No 24/25-2019

HPV vaccination for boys

Vaccination against human papillomavirus (HPV) was introduced to the Danish childhood vaccination programme in January 2009 as an offer to girls from they turn 12 years old, EPI-NEWS 35/08, and until they turn 18 years old, EPI NEWS 1-2/14.

An HPV vaccination offer for boys is expected to come into force on 1 July 2019 as decided in the Danish Parliament (Folketinget) as part of the 2019 Public Finance Act. Free vaccination is offered to boys who turn 12 years old on 1 July 2019 or later, and the offer is maintained until they turn 18 years old. HPV vaccination protects boys against anal cancer and genital warts.

For the offer to come into force, a decision is required that will be implemented via an executive order from the upcoming Danish government and pending agreement on the fee to be signed by the General Practitioner’s Association and the Regional Wages and Fees Committee.

The vaccination programme

Boys are vaccinated with Gardasil®9 in a two-dose schedule as are girls; for further information, please see this illustration. Boys receive their first vaccination when they turn 12 years old and the second no sooner than at least 5 months thereafter. The vaccination series must be concluded within 13 months. If these intervals are not observed, a total of three doses are to be given.
Girls who are immunosuppressed at the time of vaccination are recommended a 3-dose schedule.

Service codes

As is the case for girls, it is expected that doctors may use service code 8328 for the 2-3 vaccinations given to boys from they turn 12 years old to their 18th birthday. The service code is used for settlement with the region, but does not free the physician of the duty to notify the vaccination to the Danish Vaccination Register.
Vaccination may be performed by a doctor authorised to practice medicine in Denmark or it may be delegated by such doctor to other healthcare staff.

The HPV vaccine and injection

The vaccine contains virus-like protein particles (VLP) that act as an antigen and are capable of activating the immune system, thereby forming antibodies. By including several different VLPs, vaccines may be produced that trigger antibody formation that targets specific types of HPV virus. Furthermore, the virus-like particles do not contain DNA, and they are therefore incapable of being transmitted and of dividing or causing infection. Gardasil®9 includes protection against the HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58. The virus-like particles are produced in yeast cells using recombinant DNA technology and the excipient aluminum hydroxyphosphate-sulfate adjuvant (0.5 milligram AI).

The vaccine should be shaken vigorously before use. At delivery, the vaccine may appear as a clear liquid with a white precipitation. After thorough agitation, the vaccine becomes a cloudy, white liquid.

The vaccine is given intramuscularly. The preferred site is the deltoid area of the upper arm, but the vaccine may also be given in the higher anterolateral area of the thigh.
Further information on the HPV vaccine is available here.

Side effects

Reactions at the injection site and influenza-like symptoms like headache, fever, fatigue, pain, vertigo and nausea are the most frequently occurring adverse effects. The reactions are generally mild and transient.

The summary of product characteristics describes the following side effects, recorded in clinical trials:

Very common

(may affect more than 1 in 10 people): side effects found at the injection site (pain, swelling, and redness) and headache.

Common

(may affect between 1 in 10 and 1 in 100 people): side effects found at the injection site (bruising, and itching), fever, tiredness, dizziness and nausea.

Furthermore, allergic reactions and other side effects have been reported after the product was brought to market. Read more about reporting of side effects further down the page.

Read the full package leaflet here

Like several of the other vaccines in the childhood vaccination programme, Gardasil®9 contains an aluminum adjuvant excipient that increases the effectiveness of the vaccine. The excipient increases the risk of a local reaction at the injection site in the form of, e.g., soreness, swelling and redness.

HPV vaccination must be postponed in patients with acute conditions causing a high fever. An ordinary cold with a low fever is not a contraindication and should not postpone vaccination.

Post-vaccination protection

Protection after Gardasil®9 vaccination adds to available knowledge about protection following vaccination with Gardasil®.

Gardasil® contains the HPV types 6, 11, 16 and 18, and has been shown to protect young men aged 16-26 years against persistent HPV infection, genital warts and precursors of anal cancer caused by the HPV types 6, 11, 16 and 18. Studies performed to establish the effect of Gardasil®9 have shown that the antibody level against the types 6, 11, 16 and 18 are on a par with the levels observed for Gardasil®, and a robust immune response was observed for the types 31, 33, 45, 52 and 58. It is continuously being tested if antibodies against the HPV types that form part of Gardasil®9 are persistent and if they prevent the development of cellular changes caused by the HPV types that are included in the vaccine. Preliminary results after 6 years of follow-up on Gardasil®9 in girls show that the vast majority are still protected against the nine HPV types, and the effect is expected to be prolonged. Both the issue of the full duration of the protection and the need for a booster vaccination are continuously being studied.

The HPV vaccine protects only against conditions caused by the nine HPV types included in the vaccine. Relevant preventive measures against other sexually transmitted diseases must therefore also be used after vaccination.

The HPV vaccine is not indicated for treatment of cancer, dysplastic lesions or venereal warts.

Reporting of side effects

On 1 September 2019, when Gardasil®9 vaccination will be offered for boys, it will reappear on the list of drugs covered by an enhanced duty of notification of any presumed adverse effects.

Therefore, all presumed adverse effects of the vaccine must be reported by physicians to the Danish Medicines Agency.

The current list of drugs covered by an enhanced duty of notification can be seen here.

The Danish Medicines Agency also encourages other healthcare workers as well as the vacinees and their relatives to report any presumed adverse effects to the Danish Medicines Agency. When notifying, it is important to specify the vaccine’s batch number, if possible. 

Adverse effects may be reported to the Danish Medicines Agency at: www.meldenbivirkning.dk

Ordering Gardasil®9

Gardasil®9 is delivered as 10x1 doses and may be ordered using item number 99204 on Form 6 or at ordre@ssi.dk.

Registration in the Danish Vaccination Register

All vaccinations, including Gardasil®9, shall be registered in the Danish Vaccination Register in pursuance of Executive Order on Access to and Registration etc. of Medicinal Product and Vaccination Information.

Commentary

All EU/EEA countries have now introduced HPV vaccination for girls; and various countries (22% of the EU/EEA countries), including Austria, Croatia, Norway, the Czech Republic, Germany, Italy, Liechtenstein and Great Britain, have introduced or are planning to introduce an HPV vaccination offer for boys. Furthermore, a recommendation from the Swedish health authorities recommends the introduction of HPV vaccination for boys.

In addition to the direct protection against anal cancer and genital warts, HPV vaccination of boys will increase direct protection of unvaccinated girls (herd immunity). In a period with low coverage among girls, vaccination of boys will contribute to maintaining herd immunity and thus add to the robustness of the vaccination programme. An enhanced herd immunity will also mean that a more rapid decrease will be observed in the occurrence of cervical cancer and other cancer types caused by HPV.

The group of boys who feel sexually attracted to other boys/men has not been comprised by the current herd immunity achieved through vaccination of girls, and direct protection of this group is important as this group carries a markedly higher risk of developing anal cancer due to HPV infection. HPV is a contributory cause of several cancer types, e.g., penile cancer, and mouth and throat cancer. Mouth and throat cancer is observed considerably more frequently in men than in women and follows an increasing trend. Studies have demonstrated that HPV vaccinees enjoy a lower occurrence of oral HPV infection. No scientific evidence exists that HPV vaccination has an effect on the prevention of penile cancer or precursors to the condition, or on mouth and throat cancer.

(P. Valentiner-Branth, P.H. Andersen, Department of Infectious Epidemiology and Prevention, B. Søborg, the Danish Health Authority)