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# SPEAC

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## Posts

- [News](https://speacsafety.net/news/) - Posted on September 10, 2026September 10, 2026 Protected: SPEAC DSMB Training October 2026 This content is password-protected. To view it, please enter the password below. Password:... Read More 0 Posted on September 1, 2026September 1, 2026 Understanding the ABC Tool: Webinar Recap More than 230 participants joined SPEAC on August 25 for a webinar introducing
- [Understanding the ABC Tool: Webinar Recap](https://speacsafety.net/abctoolwebinarrecap/) - More than 230 participants joined SPEAC on August 25 for a webinar introducing the Automated Brighton Classification (ABC) Tool, the first session in a new webinar series highlighting tools and resources developed to support vaccine safety monitoring and assessment.The ABC Tool supports the standardized assessment of adverse events following immunization (AEFIs) using Brighton Collaboration case
- [New Brighton Case Definition: Acute Intraocular Inflammation](https://speacsafety.net/newaioicasedefinition/) - The Brighton Collaboration has published a new case definition for acute intraocular inflammation (aIOI), providing a standardized approach to identifying, assessing, and reporting cases in vaccine safety research and surveillance.The case definition, published in Vaccine, was developed through the Safety Platform for Emergency vACcines (SPEAC) project, funded by the Coalition for Epidemic Preparedness Innovations (CEPI).aIOI
- [New Living Systematic Review Dashboard Maps the Ebola Vaccine Evidence Landscape](https://speacsafety.net/ebolalsrdashboard/) - We are pleased to share the first public output of the Living Systematic Review (LSR) on Ebola vaccines, now available as an interactive dashboard through Safe in Pregnancy.The dashboard provides a detailed view of the current Ebola vaccine evidence landscape, including the populations represented in clinical studies, important evidence gaps, and the methodology behind the review.Why
- [Preterm Birth as an Adverse Event of Special Interest (AESI): Brighton GAIA Case Definition Overview](https://speacsafety.net/preterm-birth-aesi-explainer/) -  SPEAC has released a new overview video highlighting the Brighton Collaboration’s Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) case definition for preterm birth as an Adverse Event of Special Interest (AESI).Preterm birth, defined as live birth before 37 completed weeks of gestation, is an important outcome monitored in maternal immunization studies. Standardized case definitions help
- [SPEAC Special Populations Research Featured at ESPID 2026](https://speacsafety.net/speac-special-populations-research-featured-at-espid-2026/) - SPEAC’s Special Populations group was pleased to present four posters at the 2026 Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), highlighting ongoing work to strengthen vaccine safety research and surveillance for pregnant women, fetuses, newborns, and young infants.Together, the presentations reflected the breadth of SPEAC’s work to support maternal immunization research,
- [New publication: Seven years of SPEAC](https://speacsafety.net/seven-years-of-speac/) - Launched in 2019 through a partnership between CEPI and Brighton Collaboration, SPEAC was established to provide standardized tools, expert guidance, and scientific support for vaccine safety monitoring across CEPI-funded vaccine development programs. Over the past seven years, the project has grown into a comprehensive platform supporting vaccine developers, researchers, regulators, and public health stakeholders worldwide.A
- [SPEAC Newsletter Spring 2026 Edition](https://speacsafety.net/speac-newsletterspring-2026-edition/) -  SPEAC’s Spring 2026 Partner Update highlights recent progress in advancing vaccine safety through new digital tools, educational resources, global training initiatives, and scientific engagement activities.Highlights include:New AESI dashboards within CEPI Vaccine Safety Intelligence to support standardized vaccine safety assessmentLaunch of the Educational Resource Library, new ABC Tool demonstrations, and expanded resources for active safety surveillanceContinued
- [New Ebola AESI List Added](https://speacsafety.net/ebola-aesi-list/) - SPEAC has created an Ebola Adverse Events of Special Interest (AESI) List, to support the vaccine response to the 2026 Bundibugyo virus disease epidemic in the Democratic Republic of Congo and Uganda. AESI lists provide priority safety outcomes to consider for vaccine safety assessment during clinical trials and pharmacovigilance activities. AESI lists facilitate standardized vaccine safety
- [Free Webinar: Using Living Systematic Reviews to Evaluate Maternal and Child Vaccination Evidence](https://speacsafety.net/free-lsr-webinar/) - Recording Now AvailableMissed the live session? The recording of our Evidence at Your Fingertips webinar is now available on-demand.This webinar explored how Living Systematic Reviews (LSRs) can support timely, evidence-based vaccine safety decision-making during both public health emergencies and routine immunization activities.Participants heard from experts working across vaccine safety and evidence synthesis as they discussed
- [Introducing the SPEAC Educational Resource Library](https://speacsafety.net/educationlibrary/) - SPEAC has launched a new Educational Resource Library to support the effective use of its vaccine safety tools and resources.As the SPEAC portfolio continues to expand—including digital tools within the CEPI Safety Intelligence ecosystem and updated Brighton Collaboration case definitions—users increasingly need practical guidance on how to apply these resources in real-world contexts. Supporting materials
- [New AESI Dashboards Now Available on the CEPI Vaccine Safety Intelligence (CVSI) Platform](https://speacsafety.net/new-cvsi-dashboards/) - SPEAC has launched a new set of dashboards on the CEPI Safety Vaccine Intelligence platform (CVSI), continuing efforts to translate established vaccine safety standards into practical, digital tools.About the PlatformThe CVSI platform serves as a centralized environment for SPEAC-developed tools, and other vaccine development and safety data, bringing together resources that support vaccine safety monitoring,
- [SPEAC at the 2026 World Vaccine Congress](https://speacsafety.net/speac-at-the-2026-world-vaccine-congress/) - The World Vaccine Congress brings together global stakeholders across vaccine development, safety, and policy.At this year’s meeting, beginning March 30 in Washington, D.C., SPEAC (Safety Platform for Emergency vACcines) experts will present two sessions focused on strengthening how vaccine safety data are defined and used, building on the work of the Brighton Collaboration. The value of Brighton Collaboration
- [Before the First Dose: Strengthening Oversight in Vaccine Trials](https://speacsafety.net/before-the-first-dose/) -  Clinical trials are conducted within established scientific and ethical frameworks designed to support consistent and well-governed research. Data and Safety Monitoring Boards (DSMBs) are one component of this framework. These independent groups review accumulating data during a trial and provide recommendations to support appropriate study conduct.A recent article from The Task Force for Global Health highlights
- [New Video: Understanding Guillain-Barré Syndrome and the Importance of Standardized Case Definitions](https://speacsafety.net/gbs-video/) -  Guillain-Barré Syndrome, or GBS, is a rare but serious neurological disorder that can cause sudden muscle weakness or flaccid paralysis. Although uncommon, the condition is an important cause of acute flaccid paralysis worldwide and can affect people of all ages.Recognizing the condition and classifying cases consistently is important for both clinical care and vaccine safety
- [New Demonstration Video: Automated Brighton Classification (ABC) Tool](https://speacsafety.net/abc-tool-demonstration/) - A new demonstration video is now available for the Automated Brighton Classification (ABC) Tool, which supports standardized assessment of adverse events following immunization (AEFI) using Brighton Collaboration case definitions.The ABC Tool, available through the CEPI Safety Intelligence Portal, guides users through structured questionnaires and automatically determines the appropriate level of diagnostic certainty (LOC) based on
- [SPEAC Newsletter Fall/Winter 2025 Edition](https://speacsafety.net/partner-update-fall-winter-2025/) -  We are pleased to share recent updates from the Safety Platform for Emergency vACcines (SPEAC), including new safety tools, evidence resources, and global engagement activities across partner networks. Highlights from this issue include:Expanded DSMB training cohorts, including a 40+ participant cohort delivered in partnership with Africa CDCReleased updated AESI lists for Marburg virus disease and Rift
- [Welcoming Dr. Hanna Nohynek as DSMB Co-Lead](https://speacsafety.net/welcoming-dr-hanna-nohynek-as-dsmb-co-lead/) - We are pleased to announce the appointment of Hanna Nohynek, MD, PhD, as Data and Safety Monitoring Board (DSMB) Co-Lead, following the retirement of Steve Black. Steve Black’s leadership has been instrumental in shaping a culture of rigorous, independent safety oversight.We extend our sincere thanks for his many years of service and lasting contributions to vaccine safety
- [Looking Back on 2025: Strengthening Vaccine Safety Through Global Collaboration](https://speacsafety.net/2025-reflections/) - As 2025 draws to a close, we pause to reflect on a year defined by collaboration, learning, and shared commitment across the global vaccine safety community.At SPEAC, our work is grounded in a simple but vital goal: to strengthen the evidence base for vaccine safety—particularly for vaccines against epidemic-prone diseases—so that decisions can be made
- [Strengthening Global Safety Oversight: SPEAC Delivers Its Largest DSMB Training to Date](https://speacsafety.net/dsmb-training-milestone/) -  SPEAC’s mission has always centered on strengthening the foundations of vaccine safety—through tools, guidance, and evidence, in support of the people who make real-time safety decisions. This month, we’re continuing that work by delivering our largest Data and Safety Monitoring Board (DSMB) training yet, with four separate cohorts and nearly 40 participants engaged across multiple
- [New Publication from SPEAC Team Members on Active Safety Surveillance in LMICs](https://speacsafety.net/active-safety-surveillance-in-lmics/) - We are pleased to share that six members of the SPEAC team—Andy Stergachis, Esperança Sevene, Mohammad Gazi Shah Alam, Samantha Mudigonda, Dale Nordenberg, and Robert Chen—join Rebecca Chandler and Alexander Precioso of CEPI as co-authors on a newly published article in Drug Safety: “Systematic Review of Active Safety Surveillance of Vaccines and Medicines in Low- and
- [Updated AESI List for Marburg Virus Disease Now Available](https://speacsafety.net/marburg-virus-aesi-list-update/) - The SPEAC Project has released an updated list of Adverse Events of Special Interest (AESI) for Marburg virus disease (MVD) vaccines, v2.1. This update reflects the latest evidence from ongoing vaccine development efforts, advances in filovirus pathogenesis research, and emerging safety data from peer-reviewed and gray literature sources.As with all SPEAC AESI lists, this update
- [Rift Valley fever AESI list update available](https://speacsafety.net/rvf-aesi-list-update/) - The SPEAC Project has released an updated list of Adverse Events of Special Interest (AESI) for Rift Valley fever (RVF) vaccines. This update reflects the latest evidence from vaccine development efforts, disease pathogenesis research, and emerging safety data from peer-reviewed and gray literature sources.As with all SPEAC AESI lists, this update is grounded in three
- [SPEAC at ISOP 2025: Supporting Global Vaccine Safety Implementation](https://speacsafety.net/speac-at-isop-2025/) - The International Society of Pharmacovigilance (ISOP) 2025 Annual Meeting in Cairo will feature multiple presentations from the Safety Platform for Emergency vACcines (SPEAC), funded by CEPI and hosted by the Brighton Collaboration. SPEAC experts will share how existing tools and methodologies are being applied to strengthen vaccine safety monitoring and interpretation in both emergency response
- [The SPEAC team comes together at Taskforce](https://speacsafety.net/speacf2foctober2025/) - Earlier this month, members of the Brighton Collaboration’s Safety Platform for Emergency vACcines (SPEAC) Executive Board and Work Package leads convened in person at the Task Force for Global Health in Decatur, Georgia, for three days of strategic discussions and planning.The meeting brought together leaders from across SPEAC workstreams to align priorities, share progress, and
- [New Video: Understanding Case Definition Companion Guides](https://speacsafety.net/cd-companion-guide-explainer-video/) - When it comes to vaccine safety, precision matters. That’s why the Brighton Collaboration and SPEAC have created Case Definition Companion Guides—practical tools designed to ensure case definitions are applied consistently across studies, settings, and the vaccine lifecycle.But what exactly is a Companion Guide, and how does it work alongside a Brighton Collaboration case definition?We recently
- [Five Years of SPEAC: Advancing the Science of Vaccine Safety](https://speacsafety.net/speac-at-19th-vaccine-congress/) - At the 19th Vaccine Congress in Kyoto, Dr. Robert Chen, Project Lead of the Safety Platform for Emergency Vaccines (SPEAC), presented a poster reflecting on the project’s first five years. The poster offered an important opportunity to look back at what has been achieved, and to share lessons learned with the broader vaccine science community.Strengthening
- [Preparing for the Unexpected in Vaccine Safety: Dr. Eileen Farnon Presents AESI-X Preparedness at ISPE 2025](https://speacsafety.net/aesi-xprep-at-ispe2025/) - At the International Society for Pharmacoepidemiology (ISPE) 2025 Annual Conference in Providence, Rhode Island, Dr. Eileen C. Farnon, Director of Research for the Safety Platform for Emergency vACcines (SPEAC) project, presented on a critical issue in global vaccine safety: how to prepare for adverse events of special interest-X (AESI-X) that may emerge with novel vaccines.Her
- [New Evaluation Tool to Guide Vaccine Use in Pregnant and Breastfeeding Populations](https://speacsafety.net/template-tool-for-special-populations/) - The Need for Structured Guidance in Emergencies In the midst of an emerging infectious disease outbreak, decision-makers face intense pressure to evaluate vaccines rapidly. For pregnant and lactating individuals, who are often excluded from early clinical trials, this creates a serious evidence gap.To help bridge that gap, the SPEAC Special Populations Working Group has developed
- [Advancing AESI Surveillance Capacity in Africa: A CEPI–Africa CDC Workshop in Accra](https://speacsafety.net/aesi-workshop-in-ghana/) - On 24–25 July 2025, Africa CDC convened the Workshop on Adverse Events of Special Interest (AESI) for Vaccine Safety Surveillance in Africa in Accra, Ghana, in partnership with CEPI and the SPEAC project.The two-day, in-person workshop brought together 40 participants from 20 African countries for intensive training in AESI detection, investigation, and response—particularly in the
- [SPEAC and Brighton Collaboration Featured in Task Force for Global Health’s Spotlight on Mpox Vaccine Safety](https://speacsafety.net/speac-and-brighton-collaboration-featured-in-task-force-for-global-healths-spotlight-on-mpox-vaccine-safety/) - We’re proud to see the work of the Brighton Collaboration and the Safety Platform for Emergency vACcines (SPEAC) highlighted in a recent article published by the Task Force for Global Health: “Vaccine Safety: Shaping the Fight Against Mpox.”The article underscores the pivotal role of vaccine safety in outbreak response, spotlighting how SPEAC rapidly mobilized Brighton
- [SPEAC Team Joins CEPI for Clinical Office Week](https://speacsafety.net/speac-team-joins-cepi-for-clinical-office-week/) - This week, members of the SPEAC team are traveling to meet with our funder, CEPI, as part of Clinical Office Week—a dedicated period of in-person collaboration, knowledge sharing, and strategic planning.Hosted by members of CEPI’s Clinical Development Team, Clinical Office Week brings together colleagues from across CEPI’s portfolio to align on shared goals and strengthen
- [Strengthening Vaccine Safety from Outbreaks to Infants: SPEAC at the World Vaccine Congress](https://speacsafety.net/strengthening-vaccine-safety-from-outbreaks-to-infants-speac-at-the-world-vaccine-congress/) - This April, global leaders in immunization, public health, and biotechnology convened in Washington, D.C. for the 2025 World Vaccine Congress (WVC)—one of the largest and most influential gatherings in the vaccine field. Held from April 1–4, the event brought together regulators, manufacturers, researchers, and policy experts to share innovations and align on global strategies for
- [Living Systematic Review on safety of mpox vaccines now available](https://speacsafety.net/living-systematic-review-on-safety-of-mpox-vaccines-now-available/) - In collaboration with Instituto de Efectividad Clínica y Sanitaria (IECS) and Tulane University, SPEAC's Special Populations team has launched a Living Systematic Review focused on the safety, effectiveness, and immunogenicity of mpox vaccines. Access the Mpox Living Systematic Review here. What is a Living Systematic Review (LSR)? Living Systematic Reviews (LSRs) are comprehensive literature reviews that are continually updated, incorporating relevant new evidence as
- [Living Systematic Review on safety of Lassa Fever vaccines now available](https://speacsafety.net/living-systematic-review-on-safety-of-lassa-fever-vaccines-now-available/) - In collaboration with Instituto de Efectividad Clínica y Sanitaria (IECS) and Tulane University, SPEAC's Special Populations team has launched a Living Systematic Review focused on the safety, effectiveness, and immunogenicity of Lassa Fever vaccines. Access the Lassa Fever Living Systematic Review here. What is a Living Systematic Review (LSR)? Living Systematic Reviews (LSRs) are comprehensive literature reviews that are continually updated, incorporating
- [Updated Landscape Analysis for Priority List of Adverse Events of Special Interest: Chikunguyna](https://speacsafety.net/updated-landscape-analysis-for-priority-list-of-adverse-events-of-special-interest-chikunguyna/) - An Updated Landscape Analysis for the Priority List of Adverse Events of Special Interest (AESI): Chikungunya is now available on Zenodo. A landscape analysis is a comprehensive review of the latest evidence, identifying possible adverse events of special interest (AESI) that may be associated with Chikungunya vaccines, research gaps, and priorities for monitoring vaccine safety.
- [New Companion Guide for Single Organ Cutaneous Vasculitis (SOCV)](https://speacsafety.net/new-companion-guide-for-single-organ-cutaneous-vasculitis-socv/) - We are happy to announce 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.What is a Companion Guide?Under the CEPI-funded Safety Platform for Emergency Vaccines (SPEAC) Project, the
- [Living Systematic Review on safety of Chikungunya vaccines now available](https://speacsafety.net/living-systematic-review-on-safety-of-chikungunya-vaccines-now-available/) - In collaboration with Instituto de Efectividad Clínica y Sanitaria (IECS) and Tulane University, SPEAC's Special Populations team has launched a Living Systematic Review focused on the safety, effectiveness, and immunogenicity of Chikungunya (CHKV) vaccines. Access the Chikungunya Living Systematic Review here. What is a Living Systematic Review (LSR)? Living Systematic Reviews (LSRs) are comprehensive literature reviews that are continually updated, incorporating relevant new
- [Validating a proposed case definition for Vaccine-Induced Immune Thrombocytopenia and Thrombosis](https://speacsafety.net/validating-a-proposed-case-definition-for-vaccine-induced-immune-thrombocytopenia-and-thrombosis/) - Over time, the need to revisit and refine public health concepts becomes apparent to ensure they remain accurate and relevant. This process often involves validating these definitions to enhance their precision and applicability. This approach is reflected in some of the terms in AESI lists developed by Safety Platform for Emergency vACcines (SPEAC). Recently, Brighton Collaboration and
- [Report of a SPEAC webinar 22 September 2023: Sensorineural hearing loss, Lassa virus disease and vaccines.](https://speacsafety.net/report-of-a-speac-webinar-22-september-2023-sensorineural-hearing-loss-lassa-virus-disease-and-vaccines/) - 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
- [Burden of Lassa fever disease in pregnant women and children and options for prevention](https://speacsafety.net/speac-and-cepi-members-shared-insights-at-the-poster-presentationin-the-23rd-annual-conference-of-the-international-society-of-pharmacovigilance-isop/) - Lassa fever, a viral disease in West Africa, affects around 2 million people annually, with 5,000–10,000 deaths—but data on its true impact in high-risk groups is limited. Neonates, children, and pregnant women are among the hardest hit. Safety Platform for Emergency vACcines (SPEAC)'s Dr. Manu Chaudhary, MBBS, MD and Flor Munoz, MD, MSc, in collaboration with members from the Maternal Immunization Working Group of experts (co-author members include:
- [SPEAC and CEPI members participated in the 23rd annual conference of the International Society of Pharmacovigilance ISoP](https://speacsafety.net/speac-and-cepi-members-participated-in-the-23rd-annual-conference-of-the-international-society-of-pharmacovigilance-isop/) - Last week, Safety Platform for Emergency vACcines (SPEAC) and CEPI (Coalition for Epidemic Preparedness Innovations) members participated in the 23rd annual conference of the International Society of Pharmacovigilance (ISoP Online) in Montreal focused on "Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics." Chaired by CEPI (Coalition for Epidemic Preparedness Innovations)’s Rebecca Chandler,
- [Updated AESI List for Mpox Now Available](https://speacsafety.net/updated-aesi-list-for-mpox-now-available/) - The SPEAC Project updated its initial list of adverse events of special interest for mpox on 17 September. Version 1.0 is now available here. SPEAC identifies AESIs based on three criteria: 1) Known association with immunization or a specific vaccine platform, 2) Occurrence during wild-type disease as a result of viral replication and/or immunopathogenesis, and
- [Initial AESI List for mpox now available ](https://speacsafety.net/initial-aesi-list-for-mpox-now-available/) - The SPEAC Project has developed an initial list of AESI for mpox vaccines. This list was developed by reviewing the existing vaccinia-associated AESI list and Brighton Collaboration (BC) case definitions (CDs) for relevance to LC16 and MVA-BN, and focused reviews of the peer-reviewed and gray literature to inform AESIs relevant to these two vaccines. SPEAC
- [SPEAC Executive Board meets with CEPI and Meta-DSMB in London ](https://speacsafety.net/speac-executive-board-meets-with-cepi-and-meta-dsmb-in-london/) - The SPEAC Executive Board, Meta-DSMB, and Project Management Team joined CEPI’s Clinical Development Team in London in June to discuss strategy, ongoing work, and opportunities for collaboration. First, SPEAC’s Meta-DSMB met to discuss their work to support CEPI awardees. The Meta-DSMB consists of 17 global vaccine safety experts from 11 countries who review safety across
- [SPEAC experts join the World Vaccine Congress](https://speacsafety.net/speac-experts-join-the-world-vaccine-congress/) - The World Vaccine Congress was held in Washington, D.C. from April 21 – 24, 2024. SPEAC experts joined 5,000 participants to explore strategic partnerships.
- [SPEAC experts join International Neonatal and Maternal Immunization Symposium](https://speacsafety.net/speac-experts-join-international-neonatal-and-maternal-immunization-symposium/) - The Sixth International Neonatal and Maternal Immunization Symposium (INMIS) took place from March 12-14 in San Jose, Costa Rica. The conference welcomed 300 participants, including researchers, clinicians, regulators, advocates, and representatives from industry, and featured presentations from 125 experts working in maternal and neonatal immunization. Former President of Costa Rica, Laura Chinchilla, gave the keynote
- [Webinar: Use of Background Rates of AESI for COVID-19](https://speacsafety.net/webinar-use-of-background-rates-of-aesi-for-covid-19/) - SPEAC invited speakers from different regulatory agencies to provide their perspectives on how these analyses are conducted and used in different organizations.
- [Women in vaccine safety work to accelerate progress toward vaccine acceptance](https://speacsafety.net/women-in-vaccine-safety-work-to-accelerate-progress-toward-vaccine-acceptance/) - Women working on vaccine safety are pushing through barriers to advance their field and reduce vaccine hesitancy through data-driven science.
- [Video: What is a Brighton Case Definition? ](https://speacsafety.net/video-what-is-a-brighton-case-definition/) - How is a Brighton Case Definition unique? What do the levels of certainty mean? Find answers to these questions and more in our video by Dr. Barbara Law.
- [Q&A with SPEAC Expert, Dr. Esperança Sevene](https://speacsafety.net/qa-with-speac-expert-dr-esperanca-sevene/) - Dr. Esperança Sevene is an Associate Professor of Clinical Pharmacology at Eduardo Mondlane University (UEM) in Mozambique. She supports the SPEAC project.
- [Q&A with SPEAC Expert, Dr. Manu Chaudhary](https://speacsafety.net/qa-with-speac-expert-dr-manu-chaudhary/) - Dr. Manu Chaudhary co-leads SPEAC’s special populations workstream alongside Dr. Flor Muñoz. Dr. Chaudhary is an American Board of Pediatrics Certified Pediatric Infectious Disease Specialist practicing at Rainbow Children’s Hospital in Bangalore and a Fellow of the American Academy of Pediatrics. How did you get into the vaccine safety field?In my final year at Armed
- [Q&A with SPEAC Expert, Dr. Wan-Ting Huang](https://speacsafety.net/qa-with-speac-expert-dr-wan-ting-huang/) - Dr. Wan-Ting Huang leads SPEAC’s quality assurance and continuous improvement efforts. She is an adjunct instructor at the National Taiwan University’s Global Health Program.
- [Dr. Andy Stergachis awarded first place for poster on living systematic review of COVID-19 vaccine safety and pregnancy](https://speacsafety.net/andy-stergachis-isop-living-systematic-review/) - Dr. Andy Stergachis received the first-place poster award at the annual conference of the International Society of Pharmacovigilance (ISoP) in Bali, Indonesia in November 2023.
- [SPEAC Mailing List](https://speacsafety.net/speac-mailing-list/) - Sign up to receive updates on the latest tools, resources, and news of the Safety Platform for Emergency vACcines (SPEAC).
- [SPEAC and CEPI’s Clinical Development Team meet to build safety into vaccine development process](https://speacsafety.net/speac-and-cepis-clinical-development-team-meet-to-build-safety-into-vaccine-development-process/) - The SPEAC team met with CEPI’s Clinical Development Team in London the week of June 12, 2023, to discuss progress and strategies to build safety into every step of CEPI’s approach to vaccine development.
- [Webinar Recording: Sensorineural Hearing Loss (SNHL), Lassa Fever, & Vaccines ](https://speacsafety.net/webinar-recording-sensorineural-hearing-loss-snhl-lassa-fever-vaccines/) - SPEAC hosted a webinar on September 22 on the topic of Sensorineural hearing loss (SNHL) and Lassa fever vaccines. The aim of the event was to review what is known regarding SNHL, Lassa fever disease, and vaccines and to discuss how hearing abnormalities that may occur during clinical trials should be evaluated and monitored. Discussion
- [SPEAC experts discuss Real-World Evidence at IABS conference](https://speacsafety.net/news-speac-experts-discuss-real-world-evidence-iabs-conference/) - SPEAC Executive Board members joined colleagues in Leuven, Belgium at the IABS - Flanders Vaccine RWE Conference to discuss Real-World Evidence for vaccine safety.
- [SPEAC webinar on background rates for observed/expected analysis](https://speacsafety.net/speac-webinar-on-background-rates-for-observed-expected-analysis/) - SPEAC held a webinar on April 24th, 2023, on the use of background rates for observed/expected analysis. The event gathered 250 attendees from various organizations in over 60 countries worldwide
- [CEPI, Brighton Collaboration and the Task Force for Global Health expand partnership to support safety assessment of vaccines](https://speacsafety.net/cepi-brighton-collaboration-and-the-task-force-for-global-health-expand-partnership-to-support-safety-assessment-of-vaccines/) - CEPI, BC and TFGH announced the expansion of the SPEAC a partnership contributing to the safety of future vaccines to prevent and respond to pandemics.
- [SPEAC kicks off the 4th edition of the DSMB Training Course](https://speacsafety.net/speac-kicks-off-4th-edition-of-the-dsmb-training-course-with-two-new-cohorts-of-participants-from-various-african-countries/) - The 4th edition of the DSMB Training Course started in March 2023 with 16 participants from various African countries who will undergo a two-month program designed to support the training of professionals who would have the competence to serve on Data and Safety Monitoring Boards (DSMB).
- [SPEAC experts join BeCOME conference](https://speacsafety.net/speac-experts-join-become-conference/) - Several SPEAC experts joined the BeCOME Conference at Les Pensières Center for Global Health in Annecy, France from June 11 - 13, 2023.

## Pages

- [Home](https://speacsafety.net/) - The Safety Platform for Emergency vACcines SPEAC is a project of the Coalition for Epidemic Preparedness Innovations (CEPI) and Brighton Collaboration. SPEAC provides vaccine safety tools, resources, and expertise throughout the vaccine development process to enhance safety and build confidence in vaccines. Learn More Objectives Building a robust safety monitoring service with three goals: SPEAC
- [DSMB Support](https://speacsafety.net/dsmb-support/) - DSMB SUPPORT AboUT speac'S dsmb poOL Vaccine clinical trials will typically employ a study Data and Safety Monitoring Board (DSMB) to review clinical trial data and ensure the safety of study participants in the clinical trial. The Safety Platform for Emergency Vaccines (SPEAC) is working to expand DSMB expertise around the world and to connect
- [Educational Resource Library](https://speacsafety.net/educational-resouce-library/) - Educational Resources Educational resources from the SPEAC project for investigators, regulators, and public health professionals working in vaccine safety, including explainer videos, webinars, and training materials on AESIs, Brighton case definitions, and safety monitoring. Featured Resource · New Overview Video Preterm Birth as an Adverse Event of Special Interest (AESI) Preterm birth, defined as live
- [ABC Tool Webinar](https://speacsafety.net/abc-tool-webinar/) - Free Webinar Automated Brighton Classification (ABC) Tool Standardizing AESI assessment using Brighton Collaboration case definitions Tuesday, August 25, 2026 11:00 AM – 12:00 PM US Eastern Daylight Time (EDT) Online | Free Watch the Webinar Watch the SPEAC webinar introducing the Automated Brighton Classification Tool. About the Webinar This free webinar introduces the Automated Brighton
- [Special Populations](https://speacsafety.net/tools/special-populations/) - Home Tools LSRs Special Populations SPEAC’s complete collection of tools and resources for special populations (Pregnant/Breastfeeding Persons, Children, etc.) Living Systematic Reviews Ebola Vaccines for Pregnant Persons and ChildrenIn collaboration with Instituto de Efectividad Clínica y Sanitaria (IECS) and Tulane University, SPEAC’s Special Populations team has launched a Living Systematic Review focused on the safety,
- [Living Systematic Reviews](https://speacsafety.net/tools/living-systematic-reviews/) - Home Tools LSRs LIVING SYSTEMATIC REVIEWS Living Systematic Reviews (LSRs) are comprehensive literature reviews that are continually updated, incorporating relevant new evidence as it becomes available when published in databases and clinical trial registries, which is used to conduct meta-analyses for various safety, immunogenicity and efficacy endpoints. A robust methodological framework, including PRISMA guidelines for reporting, ensures high-quality evidence synthesis. Including a diverse range of populations, such
- [Rift Valley Fever](https://speacsafety.net/tools/aesi-lists/rift-valley-fever/) - Priority List of Adverse events of special interest for Rift Valley Fever Version 3.1(Updated 02 July 2026) Home Tools AESI Lists Rift Valley Fever Body System​: Cardiac AESI: Myocarditis / Pericarditis Specific to Rift Valley Fever disease: Specific to vaccine: MVA Brighton Case Definition: Click to access Brighton CD Companion Guide: Click to access Body System: Ophthalmologic
- [About Us](https://speacsafety.net/about-us/) - ABOUT THE SPEAC PROJECT The Coalition for Epidemic Preparedness Innovations (CEPI) is a global partnership that develops vaccines to stop future epidemics. Brighton Collaboration is an international community of vaccine safety experts that provides standardized, validated, and objective methods for monitoring vaccine safety profiles and benefit-risk ratios.In 2019, CEPI and Brighton Collaboration came together to
- [Publications](https://speacsafety.net/publications/) - Publications Safety Assessment of Vaccines Against Priority Pathogens: The CEPI Safety Platform for Emergency Vaccines (SPEAC) Project: 2019-2026 AUTHORS: Eileen C Farnon, Caroline Cassard, Steven Black, Cornelia L Dekker, Wan‑Ting Huang, Barbara Law, Hammad Ali, Shelly T Karuna, Emily Wellman, Marc Gurwith, Esperança Sevene, Andy Stergachis, Hanna Nohynek, Preetha Iyengar, Manu Chaudhary, Clare L Cutland, Dale
- [Ebola](https://speacsafety.net/tools/aesi-lists/ebola/) - Home Tools AESI Lists Ebola Priority List of Adverse Events of Special Interest for Ebola Recommended Protocol-specified AESIs for Ebola vaccine clinical trials V1.1, 22 June 2026 The SPEAC recommended protocol-specified AESIs for inclusion in Ebola vaccine clinical trials are listed in the table below. This list applies to vaccines targeting Ebola virus, Sudan virus,
- [AESI Lists](https://speacsafety.net/tools/aesi-lists/) - Home Tools AESI Lists Lists of ADVERSE EVENTS of SPECIAL INTEREST An adverse event is an undesirable experience associated with the use of a medical product such as a vaccine. The Council for International Organizations of Medical Sciences (CIOMS) defines an adverse event of special interest (AESI) as a scientific and medical concern specific to
- [Vaccine Safety Resources for Mpox](https://speacsafety.net/vaccine-safety-resources-for-mpox/) - Vaccine Safety Resources for Mpox Here you will find The Safety Platform for Emergency vACcines (SPEAC) Project’s protocol template for cohort event monitoring for active safety surveillance after vaccination with mpox vaccines. The protocol template includes a list of adverse events of special interest, CEM questionnaires, an adult informed consent form, and key elements for
- [Automated Brighton Classification Tool](https://speacsafety.net/abc-tool/) - Automated Brighton Classification Tool The Automated Brighton Classification (ABC) Tool supports standardized assessment of adverse events following immunization (AEFI) using Brighton Collaboration case definitions.Available through the CEPI Safety Intelligence Portal, the tool guides users through structured questionnaires and automatically determines the appropriate Level of Diagnostic Certainty (LOC) based on the information entered. This supports more
- [Evidence at Your Fingertips LSR Webinar](https://speacsafety.net/evidence-at-your-fingertips-webinar/) - Evidence at your fingertips Webinar Access real-time evidence for maternal and child vaccination About the Webinar This page highlights a webinar demonstrating the Safe in Pregnancy / Safe in Children platform—an interactive hub that brings together real-time evidence through Living Systematic Reviews and meta-analyses on the safety, effectiveness, and immunogenicity of vaccines, with a focus
- [Tools](https://speacsafety.net/tools/) - SPEAC tools and resources SPEAC develops tools for harmonized safety monitoring to support vaccine developers in vaccine studies of known epidemic and pandemic threats. Brighton Collaboration Case Definitions New Brighton Collaboration Case Definitions for AESIs that may occur with novel pathogens View all Case Definition Companion Guides Resources and tools specific to events that have
- [CEPI Safety Intelligence](https://speacsafety.net/tools/safety-intelligence/) - CEPI VACCINE SAFETY INTELLIGENCE CEPI Safety Intelligence is an interactive, web-based platform that gives public health professionals, researchers, scientists, and regulators the situational awareness needed to act during epidemics and pandemics. By integrating vaccine safety information, immunization program data, and pathogen epidemiology, the platform provides a 360-degree view of the evolving public health landscape. Vaccine
- [Marburg](https://speacsafety.net/tools/aesi-lists/marburg/) - Home Tools AESI Lists Marburg Priority List of Adverse Events of Special Interest for Marburg Virus Version 2.1 (Updated 26 November 2025) The SPEAC Executive Board welcomes input on this AESI list and will update it periodically. Please share input with the SPEAC and Brighton Collaboration team at bc-coordinator@taskforce.org.This list of potential Adverse Events of Special
- [Vaccine Safety Templates](https://speacsafety.net/tools/vaccine-templates/) - Home Tools Vaccine Templates Vaccine Safety Templates Vaccine templates serve as standardized tools that incorporate essential factors for conducting a risk/benefit assessment of new vaccine candidates. Their primary objectives are:To facilitate communication of otherwise complex and highly technical data among key stakeholders and increase the transparency, comparability, and comprehension of essential information.To offer a practical
- [Guidance Documents](https://speacsafety.net/tools/guidance-documents/) - Home Tools Guidance Documents Guidance Documents Guidance for vaccine safety data collection, presentation and analysis See document Guidance on safety data collection for COVID-19 vaccine safety See document A template tool for the evaluation of vaccines for emerging pathogens to be used for pregnant and breast-feeding women See document
- [Case Definition Companion Guides](https://speacsafety.net/tools/companion-guides/) - Home Tools Companion Guides Case Definition Companion Guides SPEAC’s Case Definiton Companion Guides support the use of Brighton Collaboration Case Definitions.While a case definition provides standardized criteria for identifying and classifying a specific condition, the companion guide offers practical tools and resources to help apply it.Together, the case definition and companion guide promote a consistent
- [Nipah](https://speacsafety.net/tools/aesi-lists/nipah/) - Priority List of Adverse events of special interest for Nipah Home Tools AESI Lists Nipah Body System​: Hematologic AESI: Thrombocytopenic Thrombosis Syndrome ²Specific to vaccine: Adeno vectorsBrighton Case Definition: End of 2023Brighton CD Companion Guide: End of 2023 Body System​: Immunologic AESI: AnaphylaxisSpecific to vaccine: AllvaccinesBrighton Case Definition: Click to accessBrighton CD Companion Guide: Click
- [COVID-19](https://speacsafety.net/tools/aesi-lists/covid-19/) - Priority List of Adverse events of special interest for COVID-19 Home Tools AESI Lists COVID-19 Body System​: Cardiac AESI: Myocarditis / PericarditisSpecific to COVID-19 disease: Specific to vaccine: mRNA, NovavaxBrighton Case Definition: Click to accessBrighton CD Companion Guide: Click to access Body System​: Endocrine AESI: Acute pancreatitisSpecific to COVID-19 disease: Brighton Case Definition: TBDBrighton CD Companion
- [Mpox](https://speacsafety.net/tools/aesi-lists/mpox/) - Home Tools AESI Lists Mpox Priority List of Adverse Events of Special Interest for MPOX Version 1.0 (Updated 17 September 2024) This list of potential Adverse Events of Special Interest (AESI) that could follow vaccines to prevent Mpox was developed based on criteria established by the Safety Platform for Emergency Vaccines (SPEAC), which include: A known
- [Lassa Fever](https://speacsafety.net/tools/aesi-lists/lassa-fever/) - Priority List of Adverse events of special interest for Lassa Fever Home Tools AESI Lists Lassa Fever Body System​: Cardiovascular / Endovascular AESI: PericarditisSpecific to LF disease: Brighton Case Definition: Click to accessBrighton CD Companion Guide: Click to accessAESI: MyocarditisSpecific to vaccine: MVA¹Brighton Case Definition: Click to accessBrighton CD Companion Guide: Click to accessAESI: Polyserositis /
- [Chikungunya](https://speacsafety.net/tools/aesi-lists/chikungunya/) - Priority List of Adverse events of special interest for Chikungunya Home Tools AESI Lists Chikungunya Body System​: Cardiac AESI: Myocarditis / PericarditisSpecific to Chikungunya disease: Brighton Case Definition: Click to accessBrighton CD Companion Guide: Click to access Body System​: Hematologic AESI: Thrombosis / ThromboembolismSpecific to Chikungunya disease: Brighton Case Definition: Click to accessBrighton CD Companion Guide:
- [MERS](https://speacsafety.net/tools/aesi-lists/mers/) - Priority List of Adverse events of special interest for MERS Home Tools AESI Lists MERS Body System​: Cardiac AESI: PericarditisSpecific to MERS disease: Brighton Case Definition: Click to accessBrighton CD Companion Guide: Click to access Body System​: Hematologic AESI: Thrombosis / ThromboembolismSpecific to MERS disease: Brighton Case Definition: Click to accessBrighton CD Companion Guide: Click to
- [SPEAC Work Packages](https://speacsafety.net/work-packages/) - About SPEAC WOrk packages The Safety Platform for Emergency vACcines (SPEAC) includes 10 work packages. Learn about each component below. Work Package 1: DSMB Support & Meta-DSMB Work Package Leads: Steve Black and Corry DekkerOptimizes vaccine safety data review for CEPI-funded trials by providing liaison observers who are highly experienced in this work to study
- [Privacy Policy](https://speacsafety.net/privacy-policy/) - Privacy Policy Last updated: March 31st, 2023 The Task Force for Global Health program Safety Platform for Emergency Vaccines – SPEAC (“us”, “we”, or “our”) operates the speacsafety.net website (the “Service”). This policy explains when and why we collect personal information about you, how we use it, the conditions under which we may disclose it
- [Brighton Collaboration Case Definitions](https://speacsafety.net/tools/case-definitions/) - Home Tools Case Definitions Brighton Collaboration Case Definitions Brighton Collaboration Case Definitions are intended to: Harmonize collection and analysis of vaccine safety data throughout the vaccine life cycle and across diverse resource settings.Enable classifying cases across a range of diagnostic certainty from definite (level 1) to probable (level 2) to possible cases (level 3).Provide a
- [Contact](https://speacsafety.net/contact/) - CONTACT If you want to know more about SPEAC, its objectives, activities and/ or partners you can contact us via email. speac-contact@speac-cepi.net
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- [Our Services](https://speacsafety.net/our-services/) - 01 BLOOD BANK & CHEMISTRY Laboratories used for scientific research take many forms because of the differing requirements of specialists. 02 COAGULATION & CYTOLOGY Laboratories used for scientific research take many forms because of the differing requirements of specialists. 03 HEMATOLOGY & HISTOLOGY Laboratories used for scientific research take many forms because of the differing

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## Services

- [Preterm Birth and Assessment of Gestational Age](https://speacsafety.net/services/preterm-birth-and-assessment-of-gestational-age-cg/) - Home Tools Companion Guides Preterm Birth and Assessment of Gestational Age Preterm Birth and Assessment of Gestational Age AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and
- [Spontaneous Abortion and Ectopic Pregnancy](https://speacsafety.net/services/spontaneous-abortion-and-ectopic-pregnancy-cg/) - Home Tools Companion Guides Spontaneous Abortion and Ectopic Pregnancy Spontaneous Abortion and Ectopic Pregnancy AESI Case Definition Companion Guide This document collates into a single document all SPEAC Spontaneous Abortion and Ectopic Pregnancy resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria
- [Generalized Convulsion](https://speacsafety.net/services/generalised-convulsion-companion-guide/) - Home Tools Companion Guides Generalised Convulsion Generalised Convulsion AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level of certainty
- [Anaphylaxis](https://speacsafety.net/services/anaphylaxis/) - Home Tools Case Definitions Anaphylaxis Anaphylaxis Revision of the 2007 Brighton Collaboration case definition Authors Michael S. Gold, Ananda Amarasinghe, Matthew Greenhawt, John M. Kelso, Sonali Kochhar, Bernard Yu-Hor Thong, Karina A. Top, Paul J. Turner, Margitta Worm, Barbara Law See the Case Definition SPEAC has developed Companion Guides that contain resources and tools specific
- [Anaphylaxis](https://speacsafety.net/services/anaphylaxis-companion-guide/) - Home Tools Companion Guides Anaphylaxis Anaphylaxis AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level of certainty algorithm) and
- [TTS and VITT](https://speacsafety.net/services/tts-and-vitt-cg/) - Home Tools Companion Guides Thrombosis with Thrombocytopenia Syndrome (TTS) and Vaccine-induced Immune Thrombocytopenia and Thrombosis (VITT) Thrombosis with Thrombocytopenia Syndrome (TTS) and Vaccine-induced Immune Thrombocytopenia and Thrombosis (VITT) AESI Case Definition Companion Guide This document collates into a single document SPEAC resources (ICD-9/10-CM, MedDRA & SNOMED CT codes, background rates, risk factors, guidance (real time
- [Thrombosis and thromboembolism](https://speacsafety.net/services/thrombosis-and-thromboembolism/) - Home Tools Case Definitions Thrombosis and Thromboembolism Thrombosis and thromboembolism Case definition & guidelines for data collection, analysis, and presentation of immunization safety data Authors Jahnavi Gollamudi, Sarah E. Sartain, Amir Hassan Navaei, Satinder Aneja, Pawandeep Kaur Dhawan, Dat Tran, Jyoti Joshi, Jane Gidudu, Jayakrishna Gollamudi, Elena Chiappini, Frederick Varricchio, Barbara Law, Flor M. Munoz
- [Thrombocytopenia](https://speacsafety.net/services/thrombocytopenia-cg/) - Home Tools Companion Guides Thrombocytopenia Thrombocytopenia AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level of certainty algorithm) and
- [Myocarditis and Pericarditis](https://speacsafety.net/services/myocarditis-and-pericarditis-cg/) - Home Tools Companion Guides Myocarditis and Pericarditis Myocarditis and Pericarditis AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level
- [Acute Intraocular Inflammation (aIOI)](https://speacsafety.net/services/acute-intraocular-inflammation-aioi/) - Home Tools Companion Guides Single Organ Cutaneous Vasculitis Acute Intraocular Inflammation (aIOI) AESI Case Definition Companion Guide This document collates into a single document SPEAC resources (ICD9/10-CM, MedDRA & SNOMEDCT codes, background rates, risk factors, guidance (real time investigation, data collection, analysis and presentation) and tools (data abstraction & interpretation form, tabular summary of key
- [Acute Respiratory Distress Syndrome (ARDS)](https://speacsafety.net/services/acute-respiratory-distress-syndrome-ards-companion-guide/) - Home Tools Companion Guides ARDS Acute Respiratory Distress Syndrome (ARDS) AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level
- [Facial Nerve Palsy](https://speacsafety.net/services/facial-nerve-palsy-companion-guide/) - Home Tools Companion Guides Facial Nerve Palsy Facial Nerve Palsy AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level
- [Myelitis](https://speacsafety.net/services/myelitis-companion-guide/) - Home Tools Companion Guides Myelitis Myelitis AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level of certainty algorithm) and
- [Vaccine-associated enhanced disease (VAED)](https://speacsafety.net/services/vaccine-associated-enhanced-disease-vaed-cg/) - Home Tools Companion Guides VAED Vaccine-associated enhanced disease (VAED) AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level of
- [Multisystem Inflammatory Syndrome In Children and Adults (MIS-C/A)](https://speacsafety.net/services/multisystem-inflammatory-syndrome-in-children-and-adults-mis-c-a-companion-guide/) - Home Tools Companion Guides MIS-C/A Multisystem Inflammatory Syndrome In Children and Adults (MIS-C/A) AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty
- [Guillain-Barré and Miller Fisher Syndromes](https://speacsafety.net/services/guillain-barre-and-miller-fisher-syndromes-companion-guide/) - Home Tools Companion Guides Guillain Barré and Miller Fisher Syndromes Guillain Barré and Miller Fisher Syndromes AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for
- [Sensorineural Hearing Loss (SNHL)](https://speacsafety.net/services/sensorineural-hearing-loss-snhl-cg/) - Home Tools Companion Guides Sensorineural Hearing Loss (SNHL) Sensorineural Hearing Loss (SNHL) AESI Case Definition Companion Guide This document collates into a single document all SPEAC resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination,
- [Acute Aseptic Arthritis](https://speacsafety.net/services/acute-aseptic-arthritis/) - Home Tools Companion Guides Acute Aseptic Arthritis Acute Aseptic Arthritis AESI Case Definition Companion Guide This document collates into a single document SPEAC resources (ICD9/10-CM, MedDRA & SNOMEDCT codes, background rates, risk factors, guidance (real time investigation, data collection, analysis and presentation) and tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithms for level of certainty determination) for Acute Aseptic Arthritis. This guide
- [Single Organ Cutaneous Vasculitis (SOCV)](https://speacsafety.net/services/single-organ-cutaneous-vasculitis/) - Home Tools Companion Guides Single Organ Cutaneous Vasculitis Single Organ Cutaneous Vasculitis (SOCV) AESI Case Definition Companion Guide This document collates into a single document SPEAC resources (ICD9/10-CM, MedDRA & SNOMEDCT codes, background rates, risk factors, guidance (real time investigation, data collection, analysis and presentation) and tools (data abstraction & interpretation form, tabular summary of
- [Acute Encephalitis](https://speacsafety.net/services/acute-encephalitis-companion-guide/) - Home Tools Companion Guides Acute Encephalitis Acute Encephalitis AESI Case Definition Companion Guide This document collates into a single document all SPEAC Aseptic meningitis resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level
- [Aseptic Meningitis](https://speacsafety.net/services/aseptic-meningitis-companion-guide/) - Home Tools Companion Guides Aseptic Meningitis Aseptic Meningitis AESI Case Definition Companion Guide This document collates into a single document all SPEAC Aseptic meningitis resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level
- [Acute Disseminated Encephalomyelitis](https://speacsafety.net/services/acute-disseminated-encephalomyelitis/) - Home Tools Companion Guides Acute Disseminated Encephalomyelitis Acute Disseminated Encephalomyelitis AESI Case Definition Companion Guide This document collates into a single document all SPEAC Acute Disseminated Encephalomyelitis resources (Risk factors, background rates, ICD9/10-CM & MedDRA codes), tools (data abstraction & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty
- [Myocarditis and pericarditis](https://speacsafety.net/services/myocarditis-and-pericarditis/) - Home Tools Case Definitions Myocarditis and Pericarditis Myocarditis and pericarditis Case definition & guidelines for data collection, analysis, and presentation of immunization safety data Authors S. Kristen Sexson Tejtel, Flor M. Munoz, Iyad Al-Ammouri, Fabio Savorgnan, Rama K. Guggilla, Najwa Khuri-Bulos, Lee Phillips, Renata J.M. Engler. Abstract The current case definitions for myocarditis and pericarditis
- [Acute respiratory distress syndrome (ARDS)](https://speacsafety.net/services/acute-respiratory-distress-syndrome-ards/) - Home Tools Case Definitions ARDS Acute respiratory distress syndrome (ARDS) Case definition & guidelines for data collection, analysis, and presentation of immunization safety data Authors Nathan A. Serazin, Bassey Edem, Sarah R. Williams, Justin R. Ortiz, Anand Kawade, Manoj Kumar Das, Maja Šubelj, Kathryn M. Edwards, Shreemanta K. Parida, T. Anh Wartel, Flor M. Munoz, Patricia Bastero a Abstract Diagnostic accuracy under typical circumstances is imperfect because ARDS is a heterogeneous disease process. Furthermore, case definitions that require positive
- [Anosmia](https://speacsafety.net/services/anosmia/) - Home Tools Case Definitions Anosmia Anosmia Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data Authors Carol Yi-Chun Liu, Flor M. Munoz, Hector S Izurieta, Arina A Tamborska, Tom Solomon, Barbara J Law, Nipun Chhabra Abstract The case definition for Anosmia has 3 levels of certainty. All require
- [Multisystem inflammatory syndrome in children and adults (MIS-C/A)](https://speacsafety.net/services/multisystem-inflammatory-syndrome-in-children-and-adults-mis-c-a/) - Home Tools Case Definitions MIS-C/A Multisystem inflammatory syndrome in children and adults (MIS-C/A) Case definition & guidelines for data collection, analysis, and presentation of immunization safety data Authors Tiphanie P. Vogel, Karina A. Top, Christos Karatzios, David C. Hilmers, Lorena I. Tapia, Pamela Moceri, Lisa Giovannini-Chami, Nicholas Wood, Rebecca E. Chandler, Nicola P. Klein, Elizabeth
- [Sensorineural hearing loss (SNHL)](https://speacsafety.net/services/sensorineural-hearing-loss-snhl/) - Home Tools Case Definitions SNHL Sensorineural hearing loss (SNHL) Case definition & guidelines for data collection, analysis, and presentation of immunization safety data Authors Yi-Chun Carol Liu, Titus Ibekwe, John M. Kelso, Nicola P. Klein, Nathan Shehu, Wendy Steuerwald, Satinder Aneja, Matthew Z. Dudley, Robert Garry, Flor M. Munoz, The Brighton Collaboration SNHL Working Group
- [Vaccine-associated enhanced disease](https://speacsafety.net/services/vaccine-associated-enhanced-disease/) - Home Tools Case Definitions Vaccine-associated enhanced disease Vaccine-associated enhanced disease Case definition & guidelines for data collection, analysis, and presentation of immunization safety data Authors Flor M. Munoz, Jakob P. Cramer, Cornelia L. Dekker, Matthew Z. Dudley, Barney S. Graham, Marc Gurwith, Barbara Law, Stanley Perlman, Fernando P. Polack, Jonathan M. Spergel, Eva Van Braeckel,

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- [General](https://speacsafety.net/ts-testimonial-group/general/)

## Client Group

- [General](https://speacsafety.net/ts-client-group/general/)