Market Updates: Routine Vaccine Introductions IPV Vaccine Industry Consultation October 2018 UNICEF Supply Division
Outline Review of rapid introduction of IPV Overview of the current situation for 2018 and 2019 Update on new tender covering 2019 to 2022
In 2013, WHA endorsed the Polio Eradication and Endgame Strategic Plan which required IPV introductions in 126 countries within 18 months This called for an unprecedented roll out of a vaccine with 126 countries required to introduced at least 1 dose of IPV by the end of 2015 before the withdrawal of type 2 containing OPV. IPV Consultations with indicated industry that they would be able to meet requirements before policy recommendation.
IPV supply offers and demand at time of awards for 2014 to 2018 Back in 2014 at the time of the initial awards the supply landscape based on the offers received was encouraging with supply availability expected to be in access of the projected demand IPV supply availability was one of the factors used to determine if the Switch from topv and bopv should go ahead as well as pricing! 4
Overview of awarded quantities compared to actual/forecasted supply For the 5 year period manufacturers will have supplied around 47% of the quantities on LTA IPV availability for 2018 is expected to increase by 50% compared to 2017
Actions taken with partners to address the supply situation In 2015 when it became clear that there was insufficient supply available for all countries to introduce 1 dose of IPV in routine schedule the responsible GPEI management group met to review the global situation and to suggest how supply should be prioritised Supply working group established with partners Allocation principles Approved by the Polio Strategy Committee and the POB (Head of Agencies) & SAGE Clear and timely communication to countries Close collaboration with manufacturers Interventions to address the supply shortage: Multi Dose Vial Policy fipv 1/5 th of a dose Strict calculation of annual doses to be supplied Updates of stock level & monthly consumption Exceptional procurement of non WHO prequalified IPV
Overview of current situation for 2018 and 2019
Update on the countries that have not received IPV through UNICEF since the switch Supply will meet demand in 2018 for 1 dose routine in the 85 countries supplied through UNICEF for the first time since switch 35* countries procuring IPV vaccines through UNICEF were unable to access supply since the Switch 18 countries did not have access to IPV for routine introduction 17 countries had supply interrupted post introduction Status on IPV for routine across the 33 (re)introducing countries (24th August 2018) Countries introduced (15) Countries reintroduced (13) Rwanda, Sierra Leone, Tanzania, Turkmenistan, Uzbekistan, Ghana, Moldova, Egypt, Burkina Faso, Eritrea, Kyrgyzstan, Tajikistan, Vietnam, Zambia, Nepal Bhutan, Burundi, Cote d Ivoire, Comoros, Sao Tome, Senegal, Sudan, Morocco, Djibouti, Gambia, Guinea Bissau, DPR Korea, Lesotho Status on remaining countries (5) Introduction: Malawi (Sept 2018), Togo & Mongolia (October 2018), Zimbabwe (2019) Re-introduction: Iran (Q4 2018) * 33 countries in total as Carbo Verde & Swaziland had sufficient supply to not interrupt
Countries using IPV vaccine to date 0 950 1,900 3,800 Kil Introduced* to date (175 countries) Re-introduced (13 countries) Formal commitment to introduce in 2018-2019 (4 countries) Introduced but need to re-introduce (2 countries) Not available Not applicable * Including partial introduction in India DESPITE THE SUPPLY CHALLENGES, FASTEST ROLL OUT OF A NEW VACCINE, WITH 121 COUNTRIES INTRODUCING SINCE 2014 Date of slide: 24 August 2018 The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the Data source: WHO/IVB Database, as of 24 August 2018 delimitation of its frontiers or boundaries. Dotted Map lines production on maps represent Immunization approximate border Vaccines and Biologicals (IVB), World Health Organization lines for which there may not yet be full agreement. WHO 2018. All rights reserved.
IPV supply & demand for 2018 2 million doses allocated for EMOG fully utilised Availability constrained throughout 2018 in particular for the 2 nd half of the year Suppressed/unmet demand for supplementary immunization activities and catch-up 10
Supply & demand estimates for 2019 After meeting requirements for routine immunisation there is 7.5 million doses available for other activities. Currently there are requires for: SIA in endemic countries Catch up immunization Other demand (refugee populations in high risk countries & catch up immunisation in older age groups 11
Next steps GPEI to agree on how the estimated availability for 2019 (7.5 million doses above RI requirements) should be allocated (SIA in endemic countries vs catch up immunisation) GPEI to make a recommendation on how doses available for catch up immunisation should be allocated in 2019: To prioritise countries that will do fipv? To prioritise purely based on risk of polio re-emergence? Based on country readiness, irrespective of fipv Some other criteria? In case doses are available for catch up, early communication with countries is required to allow time for preparation 12
Update on tender for 2019 to 2022
IPV tender demand and initial awards Additional awards expected to be made in 2018 based upon prequalification to ensure supply is sufficient to meet routine demand and SIAs for 2019 & 2020 Presentation 2018 2019 2020 2021 2022 1 dose 1 2 1 5 dose 1 1 2 2 10 dose 2 Number of new products by presentation expected to be prequalified by WHO 14
Overview of initial awards and range of offered prices The below table shows IPV prices following initial awards where vaccine security - ensuring an uninterrupted supply - has been the overriding factor behind award levels Presentation No. of suppliers awarded 2019 2020 2021 2022 Weighted Weighted Weighted average No. of average No. of average No. of Quantities price per suppliers Quantities price per suppliers Quantities price per suppliers Quantities (doses) dose awarded (doses) dose awarded (doses) dose awarded (doses) Weighted average price per dose 1 dose 1 1,500,000 $3.50 1 1,500,000 $2.80 1 1,500,000 $2.80 1 1,500,000 $2.80 5 dose 1 20,000,000 $2.95 1 15,000,000 $3.10 1 15,000,000 $3.10 1 15,000,000 $2.50 10 dose 1 40,000,000 1.81 1 35,000,000 2.18 1 33,000,000 2.18 1 33,000,000 2.18 Total 61,500,000 51,500,000 49,500,000 49,500,000 The below table shows the ranges of OFFERED prices to UNICEF for 2019 to 2022 for products under development Presentation Price Range per Dose 1 dose vial USD 1.50 to USD 2.50 5 dose vial 3 manufacturers USD 0.998 to USD 1.10 3 manufacturers USD 1.11 to USD 2.528 10 dose vial USD 1.00 to USD 2.50 15
In conclusion and lessons learned Key lessons learned Scaling up vaccine production may be more challenging than expected even with very experienced vaccine manufacturers this needs to be factored in for future highly accelerated programmes Strong collaboration across all partners vaccine manufacturers, UNICEF, programme partners, countries required to manage a supply constrained situation to optimise programme objectives Close, clear and detailed communication from manufacturers throughout on any supply issues to facilitate country planning and to ensure a good understanding and consistent messaging IPV status Global supply availability will continue to be tight for 2019 and 2020 Agree on how any excesses doses should be allocated UNICEF to communicate with countries on timing of availability for catch up immunisation Of course, any additional supply available to UNICEF would be very welcome! 16
Additional information UNICEF published awarded prices Information on polio vaccine prices can be found at https://www.unicef.org/supply/files/2018_05_28_ipv.pdf https://www.unicef.org/supply/files/2018_02_13_opv_web_ price_update.pdf https://www.unicef.org/supply/files/inactivated_polio_vaccine_supply_update.pdf 17
THANK YOU! UNICEF/UN0144148/Abramson