How are vaccines distributed through Gavi?

By Isla Gibson

What is Gavi?

Gavi was founded in 2000 as the Global Alliance for Vaccines and Immunization before recently changing its name to “Gavi.” Gavi provides comprehensive support in ensuring vaccine supply and effective roll-out in the parts of the world that need it the most. As a public-private global health partnership, Gavi is able to bring a range of stakeholders together to improve access to immunization in developing countries.

Gavi is funded by governments, philanthropic groups, multilateral organizations, and private sector partners, and has received >$21 billion during its current funding period of 2021-2025,¹ giving it the purchasing power to negotiate with vaccine manufacturers and ensure affordable prices, particularly for new and under-utilized vaccines.

Gavi’s mechanisms of support range from deciding how vaccine financing should be allocated between priority countries to broader market shaping. Their market-shaping efforts can include improving understanding of vaccine demand, increasing the number of vaccine suppliers, supporting national implementation, and conducting monitoring and evaluation.²

How does Gavi financing fit into the wider malaria vaccine distribution pipeline?

Gavi works closely with several other key groups to ensure vaccines are delivered effectively. Once a vaccine has been approved by the World Health Organisation (WHO) and evaluated by Gavi’s board, Gavi works with the United Nations Children’s Fund (UNICEF), which procures the vaccines from manufacturers. Next, Gavi aims to tailor the financial support it provides to the national priorities and plans of priority countries by communicating with governments. Finally, while UNICEF is responsible for purchasing, storing, and shipping doses to those countries that have successfully applied for Gavi financing, it is ultimately individual countries that implement vaccine distribution through national vaccination programs.

What framework does Gavi use to allocate vaccine financing between countries?

Gavi’s Independent Review Committee (IRC) aims to supply as many countries as possible with vaccines while still maintaining their first principle of prioritizing countries on the basis of need.³

Figure 1: WHO classification of malarial regions by need. Graphic from WHO Framework for the allocation of limited malaria vaccine supply, page 18

If there are multiple countries with similar levels of need and a scarce supply of vaccines, no single country will receive more than approximately 20% of the total available supply. If more vaccines become available later on, all countries that were affected by this 20% cap receive first priority for additional doses.

To assess ‘greatest need’, Gavi uses a composite measure that combines the P. falciparum prevalence rate (PfPR) in children with an under-five all-cause mortality rate (see Figure 1). Using this measure, countries are sorted into five categories, with ‘category 1’ countries being those countries deemed to have the greatest need for the vaccine. More can be read about this prioritization in our article here.

If there are unmet vaccine requests from multiple countries that score similarly in Gavi’s needs assessment, Gavi uses additional criteria to prioritize doses among high-priority countries.

First, they calculate the expected health impact of said country receiving the vaccine. This is measured with WHO-UNICEF estimates of the national drop-out rate between the third dose of the diphtheria-tetanus-pertussis vaccine (DTP3) and the first dose of the measles-virus-containing vaccine (MCV1) for the latest available year. If competing claims to scarce doses remain unresolved, the IRC then considers whether or not said countries participated in the clinical development of the vaccine.

Countries are more likely to be prioritized in funding allocation decisions if they demonstrate other desirable characteristics. The IRC assesses the capacity of the applying country’s national health system to reduce vaccine wastage, conduct post-introduction monitoring, and promote vaccine acceptance and demand.⁴ The December 2023 Interim Guidelines also require applications to identify and specify differentiated delivery strategies to reach missed communities and zero-dose children.⁵

What else does Gavi consider when allocating vaccine financing?

In order for a country to be eligible, applications must also confirm their willingness and ability to channel 10% of all financing through civil society organizations. To avoid backsliding in vaccine coverage, wealthier, ineligible countries might also be able to receive targeted financial support – for instance, to help countries cover one-off costs – provided they communicate their vaccine requirements to UNICEF or the WHO.⁶

Beyond this, Gavi’s IRC is also looking to assess the capacity and readiness of countries’ health systems to deliver vaccines effectively and sustainably. Some of their requirements include that applications discuss prioritization of vaccines within broader malaria prevention and control efforts, that plans for vaccine implementation are implemented within the country’s existing healthcare systems, and that relevant state authorities sign off their commitment to meet co-financing obligations.

What kind of support does Gavi offer in vaccine distribution and which countries are eligible for this support?

Gavi offers countries at least two forms of financial support for the phased roll-out of the malaria vaccine.

Firstly, Gavi offers eligible countries vaccine co-financing. This funding mechanism is designed around strengthening applicants’ self-financing capacity, providing a phased-out financing structure in which countries receive progressively less funding as their ability to self-finance their immunization programs increases.⁷

Eligibility is based on a country’s income per capita. Gavi’s co-financing mechanism sorts countries into one of three transition status groups, using Gross National Income per capita (GNI p.c.) as a proxy for that country’s ability to buy vaccines (see Figure 2):⁸

Initial Self Financing Group: Countries are eligible for the Initial Self Financing group if their GNI p.c. is equal to or below the World Bank’s low-income threshold (USD 1,135 GNI p.c. as of 2023). This group would be asked to contribute a fixed rate of USD 0.20 per dose for both the RTS,S and R21 vaccines until their income increases above the low-income threshold.
Preparatory Transition Group: Countries whose GNI p.c. is between USD 1,135 and USD 1,810 enter the Preparatory Transition Group where they will be asked to provide USD 0.20 in co-financing per dose in the first year, with the required contribution increasing by 15% each following year.⁹
Accelerated Transition Group: Countries whose three-year average GNI p.c. and most recent GNI p.c. are between USD 1,810 and USD 4,465 are asked to contribute 20% of the vaccine price towards co-financing in the first year, with the required contribution increasing by ten points each following year. With this timeline, countries in this group would be expected to be fully self-financing after eight years.¹⁰

Figure 2: Co-financing model. Source: Gavi (2024)

As a country’s GNI p.c. changes, their Transition Group status for Gavi financing might change too. Gavi uses the most up-to-date data released each year by the World Bank to review and potentially update the country’s Transition Group, any changes becoming effective from the 1st of January each year.¹¹ Under Gavi’s typical co-financing policy for routine programs, when a country changes Transition Group status to enter either the Preparatory or Accelerated Transition groups, Gavi applies a one-year grace period where the co-financing rules of the previous transition phase apply; whether this applies to the malaria vaccine campaign is unclear

Secondly, Gavi also offers time-limited Vaccine Introduction Grants (VIGs) to support the recipient’s routine immunization programs. In the VIGs’ first phase, countries are given an initial grant to support the introduction of the malaria vaccine in the parts of their country with the greatest need. This will be a lump sum of a minimum of USD 100,000, depending on the country’s transition status and the size of the birth cohort within the sub-national areas identified as high priority.¹² In later phases of the VIGs, Gavi expects to be able to provide further grants to support the expansion of immunization within countries outside of these high-priority sub-national areas.

What does a Gavi application round look like?

Eligible countries can apply for Gavi funding and technical assistance three times a year.¹³

Countries applying for malaria vaccine support from Gavi are invited to describe the full scope of their desired vaccine roll-out, assuming that there were no supply shortages, and with full detailing of sub-national differences in need for the vaccine. For example, applicants would be asked to provide full in-country data from different sub-national areas according to the Allocation Framework, such as parasite prevalence, under-five mortality rates, and the number of children in the target populations.

What is the latest news from Gavi on the distribution of the R21 vaccine?

According to the Interim Guidelines published in December 2023, countries eligible for transition status groups 1 (Initial Self Financing) and 2 (Preparatory Transition Group) will be offered the same co-financing arrangements, regardless of which malaria vaccine they receive.¹⁴ However, countries in group 3 (Accelerated Transition) are expected to pay less for the R21 vaccine than they would for the RTS,S vaccine. This is because their co-financing share is directly linked to vaccine prices, and the R21 vaccine is a lower-priced vaccine at currently awarded prices.

Throughout 2022 and 2023, countries were generally advised to focus the plans detailed in their applications on sub-national areas with the greatest need, given the shortage of malaria vaccines available at the time. As more doses are manufactured to eventually fulfill total demands, Gavi now invites countries to apply with details of how vaccines would be used at scale and in coordination with other malaria prevention and control interventions.

Currently, it is unclear how exactly the different malaria vaccines will be allocated between countries. Product choice is, however, likely to be guided by vaccine supply availability, product characteristics and programmatic needs, and long-term affordability considerations, particularly for countries approaching the end of the Gavi transition.