BC to offer free HPV vaccine to girls born between 1991-1993 starting in April 2012

From ImmunizeBC for Immediate Release

HPV VACCINE ONE-TIME PROGRAM FOR YOUNG WOMEN
QUESTIONS AND ANSWERS FOR IMMUNIZATION SERVICE PROVIDERS

March 12, 2012 – HPV Vaccine One-Time Vaccine Program for Women Ages 19, 20 and 21

British Columbia (BC) is launching a time limited program of free HPV vaccination for young women turning 19, 20 and 21 years old in 2012, who were born in 1991, 1992, and 1993, the three years prior to the age of the oldest cohort of girls offered the vaccine in BC schools. This program for the prevention of cervical cancer is in addition to the school-based offering of HPV vaccine since September 2008, through which girls in grades 6 through 12 are eligible.

Below are Questions and Answers to assist public health and community vaccine providers in answering questions about the program.

1. Why is this program one-time program being offered?

This program is being offered because the BC Communicable Disease Policy Advisory Committee chaired by Dr. Perry Kendall, the Provincial Health Officer determined after thorough review of the evidence that HPV vaccine is cost-effective in preventing precancerous changes and cancer of the cervix caused by HPV 16 & 18 in women until about 25 years of age.

The vaccine is preventive, and does not clear already established HPV infection. Because HPV is sexually transmitted and is a common infection, the vaccine is most beneficial to use prior to onset of sexual activity. However, young women, even those who are sexually active, are unlikely to have been infected with both of the strains of HPV associated with cervical cancer, types 16 and 18, and will benefit from vaccination.

2. Why is the program being offered on a time limited basis?

The vaccine program is being launched with available one-time funding. The vaccine has been purchased by BCCDC and will begin distribution in March 2012. All vaccine for this program has a long shelf life with an expiry date in 2015. However it is expected that most or all of the vaccine will be used within a year of its distribution.

3. How much vaccine will be made available?

The quantity of vaccine purchased is enough to provide for the anticipated demand in the age group of 19-21 year old women with the complete 3-dose series of vaccine. Vaccine uptake will be closely monitored.

4. Which vaccine will be used for the program, and how was this decided?

Cervarix™ (GlaxoSmithKline Inc.) will be used for the one-time program. Vaccine for the one time program was purchased through a competitive tender issued in January 2012.

In its updated statement on HPV vaccines published in January 2012, the National Advisory Committee on Immunization (NACI) concluded that the bivalent vaccine Cervarix™ and the quadrivalent vaccine Gardasil™ (Merck Canada Inc., provide comparable and very high levels of protection against cancer of the cervix due to HPV types 16 and 18 as well as precancerous changes to the cervix. HPV types 16 and 18 account for about 70% of cancer of the cervix. Gardasil™ also provides protection against HPV types 6 and 11, which cause about 90% of genital warts.

5. Should the vaccine be offered to any young woman of this age group?

Yes, any young woman born in 1991, 1992 and 1993 without contraindication to receipt of the vaccine should be offered the vaccine unless she has had 3 doses (a complete series) of either HPV vaccine in the past. Clinical guidelines for the use of the vaccine will be issued in the CD Control Manual, Chapter 2, Immunization, Section VII, Biological Products, posted at http://www.bccdc.ca/dis-cond/comm-manual/CDManualChap2.htm Additional Qs and As related to clinical use will be posted at http://immunizebc.ca/healthcare-professionals

6. Which providers will offer immunization services, and when will the vaccine be available to them?

The vaccine will be distributed to health authorities starting March 2012 and will be available for these women beginning mid-April.

Health authorities will distribute the vaccine to physicians, sexual health and youth clinics, college/ university student health services, and other appropriate immunization service provider settings.

Pharmacists authorized to immunize will also be able to order the vaccine beginning April 9th. All pharmacies located in Vancouver Coastal Health Authority including Sunshine Coast and Howe Sound will order from their local health unit. In other areas, big chain (see below) pharmacies will order from McKesson Canada (Coquitlam) while independent, PharmaSave and Peoples pharmacies will order from the local health unit.
Big chain pharmacies ordering from McKesson include: Costco, Loblaws, London Drugs, Medicine Shoppe, Overwaitea, Paragon, Rexall, Safeway, Shoppers, Wal-Mart, and Zellers.

Vaccination services will be available through these providers as well as through most local health units. Immunization services will begin to be offered in mid-April with some providers starting ahead of others. A vaccine locator will be available online at www.immunizebc.ca to help women find out where they can get the vaccine.

7. How is the vaccine administered, and what is the recommended schedule?

The vaccine is given intramuscularly in the deltoid (upper arm). The recommended schedule is 3 doses, with the second dose given 1 month after the first, and the 3rd dose given 6 months after the first dose. If a series is interrupted and the time between doses is longer than recommended, it does not need to be restarted, and the next dose should be given at the intervals outlined above (1 month between 1st and 2nd dose, and 5 months between 2nd and 3rd dose). There are no recommendations for booster doses at this time.

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8. Do young women need to return to the same immunization service provider for all three doses?

Young women should be encouraged to return to the same provider for series completion. This will allow providers to better forecast their vaccine requirements. However, this will not be possible in all circumstances and the series may be completed with another immunization service provider.

9. What if the free vaccine is no longer available when the young woman presents for her 1st or subsequent doses?

At this time, this is a one-time program with a finite quantity of vaccine based on anticipated demand for this program. The National Advisory Committee on Immunization recommends that the all three doses in an HPV vaccine series be completed with the same vaccine. Cervarix™ is commercially available for purchase and costs about $100/ dose. Patients should check with their drug plans to determine if the cost of this vaccine is covered.

10. What if a young woman aged 19-21 has already started on a series of HPV vaccine but has not completed it when she presents for Cervarix™?

A completed 3 dose series is expected to provide protection against HPV types 16 and 18, regardless of the HPV vaccine(s) used. Young women who started on Gardasil™ but wish to complete the series with Cervarix™ under this program may do so as long as they are aware that a series of fewer than 3 doses of the type 6 and 11 containing vaccine (Gardasil™) may not provide complete protection against these two strains which cause about 90% of genital warts. If they wish such protection, they should complete the series with Gardasil™.

The 2-dose series of Gardasil™ being offered in BC to girls in the grade 6 program is not recommended for use at older ages for either vaccine. As well, at present it is anticipated that such girls may be offered a 3rd dose in grade 11 pending data on duration of the immune response.

11. Why and how should providers and women who receive the HPV vaccine record the receipt of the doses?

All providers must maintain a clinical record of the immunization service, as required by their professional practice standards. A personal record of immunization should also be provided to the recipient containing the vaccine and product name and date of each dose received. As well, either the provider or the young woman herself should submit the record of immunization for entry into the immunization registry, where it will be maintained electronically long term and can be linked to clinical service provision in the future. Pap smear recommendations have not yet changed in relation to HPV vaccine receipt, but it is expected that the receipt of vaccine will have implications for interpretation and management of Pap smear results in future years. Therefore entry of the record into the immunization registry is important for clinical management. As well, if a vaccine recipient loses their paper record, and that record has been entered into the immunization registry, it can be retrieved by contacting the local health unit.

Young women should be encouraged to submit the date of receipt of each dose along with their personal identifiers to the registry online at www.immunizebc.ca This online process will be set up later in the spring of 2012, and will also send out reminders for the 2nd and 3rd doses. For those not wishing to use the online system a paper form may be completed and sent to BCCDC by the provider by fax or email. This form will be distributed to vaccine providers and also available at www.immunizebc.ca

12. What else is being done to promote the use of this vaccine for this program?

There will be an immunization promotion campaign which will include posters and brochures, a social media component and possibly public transit advertising. The promotion campaign will likely not occur until after April.

13. Why is this program not being offered to boys?

A recommendation for publicly funded HPV vaccine for boys has not been made in BC at this time. Only one of the two HPV vaccines is approved for use in males, and that is Gardasil™.

14. Where else can I find reliable information about this vaccine and about HPV vaccination in general?

Lots of good information is available through the following web sites:

• BC HPV vaccine educational materials www.immunizebc.ca or http://immunizebc.ca/diseases-vaccinations/hpv
• The January 2012 NACI statement is available at http://www.phac-aspc.gc.ca/naci-ccni/index-eng.php#rec
• Public Health Agency of Canada HPV vaccine information: http://www.phac-aspc.gc.ca/std-mts/hpv-vph/fact-faits-vacc-eng.php
• Information from GlaxoSmithKline Inc. about Cervarix: http://cervarix.ca/