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Innovations and Access: Vaccine Supply Updates

Innovations and Access: Vaccine Supply Updates . ARCI/ARICC Meeting 11 December 2012 UNICEF Supply Division. Presentation overview. UNICEF Procurement Overview. UNICEF procures immunization supplies on behalf of around 100 countries annually. 2.49 billion doses. 2,105 shipments.

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Innovations and Access: Vaccine Supply Updates

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  1. Innovations and Access: Vaccine Supply Updates ARCI/ARICC Meeting 11 December 2012 UNICEF Supply Division

  2. Presentation overview

  3. UNICEF Procurement Overview

  4. UNICEF procures immunization supplies on behalf of around 100 countriesannually 2.49 billion doses 2,105 shipments Vaccines Supplies: US$ 1, 030 million 2011 Source UNICEF Supply Division Immunization Supplies Vaccines BCG , DTP, TT/Td/DT, Measles containing, OPV, HepB, YF, DTP-HepB, DTP-HepB/Hib, DTP/Hib, Hib, MR, Meningitis, MMR, PCV, RV, IPV, etc. Safe Injection equipment Cold Chain Equipment Countries UNICEF procures on behalf of Full schedule Partial schedule Source: 2012 country forecasts received by UNIICEF

  5. AFRO is the key recipient of UNICEF procured vaccines based on value, and increasing considerably between 2010-2011 due to primarily early introductions of pneumococcal vaccines 65% of total procurement value • Overall, procurement value quadrupled over the past decade • For AFRO, volume driver remains to be polio vaccines, increasing to an all time high of 1.1B doses in 2011 • Pentavalent, meningococcal and pneumococcal vaccines doubling 2010 to 2011 Source UNICEF Supply Division Data based on PO placement year

  6. Vaccine Supply Updates

  7. Pentavalent vaccine: After 12 years the supply and demand capacity has ramped up, but supply market continues to be fragile Forecast LGLS Bio E Shantha SII Panacea Panacea GSK Berna/Crucell Shantha • Since 2010, 2 manufacturers with pentavalent vaccines have had their vaccines delisted and 2 new manufactures have entered with new pre-qualifiedvaccines • Multiple suspensions of shipments from suppliers throughout 2012, but so far good response from other suppliers to meet the gaps • Has taken a toll on countries – changes in vaccines, shipment plans, depleting country stocks • Important: while disruptive, voluntary suspensions of shipments are evidence of functioning quality assurance systems and action by manufacturers Supply start De-listing Suspension

  8. Conditional approval Approved for intro Introduced Pneumococcal vaccine: 46 GAVI countries approved for introduction and 4 recommended as of October 2012 • Out of 25 countries which have introduced, 19 in the AFRO Region • One African country required to postpone introduction from 2012 to 2013 due to lack of availability of preferred presentation - 3 countries postponing due to lack of readiness • A minimum of 8 countries in AFRO Region to introduce in 2013 • Tender ongoing to be concluded Q1 2013 with objective to secure additional short term supply capacity including for 6 countries

  9. Advance Market Commitment: an innovative funding mechanism to incentivize product development and early supply capacity • Supply surplus in 2012 of +10M ds – but mismatch between supply and preferences • Expect a continued tight supply situation 2013-2015, but uncertainties on demand side related to in particular large country introductions • Has the AMC achieved its objectives? Evaluations currently ongoing and projected, but: • Availability of vaccines: Compared to pentavalent vaccines, accelerated supply capacity (+50M ds 2 years after pre-qualification) • Accelerate uptake through predictable prices: 46 countries approved and 25 introductions in 2 years • AMC as a game changer for early access to affordable new vaccines (Rota/HPV)?

  10. Introduced Approved to introduce Recommended for intro Conditional approval Rotavirus: 23 GAVI countries to procure through UNICEF approved for introduction and 6 recommended as of October 2012 • 5 countries in the region introduced 2011-2012 out of 9 in total • 14 countries approved for introduction in 2013, with supply available 2nd half of the year, of which 3 postpones to 2014 • 5 countries recommended for approval – dependent on product preferences, 2013 or 2014 introductions to be supported

  11. Overall, excess supply available in 2012, however, due to predominant preference for one of two available vaccines, available supply not being fully utilised and one country to postpone introduction • In 2013, due to distribution of supply of preferred product, introductions only in Q4 • Supply sufficient to support sustainable introductions in all currently approved countries • For countries recommended for approval for this vaccine, supply available in 2014 for 2 of 3 countries based on current availability • New awards required under current tender for applications recommended for approval • UNICEF and partners continue to work with suppliers to improve availability

  12. OPV supply and demand for 2013

  13. Measles and MR vaccine procurement through UNICEF in 2000-2012 and forecasts for 2013-2016 (in doses) • Current forecasts reflect the switch from monovalent measles to MR • In 2013, Ghana, Senegal and Rwanda will conduct wide age group catch-up MR campaigns with GAVI support and consequently introduce MR vaccine in their routine immunization. • Supply of all Measles-containing vaccines meets the demand; however planning in advance is important to ensure timely availability of vaccine. • MR remains a single-supplier market for the time being; requires country flexibility for registration/licensing • 5-dose vial for Measles and MR vaccines are not available in the short-term due to manufacturing limitations. UNICEF will continue to follow-up with the supplier on this as programmatic demand is being quantified.

  14. Yellow Fever Vaccine • 2012 Emergency stockpile • 491,500 dose remain • 2013 Emergency stockpile is 6 million doses • 4 million from January • 2 million from June • Situation for 2013 and beyond • 2013 Routine & Preventive campaigns 29 million doses on contract • Working with Partner to develop procurement strategy • Expect to have increased capacities from 2 suppliers • Restart production from 4th supplier

  15. Meningitis Vaccine • Emergency stockpile for 2013 meningitis season • 4 million doses of A conjugate • 3.5 million doses of AC polysaccharide • W containing vaccine contracts to be finalised for up to 3 million doses • Meningitis A Conjugate Vaccine • 3 countries completed Meningitis campaigns in 2010/11 • 2012 - 7 countries have either completed or started preventive campaigns • 55 million doses on contract for 2013 for Preventive campaigns

  16. HPV vaccine: GAVI approved November 2011 to open a support window, contingent on achieving affordable prices • UNICEF will procure HPV vaccines for GAVI countries: • Forecasts developed by GAVI, with guidance from the AVI sub-team, resulting in a HPV SDF. Will be updated regularly. Many uncertainties & assumptions. • Tender cover first 5 years of demand; 2013-2017 • 2 windows for GAVI support: National introduction and Demonstration programme. A successful demonstration programme is a prerequisite for support to National introduction • UNICEF tender includes forecasts for graduating countries (current & future)

  17. UNICEF Middle Income Country Strategy Addressing Inequity

  18. UNICEF’s Strategy: Addressing Inequity • UNICEF’s development of a Middle Income Country (MIC) strategy is consistent with its inequity-fighting mandate and agenda and targets the accelerated introduction of new vaccines • Nearly 75% of the world’s poor live in countries classified as MIC • Factors affecting adoption in MICs • Lack of access to affordable new vaccines (or even knowledge of comparators) • Lack of comparable advocacy and technical advisory • Sustainability/lack of funding sources (both internal budget and external support) • Uneven political will • Variable institutional capacity (NITAGs, procurement capacity, disease burden data, etc.) • Can we be a catalyst to the introduction of new vaccines in non-GAVI eligible countries: PCV, HPV, Rotavirus vaccines

  19. Hybrid Strategy New Vaccine Introduction in MICs • Providing aggregated demand forecasts to industry, availability and product information to countries, pooling procurement and establishing reference pricing • Catalytic “time-limited” intervention with the aim of countries incorporating these vaccines in their regular vaccine procurement processes within a few years • Expect initially small, but evolutionary and flexible process

  20. Early Country Indications on Strategy Preferences Responses are indicative and non-binding now; however point to a strong interest

  21. Planned Tender Process Procurement activities to take place in 1H 2013 with objective of having agreements in place to support first deliveries by Mid-2013.

  22. Conclusion • Overall, the supply situation remains tight for vaccines, requiring close monitoring of supply and demand to optimise health impact • Innovative approaches to secure access to new vaccines at affordable prices • Equitable access to vaccines – strategy developed to support early access to PCV, RV and HPV through pooled or self-procurement for Middle Income Countries • Countries required to indicate nonbinding interest NOW • Tender to be issued before end of year

  23. Informationavailable ontheUNICEFpublicwebsite • Increasing transparency on vaccine prices and quantities • Historical annual procurement values and volumes: • http://www.unicef.org/supply/index_38554.html • Current Weighted Average Prices: • http://www.unicef.org/supply/index_7991.html • - Vaccine Price Data by suppliers: • http://www.unicef.org/supply/index_57476.html • UNICEF’s activities to support access and equity • http://www.unicef.org/supply/index_66523.html

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