SPEAC announces the release of a comprehensive Companion Guide for the Brighton Collaboration Case Definition of Single Organ Cutaneous Vasculitis (SOCV). This new resource combines a wealth of tools and guidance to standardize vaccine safety assessments and pharmacovigilance efforts worldwide. Read more

In June 2024, CEPI convened a workshop in Nairobi, Kenya, to discuss epidemiology and modeling for human RVF vaccine development, bringing together representatives from RVF-endemic countries, global collaborators, and international health organizations. This paper summarizes the workshop discussions and priorities. Read more

CEPI and ANVISA hosted this workshop to update global regulators on the marketing authorisation and clinical development plans in preparation for phase IV studies and future global approvals. There was robust dialogue and participation from 18 countries representing 14 NRAs. Read more

The African Union has set an ambitious goal: by 2040 over 60% of the vaccines needed for Africa’s population should be produced locally. A sustainable supply chain for the specialized input materials that go into making vaccines will be required Read more

This effort was funded by the National Institutes of Health, National Institutes of Allergy and Infectious Diseases, and CEPI. Data generated from using the Standard will help to inform current vaccine development and deployment strategies. Read more

This information is shared in a variety of locations and formats, including individually published papers, websites, and conference presentations. The Playbook is being created to enable access to these learnings in a single location. The Regulatory Chapter is now available… Read more

SPEAC’s Special Populations team, in collaboration with Instituto de Efectividad Clínica y Sanitaria (IECS) and Tulane University, has launched an LSR and meta-analysis tool focused on the safety, effectiveness, and immunogenicity of Chikungunya vaccines Read more

The two countries will enrol 1,000 people (of all ages) each, with coordination by CEPI’s Enable team, headed by Dr H. Mandi, and local and international partners. Three sites in Nigeria recruited 1,000 participants each at the end of 2024; ... Read more

A team of scientists from the UK, Kenya, and Tanzania will explore the extent to which chikungunya affects countries in East Africa. The results will be crucial in guiding the design and implementation of future vaccine trials. Read more

The resource page features a protocol template (for cohort event monitoring for active safety surveillance after vaccination with mpox vaccines), a list of adverse events of special interest, CEM questionnaires, an adult informed consent form, key elements for data collection... Read more

This article provides an overview of CEPI's efforts in controlling Mpox (including the development of assays) and highlights how lessons from prior experiences have strengthened preparedness strategies for this pathogen Read more

As part of the development of the first anti-Nipah International Antibody Standard, CEPI also provided funding to University of Malaya to evaluate the long-term humoral immune response to Nipah virus in a cohort of 25 survivors 25 years post-infection Read more

To build the network, CEPI and Gates are seeking experts to offer training and mentorship to researchers and professionals in Global South institutions on epidemic and pandemic data analytics and infectious disease modelling Read more

GCAC aims to ensure that the 18 facilities within CEPI's CLN are more actively involved in critical decision-making processes. This initiative will offer a unique opportunity to address both current and future challenges within CLN. Read more

The team developed a quality assessment tool to evaluate COVID-19 vaccine neutralizing antibody studies and identified areas for improvement that would enhance their contribution to vaccine policy decisions Read more

The CEPI CLN implemented key steps in the transfer and monitoring of the developed immunological SARS-CoV-2 assays. This article provides a brief elaboration on the specific measures and procedures implemented to standardize the transfer of assays across the network. Read more

The Companion Guide, developed by the SPEAC Project, includes ICD9/10-CM, MedDRA & SNOMEDCT codes, background rates, risk factors, guidance, and tools including a data abstraction & interpretation form for Acute Aseptic Arthritis Read more

This meeting was attended by 60+ public health and animal health experts, researchers, epidemiologists, modelers, regulators, and funders (from across Africa, the Middle East and Europe) to discuss advances and gaps in epidemiology and modelling for human RVF vaccine development. Read more

This webinar gives an overview of what is known about RVF epidemiology, where knowledge gaps impede the development of RVF vaccines for human use, and launches a Call for Proposals by CEPI to address these gaps. Read more

CEPI's Calls for Proposals invite innovators worldwide to apply to their scientific programmes to advance the development and manufacture of vaccines, enable further scientific progress, and refine tools against epidemic and pandemic threats. Read more

Membership is free & open to those working to promote & improve vaccine safety. Members receive access to a discussion group for networking and problem-solving, updates from the vaccine safety field, & opportunities to review & inform new Brighton products Read more

The project is about improving capabilities of Regulators & Ethics Experts in vaccines clinical research oversight and enhancing the Maturity Level of selected ECOWAS NRAs by focused support through FDA Ghana on regulatory systems and clinical trial functions Read more

This global systematic review of both COVID-19 vaccine clinical effectiveness and neutralization capacity has directly informed and continues to inform decisions around COVID-19 vaccine policy Read more

Yimer, S. at al discuss rapid diagnostic tests (RDTs) and their role in outbreak preparedness and response. They also discuss RDT investment challenges and provide a recommendation for the way forward. Read more

This guide includes ICD-9/10-CM, MedDRA & SNOMED CT codes, background rates, risk factors, & guidance for real-time investigation, data collection, & analysis. Also tools e.g. a data abstraction & interpretation form, and a tabular summary of key case definition criteria Read more

This article identifies threats associated with Disease X, e.g. the potential for an unknown pathogen to emerge & challenges in developing countermeasures against novel viruses. It also highlights the risk of zoonotic spillover events & the need for enhanced surveillance ... Read more

With the support of CEPI, the Open Access version of this textbook is now available to all. It discusses how epidemiologic methods can be used to study, in real life, vaccination programmes’ impacts, benefits and risks Read more

Brighton Collaboration has developed more than 80 Brighton Case Definitions for adverse events following immunization (AEFI) and adverse events of special interest (AESI). The case definitions are designed to support vaccine safety studies across the entire lifespan of a vaccine. Read more

This study was designed to confirm standardised performance of SARS-CoV-2 assays used to evaluate COVID-19 vaccine candidates at the initial 7 laboratories (in North America, Europe, and Asia) of the CEPI Centralized Laboratory Network. Read more

Published in Vaccine, February 2024. These case definitions are intended for use in clinical trials and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. Read more

"The CEPI centralized laboratory network for COVID-19 will help prepare for future outbreaks" article published in Nature Medicine, discusses CEPI's approach for the standardization of SARS-CoV-2 assays and how CEPI used these lessons learned in preparation for other potential pathogens Read more

CEPI and EFPIA collaborated to author a regulatory position paper on master files in the EU. A new “Pharmaceutical Master File” overarching model is proposed that encompasses existing master files procedures as well as expanded approaches not in place today. ... Read more

Dr. Andy Stergachis presented research on the safety, immunogenicity and effectiveness of COVID-19 vaccines for pregnant persons. Dr. Stergachis and team conducted a living systematic review and meta-analysis of nearly 600,000 pregnant persons who received COVID-19 vaccines. Read more

This CEPI funded COVID-19 study found that a half-dose of Pfizer-BioNTech's BNT162b2 boosting elicited an immune response that was non-inferior to a full-dose, with fewer reactions, in adults primed with Oxford-AstraZeneca's ChAdOx1 nCov-19 or Sinopharm's BBIBP-CorV Read more

SPEAC hosted this webinar on 22/09/23. The aim was to review what is known regarding SNHL, Lassa fever disease, & vaccines & to discuss how hearing abnormalities that may occur during clinical trials should be evaluated & monitored. Read more

Significant progress has been made in the development of several vaccines, aimed at preventing CHIKV infections. This perspective article summarizes CEPI’s efforts and strategic considerations for developing a CHIKV vaccine and ensuring equitable access for CHIKV endemic countries Read more

CEPI is pleased to share the published results of the fractional dose trial conducted by the University of Oxford and the Oxford Vaccine Group Brazil Read more

This companion guide collates the SPEAC Spontaneous Abortion and Ectopic Pregnancy resources including: the ICD9/10-CM, MedDRA and SNOMED codes, background rates, risk factors, guidance and tools for data collection and assessing the level of certainty. Read more

The Enable Lassa Research Programme is a prospective multi-site cohort study to estimate incidence of infection and disease due to Lassa fever virus, following 23,000 participants across five West African countries. To discuss the interim results of the Enable study ... Read more

Renewed partnership will broaden the scope of SPEAC to deliver world-leading vaccine safety guidance & support for CEPI’s mission to compress development of new vaccines against pathogens with pandemic potential to 100 days Read more

This news announcement forms part of CEPI’s 100 Days Mission, a campaign delving into how we can compress the vaccine development timeline to 100 days, while also counting down to CEPI’s Global Pandemic Preparedness Summit taking place in March, 2022. ... Read more

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The largest ever study created and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) to provide a more accurate assessment of the incidence of Lassa fever infections has launched in several more countries in West Africa. Read more

IAVI has received an award of €22.8 million from the European & Developing Countries Clinical Trials Partnership (EDCTP) and the Coalition for Epidemic Preparedness Innovations (CEPI) to conduct a Phase IIb clinical trial of a novel vaccine candidate to prevent ... Read more

SPEAC has completed a second update of the COVID-19 clinical literature covering the period of August 8 through November 13th 2020. Read more

This is a Brighton Collaboration Case Definition of the terms “Multisystem Inflammatory Syndrome in Children (MIS-C)” and “Multisystem Inflammatory Syndrome in Adults (MIS-A)” Read more

This is a The Brighton Collaboration Case Definition of the term “Acute Respiratory Distress Syndrome (ARDS)” to be utilized in the evaluation of adverse events following immunization. Read more

Identifying optimal combinations of symptoms to trigger diagnostic work-up of suspected COVID-19 cases in vaccine trials: analysis from a community-based, prospective, observational cohort Read more

In this Summary Document, we evaluate, from a clinical perspective, the burden of disease (BOD) endpoint recently proposed by Mehrotra et.al. for its suitability as a primary endpoint for assessing COVID-19 vaccine efficacy. Read more

CEPI has compiled COVID-19-specific national requirements and guidelines to conduct clinical trials in multiple countries across the globe, together with links to the respective regulatory authorities and ethics committees ... Read more

CEPI, alongside Gavi and the World Health Organisation, launched COVAX – the vaccines pillar of the ACT Accelerator – with the aim of ending the acute phase of the pandemic by the end of 2021... Read more

Find the complete materials of this workshop here... Read more

The Clinical Trials Community is a platform of the African Academy of Sciences. Our goal is to increase the level of Clinical Trial investments in Africa by increasing the visibility of African clinical trialists and research sites as well as ... Read more