The Coalition for Epidemic Preparedness Innovations (CEPI) is an innovative global partnership working to accelerate the development of vaccines against epidemic and pandemic threats. CEPI’s Vaccine Safety and Pharmacovigilance mission is to ensure the generation of robust safety evidence, enabling timely benefit-risk assessment of vaccines in the acceleration of their development and deployment against epidemic and pandemic threats.
To support our mission, we have been building a coalition for vaccine safety and pharmacovigilance which includes partners such as PATH, IQVIA, Global Vaccine Data Network (GVDN), Developing Countries Vaccine Manufacturers Network (DCVMN) International, The INCLEN Trust International, and Brighton Collaboration.
In addition to the coalition for vaccine safety and pharmacovigilance, the recently created CEPI Safety and Quality Review Board serves as CEPI’s framework to address important clinical safety and quality issues emerging from projects funded by CEPI.
Currently the projects within our safety and pharmacovigilance coalition are: SPEAC, CEPI Pharmacovigilance, BRAVE, INNOVATE, and INSIS.
SPEAC
The Safety Platform for Emergency vACcines (SPEAC) is a project of the Coalition for Epidemic Preparedness Innovations (CEPI) and Brighton Collaboration. SPEAC’s mission is to provide the best available scientific evidence on the safety of CEPI-funded vaccines to support timely benefit-risk assessment during the vaccine lifecycle.
The core deliverable of the SPEAC project is a library of standardized safety outcomes definitions for pathogens and platforms in the CEPI portfolio. These outcomes definitions can be used by vaccine developers, manufacturers, as well as regulators and public health decision makers to implement strategies and approaches for the generation of safety evidence which can be compared across studies executed during both vaccine development and deployment.
The SPEAC project is also responsible for the creation of guidance and tools intended to support the implementation of the outcome definitions in the variety of methodologies used for monitoring the safety of vaccines throughout their life cycle, including interventional pre-licensure clinical trials, safety surveillance in pharmacovigilance, and observational post-licensure vaccine safety trials. SPEAC tools support the generation of aggregable and comparable data from which as robust conclusions of safety as possible can be drawn.
CEPI Pharmacovigilance Project
The Pharmacovigilance project aims to support the strengthening/capacity building of Pharmacovigilance systems in CEPI-funded developers/manufacturers/Marketing Authorization Holders (MAH).
The project has three strategic objectives:
To support CEPI’s developer/manufacturer/Marketing Authorization Holder (MAH) partners to be able to perform PV activities compliant with Good PharmacoVigilance Practices (GPvP), local regulatory requirements and if applicable, with inter- and supranational requirements.
To support CEPI’s developer/manufacturer/Marketing Authorization Holder (MAH) partners to move from an underdeveloped or reactive PV system with limited or no signal detection, risk management and benefit - risk assessment capabilities to a proactive, planned, and risk-proportionate system.
To connect CEPI’s strategic and implementing partners to support the strengthening/capacity building of Pharmacovigilance systems in CEPI’s developer/manufacturer/Marketing Authorization Holder (MAH) partners.
GVDN: BRAVE
The Background Rates of Adverse Events for Vaccine Evaluation (BRAVE) project is led by the Global Vaccine Data Network (GVDN) to establish a network of sites, as a platform for the generation of evidence of safety, for the vaccines being developed against CEPI priority pathogens relevant to the African continent. Researchers from the University of the Witwatersrand in South Africa, Navrongo Health Research Center in Ghana, International Foundation Against Infectious Diseases in Nigeria, Eagle Research Center in Rwanda, and Health Research Operations Kenya (operating as KEMRI-Wellcome Trust Research Programme) in Kenya will validate relevant safety endpoint definitions from the SPEAC project within their local contexts, understand if they can be recognized and how often they occur in the absence of vaccination.
The core deliverables from this work are background incidence rates of safety outcomes, which can be used in the interpretation of safety data from both clinical development and immunization programmes ongoing in Africa. Having this network in place will help contextualise any safety concerns reported in clinical trials and will ultimately enable timely evidence generation of vaccine safety, informing benefit/ risk assessments, during public health responses in Africa.
DCVMN-INCLEN: INNOVATE
The “International Network for Vaccine Safety Surveillance (INNOVATE): An Integrated Population and Sentinel Hospital-Based Vaccine Safety Surveillance in Six Low and Middle-Income Countries” project is led by the Developing Countries Vaccine Manufacturers Network (DCVMN) and The INCLEN Trust International.
The project aims to strengthen Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) active surveillance system and determine background reference rates of AEFI/AESI, through an integrated population and linked hospital sentinel surveillance, in 9 defined population-based AEFI/AESI surveillance sites across 6 LMICs (India, Indonesia, Ethiopia, Kenya, South Africa, and Brazil. Consolidated and specific vaccine safety and background rate data will be shared with DCVMN members to support their benefit-risk assessment of their vaccines.
INSIS
The International Network of Special Immunization Services (INSIS) aims to understand the biological factors that might predict rare, serious adverse events related to vaccination. CEPI has partnered with the University of Alberta, which coordinates the network of clinical vaccinologists in multiple countries, to better understand the safety signals of thrombotic thrombocytopenia syndrome and myocarditis which were identified with the vaccines used during the global covid-19 immunisation campaign.
Data from INSIS will help to inform health authorities on the most appropriate type of vaccine that should be used in specific outbreak settings and populations. With the identification of risk factors for potential serious adverse events ahead of time, immunisation campaigns can be adapted to mitigate such risks in those who are potentially vulnerable. Commitment to investigation of harms from vaccination can contribute to increased levels of public confidence in vaccines which is critical to achieve a 100-days response.
