SPEAC (Safety Platform for Emergency Vaccines)

#DidYouKnow CEPI created and funds?Enable, the world’s largest ever study of #Lassafever?? Over 23,000 participants have taken part in the research since 2019, set up to give scientists a better picture of the true disease burden across West Africa - as many cases are likely going unreported or being misdiagnosed. “Incomplete detection of Lassa fever cases could threaten the evaluation, rollout and acceptance of future Lassa vaccines” explains?Dr Richard Hatchett, CEO of CEPI. In October 2024, Enable was expanded to improve knowledge on how commonly Lassa fever occurs, how rates of infection and symptoms vary across selected locations, ages, sex and previous exposure to the virus, and the extent of post-infection symptoms like hearing loss. Scientists will also look at how often people may be co-infected with Lassa fever and malaria since co-infections may complicate the clinical course of each disease.? “Insights gained will be crucial in guiding where and how future late-stage vaccine trials are conducted and determining priority groups for receiving the Lassa vaccine once it becomes licensed in the coming years.” Pictured is the Enable Team in Nigeria kicking off follow-up visits to participants enrolled in the expanded study at FMC Owo, ISTH Irrua, and soon AEFUTHA. Nigeria Centre for Disease Control and Prevention

Did you know that antibodies found in the blood of someone who has fought off a virus can provide key insight into how to protect others from the same virus? Pooling antibody data from patients who have recovered from a disease and have high levels of antibodies enables vaccinologists to understand what good protection looks like, what level of immunity a vaccine needs to induce for it to offer durable protection, and how a vaccine might perform in humans. This material leads to the creation of antibody standards, which help standardise and harmonise vaccine performance and facilitate regulatory approval. CEPI scientist Selorm Avumegah explains the crucial role of antibody standards in vaccine research and how CEPI's investment in such standards help the world to be better prepared to face future outbreaks. Learn more ?? https://lnkd.in/exuUVukq

*New clinical trial of vaccine candidate for Lassa fever begins* A National Institutes of Health (NIH)-sponsored clinical trial of a candidate vaccine to prevent Lassa fever has begun enrolling participants at the University of Maryland School of Medicine, Baltimore. Lassa virus (LASV), a member of the Arenavirus family, remains a critical public health challenge in West Africa, with the Nigeria CDC reporting a staggering?7767 suspected cases, 971 confirmed cases and 166 confirmed deaths?across?28 states?up to 11 August?2024. Alongside its devastating impact, LASV infection poses long-term health risks, such as?sensorineural hearing loss (SNHL)?in up to 30% of survivors. Lassa virus is spread by rodents, known as multimammate rats, that are native to many countries in West Africa. The virus can also be spread from person to person. Currently, there are no specific drug treatments or vaccines for Lassa fever. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the Phase 1 trial. https://lnkd.in/dJg6Bhtr

“Pandemic preparedness initiatives should be urgently resourced and implemented... Enhancing readiness now can save lives and reduce societal and economic disruption if H5N1 or another outbreak becomes a pandemic.” In a?letter to Science Magazine, CEPI’s Executive Director for Preparedness and Response, Dr Nicole Lurie, and six other experts say the rapid spread and mutation of a deadly bird flu virus in the United States warrants urgent global action on pandemic preparedness to close dangerous gaps in the world’s ability to develop and deliver new protective vaccines. The experts outlined three critical efforts that they said?should begin now in preparation for a potential wider human outbreak of H5N1. Find out what these are ?? https://lnkd.in/e62e7mfh

The SPEAC team is growing! Our new team members include: Anita Renahan-White as Associate Deputy Director; Clare Cutland as DSMB Support co-lead, and Sarah Jones as Communications Manager. We want to wish a warm welcome to our latest additions.

CEPI's February newsletter is now available ??? Dive in to learn more about how taking a viral family approach could help the world get ahead of a future pandemic, the latest vaccine manufacturing partnerships helping to ensure a fast and equitable response to outbreak threats, insights from CEPI's Global South Fellows and plenty more. Don't forget to subscribe if you haven't already!

Congratulations to our SPEAC?colleagues Drs. Flor Munoz and Andy Stergachis for their contributions to this project as part of the Scientific Committee.

“A bold and credible roadmap for how to be ready to better respond to future pandemic threats and, ultimately, to end pandemics" - Former British Prime Minister Tony Blair?????? It’s been just two years since Kate Kelland published DISEASE X – The 100 Days Mission to End Pandemics. Now, against a backdrop of persistent new and re-emerging viral disease outbreaks, the book’s message rings as true as ever. In DISEASE X’s drumbeat of chapters, Kelland warns against complacency and calls instead for the world to PREPARE.?If we PREPARE to be Scared, PREPARE to Move Fast, PREPARE to Share, PREPARE to Take Risks, she argues, we can PREPARE for the Next One.?Bravery, innovation, speed, collaboration, agility and humility are what the world needs, Kelland writes, to be able to tackle and contain future disease epidemics before they run out of control and wreck lives and livelihoods. This pacy and engaging book ultimately spreads a hopeful message about humanity’s battles with infectious disease threats. With better preparation, greater investment and global cooperation, it really is possible to face down the next potential pandemic within 100 Days.? DISEASE X is a must-read inside track on how the world can stop future pandemics – get your copy: https://amzn.to/4aJ3Oih

????New Companion Guide for Single Organ Cutaneous Vasculitis (SOCV) Published! ? We're thrilled to announce the release of a comprehensive?Companion Guide?for the Brighton Collaboration Case Definition of Single Organ Cutaneous Vasculitis (SOCV). This new resource brings together a wealth of tools and guidance to standardize vaccine safety assessments and pharmacovigilance efforts worldwide.??? ? ?? What is a Companion Guide? Under the CEPI-funded Safety Platform for Emergency Vaccines (SPEAC) Project, the Brighton Collaboration developed Companion Guides to enhance the harmonization of vaccine safety?assessments. Since its establishment in 2000, the Brighton Collaboration has created?74?case definitions for Adverse Events Following Immunization (AEFI) and AESI, which are critical for supporting vaccine safety research throughout a vaccine’s lifecycle.?Companion Guides provide a standardized global reference by consolidating?SPEAC resources and tools for?selected?high priority?case definitions. ? ? ?? What's inside the guide? The deliverable consolidates essential SPEAC resources, including: ?? ICD-9/10-CM, MedDRA, and SNOMED CT codes. ?? Background incidence rates and risk factors. ?? Practical guidance for real-time investigation, data collection, analysis, and reporting. ?? Tools like data abstraction forms, tabular summaries of case definition criteria, and algorithms for determining levels of certainty. ? Designed for diverse stakeholders, this guide aids in assessing the occurrence of SOCV, including as a potential adverse event following immunization. ? ?? What is Single Organ Cutaneous Vasculitis (SOCV)? Single Organ Cutaneous Vasculitis (SOCV) refers to small vessel vasculitis of the skin where systemic involvement has been excluded. This terminology is based on the 2012 revised CHCC nomenclature, which recommends naming single-organ vasculitis based on the affected organ and vessel type (e.g., cutaneous small vessel vasculitis). SOCV has been identified as an Adverse Event of Special Interest (AESI) for vaccines using vesicular stomatitis virus (VSV) vectors, such as vaccines?in development?against?#MarburgVirus?and #LassaFever. ?? ???Where to find it? This SOCV Companion Guide is now available?on?the SPEAC community on Zenodo, and is citable with a Digital Object Identifier (DOI) ?? https://lnkd.in/eC4jtuBd ? Join us in advancing vaccine safety research by exploring this and other SPEAC resources! ? #VaccineSafety #SOCV #CompanionGuide #BrightonCollaboration #SPEAC ?

As we approach the end of the year, we can't help but reflect on what 2024 has brought with it. ? For Safety Platform for Emergency vACcines (SPEAC), this year has been one of learning, progress, and hard work, as demonstrated by participation in 10 conferences, annual meetings, symposiums, seminars, and webinars. This year also brought notable publications, including the release of the #Mpox and Marburg #AESI lists, the publication of half a dozen journal articles, and the?issuing?of important, timely recommendations regarding vaccine safety. ??All of this not only helps us grow as a partnership but also as individuals working together to safeguard public health?by?monitoring?vaccine safety. ? A heartfelt thank you to those who joined us in this process and made 2024 a memorable year. ? ???SPEAC wishes you happy holidays and an excellent 2025!???