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 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 DTP Diptheria Tetanus Pertussis BCG Bacillus Calmette-Guerin
2016 EPI Schedule in Ghana Vaccine Birth 6 wks Recommended age of vaccination 10 14 6 mths 9 mths wks wks 12 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 18 mths
4.5 3.5 No. of reported cases Millions 4 3 2.5 2 1.5 1 0.5 0 Annual reported measles cases and MCV1/2 coverage (1980-2015) 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 Campaigns Measles incidence in 2015: 36 / million down by 75% since 2000 Target: < 5 / million 2004 2006 2008 2010 2012 MCV1 MCV2 2014 100 90 80 70 60 50 40 30 20 10 0 MCV Coverage* (%) 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
Steady Progress with MCV2, 2000-2015 15% 61% 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.
Ghana 2YL Project Overview 5 year project CDC, Ghana Health Services, WHO, UNICEF 3. Social Mobilization & demand generation 4. Program Integration Multi-faceted approach to strengthening the second year of life 2. Data recording & reporting 5. VPD Surveillance Address issues in 6 Key Strategic areas 1. Training & Supervision Stronger Second Year of Life 6. Special innovations
Findings and Activities 1) Training and Supervision Source Situational analysis Baseline survey Finding 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 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 Situational analysis Baseline survey Year Finding 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 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% 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 Situational analysis Finding 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 Year 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 Activity about immunization 51-97% 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 Situational analysis Baseline survey Finding 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 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 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. Countries Projects/ programmes Delivery experiences Countries with demonstration projects or national programmes: 46 Demonstration project experience only: 1 34 66 demonstration projects, defined by donor and implementer Demonstration project experience + 1 year of national rollout: 10 National rollout without demonstration project: 2 12 national programmes 1 year 77 delivery experiences 15 delivery experiences 92 delivery experiences 1 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 planned to change delivery strategy in 2015 2016. 1 3 WWW.RHO.ORG/HPVLESSONS
Planning and coordination 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 WWW.RHO.ORG/HPVLESSONS
Communication and social mobilisation 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. 50 WWW.RHO.ORG/HPVLESSONS
Delivery 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 WWW.RHO.ORG/HPVLESSONS
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