1. What is the African Vaccine Manufacturing Accelerator (AVMA)?

The African Vaccine Manufacturing Accelerator (AVMA) is one of the four pillars of Gavi’s regional manufacturing strategy, approved by the Gavi Board in December 2022 to support strengthening vaccine supply resilience at regional level.

AVMA is a financing mechanism designed to make up to US$ 1.2 billion available over ten years (2024–2034) to support the sustainable growth of Africa’s vaccine manufacturing base. AVMA operates by disbursing incentives to manufacturers to help offset high initial costs of production.

2. When was AVMA established and with what objectives?

AVMA was approved by the Gavi Board in December 2023 and launched in June 2024, following a design process conducted over nearly two years of close collaboration between Gavi, the Vaccine Alliance, the African Union and the Africa Centres for Disease Control and Prevention (Africa CDC), with extensive consultations with partners, donors, industry, civil society and other stakeholders.

AVMA aims to contribute to two overarching objectives:

  • a sustainable African manufacturing base that contributes to healthy global vaccine markets; and
  • improved pandemic and outbreak vaccine supply resilience in Africa.

3. Why does AVMA focus on Africa?

The COVID-19 pandemic brought the strategic importance of access to vaccines and supply resilience into the public eye, and to the forefront of the minds of policymakers. No region felt the negative effects of COVID-19 vaccine inequity more than Africa, and no region stands to benefit more from sustainable growth in its vaccine manufacturing sector. At present, demand for vaccines in Africa is valued at over US$ 1 billion annually, with this figure projected to grow along with the continent’s population over the next several decades.

Africa already accounts for around 20% of the world’s population, yet the continent’s vaccine industry provides only around 0.1% of global supply. A sustainable expansion of Africa’s vaccine manufacturing capacity would have a double pay-off for the continent, contributing to the growth of a high-value biotechnology sector on the continent – at the same time, supporting pandemic and outbreak prevention and response.

4. How does AVMA fit in with the larger global health architecture?

To see Africa become more self-reliant in addressing its vaccination needs, the African Union (AU) has set the ambitious goal to develop, produce and supply more than 60% of the vaccine doses required on the continent by 2040. To support this vision, the AU and the Africa Centres for Disease Control and Prevention (Africa CDC) have launched an eight-point “Platform for Harmonized African Health Products Manufacturing” (PHAHM – formerly PAVM) Framework for Action. Answering the AU and Africa CDC’s call for action, Gavi has developed a four-pillar regional manufacturing strategy that leverages Gavi’s market shaping and innovative financing expertise to contribute to the broader PHAHM Framework for Action. AVMA is one of the four pillars of this strategy – one component within the AU-led ecosystem of initiatives contributing to the vision set out in the PHAHM Framework for Action.

5. What are the roles of Gavi and of other stakeholders?

With its call for action in the Platform for Harmonized African Health Products Manufacturing (PHAHM – formerly PAVM), Africa CDC underscored that building African vaccine manufacturing capabilities will take concerted efforts across the vaccine manufacturing ecosystem. Gavi has committed to contributing to this joint agenda through its regional manufacturing strategy, of which AVMA is one of the four pillars. AVMA leverages Gavi’s track record in innovative financing instruments and primarily contributes to the ‘access to finance’ component of the PHAHM Framework.

To be successful, AVMA will require the ongoing contributions of a wide range of partners in the ecosystem across all components of the PHAHM agenda, including crowding in additional investment, regulatory strengthening, technology transfers, R&D and talent development, and infrastructure development. Vaccine Alliance partners are establishing a substantial footprint in support of this agenda, including involvement in initiatives such as the African Pooled Procurement Mechanism, the Health Emergency Preparedness, Response, and Resilience Program (HEPRR), and Gavi and UNICEF partnering with Africa CDC to Strengthen Health Systems and Immunization of Children in Africa.

6. How does AVMA relate to the Gavi replenishment?

AVMA’s success depends on African manufacturers winning competitive tenders to supply vaccines to Gavi-funded vaccine programmes. A successful Gavi replenishment – to raise funds for immunisation in lower-income countries for Gavi’s 2026–2030 strategic period (Gavi 6.0) – will be critical to upholding the markets into which these AVMA-supported vaccines will be supplied. AVMA was launched on 20 June 2024, alongside the unveiling of Gavi’s Investment Opportunity for 2026–2030, at an event co-convened by the African Union, the Government of France and Gavi. Gavi’s 6.0 strategy will strengthen health systems in lower-income countries – many across Africa – which will boost levels of vaccination; build vaccine demand; and pave the way for new vaccine introductions against diseases like malaria, HPV and tuberculosis.

7. What kind of funding does AVMA provide?

AVMA aims to provide a pathway to financial sustainability for eligible manufacturers by disbursing two types of incentives/payments at specified trigger points. Through these payments, AVMA seeks to level the playing field for African-based manufacturing, helping African-manufactured vaccines to better compete in the global market.

The first type of payment, termed a Milestone payment, is triggered when a manufacturer producing an eligible vaccine included in the list of AVMA Priority vaccines, or produced on one of the AVMA Priority technology platforms, succeeds in obtaining WHO prequalification (PQ) and enters into a Milestone payment agreement.

The second type of payment, termed an Accelerator payment, is payable upon delivering eligible vaccine doses, following award through a competitively won UNICEF tender. The Accelerator payment is a per-dose ‘top-up’, paid separately to the awarded price on UNICEF contract with manufacturers.

For more information on the incentive values, see question 12 below. Additional information is available in AVMA Guidance for Manufacturers.

8. What is WHO prequalification?

WHO prequalification (PQ) is a certification issued by the World Health Organization (WHO) that a vaccine produced by a manufacturer meets WHO standards in terms of quality, safety and efficacy. In prequalifying vaccines, WHO applies international standards to comprehensively evaluate the vaccine’s programmatic suitability, safety and quality, and good manufacturing process. WHO PQ is issued for a specific vaccine and presentation, and is a prerequisite to participate in Gavi-UNICEF vaccine procurement tenders. More information on the WHO prequalification process can be found on the WHO website.

9. Which vaccines are eligible for AVMA incentives?

All vaccines included in Gavi’s portfolio are eligible for Accelerator payments. AVMA Priority vaccines and all vaccines in Gavi’s portfolio that are produced on AVMA Priority technology platforms are also eligible for Milestone payments and Accelerator payments at a higher rate (see question 12 below). These priorities have been defined to support the supply of vaccines that would be complementary to market health on a global level, or else have strategic importance for the African continent.

The AVMA Priority vaccines are:

  • Oral cholera
  • Malaria
  • Measles-rubella
  • Hexavalent (wP)
  • Yellow fever
  • Ebola (AVMA Priority only with the following required profile: indication against at least two Ebola species and improved thermostability as from -20°C)
  • Rotavirus (AVMA Priority only with the following required profile: single-dose blow-fill-seal presentation)
  • Pneumococcal (AVMA Priority only with the following required profile: minimum 13-valent)

The AVMA Priority technology platforms are:

  • mRNA
  • Viral vector

10. Who will be the recipients of AVMA incentives?

AVMA incentives will be paid directly to manufacturers of eligible vaccines that meet the requirements to receive a Milestone payment or Accelerator payment. Milestone payments are disbursed to the WHO PQ holder of the eligible vaccine. Accelerator payments are disbursed to the entity that contracts with UNICEF for the supply of an eligible vaccine through a competitively won tender.

11. What are the requirements to receive AVMA incentives

AVMA incentives are intended for vaccines manufactured in Africa. The Gavi Board approved a set of “AVMA terms”, which define the key elements of AVMA including the eligibility criteria a vaccine must meet to qualify for AVMA incentives, outlined in the box below. For more information on AVMA eligibility, please refer to AVMA Guidance for Manufacturers.

AVMA eligibility criteria

The requirements for AVMA eligibility are:

Vaccine Type: Qualifying Vaccine that is WHO prequalified

Manufacturing Type: 

  • The Qualifying Vaccine is Fully Manufactured on the African continent;

or 

  • Fill & Finish of the Qualifying Vaccine is carried out in a manufacturing facility on the African continent that is Controlled by the holder of the WHO prequalification of the Qualifying Vaccine.

Where capitalised terms have the following meanings:

AVMA Drug Substance Manufacture: the process of manufacturing every constituent antigen of a vaccine, with the exception of manufacturing of the polio antigen or any other antigen designated by the WHO as necessitating a Containment Certification Scheme (or similar). For the avoidance of doubt, manufacture of adjuvants, conjugate carrier proteins, preservatives and excipients as well as lyophilization and formulation of bulk vaccine are not considered under this definition.

Fill & Finish: The process of filling vials (or equivalent final container) with formulated drug substance with or without subsequent intermediate and final packaging. For the avoidance of doubt, packaging of intermediate or final product alone without the process of filling will not constitute Fill & Finish.

Fully Manufactured: both (i) AVMA Drug Substance Manufacture; and (ii) Fill & Finish.

Qualifying Vaccine: A Qualifying Vaccine is defined as all vaccines in Gavi’s vaccine portfolio. A Qualifying Vaccine is also considered an AVMA priority (and therefore eligible for Milestone payment and higher Accelerator payments) if it is identified as an AVMA Priority vaccine and/or manufactured on an AVMA Priority technology platform.

Controlled: The decision-making executives of the WHO prequalification holder of the Qualifying Vaccine are authorised to make final decisions with respect to the operations and strategic planning of the facility.

12. What are the values of incentives disbursed by AVMA?

AVMA has a tiered incentive structure, designed to align with AVMA’s objectives. The amount of the Milestone payment varies between US$ 10 million and US$ 25 million depending on the product and technology platform. The Accelerator payment is a per dose ‘top-up’ of up to US$ 0.50 per dose, depending on the product, paid separately to the awarded price on UNICEF contract with manufacturers. The detailed incentive values are specified in AVMA Guidance for Manufacturers.

13. Are there limitations to the financing disbursed by AVMA?

To ensure diversification of the funds disbursed by AVMA, a set of ‘caps’ has been established as part of AVMA’s design. The caps set the maximum amount that can be disbursed by AVMA per manufacturer, per vaccine category, as Milestone payments, and across total incentives paid in relation to ‘fill and finish-only vaccines’. The values of the caps are specified in AVMA Guidance for Manufacturers.

These caps aim to ensure that AVMA funding mainly incentivises ‘drug substance’ manufacturing, as well as a diversified manufacturer and vaccine/platform base across the continent. Milestone payments are capped to ensure sufficient funding is available to help manufacturers bring their product to market.

14. What is the difference between ‘drug substance’ and ‘fill and finish’ for AVMA?

For the purposes of AVMA, ‘drug substance’ manufacture is defined as the process of manufacturing every constituent antigen of a vaccine. Manufacturing of adjuvants, conjugate carrier proteins, inactive ingredients and excipients, as well as lyophilisation and formulation of bulk vaccine, are not considered under this definition of ‘drug substance’ manufacture. For vaccines that contain multiple antigens, every constituent antigen must be manufactured in Africa for the vaccine to qualify for the AVMA ‘drug substance’ incentive levels. There is an exception for specific cases in which an antigen cannot be manufactured in Africa due to specific WHO requirements or similar reasons (e.g. polio, due to the requirement for a Containment Certification Scheme).

For the purposes of AVMA, ‘fill and finish’ is defined as the process of filling vials (or equivalent final container) with formulated drug substance, with or without subsequent intermediate and final packaging. The packaging of intermediate or final product without the process of filling is not sufficient to constitute ‘fill and finish’.

To achieve its ultimate objectives, AVMA aims to incentivise ‘drug substance’ manufacturing localisation in the long term and therefore provides higher incentives for ‘drug substance’ manufacturing. However, ‘fill and finish’ can serve as a pathway for new manufacturers, helping them generate revenue while expanding their technical capacity. Therefore, AVMA provides incentives for ‘fill and finish’ activities as well, although with lower incentive levels and with the majority of funding ringfenced for ‘drug substance’ manufacturing.

15. What vaccine procurement mechanisms are eligible for AVMA incentives?

As of the launch of AVMA, only vaccines that are procured via successful UNICEF tenders (and fulfil all other criteria) are eligible for Accelerator payments. The integration of a future pooled procurement mechanism established on the African continent could also be considered at a later stage, with the process and decision guided by the decisions of the AVMA governance structure.

16. How does the application process for AVMA incentives work?

Applications for AVMA incentives are operationally handled by the Gavi Secretariat. More detailed information on the application process can be found in AVMA Guidance for Manufacturers.

17. What is the governance structure of AVMA?

The Gavi Secretariat runs the day-to-day operations of AVMA in collaboration with Alliance partners. The Gavi Board provides overall strategic oversight and is the ultimate decision-making body for AVMA.

Two advisory forums have been established to ensure an effective two-way flow of critical information between Gavi and key stakeholders: the AVMA Investors Forum and the African Vaccine Manufacturing Forum. The AVMA Investors Forum gathers donors that have invested funds into AVMA. The African Vaccine Manufacturing Forum gathers stakeholders from across the enabling environment for vaccine manufacturing in Africa, including vaccine manufacturers, implementing countries, donors, investors, development finance institutions, civil society organisations, national regulatory authorities and Alliance partners.

18. Can AVMA’s strategy and approach change over its ten-year duration?

Gavi will offer support that balances the stability of market signals with responding to the evolving needs of the African continent over AVMA’s ten-year lifetime. To achieve this, periodic adjustments to the instrument may be necessary, such as adding new priorities, increasing incentive levels or adjusting caps upwards. These strategic changes will be considered as part of a triennial review and ‘course correction’ process at scheduled review points in 2027, 2030 and 2033. In the context of the triennial reviews, the Gavi Secretariat may propose to the Gavi Board to approve strategic changes to the instrument. Additionally, in circumstances assessed as exceptional by Gavi (e.g. a pandemic scenario), Gavi may launch an ad hoc course correction process. All proposed changes will be developed through a transparent and evidence-based process with stakeholder engagement, and will follow the AVMA governance structure for approval.

19. How will AVMA’s impact be measured?

As part of the design of AVMA, a Theory of Change and a comprehensive monitoring, evaluation and learning framework have been developed. Metrics and targets will be used to track AVMA’s progress and results over time. The framework will provide the basis for annual reporting and triennial reviews, and will set the foundation for a fully independent evaluation at the end of AVMA’s lifetime. The four key outcome targets set for AVMA are:

  • at least four African manufacturers securing at least one UNICEF tender on the path to long-term sustainability; 
  • at least 800 million vaccines manufactured on the African continent procured with support from AVMA by 2035; 
  • AVMA supporting the localisation of three drug substance platform technologies on the continent to provide the diversity in capabilities contributory to future outbreak and pandemic response; and
  • supporting a fill and finish production base in Africa, which, by the end of AVMA’s ten-year lifespan, could yield 700 million doses annually when repurposed in an outbreak scenario.

20. Where can I find additional information on AVMA?

Please refer to the African Vaccine Manufacturing Accelerator page for additional information, or reach out to the contact below for any queries.

Disclaimer

The information on this webpage represents the most current description of how Gavi operates AVMA. It is subject to periodic updates, including in accordance with Gavi governance procedures. The information contained on this webpage is not a comprehensive description of all aspects of AVMA, and receipt of any AVMA incentives by manufacturers is subject to contract. The publishing of information by Gavi on this website is not a commitment to enter into any transaction or contractual relationship. In case any information contained in this webpage appears inconsistent with the information provided in the AVMA Guidance for Manufacturers, please refer to the AVMA Guidance for Manufacturers.

Last updated: 28 Aug 2024

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