
Bosch FX, Castellsague X, Munoz N, de Sanjose S, Ghaffari AM, Gonzalez LC, et al. Male sexual behavior and human papillomavirus DNA: key risk factors for cervical cancer in Spain. J Natl Cancer Inst 1996;88(15):1060–7.
Habel LA, Van Den Eeden SK, Sherman KJ, McKnight B, Stergachis A, Daling JR. Risk factors for incident and recurrent condylomata acuminata among women. A population-based study. Sex Transm Dis 1998;25(6):285–92.

6. Impact of HPV on Men Any strain of HPV – 65.4%
Oncogenic strains – 22.9%
To prevent:
HPV related anogenital head and neck cancers in males,
Male bisexual HPV related diseases
The viral transmissions both to males and females.
Evidence that as males’ get past their adolescent years and become older they are less likely to use the health care system in comparison to female adolescents
Male vaccination can be important for achieving the maximum prevention for both males and females, because currently not great rates of females actually complete their full vaccination course.
Prevalence in asymptomatic males in the US is over 20% (MS)
The major oncogenic subtypes HPV 16 and 18 cause most anal cancers, 25–35% of oral cancers and 40% of penile cancers (MS)
Non-oncogenic HPV 6 and 11 HPV cause genital warts
Use Elani’s first article. “Risk factors for anogenital human papillomavirus infection in men”
Use Golshan’s second article : “Epidemiology and pathology of HPV disease in males”
Use Elani’s article:
(MS) Michael’s article : Reiter PL, McRee A-L, Gottlieb SL, Brewer NT. HPV vaccine for adolescent males: Acceptability to parents post-vaccine licensure. Vaccine. [doi: DOI: /j.vaccine ].In Press, Corrected Proof.

7. What is the Vaccine? Gardasil® by Merck and Co. Inc
The quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine available under NIP for females aged 12–26 years.
Approved by (FDA) in 2006 (for use in 9–26 year old females)(MS)
Consists of three doses, intended to be given three months apart.
(MS) Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER, et al. Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007;56(RR-2):1–24.

8. Evidence for Use
Females United to Unilaterally Reduce Endo/Ecto-Cervical Cancer (FUTURE) Phase III trial of Gardasil® (safety and efficacy).
Randomised, double-blind, placebo controlled, trial with 3 years follow up in 5455 healthy women aged 16–24.
98% effective in preventing high grade lesions.
Some cross protection against other HPV types (52, 45, 31).
Long term safety and efficacy will require decades to establish.
The vaccine is intended as a prophylactic agent. Hence, its efficacy is most superior in younger women/men that have not been exposed to the virus strains.
(Joseph’s page, last article) called “Cervical cancer vaccination indications, efficacy, and side effects”

9. The Indication For the Vaccine
Subsidised for women <26 years. The vaccine is largely distributed to high schools.
Ineligible persons may pay $460 for the 3-dose course.
The vaccine received provision from the (US) Advisory Committee on Immunization Practices for men in October 2009 and full approval in May 2010 for males aged 9-26 for the prevention of genital warts, penile and anal cancer. (MS1, 2)
Similarly, there is recognition of the efficacy in males but no government subsidy in Australia for the vaccine.
NIP is the national immunisation program, where vaccines are subsidised by the government.
(MS1) Centers for Disease Control and Prevention. ACIP provisional recommendations for HPV vaccine; Available at: gov/vaccines/recs/provisional/downloads/hpv-vac-dec pdf.
(MS2) Centers for Disease Control and Prevention. FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP).MMWRMorb Mortal Wkly Rep 2010;59(20):630–2.

10. Factors Affecting Vaccine Acceptance
Side effects/tolerance Financial costs Urban Myths Less Awareness of the Condition in Males
Use Michael’s second reference "HPV vaccination for adolescent males: Acceptability to parents post-vaccine licensure“

11. Side Effects of the Vaccine
Anecdotal reports of
Guillain Barré syndrome
Facial palsy
These complications occurred in 5 people (of the ) that were given the vaccine concomitantly with another vaccine, namely the meningococcal vaccine.
Is there any information relating to how long you should wait before giving another vaccine?
The anecdotal reports sourced from Michael’s
The two tables were taken directly from the MIMS Online.

12. Financial Impact
Currently, the vaccine is only subsidised for women. US based Survey conducted on 406 women with adolescent sons “How willing would you be to get the HPV vaccine for your son if it was free?” (Yes = 47%) “How willing would you be to get the HPV vaccine for your son if it cost $400 out of pocket?” (Yes = 11%)
This graph is based on information collected through a survey of 406 women with adolescent sons. The survey was conducted in the US and so the price is based on the cost in American dollars but likewise, what is demonstrated is the difference between a subsidy and a private cost.
Wealthier families were more likely to accept the vaccine. The age of the child did not appear to influence acceptance.

13. HPV Vaccination Acceptance Amongst Males
Studies suggests that:
Male HPV vaccination is seen as acceptable to parents, adolescent and young adult males, and health care professionals (HCP).
To some parents it may be more acceptable vaccinating males than females.
HCPs showed interest to recommend HPV vaccine for their male patients
HPC generally preferred vaccinating females.
The females’ acceptance of HPV vaccination was higher than males.
A larger portion of males from the bisexual group expressed willingness to be vaccinated in comparison to the heterosexual group of males. Statistics to back this up? This sounds a little bit opinionative without stats.
NIP is the national immunisation program, where vaccines are subsidised by the government.
Use Michael’s NPS webpage and Golshan’s article “HPV vaccine and males: Issues and challenges”. Talk about how effective it prevents cancer in both males and females and what types of cancer it prevents.

14. Summary
Is this necessary?