Here is an archive of outdated news items on the Cepi Knowledge Hub.
The news items are listed chronologically with the top ones being more recent.
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
COVID-19 has touched all of our lives and changed our world beyond recognition. What comes next? ... Read more
See more here... Read more
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
FDA is issuing this guidance to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines… 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