The full scope of the Gavi Middle-Income Countries (MICs) Approach, as approved by the Gavi Board in June 2022, has two overarching objectives:

• prevent backsliding in vaccine coverage in former Gavi-eligible countries; and
• drive the sustainable introduction of key missing vaccines in both former and select never Gavi-eligible countries.

The below focuses on the support to drive New Vaccine Introductions by addressing relevant barriers, including pricing. A more comprehensive summary of the MICs Approach can be found here.

Country eligibility

The list of countries and economies eligible for support under the Gavi MICs Approach as of 1 July 2023 is available here. This excludes the majority of World Bank-classified upper middle-income countries (UMICs).¹

Of the 19 countries that have transitioned from Gavi support as of 2023, nine are missing from their routine immunisation schedule at least one of the antigens supported under the MICs Approach: four countries have not yet introduced pneumococcal conjugate vaccine (PCV); seven countries have not yet introduced rotavirus vaccine; and seven countries have not yet introduced human papillomavirus (HPV) vaccine. Of the 27 never Gavi-eligible countries, 17 countries were missing at least one of the antigens as of end 2023: 11 countries had not yet introduced PCV; 13 countries had not yet introduced rotavirus vaccine; and ten countries had not yet introduced HPV vaccine.

Support to drive sustainable New Vaccine Introductions

As part of the MICs Approach, Gavi offers a suite of catalytic tools to help drive the sustainable and equitable introduction of PCV, rotavirus and HPV vaccines in both former and never Gavi-eligible countries, which includes: 

• technical assistance focused on addressing country-specific needs through Gavi’s in-country partners, as well as technical assistance at global and regional levels to strengthen the enabling environment (e.g. behavioural insights and demand generation, decision-making and NITAG strengthening, disseminating market information, and support to financial sustainability, including development of National Immunisation Strategies (NIS);
• flexible funding to cover one-off costs related to activities that are traditionally unfunded or challenging to fund (e.g. communications campaign);
• vaccine catalytic financing to cover half of the first birth/target cohort (beyond this, procurement costs are covered by countries); and
• facilitated access to UNICEF pooled procurement services, by contributing funding to the UNICEF MICs Financing Facility, which offers pre-financing and special contracting modalities, with capacity to manage larger transactions and multiyear contracting (most of which may not be possible or available when countries attempt to procure from manufacturers directly). 

Beyond these specific interventions, Gavi-eligible MICs can also benefit from the Vaccine Alliance’s broader market shaping work and pooled procurement, to further drive access to sustainable supply and affordable pricing.

Leveraging the Vaccine Alliance's market shaping to support and sustain New Vaccine Introductions in MICs

There are three fundamental determinants of achievable vaccine price within countries’ direct control: (1) demand predictability and materialisation; (2) product choice; and (3) procurement approach, including choice of procurement channel.

Demand predictability and materialisation

The Alliance's market shaping approach helps address vaccine market failures, and create sustainability by fostering a sustainable and competitive supplier base, healthy demand and an environment that encourages innovation – all of which ultimately benefits global markets beyond low-income countries . Through market shaping roadmaps (available here), Gavi aims to improve demand predictability and materialisation (e.g. by incorporating demand from MICs in demand forecasts, and sharing that visibility with manufacturers to influence procurement outcomes – as was done recently with the updated HPV roadmap).

MICs' contribution: improve demand visibility for MICs in multiyear demand forecasts and timely procurement of forecasted demand.

Product choice

With over 20 years of successful market shaping interventions, the Vaccine Alliance has enabled the diversification of manufacturing and supply from five vaccine manufacturers in five countries of production in 2001, to 19 vaccine manufacturers from 12 countries of production by 2023. These new market entrants, and the competition they have brought, have directly contributed to improving affordability and can support cost reductions for MICs, including countries transitioning from Gavi support, through rational product choices and portfolio optimisation. 

MICs’ contribution: countries select vaccine products (e.g. by considering new suppliers and facilitating regulatory and product selection process) that are financially sustainable. 

Procurement approach

MICs’ commitment to immunisation and therefore to purchasing vaccines, including their choice of procurement channel, are a key driver of sustainable prices. Procuring through UNICEF – leveraging UNICEF’s procurement scale, access, market expertise and multiyear agreements – pools demand and strengthens market leverage to achieve desired procurement outcomes and better pricing. Countries in the Americas, including Gavi-eligible MICs from that region, can source vaccines through the Pan American Health Organization (PAHO) Revolving Fund – a pooled procurement mechanism that aims to provide access to safe, quality vaccines at affordable prices for Member States and Territories throughout the region.

MICs’ contribution: choose to participate in UNICEF or PAHO pooled procurement mechanisms.

Affordable pricing and visibility available to Gavi-eligible MICs through pooled procurement mechanisms

• Prices available through UNICEF Supply Division (SD) are publicly posted here. Given the multiple variables that define price terms for some products targeting MICs (e.g. PCV, HPV, rotavirus vaccines), a price range may be published. The actual price is then determined based on the country context and willingness to enter into multiyear procurement commitments through engagement with UNICEF. For any questions related to UNICEF procurement services and pricing, countries are encouraged to contact their UNICEF country offices and UNICEF SD.
• Prices available through PAHO Revolving Fund are publicly posted here.  

Public UNICEF data shows that former Gavi-eligible countries continue to access the same price as Gavi-eligible countries post-transition for at least one vaccine product in each Gavi-supported vaccine group²,  underscoring the importance of countries remaining vigilant about product choice and portfolio optimisation to sustain immunisation costs. Although UNICEF has also established prices for never Gavi-eligible MICs for specific products in a number of vaccine groups (e.g. PCV, rotavirus), there is currently less pricing visibility and a broader range of prices for these countries. Access to affordable vaccine products is expected to improve over time with aggregated MICs demand, solidified demand forecasts, reduction of regulatory barriers and optimal product choice. This is the objective of the MICs Approach levers presented above, which will help drive New Vaccine Introductions, prevent backsliding in vaccine coverage, and lead to a more robust and predictable MICs market.

Pricing visibility and predictability is an important enabler of financial planning and sustainability, especially if manufacturers’ tiered pricing approaches translate into a premium over prices available to Gavi-eligible countries. Gavi recognises that tiered pricing strategies may be necessary to ensure sustainability of supply and for the lowest prices to remain available to the lowest-income countries; however, the only win-win outcome is when prices offered by manufacturers match the affordability threshold at which New Vaccine Introductions occur and existing programmes continue. While the Vaccine Alliance works with MICs to strengthen demand signals within markets it has shaped over many years, suppliers are strongly encouraged to commit to sustainable and affordable supply to MICs, with a high level of pricing visibility. 

1. Countries eligible under the MICs Approach include all former Gavi-eligible countries (regardless of World Bank income classification), and never Gavi-eligible countries that are either classified by the World Bank as lower middle-income countries (i.e. GNI p.c. is below US$ 4,465) or eligible to the International Development Association (this includes Small Island Developing States).

2. Exceptions apply for Hexavalent and Typhoid conjugate vaccines, as well as for some PAHO countries, but in these instances UNICEF and PAHO have successfully established pricing within a reasonable range of Gavi-eligible pricing, which applies to a broader set of MICs providing much-needed visibility.