No 28-32 - 2014

Amendment of the HPV vaccination programme for 12- and 13-year-old girls

Vaccination against human papillomavirus (HPV) was included in 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.

Furthermore, HPV vaccination may still be provided for women from the 1993-1997 birth cohorts until the end of 2015.

Background for the amendment to the vaccination programme

To date, the HPV vaccination has been provided as a three-dose Gardasil® programme at day 0, at 2 months and at 6 months. This recommendation was based on reports that in 9-13-year-old girls this programme produced antibody levels that were not lower than those of young women aged 16-26, who received the same programme.

In the latter age-group, Gardasil® vaccination was shown to prevent the development of premalignant genital lesions, premalignant anal lesions, cancer of the cervix, anal cancer and genital warts related to specific types of HPV. A total of 70% of all cervical cancer cases are caused by HPV type 16 or 18, and 90% of all condyloma cases are caused by HPV type 6 or 11.

New research has demonstrated that, after three years of follow up, the antibody level after HPV vaccination was not lower in a two-dose programme with a 6-month interval between doses in 9-13-year-old girls than after a three-dose programme in young women aged 16-26 years.

In view of these results, the European Medicines Agency (EMEA) has approved Gardasil® in a two-dose programme given at day 0 and at 6 months in 9-13-year-olds. Correspondingly, the Danish Health and Medicines Authority has decided that Gardasil® may now be provided as a two-dose programme for girls under the childhood vaccination programme. This amendment took effect as of August 6 2014.

The vaccination programme

12-year-old girls who have not initiated Gardasil® vaccination shall therefore receive a two-dose vaccination programme. The normal service codes for the first HPV vaccination = 8328 and for the second HPV vaccination = 8329 are used.

The minimum interval separating the two doses is 6 months, and the vaccination series shall have been completed within a year. If these intervals are not observed, a total of three doses are to be given. In that case the minimum interval between the second and third dose is the usual 3 months. Girls who are immunosuppressed at the time of vaccination shall receive a three-dose programme.

Adaptation to the vaccination programme

1. Girls who have only received one dose of Gardasil® when aged 12-13 years.
If the girl has received her first dose before turning 14 years old, and less than one year has passed since the first dose, the vaccination series can be concluded as a two-dose programme.

2. Girls who have received two doses of Gardasil® at a minimum interval of 6 months and a maximum interval of 12 months and who received their first dose before turning 14 years old.
These girls should be considered to have concluded their vaccination.

All girls who had turned 14 years old at the first vaccination, or who do not fall into the two above-mentioned categories that can be adapted to the vaccination programme should be offered to conclude their vaccination as a three-dose programme.

Commentary

The effect of HPV vaccination is greater in girls who are not infected with HPV, and the Danish Health and Medicines Authority still recommends that girls be vaccinated as early as possible and prior to their sexual debut in order to achieve optimal protection against cervical cancer.

In the Danish childhood vaccination programme, HPV vaccination is scheduled for girls aged 12 years. However, the free vaccination offer under the childhood vaccination programme applies until the girls turn 18 years old.

There are no studies on the effect of a two-dose programme with Gardasil® beyond 3 years, but the effect is expected to be long-lasting.

The Danish Health and Medicines Authority is currently printing an updated information insert for the vaccination folder for parents. The updated insert replaces the previous insert and shall therefore be handed out to children who are vaccinated with the DTaP-IPV-Hib-HBV vaccine and to children who receive the HPV vaccine.

The updated printed inserts will be sent out with future vaccine orders from the SSI. Until the updated printed inserts have been received, a PDF file facilitating print out of the updated insert is available at these two links: 

Danish version 
English version
(Danish Health and Medicines Authority)

Link to previous issues of EPI-NEWS

6 August 2014