Coalition for Epidemic Preparedness Innovations (CEPI)

Core Mission and Strategic Objectives

CEPI operates under a central mission: to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats so they can be accessible to all people in need.

In pursuit of this mission, CEPI launched its "CEPI 2.0" strategic plan, a five-year, $3.5 billion program designed to dramatically reduce the risk of future pandemics. A cornerstone of this strategy is the "100 Days Mission"â??an ambitious goal backed by the G7 and G20 to compress the timeline for developing safe, effective, and globally accessible vaccines against new pathogen threats (referred to as "Disease X") to just 100 days from the moment the pathogen's genetic code is sequenced.

What CEPI Does: Core Functions and Offerings

CEPI does not directly manufacture vaccines in its own commercial facilities, nor does it operate as a traditional pharmaceutical company. Instead, it acts as a global developer, funder, and coordinator of vaccine R&D, manufacturing infrastructure, and regulatory pathway alignment.

Its operations, products, and services can be categorized into five primary pillars:

1. Research & Development (R&D) Funding and Portfolio Management

CEPI functions as a major venture-philanthropy funder for vaccine candidates targeting high-consequence pathogens. It issues Calls for Proposals and awards substantial grants to biotechnology companies, academic institutions, and pharmaceutical developers. * Target Pathogen Portfolio: CEPI funds the development of vaccine candidates against priority pathogens identified by the World Health Organization (WHO) as having epidemic potential. This includes: * Lassa fever * Middle East Respiratory Syndrome (MERS) * Nipah virus * Rift Valley fever * Chikungunya * Ebola (Sudan and Zaire strains) * SARS-CoV-2 (COVID-19) and next-generation pan-beta-coronavirus vaccines * Disease X Preparedness: CEPI funds "rapid response" platform technologies that can be quickly adapted to construct vaccines against entirely unknown pathogens (Disease X).

2. Vaccine Platform Technologies (The Product Offerings)

CEPI invests heavily in cutting-edge platform technologies that can be repurposed quickly when a new threat emerges. By funding these platforms, CEPI secures access to innovative vaccine modalities, including: * mRNA Platforms: Supporting the development of next-generation messenger RNA technologies that are thermostable, making them easier to transport and store in low-resource settings without ultra-cold chain infrastructure. * Viral Vector Platforms: Utilizing modified, harmless viruses (such as ChAdOx, Vesicular Stomatitis Virus, or Measles Virus vectors) to deliver antigen blueprints into cells. * Protein Subunit Platforms: Funding highly stable recombinant protein vaccines that can be manufactured using established global bioreactor infrastructure. * DNA Vaccine Platforms: Supporting nucleic acid designs that offer rapid development cycles and high stability.

3. Enabling Sciences and Standardization Services

One of the most significant barriers to rapid vaccine development is the lack of standardized tools to evaluate and compare different vaccine candidates. CEPI has established a suite of "Enabling Sciences" services to address this challenge: * Centralized Laboratory Network: CEPI funded and established a global network of centralized laboratories (including partners in Europe, North America, Asia, and Africa). This network allows vaccine developers to test their candidates using the exact same reagents, protocols, and wild-type virus strains, ensuring that immunogenicity data is directly comparable across different vaccine platforms. * Biological Standards and Assays: In collaboration with the National Institute for Biological Standards and Control (NIBSC) and the WHO, CEPI funds the creation of international biological standards and reference antibody/antigen panels for emerging diseases. * Biobanks and Sample Repositories: CEPI supports the collection and sharing of clinical samples from epidemic areas, giving researchers access to the raw biological materials needed to design and validate diagnostic assays and vaccines.

4. Global Manufacturing and Scale-Up Network

To ensure that newly developed vaccines can be produced in billions of doses rather than millions, CEPI provides end-to-end manufacturing support: * Global South Manufacturing Network: CEPI actively funds and partners with manufacturers in developing countries (such as the Serum Institute of India, Aspen Pharmacare in South Africa, and Bio Farma in Indonesia). This initiative aims to decentralize vaccine manufacturing capacity so that regions are not dependent on imports during a crisis. * Technology Transfer Services: CEPI facilitates the transfer of complex manufacturing processes and intellectual property from northern biotech innovators to regional manufacturing hubs in Asia, Africa, and Latin America. * Fill-and-Finish Capacity Reservation: CEPI maintains agreements to secure manufacturing lines and raw materials (such as glass vials and adjuvants) ahead of time, ensuring that production does not stall due to global supply chain bottlenecks.

5. Clinical Trial Networks and Regulatory Support

CEPI actively works to simplify and accelerate the clinical validation and regulatory approval processes for epidemic vaccines: * Clinical Trial Networks: CEPI funds and maintains ready-to-use clinical trial sites in endemic regions (e.g., for Lassa fever in West Africa). This ensures that when an outbreak occurs, clinical trials can be initiated immediately without having to build local infrastructure from scratch. * Regulatory Science Advocacy: CEPI collaborates with global regulatory bodies (such as the US FDA, the European Medicines Agency, and the WHO Prequalification team) to establish harmonized pathways for the rapid approval of platform-based vaccines during emergencies.

The Equitable Access Policy

A defining characteristic of CEPI's funding agreements is its strict Equitable Access Policy. Every partner receiving funding from CEPI must agree to terms ensuring that any resulting vaccines are: * Produced in sufficient quantities to meet public health needs during an emergency. * Priced affordably, ensuring that cost is not a barrier to access for populations in low- and middle-income countries. * Distributed according to public health need, rather than the purchasing power of individual nations.

During the COVID-19 pandemic, this policy led to CEPI co-founding and co-leading the COVAX facility alongside Gavi, the Vaccine Alliance, and the WHO, which successfully delivered nearly 2 billion doses of COVID-19 vaccines to 146 countries.

Target Audience and Key Partners

CEPI occupies a unique intersection in the global health ecosystem. Its primary stakeholders and partners include: * National Governments: Providing both donor funding (e.g., Norway, Germany, Japan, United Kingdom, Canada, USA) and receiving support for national epidemic preparedness. * Biotechnology & Pharmaceutical Companies: Ranging from multinational corporations to small, specialized biotech startups that receive R&D capital and manufacturing partnerships. * Academic and Research Institutions: Collaborating on early-stage antigen design, epidemiology studies, and assay development. * Multilateral Health Organizations: Working hand-in-hand with the WHO, UNICEF, and Gavi to align scientific advancements with global deployment strategies.