Contents

Share

 

What is AVMA?

  • The African Vaccine Manufacturing Accelerator (AVMA) is a financing mechanism established to make up to US$ 1.2 billion available over ten years commencing with AVMA’s launch in June 2024 to accelerate the expansion of commercially viable vaccine manufacturing in Africa.
  • AVMA offers a ‘pull financing mechanism’ by providing downstream incentives to manufacturers to help offset initial costs of development and production.
  • The instrument 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 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.


 

Why is it important?

  • 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.
  • Due to the high startup costs for vaccine manufacturing, the commercial sustainability required for ongoing supply security is unlikely to develop without downstream incentives. 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.

How does it work?

  • AVMA aims to provide a pathway to financial sustainability for eligible manufacturers by disbursing two types of incentives/payments at specified trigger points:
  1. 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.
  2. 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.

Eligibility criteria

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. Please see AVMA Guidance for Manufacturers for more details.

Priorities

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 “Incentive values” tab above). 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)

More information on the priority vaccine markets can be found on the Vaccine Markets Dashboard.

The AVMA Priority technology platforms are:

  • mRNA
  • Viral vector

Additional important details are provided in AVMA Guidance for Manufacturers.

Incentive values

AVMA has a tiered incentive structure, designed to align with AVMA’s objectives, with the following incentive values for Milestone and Accelerator payments (subject to caps (see Funding caps tab above):

Milestone payment

  • US$ 25 million: any Gavi portfolio vaccine whose drug substance is manufactured in Africa on an AVMA Priority technology platform (i.e. mRNA or viral vector)
  • US$ 20 million: AVMA Priority vaccines whose drug substance is manufactured in Africa
  • US$ 10 million: AVMA Priority vaccines for which only ‘fill and finish’ takes place in Africa

Manufacturers may only receive a single Milestone payment per eligible vaccine. For instance, manufacturers performing both ‘drug substance’ and ‘fill-finish’ steps will only receive the ‘drug substance’ incentive payment (either “AVMA Priority platform drug substance” at US$ 25 million or “AVMA Priority vaccine on any other platform” at US$ 20 million).

Accelerator payment

  • US$ 0.50 per dose: any Gavi portfolio vaccine whose drug substance is manufactured in Africa on an AVMA Priority technology platform (i.e. mRNA or viral vector)
  • US$ 0.50 per dose: AVMA Priority vaccines whose drug substance is manufactured in Africa
  • US$ 0.40 per dose: any other Gavi portfolio vaccine whose drug substance is manufactured in Africa
  • US$ 0.30 per dose: any Gavi portfolio vaccine for which only ‘fill and finish’ takes place in Africa, up to a cap of US$ 1.00 per vial

Manufacturers may only receive the highest applicable Accelerator payment for each delivered eligible vaccine dose. For instance, manufacturers performing both ‘drug substance’ and ‘fill and finish’ steps will only receive the ‘drug substance’ incentive payment for each delivered dose (at either the US$ 0.50 or the US$ 0.40 rate).

Additional important details are provided in AVMA Guidance for Manufacturers.

Procurement pathway

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 subject to determination in line with AVMA’s governance arrangements.

Additional important details are provided in AVMA Guidance for Manufacturers.

Funding caps

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 for all payments made in relation to ‘fill and finish-only vaccines’. 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. Hence disbursement caps are set as follows:

  • US$ 250 million per manufacturer (across Milestone and Accelerator payments cumulatively), of which US$ 50 million for ‘fill and finish-only vaccines’
  • US$ 300 million per vaccine category/market
  • US$ 250 million for total Milestone payments across the life of AVMA
  • US$ 250 million for ‘fill and finish-only vaccines’
  • The overall mechanism is capped at net funds raised for AVMA, deducting operational costs incurred.

Additional important details are provided in AVMA Guidance for Manufacturers.

Expression of Interest (EOl)

  • Interested manufacturers are invited to submit to Gavi an Expression of Interest (EOI). Submitting an EOI offers manufacturers the opportunity to share their plans with Gavi on a voluntary basis. EOIs are open as of AVMA’s launch; links to the EOI documents are provided below.

Expression of Interest (EOI)

Interested manufacturers are invited to submit an EOI following the guidelines outlined in “Gavi RMS Request for Expressions of Interest”.

How can manufacturers apply?

  • Manufacturers may submit an application to Gavi for an AVMA eligibility assessment during the WHO prequalification process but only after the vaccine manufacturing site visit by WHO Inspection Services is completed.
  • Applications are managed by Gavi. Information on the application process may be found in AVMA Guidance for Manufacturers.

Guidance for Manufacturers

This provides guidance for manufacturers who are seeking more information on AVMA, its key elements, requirements and processes.

Application for incentives

This is the form manufacturers must submit to Gavi to apply for AVMA in-principle eligibility, following the process outlined in the AVMA Guidance for Manufacturers.

How are AVMA stakeholders involved?

  • The African Union (AU) and the Africa Centres for Disease Control and Prevention (Africa CDC) have been key partners in the design of AVMA. Gavi’s Regional Manufacturing Strategy was conceived as a response to the AU’s call to action to accelerate vaccine manufacturing capacity in Africa.
  • The African Vaccine Manufacturing Forum will be co-convened by Gavi and Africa CDC on an annual basis, with a broad focus on regional manufacturing (including but not limited to AVMA), gathering 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.
  • The forum will serve to collect the perspectives of stakeholders, and for Gavi, Africa CDC and Alliance partners (e.g. UNICEF, WHO, the World Bank and the Bill & Melinda Gates Foundation) to share information regarding AVMA, Gavi’s regional manufacturing strategy, and the broader enabling environment.

Reporting and reviews

  • Information on AVMA will be included in Gavi’s Annual Progress Report, which gives a comprehensive overview of the activities and performance of Gavi, illustrating the work and achievements of this public-private partnership. Additionally, an annual report will be produced for AVMA. Reporting, reviews and evaluations of AVMA will be grounded in the comprehensive AVMA monitoring, evaluation and learning framework.
  • Over AVMA’s ten-year lifetime, Gavi will offer support that balances the stability of market signals with the evolving needs of the African continent. Recognising the need to ensure AVMA’s design and implementation remain appropriate and effective over this lifetime, Gavi will undertake a triennial review and course correction process, as defined under AVMA governance, 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. All proposed changes will be developed through a transparent and evidence-based process with stakeholder engagement.

Additional resources

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: 2 Sep 2024

Subscribe to our newsletter