Presentation on theme: "HPV Vaccine Introduction Demo Project in Zimbabwe Where Are We?"— Presentation transcript:
1 HPV Vaccine Introduction Demo Project in Zimbabwe Where Are We? By M.N Munyoro, WHO/ NPO/EPIPresentation to The Health Cluster12/11/13
2 Presentation OutlineLeading Causes of Cancer Morbidity and Mortality in the RegionCervical Cancer Disease BurdenBackground to HPV ApplicationAdvocacy Social Mobilization and CommunicationPreventionProposed Vaccination Strategy in ZimbabweHPV VaccinesLessons Learnt from Other countries and Way Forward
3 Cancer of the Cervix is an abnormal growth in the lower, narrow part of the womb 6 April, 2017The vast majority of cervical cancers are caused by:Infection with the Human Papilloma Virus (HPV)Risk factors include:SmokingImmunosuppression, e.g. HIV infectionUnhealthy diet (low in fruits/vegetables)Long term oral contraceptives useMultiple full term pregnanciesMultiple partnersCervical cancer is an abnormal growth in the lower, narrow part of the womb—known as the cervix. Almost all cervical cancers are caused by virus—known as human papilloma virus (HPV). HPV is a common virus that is passed from one person to another through sexual intercourse.Usually the body fights off the HPV infection—however, over time there are few instances whereby it evolves into cancer.
4 Natural History of HPV infection World Health OrganizationWorld Health Organization6 April 20176 April, 2017Natural History of HPV infection2° and 3° Intervention: Screening/ Treatment1°Intervention:HPV Vaccination2°Intervention:Screening/TreatmentImmuneAcuteinfectionChronicinfectionPrecancerous lesionSusceptibleCervicalcancerTimeframe following acute infection:2 years5-15 years20+ yearsTo consider comprehensive cervical cancer prevention and control, we need to briefly review the natural history of HPV infection.Unlike most of the diseases that infant vaccines prevent (for example measles or rotavirus diarrhea), cervical cancer is not an acute or quick disease – it is a chronic disease that takes years to develop. Let us take a look at the diagram on this slide, going from left to right. A person who is susceptible gets exposed to human papillomavirus and first develops an acute infection. Most people are exposed and get infected by HPV soon after becoming sexually active. There are some 90 or so different HPV types. A handful of HPV types cause cervical cancer. HPV types 16 and 18 cause around 70% of cervical cancers throughout the world. HPV infection with the cervical cancer causing HPV types is asymptomatic. Most women who get infected are able to resolve the infection and are then immune to the HPV type with which they were infected. But some women have HPV infections that persist; they are chronically infected. Chronic infection with HPV 16, 18 or one of the other cancerous types will lead to precancerous lesions in around 5-15 years. At this point, cervical cancer screening offers the ability to detect the lesion. If a precancerous lesion is identified during screening, it can be removed as an outpatient and no cancer will develop. However, if there is no intervention, the precancerous lesion will progress over the coming years to cervical cancer. In these later years, if screening takes place and cervical cancer is detected, early cervical cancer lesions can also be readily treated, while later and larger cervical cancer lesions are more difficult to treat. Women who are immunocompromised, such as those living with HIV infection, have faster progression from chronic infection to precancerous and cancerous lesions. The shorter time intervals are typical timeframes for women who have impaired immune systems, while the longer time intervals you see on this timeline are for women with normal immune systems.The 3 dotted lines on this figure depict the opportunities for prevention and control. HPV vaccination offers the earliest opportunity to prevent cervical cancer before a girl is even infected. The important message of this slide, however, is that cervical cancer is a slow disease over decades that is readily preventable – if options for prevention were in place, no woman should have to die of cervical cancer.Most HPV infections are asymptomatic>90% of new infections (including those with high risk types) clear or become undetectable within 2 yearsBut persistent infection with high risk types leads to cervical cancer4
5 The leading cause of cancer morbidity and mortality in this Region 6 April, 2017The leading cause of cancer morbidity and mortality in this RegionWorld-wide estimated 530,000 new cases of cervical cancer in 200814% of these occurred in AfricaOf all cancers, cervical cancer is the most common in Africa, followed by breast cancerThe death ratio in Africa is 67%, while it is 52% globallyMore than 85% of the global burden occurs in developing countries, where it accounts for 13% of all female cancers. Our region has the highest cervical cancer burden in the world with age-adjusted rates of above 30 per 100,000 in the Eastern and Western sub-regions and 26.8 per 100,000 and 23 per 100,000 for Southern Africa and Central Africa—respectively. In this region, two-thirds of women with cervical cancer die—with mortality: incidence ratio of 67%, which is the highest in all regions. In 2008, WHO estimated a total of 53,000 cervical cancer deaths in Africa.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)
10 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/Which age groups are most affected?-40 to 49 yearsWhat are the annual death rates from cervical cancer?- 33 /
11 Cervical Cancer in Zimbabwe According to records at Parirenyatwa radiotherapy centre where most of the patients are referred, cervical cancer burden increased almost 2 fold from to 2010
12 Background Information National Cancer Registry established in 1985HPV Vaccine Advocacy Group was formed in 2008.Zimbabwe-specific HPV vaccine guidelines formulated at the stakeholders workshop on 16th April 2009Guidelines based on the model HPV vaccine recommendations for sub-Saharan Africa by the sub- Saharan Africa cervical cancer working group expert panel year 2008
13 Background ContdHPV Vaccine Advocacy workshop with stakeholders was held in June 2009During the workshop, MoHCW re-affirmed its commitment to introduce HPV vaccine as part of the overall fight against cancer of the cervixHPV Vaccine introduction officially approved with HPV Vaccine Launch in October 2009.GSK paid for Vaccine Registration Dec 2009Vaccine registration 8 August 2012Cervarix launch, 31 October 2012
14 Events leading to HPV application March 2012 communication from GAVI advising interested countries to applyICC meeting convened to support the need to applyMinistry officials (NCD, CH, Reproductive Health) attended WHO supported regional meeting in SA on HPV Demo projects implementation- May 2012Application 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.
15 Events contd GAVI HPV vaccine demo application June 2012 October 2012 Zimbabwe submitted its first application which was not successful-GAVI requested for some clarificationsGAVI response required some clarifications centered on :- Need to involve Civic Organization GroupsNeed to detail how to reach the HPV vaccine target group bearing in mind that this group is outside the usual EPI target group
16 Events contd Clarifications submitted and HPV application approved GAVI HPV vaccine demo approval -June 2013MOHCC Strategic Advisory Group on HPV vaccine introduction was recently appointed by PSFirst SAG meeting on HPV Vaccine introduction convened.
17 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
18 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
19 The core of Cervical Cancer “Primary Prevention” is immunization of girls against HPV infection 6 April, 2017HPV vaccination:Girls age 9 – 13 yearsPriority given to areas with low access to cervical cancer screeningSo far Rwanda and Lesotho included it in national programsAbout 8 other countries in demo phaseOther interventions:Health information and warnings about tobacco useSexuality education tailored to age and cultureCondom promotion/provision for those sexually activeMale circumcisionCapeVerdeMauritiusSeychellesComorosNationwide introductionNot yet in country EPINot AFRDemonstration project in 20132 Countries wide introduction : Rwanda and Lesotho
20 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.
21 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
22 WHO Position Paper on HPV Vaccine - 2009 HPV vaccination should be introduced into national immunization programmeswhere prevention of cervical cancer and other HPV-related diseases is a public health priority andwhere 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.WHO’s position paper on HPV vaccine was published in WHO recommends that 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. Furthermore, WHO recommends that countries should prioritize achieving high coverage in the primary target population of 9 to 13 year old girls.
23 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.The position paper identifies 4 additional considerations for countries to address when making a decision to introduce HPV vaccination:The vaccine should be introduced as part of a coordinated strategy to prevent cervical cancer and other HPV-related disease.Countries introducing HPV vaccine should prioritize populations who are likely to have less access to cervical cancer screening later in life.Countries should seek opportunities to link vaccine delivery to other health services and programmes targeting young people.When funding HPV vaccine introduction, countries should not divert resources from effective cervical cancer screening programmes.
24 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 year old girls, is targeted.GAVI will support the purchase of the HPV vaccine and injection materials at a total cost of $ for two years and GOZ and partners will meet the remaining costs.
25 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
26 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.
27 World Health Organization 6 April 2017HPV VaccinesTwo vaccines currently available, widely licensed, and WHO prequalified:Cervarix® (bivalent): Prevents precancerous lesions from HPV types 16 and 18Gardasil®/Silgard® (quadrivalent): Prevents precancerous lesions from HPV types 16 and 18 and anogenital warts from HPV types 6 and 11Up 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 screeningBoth vaccines require 3 doses administered over 6 monthsBoth vaccines have excellent safety profiles
28 HPV Vaccines (continued) World Health Organization6 April 2017HPV 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 year old girls)For both vaccines, younger girls have higher immune responses than 15 to 26 year old femalesThere 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
29 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).
30 Way ForwardPreparations for HPV introduction have started and to be intensified as from 4th quarter 13Two demonstration project districts have been identified-Marondera and BeitbridgeNeed for TA (HQ,AFRO,IST) support in planning, implementation, monitoring and evaluation cannot be overemphasized
31 ConclusionSmooth implementation of the demonstration project will create a good environment for the national roll outInvolvement of the community based organisations will also enhance community ownership of the projectPartner collaboration in the process is of Paramount importanceAdvocacy and communication and social mobilisation activities also need to be emphasised before and during implementation