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Vaccine Pricing: Gavi Fully Self-financing & Accelerated Transition Countries

Manufacturer commitments presented in this document – provided solely for the purpose of helping Gavi fully self-financing and accelerated transition countries to plan and budget adequately for self-financing – are not legally binding; they do not represent contractual obligations between sellers and countries and as such are not a guarantee of price, eligibility criteria or duration. All commitments are subject to supply availability. The Gavi product menu This document intends to address questions that procurement officials with information on product availability is provided by UNICEF at https:// and immunisation stakeholders www..org/supply/index_gavi.html (within Ministry of Health and Ministry of Finance, among others) This document reflects 2018 prices and will be updated annually. may have about pricing in countries that are transitioning or have transitioned out of Gavi support. These are countries that have surpassed or will surpass the Gavi Gross National Income (GNI) Summary eligibility threshold and therefore are no longer eligible for Gavi support As of November 2018, nine countries are in a state of accelerated (including co-financing of vaccine transition from Gavi support to self-financing1, and 16 countries have procurement). transitioned out of Gavi support2. These countries have requested WHO In particular, the document aims to provide more visibility on their vaccine purchase price prospects, for to provide information on public sector vaccine prices that can both the proper budgeting of ongoing programs and the assist Gavi-transitioning countries’ introduction of new . financial planners in establishing appropriate budgets when countries Three manufacturers – GSK, Merck and – have committed to assume full self-financing of previously Gavi-supported vaccines. continue providing countries that transition out of Gavi support with Importantly, this document can access to prices similar to those offered to Gavi-supported countries, or also provide crucial information to to maintain the prices that these countries are currently paying for certain countries contemplating new vaccine vaccines, for a certain period of time, depending on commitment terms. introductions. These commitments apply to: This is one of several tools available to Gavi-transitioning countries on • human papillomavirus vaccine (HPV) the MI4A website. MI4A has vaccine price and procurement data from • pneumococcal (PCV) 151 countries. The database, as well as documents on vaccine pricing, • vaccine (Rota)3 are available on the MI4A website: http://www.who.int/immunization/ MI4A Information for Gavi-transitioning countries is also available on the Gavi website: http://www.gavi.org/ support/sustainability/transition- process/ UNICEF vaccine price data is available: https://www.unicef.org/ supply/index_57476.html This document has been prepared by the Expanded Programme on (EPI) of the Department of Immunization, Vaccines and Biologicals. This version is up to date as of 1India, Lao PDR, Nicaragua, , Papua New Guinea, Sao Tome and Principe, Solomon Islands, Uzbekistan, November 2018. Vietnam. For more information on this 2Angola, Armenia, Azerbaijan, Bhutan, Bolivia, Congo, Cuba, Georgia, Guyana, Honduras, Indonesia, Kiribati, document or on vaccine price and Moldova, Mongolia, Sri Lanka, Timor-Leste, Ukraine. procurement, please email MI4A@ 3 Manufacturers have also made commitments for Gavi-transitioning countries for pentavalent vaccines. who.int However, as of 2017, all UNICEF suppliers of are offering the same price to all countries buying through UNICEF, irrespective of their Gavi status. Therefore, information on pentavalent prices is not covered in this fact sheet, but is available from UNICEF at: https://www.unicef.org/supply/files/Penta_Price_ Update_17_10_06.pdf

November 2018 | 1 The GAVI Framework for Transitioning Details of Manufacturer Commitments Countries Three vaccine manufacturers have committed to The aim of the Transition Policy is to contribute to continue to offer PCV, Rota, and HPV vaccines (specific the vision that, when countries transition out of Gavi presentations) to countries that transition out of support, they have successfully expanded their national Gavi support at prices similar to those paid by Gavi- immunisation programmes with vaccines of public supported countries or to maintain fixed prices for a health importance and sustain these vaccines post- certain period of time and under specific conditions transition with high and equitable coverage of target terms. For most manufacturers, procurement must be populations, while having robust systems and decision- through UNICEF.8 Additionally, GSK has allowed for making processes in place to support the introduction the possibility of self-procurement for any of their price of future vaccines (see the Gavi website at: http:// commitments; countries should contact GSK to check www..org/about/programme-policies/eligibility- for availability. and-transition/ and http://www.gavi.org/support/ The product-specific price commitments announced sustainability/transition-process/). Low vaccine prices by vaccine manufacturers are summarised in Tables (in addition to a variety of other factors) are necessary 1–3 for ease of reference. Commitment prices for for supporting countries to sustain immunization 2018 are listed for each product. This commitment programmes and introduce new vaccines after they price only applies to countries that are transitioning no longer receive Gavi financial support. Per the Gavi in 2018 and may not apply for countries transitioning website, “fully self-financing countries can no longer at a later date due to possible long-term agreement access new financial support from Gavi. However, (LTA) price changes (this is not applicable to fixed several manufacturers have made commitments to price commitments). More information is available on continue providing these countries with access to prices the Gavi website at: http://www.gavi.org/library/gavi- similar to those Gavi pays, under specific circumstances documents/supply-procurement/. and for a specified time period”.4 It is important for countries to note that since the price In 2019, 14 countries will be in the “preparatory commitments were made in 2015, there have been transition” phase5, 9 in the “accelerated transition” 6 7 pricing evolutions for some vaccines and countries can phase , and 16 in the “fully self-financing” phase . In all, now access lower prices through UNICEF. The current 25 countries are expected to be fully self-financing by (2018) UNICEF LTA prices for two products are lower 2025. than the manufacturer commitment prices: • Pfizer 4- PCV is now offered via UNICEF procurement at $2.95 • Merck 1-dose Rota is now offered via UNICEF procurement at $3.20 Prices shown are either price freezes based on UNICEF LTA or supply agreement prices or fixed prices stated within the commitment terms. Prices shown are indicative only and are not a guarantee of price.

4 https://www.gavi.org/about/programme-policies/eligibility-and-transition/ 5 Bangladesh, Cambodia, Cameroon, Cote d'Ivoire, Djibouti, , Kenya, Kyrgyzstan, Lesotho, Mauritania, Myanmar, , Sudan, Zambia 6 , Lao PDR, Nicaragua, Nigeria, Papua New Guinea, Sao Tome and Principe, Solomon Islands, Uzbekistan, Vietnam. 7 Angola, Armenia, Azerbaijan, Bhutan, Bolivia, Congo, Cuba, Georgia, Guyana, Honduras, Indonesia, Kiribati, Moldova, Mongolia, Sri Lanka, Timor-Leste, Ukraine. 8 Self-procuring countries should contact manufacturers to check for eligibility.

November 2018 | 2 Human Papillomavirus Vaccine

Table 1. Price commitments, for HPV, to fully self-financing Gavi countries procuring through UNICEF SD*, 2018

Manufacturer Presentation Conditions of Price Commitment Commitment Commitment Size (form) Duration Prices (2018)

GSK 2-dose (liq) Fully self-financing countries are eligible at the current commitment 10 years $4.60 price of $4.60 per dose. Countries that transition in the future will be from date of eligible for the price at time of transition. transition to Countries that had not applied for Gavi support at the time of full fully self- transition, the same price commitment will be made provided that: financing** • A supply agreement for an immunization program is entered on or before 31 December 2017 • The price freeze offer will apply for 10 years from the effective date of such supply agreement and will take the form of an initial five-year contract, renewable once for an additional period of five years • The price will be the same as the price last offered to the Gavi Alliance at the effective date of such agreement. Not valid if a country has introduced an HPV vaccine programme under Gavi support using a different manufacturer’s product and wishes to switch after transition.

Merck 1-dose (liq) Commitment of $4.50 per dose is at the 2015 price, regardless of Until end of $4.50 subsequent UNICEF LTA price changes that may occur. 2025 Applies to: 1. Gavi accelerated transition or fully self-financing countries with a GNI per capita ≤ US$3,200 in 2013 (, 2014) that wish to introduce HPV4 or to continue an existing HPV vaccination program 2. Gavi accelerated transition or fully self-financing countries with a GNI per capita > US$3,200 that meet Gavi’s Exceptional Opportunity criteria in 2016, for introduction by end of 2017. Procurement through UNICEF or PAHO beginning with HPV programme initiation is required. Valid if countries using a competitors’ product, who meet Merck’s eligibility criteria, elect to switch to Merck’s product. Not valid for HPV9.

* Self-procuring countries can contact GSK for price availability. **GSK price freeze commitment is always subject to volumes of vaccine(s) available at the time of procurement and GSK reserves the right to increase in the freeze price subject to inflation.

November 2018 | 3 Pneumococcal Conjugate Vaccine

Table 2. Price commitments, for PCV, to fully self-financing Gavi countries procuring through UNICEF SD*, 2018

Manufacturer Presentation Conditions of Price Commitment Commitment Commitment Size (form) Duration Prices (2018)

GSK 4-dose (liq) Fully self-financing countries are eligible at the current commitment 10 years $3.05 price of $3.05 per dose. Countries that transition in the future will be from date of eligible for the price at time of transition. transition to fully self- Not valid if a country has not introduced PCV with Gavi support*** financing** or is currently using a different manufacturer’s product and wishes to switch after transition. However, countries still have access to the Gavi AMC tail-price under the conditions of the AMC until the end of 2027.

Pfizer 1-dose (liq) Commitment of $3.30 per dose, regardless of subsequent supply Until end of $3.30 agreement price changes that may occur. 2025 Until 2025 for all Gavi-eligible countries, whether vaccine is introduced before or after fully self-financing.**** Valid if a country is currently using a different manufacturer’s product and wishes to switch to a Pfizer vaccine.

4-dose (liq) Commitment of $3.05 per dose, regardless of subsequent supply Until end of $3.05 agreement price changes that have occurred. 2025 Until 2025 for all Gavi-eligible countries, whether the vaccine is introduced before or after fully self-financing.**** Valid if a country is currently using a different manufacturer’s product and wishes to switch to a Pfizer vaccine.

The 2018 UNICEF Advanced Market Commitment (AMC) tail price of $2.95 per dose is available to Gavi transitioned and transitioning countries procuring through UNICEF.

*Self-procuring countries can also contact GSK for price availability. **GSK price freeze commitment is always subject to volumes of Eligible Vaccine(s) available at the time of procurement and GSK reserves the right to increase the freeze price subject to inflation. ***Only countries with DTP3 coverage levels greater than or equal to 70%, based on the latest WHO/UNICEF estimates for 2017 (published in July 2018), can apply to Gavi for access to PCV. As of October 2017, countries that have passed the eligibility threshold and have DTP3 coverage levels greater than or equal to 70% but have not yet applied to access the AMC Tail Price for PCV are as follows: Cuba, Indonesia, Sri Lanka, Timor-Leste, Vietnam. For more information, see PCV Application Guidelines Transitioning Countries, available at: http://www.gavi.org/library/gavi-documents/guidelines-and-forms/. ****All procurement is subject to ongoing availability of Pfizer PCV.

November 2018 | 4

Table 3. Price commitments, for Rota, to fully self-financing Gavi countries procuring through UNICEF SD*, 2018

Manufacturer Presentation Conditions of Price Commitment Commitment Commitment Size (form) Duration Prices (2018)

GSK 1-dose (liq)** Fully self-financing countries are eligible at the current commitment 10 years €1.88 price of €1.88 per dose. Countries that transition in the future will be from date of eligible for the price at time of transition. transition to fully self- Not valid if a country has introduced a rotavirus vaccine programme financing*** under Gavi support using a different manufacturer’s product and wishes to switch after transition.

Merck# 1-dose (liq) Commitment of $3.50 per dose, regardless of subsequent price Until end of $3.50 changes that have occurred. 2025 Commitment to: Gavi accelerated transition or fully self-financing countries with GNI per capita ≤ US$3,200 in 2013 (World Bank, 2014) that wish to introduce Merck rotavirus vaccine or continue an existing rotavirus vaccination program. Valid if countries using a competitors’ product, who meet Merck’s eligibility criteria, elect to switch to Merck’s product.

# No supply is currently available from this source for countries in accelerated transition and fully self-financing.

* Self-procuring countries can contact GSK for price availability. ** New presentations of the same vaccines or new vaccines will be evaluated for inclusion in the commitment as they become available *** GSK price freeze commitment is always subject to volumes of vaccine(s) available at the time of procurement and GSK reserves the right to increase the freeze price subject to inflation.

November 2018 | 5 Details of Countries' Eligibility for Prices PCV – Eighteen countries are not eligible for GSK’s PCV Similar to Those Offered to Gavi-supported pricing commitments, at the listed price, because they Countries are already using a Pfizer product, or did not introduce the product with Gavi’s support. However, countries Countries that are soon-to-be or are currently fully have access to the tail price ($3.05) under conditions of self-financing should be aware that they can continue the AMC. to access to prices similar to those offered to Gavi- supported countries, under the conditions listed above. All countries can access the Pfizer PCV products at the listed price up to 2025, even if the country has As of 2018, most of the 26 transitioning or fully self- transitioned from Gavi and is fully self-financing. financing countries are eligible to benefit from some price commitments of manufacturers. However, some Rota – Five countries that have not introduced Rota countries, detailed below, are ineligible for the pricing with Gavi support – Azerbaijan, Cuba, Indonesia, 9 commitments for some vaccines. These countries can Mongolia, Sri Lanka – are not currently covered by the still contact manufacturers. price commitments for Rota vaccines. HPV – Four countries that have not introduced HPV Thirteen countries are not eligible for the GSK product, vaccine with Gavi support – Angola, Azerbaijan, at the listed price, because they are currently using a Cuba, Mongolia –are no longer covered by the price different manufacturer’s product or had not introduced commitments for HPV vaccines as all had a Gross the product with Gavi’s support. National Income (GNI) per capita > $3,200 in 2013 Nine fully self-financing countries are not eligible for the (source: World Bank) and an agreement for introduction Merck product, at the listed price, because their GNI was not reached by the end of 2017 (as recommended per capita exceeds $3,200 as of 2013. However, these in the commitments). countries would re-qualify for the Merck product, should All fully self-financing countries are no longer eligible their GNI per capita fall below the $3,200 threshold. for the GSK product at the listed price. All countries in accelerated transition are still eligible.

9 Merck price commitment eligibility is based on GNI and all five countries listed exceed the maximum GNI for eligibility. GSK offers no opportunity to regain eligibility.

November 2018 | 6 Table 4. Gavi fully self-financing (A) and accelerated transition (B) countries’ introduction status of HPV, PCV, and Rota and UNICEF LTA prices (2018) for countries that meet the manufacturers’ conditions for access.

A. GNI per Period HPV (2017) PCV (2017) Rota (2017-2021) Capita 1st year Intro GSK Merck Intro GSK Pfizer Pfizer Intro GSK Merck (2017) accelerated with with 2-dose vial 1-dose vial 4-dose 1-dose 4-dose with 1-dose 1-dose transition / Gavi Gavi (bivalent) (quadrivalent) viala vial vial Gavi (2-dose (3-dose self-financing course) course)b Angola $3,330 2011 2018 N NE NE Y $3.05 $3.30 $2.95 Y €1.88 NE Armenia $4,000 2011 2018 Y NE $4.50 Y $3.05 $3.30 $2.95 Y €1.88 NE Azerbaijan $4,080 2011 2018 N NE NE Y $3.05 $3.30 $2.95 N NE NE Bhutan $2,720 2011 2016 Y NE $4.50 N $3.05 $3.30 $2.95 N NE $3.50 Bolivia $3,130 2011 2018 Y NE $4.50 Y $3.05 $3.30 $2.95 Y €1.88 $3.50 Congo $1,360 2011 2018 N NE $4.50 Y $3.05 $3.30 $2.95 Y €1.88 $3.50 Cuba - 2011 2017 N NE NE N $3.05 $3.30 $2.95 N NE NE Georgia $3,790 2011 2018 Y NE $4.50 Y $3.05 $3.30 $2.95 Y €1.88 NE Guyana $4,460 2012 2017 Y NE $4.50 Y $3.05 $3.30 $2.95 Y €1.88 NE Honduras $2,250 2011 2016 Y NE $4.50 Y $3.05 $3.30 $2.95 Y €1.88 $3.50 Indonesia $3,540 2011 2017 N NE $4.50 N $3.05 $3.30 $2.95 N NE NE Kiribati $2,780 2011 2017 N NE $4.50 Y $3.05 $3.30 $2.95 Y NE $3.50 Moldova $2.180 2011 2017 Y NE $4.50 Y $3.05 $3.30 $2.95 Y €1.88 $3.50 Mongolia $3,290 2011 2016 N NE NE Y $3.05 $3.30 $2.95 N NE NE Sri Lanka $3,840 2011 2016 Y NE $4.50 N $3.05 $3.30 $2.95 Y NE NE Timor-Leste $1,790 2013 2018 N NE $4.50 N $3.05 $3.30 $2.95 N NE $3.50

B. India $1,820 2017 2022 N $4.60 $4.50 Y $3.05 $3.30 $2.95 Y NE $3.20 Lao PDR $2,270 2017 2022 N(p) $4.60 $4.50 Y $3.05 $3.30 $2.95 N €1.88 $3.20 Nicaragua $2,130 2016 2021 N $4.60 $4.50 Y $3.05 $3.30 $2.95 Y €1.88 $3.20 Nigeria $2,080 2017 2022 N $4.60 $4.50 Y $3.05 $3.30 $2.95 N NE $3.20 Papua New $2,410 2016 2021 N $4.60 $4.50 Y $3.05 $3.30 $2.95 N NE $3.20 Guinea Sao Tome $1,770 2018 2023 N $4.60 $4.50 Y $3.05 $3.30 $2.95 Y NE $3.20 and Principe Solomon $1,920 2017 2022 N $4.60 $4.50 Y $3.05 $3.30 $2.95 N €1.88 $3.20 Islands Uzbekistan $1,980 2014 2021 N(p) $4.60 $4.50 Y $3.05 $3.30 $2.95 Y €1.88 $3.20 Vietnam $2,170 2015 2020 N $4.60 $4.50 N $3.05 $3.30 $2.95 N NE $3.20 a) Eleven fully self-financing and seven accelerated transition countries* are not eligible for the GSK price freeze but have access to the GSK Gavi tail-price ($3.05) under the conditions of the AMC and until it is renegotiated (*Angola, Armenia, Azerbaijan, Bhutan, Bolivia, Congo, Cuba, Guyana, Honduras, Kiribati, Moldova, Mongolia and India, Lao PDR, Nicaragua, PNG, Sao Tome, Solomon Islands, Uzbekistan). b) The Merck Rota commitment price (not the UNICEF LTA price) is listed for Gavi fully self-financing countries.However , no supply is currently available from this source for countries in accelerated transition and fully self-financing. Legend: Y = yes, N= No, N(p) = No, but planned introduction with Gavi-support; NE = Not Eligible; Dark-shaded boxes = countries that are not eligible, or at risk of not being eligible, for UNICEF prices offered to Gavi-supported countries, from any of the manufacturers offering a specific vaccine.

Sources: World Bank GNI per capita US$ Atlas Method, 2017: https://data.worldbank.org/indicator/NY.GNP.PCAP.CD. Cuba’s GNI per capita is unknown but the country is estimated to be upper middle income ($3,896 to $12,055).

November 2018 | 7 Vaccine Prices Paid by Self-Procuring Table 5. Price ranges reported by self-procuring non-Gavi, non-PAHO LMICs and UMICs for 2017 Non-Gavi, Non-PAHO MICs Since not all fully self-financing countries are willing to Presentation Non-Gavi LMIC* Non-Gavi UMIC** procure through UNICEF or able to procure through size (n) (n) PAHO, and some Gavi-transitioning or fully self-financing HPV 1 dose $13.69 (1)*** $8.41-103.73 (10) countries are not covered by the manufacturers’ price PCV 1 dose $12.31–22.04 (3) $9.85–61.48 (15) commitments, a list of price ranges for PCV, Rota and HPV vaccines as reported by self-procuring non-Gavi, Rota 1 dose $3.57–9.52 (3) $3.98–15.24 (7) non-PAHO lower middle-income countries (LMICs) and *GNI per capita of between $1,006 and $3,955 upper middle-income countries (UMICs) in 2017 are **GNI per capita of between $3,956 and $12,235 shown in Table 5. Additionally, countries self-procuring *** LMIC HPV price is from 2016 as no non-Gavi, non-PAHO self-procured prices for HPV were reported for 2017 any of the three products should contact GSK about (n) = number of countries reporting price data price commitment availability. Source: MI4A Database: http://www.who.int/immunization/MI4A

Disclaimer Information contained in the MI4A database is provided by participating countries and/or organizations procuring on behalf of countries that have agreed to share vaccine price and procurement data with MI4A. Participating countries are solely responsible for the accuracy of the data provided. The information contained in the MI4A database does not in any way imply an endorsement, certification, warranty of fitness or recommendation by WHO of any company or product for any purpose, and does not imply preference over products of a similar nature that are not mentioned. WHO furthermore does not warrant that: (1) the information is complete and/or error free; and/or that (2) the products listed are of acceptable quality, have obtained regulatory approval in any country, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to laws. Inclusion of products in the database does not furthermore imply any approval by WHO of the products in question (which is the sole prerogative of national authorities). WHO will not accept any liability or responsibility whatsoever for any injury, death, loss, damage, or other prejudice of any kind that may arise as a result of, or in connection with the procurement, distribution and use of any product listed in the MI4A database.

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