Challenges of building a new vaccine delivery platform for LMICs

Terri B. Hyde, MD MPH Immunizations Systems Branch, GID, CDC 23 March 2017 Immunization in the Elderly Geneva, Switzerland

What has been the experience of vaccination platform development initiatives in ages beyond infancy (HPV, MCV2)?

Are there generalizable lessons learned for a new vaccine platform contexts in LMICs?

Expanded Program on Immunization (EPI) Launched by WHO in 1974 with a standard immunization schedule of 6 basic antigens for infants

DTP Diptheria Tetanus Pertussis BCG Bacillus Calmette-Guerin

Vaccine Recommended Age of Vaccination

Birth 6 weeks 10 weeks 14 weeks 9 months

BCG X

OPV X X x

DTP X X X

Measles X

2016 EPI Schedule in Ghana Vaccine Recommended age of vaccination

Birth 6

wks 10

wks 14

wks 6 mths 9 mths

12 mths

18 mths

BCG X OPV X X X X Rotavirus X X PCV X X X DPT/HepB/Hib X X X IPV (Q3 2016) X Measles/Rubella* X X Yellow Fever X Men A (Q3 2016) X Vitamin A supplement X X X ITN distribution X

*MCV2 introduced 2012; changed to MR 2016

0

10

20

30

40

50

60

70

80

90

100

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

1980

1982

1984

1986

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

2012

2014

MCV

Cov

erag

e* (%

)

No.

of r

epor

ted

case

s M

illio

ns

Number of cases MCV1 Coverage* MCV2 Coverage** Coverage as estimated by WHO and UNICEF. **MCV2 estimates is only available from 2000 when global data collection started, however some countries have introduced the vaccine earlier.

Source: JRF 194 WHO Member States. Updated on 18 July 2016

Annual reported measles cases and MCV1/2 coverage (1980-2015)

Campaigns

MCV1

MCV2 down / million 36 : 2015Measles incidence in

by 75% since 2000 Target: < 5 / million

Steady Progress with MCV2, 2000-2015

Source: WHO/UNICEF coverage estimates 2015 revision. July 2016 and WHO database as at 25 July 2016 Immunization Vaccines and Biologicals, (IVB), World Health Organization. 194 WHO Member States. Date of slide: 25 July 2016.

61% 15%

Ghana 2YL Project Overview 5 year project CDC, Ghana Health Services, WHO, UNICEF

Multi-faceted approach to strengthening the second year of life

Address issues in 6 Key Strategic areas

Stronger Second Year of

Life

1. Training & Supervision

2. Data recording &

reporting

3. Social Mobilization & demand generation

4. Program Integration

5. VPD Surveillance

6. Special innovations

Findings and Activities 1) Training and Supervision

Source Finding

Situational analysis

• Minimal MCV2 and 2YL specific training during introduction • Reference materials for health care workers had no 2YL specific content • Vague catch-up policy • Reports of batching children for MR and/or MCV

Baseline survey

Received EPI training >1 year ago or did not remember 54-80%

Responded one dose MCV was sufficient to protect against measles disease 18-40%

Responded it was more important to immunize children <12m vs 12-23m 40-45%

Would give MCV (not MR) to 18mo missing first dose measles 20-48%

Year Activity

2016 Interpersonal communication training, Job aides

2017 Training (pre-service, in-service, new hire); focus 2YL & adult learning, Regional and District Health Teams

Findings and Activities 2) Data Recording & Reporting

Source Finding

Situational analysis

• New tally sheets and registers included MCV2 but confusion on how to record doses • Lack of strategies to track children into the 2YL • Electronic registries compatible with DHIS2 planned in some districts

Baseline survey

Prepared written list of defaulters 15-23%

For scenario of 18mo receiving first dose of MCV:

Recorded dose incorrectly in tally sheet (MCV1 0-11m or MCV2 12-23m) 26-50%

Recorded dose incorrectly as MCV2 in register 17-42%

Told caregiver to return in 1 month for second dose 79-85%

Cards reviewed had MCV2 return date indicated 1-9%

Year Activity

2016 Child health record books, EPI data dictionaries, Vaccine reporting & management books

2017 Training on defaulter tracing, recording doses; Evaluation of eTracker (DHIS2) and SMS

Findings and Activities 3) Demand and Social Mobilization

Source Finding

Situational analysis

• General trust in the EPI system for infant antigens • Predominant norm that routine immunization services end at 9 months of age • Cultural perception that children are not at risk once they begin to walk • Minimal demand creation during MCV2 introduction: one radio message

Baseline survey

Had heard of a vaccine against measles 68-75%

Did not know of age for either MCV1 or MCV2 23-78%

Children who went to growth monitoring at 18m and did not receive MCV2

7-24%

Reported easier to bring 9mo to clinic than 18mo 52-54%

HCW was most trusted source of information about immunization 51-97% Year Activity

2016 Television and radio ‘blasts’, Posters

2017 2YL specific communications materials for HF staff and caregivers, 5 key messages

Findings and Activities 4) Program Integration

Source Finding

Situational analysis

• EPI integrated with growth monitoring, nutrition, deworming and bednet distribution in most areas

• Up to 70% of children enrolled in daycare or crèches by age 3, particularly in Accra • School health program disconnected with EPI

Baseline survey

Child cared for by another adult during the day 7-29% 12-23mo 16-35% 24-35mo

Caregivers receptive to child being immunized in daycare or crèche 58-100%

Workload: 2YL increased the number of sessions held 56-74%

Workload: 2YL increased the time to hold those sessions 55-64%

Year Activity

2016 Pilot workshop with daycare/crèche proprietors in Greater Accra

2017 Daycare/crèche proprietor workshops across all 3 regions

HPV vaccine introduction to date

2012 ≈530,000 women developed cervical cancer, 270,000 died.

85% in LICs /MICs 2013 GAVI Support for HPV vaccine introduction Initially required evidence of ability to reach adolescent

girls with high coverage as it was a new platform, 2 year demonstration projects funded.

2015 < 5% age cohort of girls fully immunized 2016 (March), 70 countries had introduced HPV vaccine, mainly in limited demonstration settings

Slow move towards national introduction in low and middle income countries

2017 Gavi guidelines aim to accelerate national introduction

National introduction (phased introduction optional) Support for multi-age cohort (9-14 years) in first year Followed by single age cohort (e.g. 9 years) in

subsequent years

Study by numbers

WWW.RHO.ORG/HPVLESSONS

• Data from 46 countries (18 LIC, 22 LMIC, 5 UMIC, 1 HIC): 12 national introductions. 66 demonstration projects.

• 92 distinct delivery experiences. • 120 years of cumulative vaccination experience. • >1,750,000 girls reached. • >1,400,000 girls fully vaccinated. Ninety-two distinct delivery experiences: defined by the vaccination venue and target population within a specific project/programme.

1Data was received from three countries planning to scale up to national rollout from their demonstration project in 2015–2016 and four other programmes which had

Countries

Projects/ programmes

Delivery experiences

Countries with demonstration projects or national programmes: 46

Demonstration project

experience only:1

34

National rollout without

demonstration project:

2

Demonstration project

experience + ≥1 year of

national rollout: 10

66 demonstration projects,

defined by donor and implementer

12 national programmes ≥1 year

77 delivery experiences 15 delivery experiences

92 delivery experiences1

planned to change delivery strategy in 2015–2016.

13

Planning and coordination

WWW.RHO.ORG/HPVLESSONS

Findings • Lack of political commitment created delays in

vaccine importation and funds disbursement. • Lack of initial involvement by health and education

sectors created difficulties in planning and implementation.

• Lack of strong involvement by the national immunisation programme caused problems with systems, transportation, and human resources.

• Weak supervision of training created challenges; resulted in inadequate knowledge transfer.

• Insufficient time for planning posed a challenge to implementation.

Lessons learnt • Lack of political commitment early in the

process caused delays later in the programme.

• Failure to coordinate early with national immunisation programme staff, MOE, and MOF led to planning, social mobilisation, and delivery problems.

• Not allowing enough time for planning led to poor decision-making, lack of availability of funds, and untimely disbursement.

49

Communication and social mobilisation

WWW.RHO.ORG/HPVLESSONS

Findings • Gaps in communications training for school staff,

teachers, and community leaders allowed rumours to take hold when questions could not be answered.

• Some countries underestimated the power of negative media exposure, including social media.

• Several countries faced challenges with HPV vaccine acceptance in private schools if they were not engaged early in social mobilisation.

Lessons learnt • Not engaging, or engaging too late, with

local community leaders derailed social mobilisation efforts in some cases.

• Insufficient training of school staff/teachers and lack of a crisis communications plan perpetuated rumours.

• Failure to engage sufficiently or early enough with private schools led to resistance by school leaders and parents.

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Delivery

WWW.RHO.ORG/HPVLESSONS

Findings • Specific strategies are needed to reach out-of-school

girls and those without them often saw low coverage in this group.

• Strategies that did not clearly define, implement, or train health workers on eligibility criteria faced challenges in enumeration and calculation of coverage.

Lessons learnt • Limited focus on strategies to deliver HPV vaccine

to out-of-school girls led to low coverage in that group. • Failure to understand and implement eligibility criteria

during enumeration and vaccine delivery created difficulties estimating coverage. PATH/Le Thi Nga

Lessons from 2YL and adolescent vaccination Political commitment and early engagement of national immunization program is

important to success

New platforms involve behavior change in individuals, caregivers, and health staff

New vaccine delivery sites require close coordination, planning, and delivery with all entities involved in vaccination and the new sites

National immunization programme, schools, ministry of education, ministry of finance

New vaccine strategies may be needed to reach the entire population Simplify logistics to access care Children may be in school in 2YL, parents working In school vs out of school girls The least complicated delivery strategy is best

Vaccine safety Understanding concerns of health staff and caregivers Communication and training to address concerns and rumors in communities

Challenges in developing a new vaccine platform No current uniform platform to deliver vaccine to adult and elderly populations Wide scale roll-out limited without global recommendation/ financial support Public policy recommendation (SAGE), GAVI support for vaccine Strong political commitment needed for successful implementation Mobilization of financial and human resources needed to achieve program goal

Adequately funded programs, health care worker workload Where does the target population receive health care Match vaccine delivery sites to population Assess need for alternate delivery strategies, defaulter tracing Is there a reliable denominator of target population to estimate needs Adequate demand creation among target population and health care workers Social mobilization and behavior change to request vaccine

Opportunities in developing a new vaccine platform

New vaccine platforms provide the opportunity to reach elimination goals, provide catch-up vaccination, booster doses, new vaccines, other preventive services

Countries are already gaining experience in reaching new populations beyond

infancy Areas identified to improve performance of the new vaccine platforms are

similar in both the second year of life and adolescent platforms, and strategies to address these are being tested