CEPI Launches Two Major Initiatives to Accelerate Vaccine Development and Regulatory Approval in Disease Outbreaks
核心洞察
CEPI is providing $1 million to the African Vaccine Regulatory Forum (AVAREF (搜索)) to enhance multi-country clinical trial application reviews, aiming to reduce approval times from 6-18 months to 10-15 days during health emergencies.
The Coalition has also committed up to $1.9 million to support FEEVA, a new framework that will develop standardized tools for evaluating early vaccine efficacy data to enable faster regulatory approvals.
Both initiatives directly support CEPI's ambitious 100 Days Mission to develop new vaccines in response to novel outbreaks within 100 days.
The Coalition for Epidemic Preparedness Innovations (CEPI) has announced two significant funding initiatives totaling $4 million to accelerate vaccine development and regulatory approval processes during infectious disease outbreaks, directly supporting its ambitious goal to develop new vaccines within 100 days of a novel outbreak.
CEPI Partners with AVAREF to Transform African Regulatory Reviews
CEPI is providing $1 million to the African Vaccine Regulatory Forum (AVAREF (搜索)) as part of a two-year project designed to enhance the efficiency of clinical trial application reviews across African regulatory agencies and ethics committees. The initiative addresses a critical bottleneck in vaccine development, where standard review times currently range from 6-18 months—a timeline that could allow outbreaks to spread beyond containment.
"From Mpox (搜索) to Marburg (搜索) and Ebola Sudan (搜索) to Lassa fever (搜索), Africa has tackled an abundance of deadly outbreaks in recent years and vaccines are urgently needed to mitigate these persistent threats," said Jacqueline Rodgers, Senior Regulatory Affairs Lead for Africa at CEPI. "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 gamechanger in helping to control the spread of a disease."
The funding will support AVAREF (搜索)'s emergency clinical trial application joint review process, which brings together national authorities of regulators and ethics committees to approve multi-country studies in as little as 10 to 15 days from receiving the application. Currently, not all African countries have emergency review and scientific advice procedures suitable for public health emergencies.
Dr Benido Impouma, Director of Health Promotion / Diseases and Prevention Control Cluster at the World Health Organization Regional Office for Africa, emphasized the collaboration's importance: "This contribution will strengthen the capacity of African regulatory authorities and ethics committees to conduct timely and high-quality reviews of clinical trial applications."
FEEVA Framework Targets Early Evidence Evaluation
In a parallel initiative, CEPI is contributing up to $1.9 million, alongside $1.1 million from Wellcome (搜索), to support FEEVA (Framework for Evidence Evaluation in Vaccine Assessment), a collaborative project led by the Kirby Institute at UNSW Sydney (搜索) and the Australian Living Evidence Collaboration at Monash University.
FEEVA represents a first-of-its-kind approach to addressing the challenge of vaccine efficacy assessment during outbreaks. Traditional late-stage trials involving thousands of participants may not be feasible in the early months of an outbreak when confirmed cases are limited. The framework will develop standardized tools to evaluate early efficacy data from preclinical studies, human challenge trials, and observational studies.
"Data from early preclinical and clinical studies could help move away from efficacy trials to the pre-agreed use of early immune markers for accelerated development and approvals of vaccines," explained Dr Adam Hacker, Director and Global Head of Regulatory Affairs and Quality at CEPI. "However, there are currently no harmonised guidelines on how to determine the importance of different and often complex sources of evidence that get produced from these early vaccine explorations."
Professor Miles Davenport, Head of the Infection Analytics Program at the Kirby Institute, noted that "the process for assessing and integrating the results of these studies is not always clear. The FEEVA project aims to ensure we can make the best use of all of the available evidence to inform the development and use of vaccines."
Addressing Global Vaccine Development Bottlenecks
Both initiatives directly support CEPI's 100 Days Mission, which aims to compress vaccine development timelines against new threats to just 100 days. The projects address different but complementary challenges in the vaccine development pipeline.
Hon Professor Jane Halton, Chair of the CEPI Board, stated: "During a deadly disease outbreak, every day without a vaccine costs lives. This innovative partnership aims to speed up vaccine development and approval when each day counts, accelerating access to vaccines during future epidemics and pandemics."
The FEEVA framework will run for four years and will include reviewing previous examples of vaccine approvals without human efficacy data, such as Janssen's Ebola Zaire vaccine (搜索) approval based on preclinical and immunogenicity findings. The guidelines will be made available online and open-access for global use.
Debbie King, Research Lead in the Infectious Disease team at Wellcome (搜索), highlighted the broader impact: "Currently there is a bottleneck in the vaccine pipeline, with later-stage trials requiring large numbers of participants and long periods of follow-up resulting in high costs. By enabling early-stage data to be consistently evaluated, we are increasing the chance of developing and delivering potentially life-saving vaccines to the people most in need."
Building Global Preparedness Infrastructure
The AVAREF (搜索) partnership includes support from regulatory experts at Germany's Paul Ehrlich Institute (搜索), who will provide expertise for simulations and training elements. The project will also support AVAREF in coordinating scientific advice procedures for developers, an important element of product development and eventual licensure.
AVAREF (搜索), created by WHO in 2006, brings together all 55 African national regulatory authorities and ethics committees. The enhanced processes could serve as models for establishing similar forums in Asia and the Americas to fulfill a vision of global preparedness.
Both projects represent significant investments in pandemic preparedness infrastructure, with CEPI having already supported the development of more than 60 vaccine candidates or platform technologies against multiple known high-risk pathogens and future Disease X scenarios.