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By M.N Munyoro, WHO/ NPO/EPI Presentation to The Health Cluster

HPV Vaccine Introduction Demo Project in Zimbabwe Where Are We?. By M.N Munyoro, WHO/ NPO/EPI Presentation to The Health Cluster 12/11/13 . Presentation Outline.

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By M.N Munyoro, WHO/ NPO/EPI Presentation to The Health Cluster

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  1. HPV Vaccine Introduction Demo Project in Zimbabwe Where Are We? By M.N Munyoro, WHO/ NPO/EPI Presentation to The Health Cluster 12/11/13

  2. Presentation Outline • Leading Causes of Cancer Morbidity and Mortality in the Region • Cervical Cancer Disease Burden • Background to HPV Application • Advocacy Social Mobilization and Communication • Prevention • Proposed Vaccination Strategy in Zimbabwe • HPV Vaccines • Lessons Learnt from Other countries and Way Forward

  3. Cancer of the Cervix is an abnormal growth in the lower, narrow part of the womb • The vast majority of cervical cancers are caused by: • Infection with the Human Papilloma Virus (HPV) • Risk factors include: • Smoking • Immunosuppression, e.g. HIV infection • Unhealthy diet (low in fruits/vegetables) • Long term oral contraceptives use • Multiple full term pregnancies • Multiple partners

  4. Natural History of HPV infection Acute infection 2° and 3° Intervention: Screening/ Treatment 1°Intervention: HPV Vaccination 2°Intervention: Screening/Treatment Immune Chronic infection Precancerous lesion Cervical cancer Susceptible Timeframe following acute infection: 5-15 years 20+ years 2 years • Most HPV infections are asymptomatic • >90% of new infections (including those with high risk types) clear or become undetectable within 2 years • But persistent infection with high risk types leads to cervical cancer

  5. The leading cause of cancer morbidity and mortality in this Region • World-wide estimated 530,000 new cases of cervical cancer in 2008 • 14% of these occurred in Africa • Of all cancers, cervical cancer is the most common in Africa, followed by breast cancer • The death ratio in Africa is 67%, while it is 52% globally Globocan 2008: Factsheets

  6. Annual number of deaths from Caner of Cervix by age group, Globocan 2008

  7. High Cervical Cancer Disease Burden-Justification for HPV Application • In Zimbabwe Cervical Cancer remains the leading cause of morbidity among all the cancers. • In 2009 cervical cancers contributed to 19% (669 cases) of all new cancers and 13 % (134) of all cancer deaths.(Cancer Registry 2009)

  8. Cancer Incidence Zimbabwe,2010 Source: ZNCR

  9. Burden of Cervical Cancer Zimbabwe • How many cases are diagnosed each year? - Approx 1000 new cases / year (32% all cancers) • What is the incidence of disease? -ASR 47/100 000 • Which age groups are most affected? -40 to 49 years • What are the annual death rates from cervical cancer? - 33 / 100 000

  10. Cervical Cancer in Zimbabwe

  11. Background Information • National Cancer Registry established in 1985 • HPV Vaccine Advocacy Group was formed in 2008. • Zimbabwe-specific HPV vaccine guidelines formulated at the stakeholders workshop on 16th April 2009 • Guidelines based on the model HPV vaccine recommendations for sub-Saharan Africa by the sub-Saharan Africa cervical cancer working group expert panel year 2008

  12. BackgroundContd • HPV Vaccine Advocacy workshop with stakeholders was held in June 2009 • During the workshop, MoHCW re-affirmed its commitment to introduce HPV vaccine as part of the overall fight against cancer of the cervix • HPV Vaccine introduction officially approved with HPV Vaccine Launch in October 2009. • GSK paid for Vaccine Registration Dec 2009 • Vaccine registration 8 August 2012 • Cervarixlaunch, 31 October 2012

  13. Events leading to HPV application • March 2012 communication from GAVI advising interested countries to apply • ICC meeting convened to support the need to apply • Ministry officials (NCD, CH, Reproductive Health) attended WHO supported regional meeting in SA on HPV Demo projects implementation- May 2012 • Application process started with EPI team in the lead. (Team included CAH, RH,EPI MoHCW staff including HPO, EPI partners ,WHO,MCHIP, UNICEF,NCD officer). Ministry of Education was extensively consulted.

  14. Events contd • GAVI HPV vaccine demo application June 2012 • October 2012 Zimbabwe submitted its first application which was not successful-GAVI requested for some clarifications • GAVI response required some clarifications centered on : - Need to involve Civic Organization Groups • Need to detail how to reach the HPV vaccine target group bearing in mind that this group is outside the usual EPI target group

  15. Events contd • Clarifications submitted and HPV application approved • GAVI HPV vaccine demo approval -June 2013 • MOHCC Strategic Advisory Group on HPV vaccine introduction was recently appointed by PS • First SAG meeting on HPV Vaccine introduction convened.

  16. Advocacy Social Mobilization and communication • ACS to be carried out among key community opinion leaders for acceptance of the new vaccine. • The sero-prevalence of HIV/AIDS is high in Zimbabwe, among which 60% are women. Cervical cancer is more prevalent in immuno suppressed HIV positive women and progresses faster in these women

  17. Advocacy Social Mobilization and communication: • Questions likely to arise from the community in relation to the HPV vaccination : -Why give HPV vaccine to 10 year olds only? -Why not give HPV to Boys? -Why not give HPV to Women -Why in two Districts only

  18. The core of Cervical Cancer “Primary Prevention” is immunization of girls against HPV infection • HPV vaccination: • Girls age 9 – 13 years • Priority given to areas with low access to cervical cancer screening • So far Rwanda and Lesotho included it in national programs • About 8 other countries in demo phase • Other interventions: • Health information and warnings about tobacco use • Sexuality education tailored to age and culture • Condom promotion/provision for those sexually active • Male circumcision Cape Verde Seychelles Comoros Mauritius 2 Countries wide introduction : Rwanda and Lesotho Nationwide introduction Demonstration project in 2013 Not yet in country EPI Not AFR

  19. Secondary prevention Entails screening & early diagnosis • Currently the best chance of saving lives. • Traditionally cervical cytology (Pap smear) is known to have reduced incidence in developed countries. • Visual inspection with acetic acid or iodine is better alternative in this region followed by cryotherapy.

  20. Secondary Prevention contd • HPV testing for high risk HPV type (e.g. HPV 16; 18 and others) is available in the Region. • 15% of countries in the Region have capacity to conduct Acetic acid visualization whilst 25% have capacity to carry out Cervical cytology

  21. WHO Position Paper on HPV Vaccine - 2009 • HPV vaccination should be introduced into national immunization programmes • where prevention of cervical cancer and other HPV-related diseases is a public health priority and • where vaccine introduction is programmatically feasible and financially sustainable. • Countries should prioritize achieving high coverage in the primary target population of 9 to 13 year old girls.

  22. WHO Position Paper on HPV Vaccine (2009) Other considerations for HPV vaccination: • Introduce as part of a coordinated strategy to prevent cervical cancer and other HPV-related disease. • Prioritize populations who are likely to have less access to cervical cancer screening later in life. • Seek opportunities to link vaccine delivery to other health services and programmes targeting young people. • Do not divert resources from effective cervical cancer screening programmes.

  23. Proposed Vaccination Strategy in Zimbabwe • In view of the age of girls in and out of school in Zimbabwe, a mixed strategy (school-based, health facility-based and outreach) approach. • A total of 4 441 10 year old girls, is targeted. • GAVI will support the purchase of the HPV vaccine and injection materials at a total cost of $159 500 for two years and GOZ and partners will meet the remaining costs.

  24. Vaccination strategy Contd • Each child will be expected to receive 3 doses for full protection; -First dose to be given in April 2014 then ---second dose in May 2014 - 3rd dose in October 2014. • Demonstration project will be followed up with a national roll out of HPV

  25. Vaccination Strategy Contd • Cervical Cancer screening services are currently in the urban setting in both private and public health sector which marginalizes the rural women. • Plans are in place to roll-out cervical cancer screening and treatment services to provincial and district hospitals which to a larger extent are made up of rural populations.

  26. HPV Vaccines • Two vaccines currently available, widely licensed, and WHO prequalified: • Cervarix® (bivalent): Prevents precancerous lesions from HPV types 16 and 18 • Gardasil®/Silgard® (quadrivalent): Prevents precancerous lesions from HPV types 16 and 18 and anogenital warts from HPV types 6 and 11 • Up to 30% of all cervical cancer cases caused by HPV types other than 16 and 18, so these vaccines do not eliminate -need for future cervical cancer screening • Both vaccines require 3 doses administered over 6 months • Both vaccines have excellent safety profiles

  27. HPV Vaccines(continued) • Both vaccines demonstrate best efficacy in individuals HPV-naïve to the vaccine types so best to vaccinate girls prior to initiation of sexual activity (target is 9-13 year old girls) • For both vaccines, younger girls have higher immune responses than 15 to 26 year old females • There is no evidence of waning protection over time for either vaccine (post-vaccination follow-up period exists up to 9 years) • Small studies in HIV-infected persons show that HPV vaccine is safe and immunogenic but duration of protection is unknown

  28. Some lessons from countries who have introduced HPV(Tanzania) • Adequate sensitisation, to inform the public and to dispel rumours. • Improved and timely school record keeping. • Adequate training and resources for health workers (including vaccine cold storage).

  29. Way Forward • Preparations for HPV introduction have started and to be intensified as from 4th quarter 13 • Two demonstration project districts have been identified-Marondera and Beitbridge • Need for TA (HQ,AFRO,IST) support in planning, implementation, monitoring and evaluation cannot be overemphasized

  30. Conclusion • Smooth implementation of the demonstration project will create a good environment for the national roll out • Involvement of the community based organisations will also enhance community ownership of the project • Partner collaboration in the process is of Paramount importance • Advocacy and communication and social mobilisation activities also need to be emphasised before and during implementation

  31. THANK YOU , TATENDA, SIYABONGA

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