5th Global Meeting on Implementing New and Under-utilized Vaccines, 22-24 June 2011
Introductory session
Global NUVI Plan of Action: Update and progress report
The updated Global NUVI Plan of Action was presented and discussed. It will undergo further updates based on the discussions at this meeting related to its revised work areas. Highlights since June 2010 include the following:
1. Norms & Standards
- There were 15 vaccine pre-qualifications since the last meeting
- The prequalification procedure was revised to meet current challenges
- The Immunization Practices Advisory Committee regularly reviews programmatic issues including the programmatic suitability of prequalification
- Routine vaccine schedules are under periodic review
- The Chinese National Regulatory Authority was officially declared functional in February 2011 and an orientation workshop was held in Beijing in March with more than 30 vaccine manufacturers.
2. Information & Knowledge Management for Country Decision-Making on NUVI
- 75 new GAVI applications from 50 countries were received for Hib, PCV, RV, MenA, MSD, and YF vaccines
- WHO Position papers were published on: Rabies, Pertussis, Polio, Tick-borne Encephalitis, and Rubella (forthcoming)
- A new NUVI website was launched: "Introducing a vaccine: policy and programmatic considerations"
- Burden of Disease estimates were updated for rotavirus disease for the year 2008; and for cervical cancer for the year 2008 (IARC)
- GAVI eligibility criteria and implementation guidance is being developed for HPV, Typhoid, JE and Rubella vaccines
- The Pneumococcal Awareness Council of Experts comprised of 117 medical societies from 50 countries endorsed a Global Call to Action on Pneumococcal Disease Prevention
- Questions related to National Immunization Technical Advisory Groups are now included on the WHO/UNICEF Joint Reporting Form, a web-based NITAG Resource Center was initiated and work on collaboration between NITAGs and NRAs is ongoing. WHO has also initiated the Evidence-informed policy network.
3. Planning, Financing & Procurement
- Donors have committed 4.3 billion USD for vaccines and immunization to 2015
- The Sustainable Immunization Financing Program (SABIN) works with eight African and Asian countries to increase immunization budgets using national resources.
- Pricing analysis for pentavalent, PCV, RV and polio vaccines have been conducted and prices are now available on the UNICEF and NUVI websites
- An analysis of human resource planning in cMYPs is ongoing.
- A standardized demand and supply forecasting process has been established for 9 vaccines coupled with a vaccine pipeline analysis for PCV, Rota, HPV, and Typhoid vaccines.
- The Decade of Vaccines Collaboration was established with four work streams: Global Access, Public and Political Support, Research and Development and Vaccine Delivery and goals, targets and indicators were drafted for a Global Vaccines Action Plan revisiting the GIVS.
4. Vaccine Delivery in Synergy with Vaccine Preventable Disease Control
- Since June 2010: 6 Hib, 22 PCV, 5 RV, 9 HPV, 3 MenA introductions have taken place.
- Guidelines for PCV and RV introduction and training materials were developed.
- A special GAVI Task Team is working with India and Nigeria.
- A country readiness dashboard was established between AVI partners to manage introductions.
- A tool for assessing use of schools for delivery of health services to adolescent girls was developed.
- Effective Vaccine Management assessments were conducted in 22 countries.
- A communication framework for Pneumonia and Diarrhoea Control has been finalized.
- The impact of NUVI on immunization and health systems has been further investigated through finalization of an extensive literature review and the development of a tool and checklist for country use to mitigate negative and maximize positive effects.
- Two workshops on "Protect, Prevent, Treat" for 15 African countries were held in Nairobi and Dakar in the context of the Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea with intensified follow-up in the priority countries: Ethiopia, Kenya, Mali, Niger, Zambia.
5. Monitoring & Surveillance
- RV and PCV immunization coverage data were published for 2009 for all member states – updates for 2010 are to be published in July 2011.
- The global network of invasive bacterial disease and rotavirus gastroenteritis surveillance was maintained and strengthened with a focus on data quality, data management and site assessments, working global reference Labs and regional reference labs, piloting of external quality assurance processes, training of laboratory staff at all levels and the publication of global and regional surveillance bulletins. Further support is needed to enable a full transition to national ownership and funding.
- HPV coverage and impact monitoring methods were developed in collaboration between immunization, cancer control, adolescent health and reproductive health units.
- The Central African Surveillance Project SURVAC for integrated vaccine preventable and epidemic prone disease surveillance is up and running and has been fully transitioned into AFRO (IST Central) coordination.
- Post introduction evaluations were conducted in 10 countries for Hib/Penta, Rota, PCV and HPV introductions and the PIE tool was published in August 2010 (English version) and April 2011 (French version).
- A review of tools and processes for immunization programme evaluation is ongoing.
In the area of specific vaccines, the following key achievements and challenges were noted:
Hib vaccine
Achievements
- 6 new GAVI applications with 176/193 countries having Hib/penta vaccines in their national schedules.
Key Challenges
- India introduction is still pending following extended decision-making process. Today still half of the world's children do not yet have access – but large countries will hopefully introduce soon, Nigeria, and Indonesia.
- The price reduction of pentavalent vaccine is still less than expected.
Pneumococcal Conjugate Vaccine
Achievements
- PCV10 and PCV13 have been introduced in 7 developing countries – only 1.5 years after first introduction in an industrialized country (Canada)
- Supply constraints for 2010/11 were managed without need to resort to supply allocation. A new Request for Proposal was issued in April 2011 for new procurements under the AMC.
- 28 new GAVI applications were received in the May 2011 round.
Key Challenges
- The continued AMC eligibility of all 72 GAVI countries needs to be managed
- The tail price of 3.50 USD should need to come down.
- PCV10 conditions for prequalification are being dealt with through studies in Kenya and Ethiopia.
- The changing Streptococcus pneumoniae epidemiology needs to be under constant review.
Rotavirus Vaccine
Achievements
- The first introduction in Africa (Sudan) is imminent.
- A first UNICEF procurement round was finalized.
- There was an announcement of a price of 2.50 USD/dose (GSK) for GAVI procurement.
- 25 new GAVI applications were received in the May 2011 round.
Key Challenges
- The narrow age window for the 1st (6 -15 weeks) and last (< 32 weeks) dose could lead to reduced vaccine coverage.
- There is a lower efficacy of the vaccine in high mortality countries, but a higher absolute number of severe GE episodes are prevented there.
- An appropriate price for graduating countries needs to be set.
HPV Vaccine
Achievements
- There is ongoing high-level advocacy for the vaccine in many countries.
- An announcement of a price of 5 USD/dose (Merck) for GAVI purchase has been made.
Key Challenges
- Delivery costs are higher than for 'traditional' EPI vaccines - additional costs are in the range of 3 to 5 USD/girl vaccinated.
- HPV "access" programmes by manufacturers challenge WHO/ GAVI guidance to vaccine introduction.
- Work is ongoing towards opening a GAVI support window.
- Intensive collaboration across institutions, departments and groups is necessary on prevention including vaccines, cervical cancer screening and treatment.
Meningitis A Conjugate Vaccine
Achievements
- The MenAfriVac vaccine was successfully rolled out in Burkina Faso, Mali and Niger in 2010 (for the age groups 1–29 years). Campaigns are planned in Chad, Cameroon and Nigeria for late 2011.
- 7 new GAVI applications have been received.
Key Challenges
- MenA conjugate vaccine for < 1 year olds: an ongoing clinical trial in Ghana assesses dose ranging and schedules.
- The best immunization strategy to induce rapid protection and herd immunity needs to be defined, either through single dose mass campaigns targeted at 1-29 year olds, or an EPI schedule plus follow-up campaigns in 1-4 year olds. The evaluation of the effect of the vaccine on meningococcal transmission is being assessed.
Typhoid Vaccine
- Several countries have introduced typhoid vaccines so far: China, Fiji, Delhi State in India, Sri Lanka, Viet Nam, while Bhutan and Nepal are initiating introduction.
- The Coalition against Typhoid (CaT) with a secretariat at the Sabin Vaccine Institute was launched in 2010 – works to accelerate vaccine uptake in endemic countries.
- The first typhoid vaccine (Vi-polysaccharide) was WHO-prequalified in June 2011.
- Countries in the SEA Region are to strengthen typhoid surveillance and IVI has initiated lab-based surveillance for Salmonella Typhi in Africa.
- Work is ongoing towards opening a GAVI window for support.
Japanese Encephalitis Vaccine
- Vaccination is ongoing in Cambodia, China, India, Japan, Nepal, Sri Lanka, Thailand and Viet Nam. The SA-14-14-2 is the most widely used vaccine - but not yet WHO prequalified.
- There is need to strengthen surveillance and laboratory capacity in endemic countries.
- Work is ongoing towards opening a GAVI window for support.