Download HPV Vaccine Introduction - Demo Project in Zim

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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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
Cancer of the Cervix is an abnormal growth in
the lower, narrow part of the womb
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The vast majority of cervical cancers are
caused by:
◦ Infection with the Human Papilloma Virus (HPV)
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Risk factors include:
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Smoking
Immunosuppression, e.g. HIV infection
Unhealthy diet (low in fruits/vegetables)
Long term oral contraceptives use
Multiple full term pregnancies
Multiple partners
Natural History of HPV infection
1°Intervention:
HPV Vaccination
Susceptible
2°Intervention:
Screening/Treatment
Immune
Acute
infection
Timeframe following acute infection:
Chronic
infection
2 years
Precancerous
lesion
5-15 years
2° and 3°
Intervention:
Screening/
Treatment
Cervical
cancer
20+ 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
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
Annual number of deaths from Caner of Cervix
by age group, Globocan 2008
High Cervical Cancer Disease BurdenJustification for HPV Application
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In Zimbabwe Cervical Cancer remains the leading
cause of morbidity among all the cancers.
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In 2009 cervical cancers contributed to 19% (669
cases) of all new cancers and 13 % (134) of all cancer
deaths.(Cancer Registry 2009)
Cancer Incidence Zimbabwe,2010
Source: ZNCR
Burden of Cervical Cancer Zimbabwe
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How many cases are diagnosed each year?
- Approx 1000 new cases / year (32% all cancers)
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What is the incidence of disease?
-ASR 47/100 000
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Which age groups are most affected?
-40 to 49 years
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What are the annual death rates from cervical
cancer?
- 33 / 100 000
Cervical Cancer in Zimbabwe
Total other cancers & Total cervical cancer cases by
year Parirenyatwa Hospital Radiotherapy
2000 to 2010 (unpublished)
1000
800
600
400
200
Year
Total cervical cancer
other cancers
2010
2009
2008
2007
2006
2005
2004
2003
2002
2001
0
2000
Total cases per year
1200
Background Information
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National Cancer Registry established in 1985
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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 subSaharan Africa cervical cancer working group expert
panel year 2008
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Background Contd
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
 Cervarix launch, 31 October 2012
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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.
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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
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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.
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Advocacy Social Mobilization and
communication
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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
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
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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
2 Countries wide introduction : Rwanda
and Lesotho
Seychelles
Comoros
Nationwide introduction
Demonstration project in 2013
Not yet in country EPI
Not AFR
Mauritius
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.
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
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WHO Position Paper on HPV Vaccine 2009
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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.
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Countries should prioritize achieving high coverage in the
primary target population of 9 to 13 year old girls.
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.
Proposed Vaccination Strategy in
Zimbabwe
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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.
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A total of 4 441 10 year old girls, is targeted.
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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.
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
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Vaccination Strategy Contd
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Cervical Cancer screening services are currently
in the urban setting in both private and public
health sector which marginalizes the rural
women.
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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.
HPV Vaccines
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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
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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
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Both vaccines require 3 doses administered over 6
months
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Both vaccines have excellent safety profiles
HPV Vaccines (continued)
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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)
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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
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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).
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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
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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
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THANK YOU , TATENDA,
SIYABONGA