Source: APO
New funding to the AdVAncIng Clinical TRials Excellence in Africa (AVAREF) could help accelerate the development of life-saving vaccines to contain infectious disease outbreaks on the continent.
The Coalition for Epidemic Preparedness Innovations (CEPI) is providing $1 million to AVAREF as part of a new two-year project to enhance the efficiency with which African regulatory agencies and ethics committees—who are already part of the AVAREF network—review and make emergency decisions on multi-country clinical trial applications. Part of the funding will also support AVAREF to coordinate and further fine-tune the procedure for issuing scientific advice to developers, an important element which aids the development and eventual licensure of vaccines and other health products.
At present, not all countries on the continent have emergency review and scientific advice procedures suitable for public health emergencies. In certain cases, the standard time to review a clinical trial application, often driven by sequential ethics and regulatory reviews, could take anywhere between 6-18 months – by which point an outbreak could have spread beyond containment.
With CEPI funding, experts at national regulatory authorities and ethics committees across Africa will gain further experience in accelerating the regulatory process by participating in existing AVAREF scientific advice, joint emergency reviews and simulation exercises. The emergency joint review process is used by AVAREF to bring together relevant national authorities of regulators and ethics committees and decide whether a clinical trial—typically submitted to AVAREF by a vaccine developer looking to run a multi-country study—is to be approved and enable recruitment of participants in as little as 10 to 15 days from receiving the application, without compromising robust technical considerations.
Greater understanding and experience in issuing scientific advice and in approving clinical trial submissions could help AVAREF safely accelerate the parallel regulatory and ethics review of the clinical trial applications of vaccine and other health intervention candidates during a future epidemic or pandemic threat affecting Africa. Expedited mechanisms could support faster regulatory approvals, meeting CEPI’s ambitious goal to develop a new vaccine in response to a novel outbreak in as little as 100 days.
Jacqueline Rodgers, Senior Regulatory Affairs Lead for Africa at CEPI, said: “From Mpox to Marburg and Ebola Sudan to Lassa fever, Africa has tackled an abundance of deadly outbreaks in recent years and vaccines are urgently needed to mitigate these persistent threats. Each day counts in an outbreak, so rapid meaningful response to requests for scientific advice and well-designed vaccine clinical trials that meet the criteria for emergency approval by relevant authorities can be a game changer in helping to control the spread of a disease. Building robust, pandemic-ready regulatory systems on the continent advances Africa’s self-sufficiency, with more streamlined and efficient AVAREF processes acting as models that could drive the establishment of similar AVAREF-like forums in Asia and the Americas to fulfill a vision of global preparedness.”
Emphasizing the importance of this collaboration, Dr Benido Impouma, Director of Health Promotion / Diseases and Prevention Control Cluster at the World Health Organization, Regional Office for Africa, said: “We greatly appreciate CEPI’s financial support to AVAREF. This contribution will strengthen the capacity of African regulatory authorities and ethics committees to conduct timely and high-quality reviews of clinical trial applications. With WHO’s continued support, this partnership will help countries accelerate access to safe and effective vaccines and health products, protect communities, and improve preparedness for future health emergencies. Together, we are building stronger systems that safeguard the health and security of our communities.”
AVAREF supports the countries by identifying subject matter experts from within the continent, as well as globally to support the scientific advice process. CEPI funding allows for simulations of this process, in preparation for product development to address epidemics and future pandemics including an unknown ‘Disease X’. Experiencing the joint review process and simulation exercises can provide national regulators and relevant ethics committees with insights on how to better optimise local clinical trial application review timelines and share knowledge with peers also involved in the process.
Regulatory experts from Germany’s medical regulatory body, the Paul Ehrlich Institute, will provide expertise to support simulations and training elements of the project.
Distributed by APO Group on behalf of WHO Regional Office for Africa.