6th Global Meeting on Implementing New and Under-utilized Vaccines, 15-17 May 2012
Introductory Session
Following is an Executive Summary of the achievements and key challenges in implementing new vaccines over the last 12 months. Further details are provided in the subsequent sections.
New Vaccine Implementation – Overview of Achievements
In the past year, many more children have been protected against vaccine-preventable diseases with the additional introduction of Hib, pneumococcal, rotavirus , HPV, and Meningococcal A vaccines.
- Fewer countries below the 70% DTP3 coverage mark
- New opportunities through HPV introduction in young adolescents – synergy with adjunct interventions
- Further development of school-based programmes
- Hib introduction closer to reaching final goal
- Renewed focus on supply chain and logistics
- Development and deployment of NVI training materials
- cMYP revision engaging more broadly with health systems planning
New Vaccine Implementation – Overview of Key Challenges
- Sustaining implementation of larger portfolio of vaccines
- Initiating and sustaining additional delivery strategies, e.g., for HPV
- Support to NUVI beyond GAVI countries:
- New policy for working with and for MIC
- Improving access to GAVI prices for graduating countries
- Need for enhanced economic analyses to justify expenditure
- Alleviation of supply constraints
- Improved coordination of technical assistance to countries
- Improved impact assessment and more reliable and timely data (coverage, surveillance, targeted studies)
- HR developments: Raise technical capacity in countries
- Need for enhanced post-marketing surveillance
Global NUVI Plan of Action: Update and progress report
Key achievements in the implementation of the Global NUVI Plan of Action were presented. Highlights since June 2011 include the following:
1.Norms and Standards
- There were eight vaccine pre-qualifications since the last meeting
- An expedited procedure for licensing MenAfriVac™ in countries in the Meningitis belt has been put in place
- The Programmatic Suitability for Prequalification (PSPQ) Standing Committee regularly reviews vaccines presented for WHO pre-qualification in respect of their programmatic suitability
- Routine vaccine schedules tables are regularly updated
2. Information for Country Decision Making
- Eighteen GAVI new vaccine introduction applications from 15 countries were approved for Hib, pneumococcal and rotavirus vaccine introduction
- At least 23 countries are planning to submit new vaccine introduction applications to GAVI in August 2012 for Hib, pneumococcal, rotavirus, HPV, measles 2nd dose, rubella, Meningococcal A and Yellow Fever vaccine
- Four new WHO position papers have been published on: Meningococcal, Pneumococcal, Rubella, Tick-borne encephalitis vaccines
- 43 NITAGS met all six quality criteria in 2010
- Burden of Disease estimates have been updated as follows:
- Rotavirus mortality estimates for the year 2008 (Lancet, 25 Oct 2011)
- Regional and global estimates for Spn and Hib deaths for 2008 (WHO website)
- Cervical cancer incidence, mortality, prevalence for 2008 (Globocan website)
- WHO NUVI website updated with revised information and slide sets
3. Planning, Financing & Procurement
- Prices contracted by UNICEF with suppliers are now published on the UNICEF and WHO NUVI websites
- Assessment tools and benchmarks for planning have been developed to guide countries in developing their Human Resources for Immunization
- Strategic demand forecasting is in place for 14 vaccines
- cMYP guidance is being revised to achieve better alignment with health sector planning and the GVAP
- WHO’s Eastern Mediterranean Region is intending to use the PAHO platform to develop its pooled procurement initiatives. Other regions are interested in expanding this activity, e.g. the European Region (Baltic states) and the South-East Asian Region
- Preparation of DOV GVAP companion paper on middle income countries is underway
4. Delivery in Synergy with Disease Control Interventions
- Since June 2011 the following vaccine introductions have taken place: 6 Hib, 13 PCV, 6 RV, 6 HPV, 3 MenA
- The upward revision of the GAVI introduction grant for countries will be reviewed at its Board Meeting in June 2012
- Guidelines for PCV and RV introduction and accompanying training materials have been developed
- There is a GAVI Alliance Task Team working with India, Nigeria and DR Congo
- A WHO data repository on country immunization (systems) indicators is being established with the goal of if being available to countries, Regions and partners, and eventually to be used for coordination of technical assistance
- School immunization readiness assessment tools are now available
- A checklist approach has been initiated to improve the quality of immunization sessions
- 26 assessments with on-going implementation of improvement plans
- Next version will include supply chain modelling and wastage assessment
- 26 priority EVM assessments planned for 2012
- Project Optimize
- Development of new cold chain technologies
- Controlled temperature chain strategies
- Vision for immunization supply systems 2020
- Communication Framework for Pneumonia and Diarrhoea Control has been made available to countries
- Four Integrated Approaches GAPP Workshops have been held in Africa and Asia with participation from 35 countries
- Principles of adding a new vaccine to a national immunization programme endorsed by SAGE in April 2012
- The revised New Vaccine Introduction Guidelines include consideration of impact of NUVI on immunization and health systems
5. Monitoring and Surveillance
- RV and PCV Immunization coverage updates for 2010 to be published in July 2012
- Global rotavirus gastroenteritis and invasive bacterial disease surveillance networks:
- RV surveillance robust, quality data being generated
- IBD surveillance being strengthened
- Standardized site evaluations
- Rapid diagnostic tests
- External quality assurance process
- Global Reference Labs and Regional Reference Labs support sentinel sites
- Improved data management
- Surveillance bulletins regularly published
- Documenting impact of new vaccines for sustaining their use - both for countries and donors
- High quality surveillance critical to generate empiric data, but not sufficient in itself
- Needs to be complemented by methods to convert surveillance data to measures of vaccine impact and link with special studies
- Complementary methods:
- Monitoring hospitalization rates
- Establishing denominators for sentinel sites
- Performing sero-surveys and special studies
- Using surrogates, e.g. nasopharyngeal carriage
- Post introduction evaluations conducted in 11 countries for penta, RV, PCV and HPV introductions
- Immunization programme evaluation
- Experiences with new regional tools in AFR, AMR, EMR
- Integration of pre- and post introduction evaluations
In the area of specific vaccines, the following key achievements and challenges were noted:
Vaccine Supply Situation
- Supply and demand situation is dynamic and requires close monitoring and management
- Unprecedented scale-up of demand through GAVI applications
- Scale-up of supply, but short-term constraint supply of PCV and rotavirus and continued issues with YF vaccine
Hib Vaccine
Achievements
- 1 additional GAVI application (Myanmar)
- 177/193 countries (92%) have Hib/penta vaccines in national schedules
- Hib in large countries:
- India introduced in 2 States in 2011
- Russia partially introduced in 2011
- Nigeria to introduce in 14 States in Q2/2012
- Indonesia to introduce in 2013
Key Challenges
- India to scale up Hib introduction to at least 6 additional states this year
- More than a quarter of the world's children still do not have access – China?!
Pneumococcal Conjugate Vaccine
Achievements
- PCV10 prequalified with recommendations for benefit-risk information, additional training and materials, close monitoring
- PCV10 and PCV13 introduced in 77 countries (of which 17 low-income)
- GAVI graduating countries can apply for access to vaccine at AMC tail-price
Key Challenges
- Supply constraints for 2012/13 caused delay of introduction in 4 countries
- Spn serotype replacement (after PCV7):
- Overall reduction of IPD in children <5 years despite increases in incidence of non-vaccine serotypes
- Likely to be mitigated by use of PCV10/13
Rotavirus Vaccine
Achievements
- 6 countries introduced since June 2011
- First UNICEF procurement round finalised – price for two-dose course now at 5.00 USD
- Age restrictions relaxed by WHO SAGE – focus on timeliness of vaccination starting at 6 weeks of age
Key Challenges
- Managing relaxation of age restrictions in already introduced countries
- Intussusception surveillance to be intensified in all countries
HPV Vaccine
Achievements
- GAVI opening application window for HPV vaccine support
- HPV demonstration project application criteria under development
- WHO cervical cancer prevention and control costing tool available
- HPV vaccine coverage monitoring tool piloted
- Announcement of a price of 5 USD/dose for UN purchase
- GAVI support to operational costs to be increased
Key Challenges
- Increased collaboration across ministries, institutions, departments and groups on cervical cancer prevention, screening, treatment and adjunct interventions (e.g., adolescent health, cancer control)
Meningitis A Conjugate Vaccine
Achievements
- Successful rollout of MenAfriVacTM in Mali, Niger, Cameroon, Chad and Nigeria in 2011 (1–29 years old), more than 35 million vaccinated
- Planned campaigns in Benin, Ghana, Senegal and Sudan in late 2012
- Successful demonstration of vaccine effect on MenA carriage in Burkina Faso
Key Challenges
- Strengthen surveillance to measure the MenAfriVacTM impact
- Define policy for use of MenA conjugate vaccine in infants
- Review co-administrations with other EPI vaccines
- Define immunization strategy to induce rapid protection and herd immunity
Japanese Encephalitis and Typhoid Vaccines
Japanese Encephalitis
- GAVI Board to open window for vaccine support after availability of a WHO prequalified vaccine
Typhoid
- GAVI Board to open window for vaccine support after availability of a conjugate vaccine
- Recent report of high disease burden in Africa
- IVI surveillance project in Africa (TSAP)
- Evaluation of programmatic feasibility of school-based typhoid programmes in Nepal and Pakistan
In addition to this, plenary presentations were made on the following topics:
- Pneumo Lessons Learned
- Rota Lessons Learned
- MenA Lessons Learned
- GAVI update