Communiqué: The 2nd Vaccines and other Health Products Manufacturing Forum for African Union Member States

PREAMBLE: The Ministers of Health and representatives of African Union Member States gathered for the 2^nd Vaccines and other Health Products Manufacturing Forum in Cairo, Arab Republic of Egypt from 4-6 February 2025.

The Manufacturing Forum was attended by 12 Member States: Algeria, Egypt, Ethiopia, Ghana, Kenya, Morocco, Nigeria, Rwanda, Senegal, South Africa, Uganda, and Zambia; including the National Regulatory Authorities: l’Autorité Congolaise de Réglementation Pharmaceutique (ACOREP), Egyptian Drug Authority (EDA), Ghana FDA, Kenya Pharmacy and Poisons Board (PPB), Moroccan Agency for Medicines and Health Products, Tanzania Medicines and Medical Devices Authority (TMDA), NAFDAC, SAHPRA, Rwanda FDA, Uganda NDA, Medicines Control Authority of Zimbabwe (MCAZ), Zambia Medicines Regulatory Authority (ZAMRA), Regional Economic Communities (RECs), AUDA-NEPAD/AMRH, AMA, Gavi, the Vaccine Alliance, Regionalized Vaccine Manufacturing Collaborative (RVMC), African manufacturers, African Vaccine Manufacturing Initiative (AVMI), Development Finance Institutions (DFIs), Philanthropies and Civil Society Organizations (CSOs). The delegates deliberated on the submission by Africa CDC on bottlenecks and challenges facing vaccines, diagnostics, medicines and other health products manufacturing in Africa and proposed solutions to advance the agenda of local manufacturing.

The 2^nd Vaccines and other Health Products Manufacturing Forum was convened by the Africa CDC, Gavi, RVMC and hosted by the Unified Procurement Authority of Egypt (UPA) and expresses gratitude to the Government of the Arab Republic of Egypt for hosting the event.

The Forum:

1. Recalls the establishment by the AU of the Partnerships for African Vaccine Manufacturing (PAVM) in April 2021 and endorsement by the Executive Council (EX.CL/ Dec.1129(XXXIX)).
   
2. Further recalls the communique of the Meeting of the Bureau of the Assembly of Heads of State of the African Union (AU) Heads of State and Government, held on the 10^th of May 2022 reminding international partners, organizations and agencies responsible for bulk purchasing of vaccines such as Gavi, UNICEF, to prioritize procuring vaccines meant for African countries from African producers. The Bureau called for GAVI and other partners to offtake at least 30 per cent of all vaccines produced by the continent for global consumption.
   
3. Notes the decisions of the African Union Heads of States and Governments in their 37^th Ordinary Session of February 2024 (Assembly/AU/Dec. 866-902(XXXVII) which directed Africa CDC to:
   
   i. Upgrade the Partnerships for African Vaccine Manufacturing (PAVM) to the Platform for Harmonized African Health Manufacturing (PHAHM) to reflect the New Public Health Order which encompasses the inclusion of local manufacturing of all medical countermeasures (vaccines, therapeutics, personal protective equipment and diagnostics) towards building a self-sufficient healthcare manufacturing sector within Africa;
   
   ii. Establish the African Pooled Procurement Mechanism (APPM) as the continental pooled procurement mechanism for health products with the support of Afreximbank and UNECA.
   
4. Recognizes the call by the AU Heads of State and Government for Member States, Regional Economic Communities, and Regional Mechanisms (RMs) to adopt measures to promote resilience against future pandemics, including investment in domestic vaccine manufacturing capacity (Assembly/AU/Dec. 829(XXXV));
   
5. Welcomes the launch and operationalization of Gavi’s African Vaccine Manufacturing Accelerator (AVMA), a US$ 1.2 billion innovative financing facility designed to incentivize vaccine manufacturing in Africa.
   
6. Acknowledges the role of the Regionalized Vaccine Manufacturing Collaborative (RVMC) in providing a strategic framework for regional collaboration and support to advance vaccine manufacturing.
   
7. Appreciates the initial progress made in establishing the African Pooled Procurement Mechanism
   
8. Commends African leaders for pledging to prioritize the selection and procurement of African-made vaccines in line with their commitment to support the growth of vaccine and other production across Africa, fostering a resilient and self-reliant health system for our continent.

The Forum recommended the following next steps:

1. Enhance demand certainty: The African Vaccine Manufacturing Landscape; a report prepared by Africa CDC, CHAI and PATH which projects 8 Antigens to achieve WHO prequalification (PQ) and enter the continental market between 2025 – 2030. Ensuring demand certainty and predictability through offtake agreements of the near-term African Vaccine Manufacturer’s products is crucial for the sustainability of vaccine manufacturing in Africa. Further, it is essential to identify and tackle the obstacles that hinder Member States from committing to procure African-made vaccines, therapeutics, personal protective equipment, diagnostics and other medical devices.
   
2. Establish a clear and mutually agreed mechanism for Member States to express their preference for African-made vaccines and other health products, leveraging existing and future procurement systems. Furthermore, urge international procurers to COMMIT to procure at least 30% of their purchases for Africa from Africa.
   
3. African Vaccine Manufacturing Accelerator (AVMA): Support this major initiative aimed at providing incentives to increase the competitiveness of AVM and Call on Gavi and AVMA Investors to generate policies to unlock funding support to manufacturers on the pathways to achieving WHO PQ.
   
4. Increased Investments in regulatory capacities of Member States through initiatives such as the African Medicines Regulatory Harmonization (AMRH) and the African Medicines Agency (AMA), ensuring clear pathways to regulatory approval, including prequalification and provide relevant assistance for manufacturers to achieve this. Additionally, to support implementation of the Memorandum of Understanding on Reliance for Regulatory Decisions to streamline African regulatory processes for timely decision to guarantee the safety and efficacy of the products.
   
5. Support the African Pooled Procurement Mechanism (APPM): as directed by the African Heads of State and Government; to support the start-up phase of the APPM with an aim of improving affordability, availability and equitable access to essential quality medical supplies across the continent. Member States to concretize their commitment by integrating African-made health products into their national procurement plans.
   
6. Support talent development initiatives through partnerships and collaboration to enhance Regional Capability and Capacity Networks (RCCNs). Address hiring gaps and build a sustainable skilled workforce for vaccine, diagnostics, medicines and other medical devices manufacturing ecosystem in Africa including Research and Development and Technology Transfer.
   
7. Increase relevant financing support by engaging funders to address existing gaps, ensuring sustainable investment in African health manufacturing ecosystems. Call for better coordination and collaboration among International Development Financiers and tailored funding mechanisms, towards supporting the needs of African manufacturing and to scale up production and capacity.
   
8. Advocate for the full replenishment of Gavi’s next strategic period of 2026-2030, which is the most important for Africa to (i) drive higher levels of immunization on the continent and (ii) strengthen the impact of AVMA by developing larger volumes of vaccines to become available for tender for African manufacturers.
   
9. Agree to extend coordination and mutual continental and regional reliance across the value chain of health-related products. Member states and manufacturers will benefit from committing parts of healthcare product demand volumes to Africa CDC for consolidated procurement through the APPM. This will ensure better pricing and reliable supply while strengthening local production capacity and reducing import dependence for pharmaceuticals, diagnostics, and other critical medical products. Further, extend coordination and mutual continental and regional reliance to enable trading of African health products through the RECs and the African Continental Free Trade Area (AfCFTA).
   
10. Call upon the G20, under the current leadership of the Republic of South Africa as Chair of G20 (December 2024 to November 2025) to support fit-for-purpose investment into science and technology and thus create the skills necessary for a successful end-to-end African health product manufacturing.
    
11. Notes with concern that the perception of vaccine-related risks is often influenced by rumors that are mostly difficult to counter which can threaten the effectiveness of immunization programs despite reliable scientific data. It is therefore crucial, to establish strong mechanisms for detecting and responding to post-vaccination adverse events. This requires strengthening, supporting, and promoting pharmacovigilance systems among member states and implementing advances surveillance framework. Furthermore, it essential to ensure the timely detection, assessment, documentation, and communication of adverse events during and after clinical trials.
    
12. Call upon the Heads of State and Government to approve the Africa CDC’s leadership on therapeutics and diagnostics manufacturing as per the PHAHM mandate to respond to the New Public Health Order call to action.
    
13. Uphold the principles stated in this Communiqué by ensuring and advocating for alignment with regional and domestic legislation and policies.