1 HPV Vaccine Extended Dosing Schedule for Grade 6 September 2010 Revised December 2010

2 HPV Vaccine Program Change: All girls receiving their first dose between the ages of 9-13 Grade 6 HPV Vaccine Program Schedule Changed Extended dosing schedule: 2 doses in grade 6, 3 rd dose in grade 11 Why is the program changing in this age group? Provides comparable protection in this age group due to their strong immune response.

3 Why the change? Who qualifies?

4 Why is the schedule changing? Newly introduced vaccine programs may change as additional evidence becomes available. Data from the BCCH affiliated Vaccine Evaluation Centre confirms that two doses of HPV vaccine are protective in this age group due to a strong immune response in girls years after two doses given at 0 & 6 months.

5 Who qualifies for new schedule? Girls who are receiving/ have received their first dose of HPV vaccine between the ages of 9-13 years.

6 Who qualifies for new schedule?

7 What about girls >13 years when commencing HPV vaccination? Girls who missed commencing the series between the ages of 9-13 years and who present later for vaccine should continue to be vaccinated on the 0, 2, and 6 month schedule.

8 Is the new grade 6 schedule “off- label” based on the current Gardasil product monograph? Yes it is. However, the BC Communicable Disease Policy Advisory Committee has reviewed the results at 24 months of a study of two doses given at 0 and 6 months to girls aged 9-13 years. The third dose is being planned to ensure sustained protection into sexually active years of life. This is a similar situation to the 2007 Pneumococcal Conjugate program schedule change from 2, 4, 6 & 12 months to 2, 4 & 12 months.

9 What about girls with impaired immune responses? Girls who are known to have immune system defects associated with solid organ transplant, stem cell transplant, or HIV infection and who are between 9-13 years should receive HPV vaccine in the three dose schedule at 0, 2 and 6 months. The immunosuppressed state results in a less robust immune response, and those with such conditions are at risk of persistent HPV infection and associated HPV disease if they become infected.

10 Are other jurisdictions using an extended HPV vaccine schedule? In Canada, Quebec has been using a 0, 6 & 60 month schedule in their grade 4 program since Around the world, many countries and agencies are investigating the use of altered or extended schedules.

11 School based program considerations:

12 What dose volume will be used in the grade six extended schedule? For all doses the volume remains 0.5mL.

13 Will HPV dose #2 timing coincide with the hepatitis B vaccine scheduling? Yes, in the school vaccination setting, these will both be offered six months after dose one.

14 What process will be in place to track girls for receipt of dose #3? All HPV vaccines given in schools are recorded by nurses in 2 steps: a) manually on consent forms b) in registries (iPHIS or PARIS). Registries allow the bringing forward of clients for doses for which they are eligible.

15 Are grade six consents being changed to reflect the new schedule? For the school year, grade 6 consent forms were sent out with a cover letter, explaining the schedule change. For the grade 6 school year, the provincial Informed Consent Working Group will revise the consent form to list only the 2 doses given in grade 6.

16 Will girls on the extended schedule need to be re-consented for the 3rd dose? Yes. Due to the long interval between the second and third dose, health authorities should plan to re-consent girls before their third dose. When the grade 11 program is conducted, the girls’ prior record in the immunization registry will be brought forward for review. As well, parents will be able to record previous HPV dose receipt on the consent form.

17 For more information: ImmunizeBC.ca