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BRAZZAVILLE/OSLO, October 2, 2025 —New financial support for the African Vaccine Regulatory Forum (AVAREF) may speed up the creation of critical vaccines aimed at controlling infectious disease outbreaks across Africa.

The Coalition for Epidemic Preparedness Innovations (CEPI) is offering $1 million to AVAREF as part of a new two-year initiative aimed at improving the effectiveness with which African regulatory authorities and ethics committees—currently part of the AVAREF network—assess and make urgent decisions on multi-country clinical trial applications. A portion of the funding will assist AVAREF in managing and refining the process for providing scientific guidance to developers, a crucial aspect of product development and eventual approval.

Currently, not every country on the continent has emergency review and scientific guidance processes that are adequate for public health crises. In some instances, the typical time required to review a clinical trial application, usually involving sequential ethics and regulatory assessments, can range from 6 to 18 months – by the time this process is completed, an outbreak may have already gone beyond control.

A deeper understanding and practical experience in providing scientific guidance and reviewing clinical trial applications could enable AVAREF to securely speed up the simultaneous regulatory and ethical evaluation of vaccine and other health intervention proposals during a future epidemic or pandemic impacting Africa. Streamlined processes could thus facilitate quicker regulatory approvals, aligning with CEPI’s goal of creating a new vaccine for a novel outbreak within 100 days.

Jacqueline Rodgers, Head of Regulatory Affairs for Africa at CEPI, said: “From Mpox to Marburg and Ebola Sudan to Lassa fever, Africa has faced a wide range of deadly outbreaks in recent years, and vaccines are desperately needed to address these ongoing threats. Every day is crucial during an outbreak, so swift and effective responses to requests for scientific guidance and well-structured vaccine clinical trials that meet the standards for emergency approval by relevant authorities can make a significant difference in controlling the spread of a disease. Developing strong, pandemic-ready regulatory systems across the continent enhances Africa’s independence, with more streamlined and efficient AVAREF processes serving as examples that could inspire the creation of similar AVAREF-like platforms in Asia and the Americas to achieve a global preparedness vision.”

Professionals from national regulatory agencies and ethics committees throughout Africa will enhance their expertise in expediting the regulatory process by engaging in current AVAREF scientific guidance, collaborative emergency assessments, and simulation activities. The emergency CTA joint review mechanism employed by AVAREF unites pertinent national regulatory and ethics bodies to determine if a clinical trial—usually submitted by a vaccine developer aiming to conduct a multi-country study—is approved, allowing participant enrollment within as few as 10 to 15 days after the application is received, without sacrificing thorough technical evaluations.

Highlighting the significance of this partnership,Dr. Benido Impouma, Head of the Health Promotion and Disease Prevention Control Cluster at the World Health Organization’s African Regional Office, said: “We are very grateful for CEPI’s financial assistance to AVAREF. This funding will enhance the ability of African regulatory agencies and ethics committees to carry out prompt and high-standard evaluations of clinical trial applications. With WHO’s ongoing support, this collaboration will enable nations to speed up access to safe and effective vaccines and medical products, shield communities, and boost readiness for upcoming health crises. Together, we are creating more robust systems that protect the health and safety of our communities.”

AVAREF assists nations by locating subject matter experts both within the continent and worldwide to aid in the scientific advisory process. CEPI funding facilitates simulations of this process, preparing for product development to tackle epidemics and future pandemics, including a hypothetical Disease X. Participating in the joint review process and simulation activities can offer national regulators and relevant ethics committees valuable insights into improving local clinical trial application review timelines and exchanging knowledge with colleagues involved in the process.

Experts from Germany’s medical regulatory authority, the Paul Ehrlich Institute (PEI), will contribute their knowledge to assist with the simulation and training components of the project.

About CEPI

CEPI is a forward-thinking collaboration involving public, private, charitable, and civil society entities. Its objective is to speed up the creation of vaccines and other biological solutions to combat epidemic and pandemic risks, ensuring they are available to everyone who needs them. CEPI has funded the development of over 60 vaccine candidates or platform technologies targeting various high-risk known pathogens or an unknown Disease X. A key component of CEPI’s strategy to fight pandemics is the ‘100 Days Mission,’ aiming to reduce the time required to develop safe, effective, and globally accessible vaccines against new threats to only 100 days. Find out more atCEPI.net.

About AVAREF

The World Health Organization established the AdVAncIng Clinical TRials Excellence in Africa (AVAREF) in 2006. This regional initiative unites all 55 African national regulatory bodies and ethics committees. Through enhancing cooperation and developing skills, AVAREF supports nations in aligning and expediting clinical trial evaluations. Its goal is to ensure that safe, effective, and high-quality vaccines and medical products are delivered to African communities faster, particularly in times of public health crises. Find out more atAVAREF

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