FACT SHEETNATIONAL IMMUNISATION PROGRAM –HPV VACCINATION FOR BOYSHuman papillomavirus (HPV) is a highly contagious virus which is transmitted via sexual contact.Most people become infected upon becoming sexually active. Around 80% of people are infectedwith at least one genital type of HPV at some stage in their life. HPV can cause genital warts andcertain cancers (and their precursors) in both women and men.Human papillomavirus (HPV)There are 40 distinct HPV genotypes that affect the genital tract; of these 15 genotypes aredesignated as ‘high risk’. High-risk genital HPV genotypes are causally associated with thedevelopment of cervical cancer, a spectrum of other anogenital diseases, including vulva, vaginal,penile, and anal cancers, and their precursors (anal intraepithelial neoplasia (AIN) and cervicalintraepithelial neoplasia (CIN)) and with extragenital diseases, including squamous cell carcinomasof the head and neck. HPV genotypes 16 and 18 are the causative agents in 70-80% of all cervicalcancers.HPV genotypes 6 and 11 are among the HPV genotypes designated as ‘low-risk’ (for cancer) andare associated with 90% of genital warts and 100% of recurrent respiratory papillomatosis (RRP)cases (warty growths in the upper airway which may cause significant airway obstruction or voicechange).Source: Australian Immunisation Handbook 9th edition 2008The HPV vaccine, Gardasil� is highly efficacious in providing protection against four HPVgenotypes (6, 11, 16 and 18) associated with genital warts; precancerous lesions (anal intraepithelialneoplasia (AIN)); and cervical, anal, oropharyngeal, penile, and perineal cancers.Vaccinating boys against HPV infection will complement the current vaccination program for girlsthat was introduced in 2007; extending the program to boys will increase herd immunity and provideindirect protection to the 28% of girls who are estimated to be not fully vaccinated1.HPV 16 is the predominant HPV type seen in male cancers; HPV 18 has a lesser role. Together, thesetypes around for around 90% of all HPV attributable cancers in males.The vaccine is most effective when the primary course is completed before a person’s first sexualcontact and exposure to HPV. Long-term follow up studies have demonstrated that at 8.5 years thevaccine remains highly immunogenic and efficacious with no disease reported in the vaccinatedgroup2.Herd immunityHigh immunisation coverage rates limit the spread of a disease among a population, reducing therisk that non immune people (ie, those people who have not been vaccinated and those whowere vaccinated but whose immune systems did not respond to the vaccine) will becomeinfected.

additional 24% of new HPV infections will be avoided with a male vaccination program that achievessimilar coverage in men to that achieved in women3.This approach is consistent with the provision of funding to vaccinate boys against rubella (Germanmeasles) as well as girls to prevent congenital rubella syndrome (which can include severe heartdisorders, blindness, deafness, or other life threatening organ disorders and spontaneous abortion).In the early 1940s, an Australian ophthalmologist, Norman Gregg, discovered the association betweenrubella infection in pregnancy and a pattern of congenital birth defects. In the early 1990s there wererubella epidemics through Australia with more than 5,000 notifications during 1995. The introductionof the measles-mumps-rubella (MMR) vaccine in 1993 ensured that boys as well as girls received thevaccine. Between 1999 and 2009 there were 10 notifications of congenital rubella syndrome reportedin Australia, with the last case reported in 2007.A recent analysis of national sentinel surveillance data4collected during the period January 2004(prior to the introduction of the HPV vaccination program for girls which commenced in 2007) andDecember 2009 has shown a decrease of around 59% in frequency of genital warts in youngAustralian women and 28% decrease in heterosexual men, more pronounced in younger menindicating HPV vaccination is providing protective effects in heterosexual men through herdimmunity. These results are very promising given that surveillance was undertaken only 2 yearsfollowing the introduction of the HPV immunisation program. Further significant reduction in wartsprevalence could be expected if more boys were vaccinated.In the absence of a HPV vaccination program for males, men who exclusively have sex with men(MSM) would not be protected as they are exposed to other unvaccinated men.HPV infection and disease in womenThe peak prevalence of HPV infection in women is seen in adults younger than 25 years of age, ingeneral after sexual activity begins2.There is no screening test to check for overall ‘HPV’ status. The only available screening for HPVrelated cancer is the Pap test which is available to women through the National Cervical ScreeningProgram which screens for cervical lesions that can lead to cervical cancer.The progression from HPV infection to cervical cancer is well understood due to the availability ofcervical screening. While a HPV infection may result in low grade changes to the cervix and mayresolve itself, some infections of high risk HPV genotypes go on to become high grade lesions andover many years can develop into cervical cancer. Cervical screening aims to identify high gradelesions and remove them prior to cancer developing.While women have access to Pap tests to detect early changes which may lead to cervical cancer,similar screening tests are not available for the detection of other HPV cancers.The incidence of cervical cancer is three times higher in Aboriginal and Torres Strait Islander womenthan non-Indigenous women and the mortality rate is five times higher than in non-Indigenouswomen5. The proportion of Aboriginal and Torres Strait Islander women who are fully immunisedagainst HPV disease is likely to be less than non-Indigenous women.There is early evidence with the implementation of HPV vaccination in women that the rate of highgrade cervical lesions in women in the vaccinated age cohort has reduced.

HPV infection and disease in menKnowledge of the natural history of HPV infection and associated diseases in men is increasing, butremains less extensive than that for women. As in women, most HPV infections in men are transient,asymptomatic, and resolve spontaneously. The progression from AIN to anal cancer in men(and women) is expected to be similar to the progression from HPV infection to CIN to cervicalcancer. In men HPV infection is evident at all ages and the risk of acquiring new infections remainsstable over time2.Cancer of the anus is rare. Australian data indicate that there were around 234 new cases in men andwomen per year in the period 1998-2002; 40% of cases were in men. The incidence of anal cancer hasbeen increasing in both men and women over the last 4 decades. Over the same period, there were347 new cases of penile cancer (around 69 new cases per year). In 2008, there were 2,076 new casesof oral cavity cancer (65%: 1344 in men). Of 390 deaths, 64% (250) were among men6.

At risk groups

Men who have sex with men (MSM)are likely to have the greatest benefit from the vaccine.An incidence of anal cancer of cancer in MSM is more than 30 times that that in other men.The incidence is particularly high with similar rates to that of cervical cancer prior to screening2.Unvaccinated women– an estimated 28% of women have not completed the full course of threedoses of HPV vaccine. Coverage of 72% is considered good both in international comparisonsand for a program delivered to adolescents in high schools given three doses are required.Women not participating in cervical screening– around 30% of women do not participateregularly in cervical screening in Australia.Aboriginal and Torres Strait Islander womenhave a higher incidence of cervical cancer thannon-Indigenous women and lower participation in cervical screening.

Safety of GardasilHPV vaccines have a good safety record. The US Institutes of Medicine has reviewed the evidencefor adverse events to common vaccines, including HPV vaccines. This reportAdverse Effects ofVaccines: evidence and Causality,published on 25 August 2011, identified that the only adverseevent for which there is evidence of a causal relationship with HPV vaccine is anaphylaxis.In September 2008, theJournal Multiple Sclerosispublished electronically an article by a group ofneurologists at St Vincent’s Hospital, Sydney, describing five patients who presented with multifocalor atypical symptoms of multiple sclerosis (MS) within 21 days of immunisation with Gardasil.Following these reports the Therapeutic Goods Administration established a Gardasil Expert Panel(GEP), chaired by Nobel Laureate Professor Peter Doherty, to evaluate the safety of Gardasil vaccine.The GEP found that the rate of anaphylaxis to be similar to that associated with other vaccines.The panel also found the incidence of demyelinating disorders including MS, following Gardasil to beno higher than would be expected by chance.An analysis of several clinical trials (cumulative enrolment of more than 29,000 men and women)identified that 40 deaths were reported in 29,323 individuals. The death rates were comparable tothose expected in healthy adolescent and adult populations and they were the same in the vaccine thecontrol arm7.In the UK a 14 year old girl died within hours of receiving an HPV vaccine. An autopsy laterattributed the death to an undiagnosed malignant tumour.Given the serious nature of these adverse events the program includes the establishment of anenhanced adverse event surveillance system in the program’s initial implementation so that theexpected high safety profile of the vaccine can be confirmed in practice.6