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This is a Brighton Collaboration case definition of anosmia to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by two expert reviewers prior to submission., The SPEAC Project is funded in whole by CEPI.

Replication-deficient adenoviral vectors have been under investigation as a platform technology for vaccine development for several years and have recently been successfully deployed as an effective COVID-19 counter measure. A replication-deficient adenoviral vector based on the simian adenovirus type Y25 and named ChAdOx1 has been evaluated in several clinical trials since 2012. The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) was formed to evaluate the safety and other key features of new platform technology vaccines. This manuscript reviews key features of the ChAdOx1-vectored vaccines. The simian adenovirus Y25 was chosen as a strategy to circumvent pre-existing immunity to common human adenovirus serotypes which could impair immune responses induced by adenoviral vectored vaccines. Deletion of the E1 gene renders the ChAdOx1 vector replication incompetent and further genetic engineering of the E3 and E4 genes allows for increased insertional capability and optimizes vaccine manufacturing processes. ChAdOx1 vectored vaccines can be manufactured in E1 complementing cell lines at scale and are thermostable. The first ChAdOx1 vectored vaccines approved for human use, against SARS-CoV-2, received emergency use authorization in the UK on 30th December 2020, and is now approved in more than 180 countries. Safety data were compiled from phase I-III clinical trials of ChAdOx1 vectored vaccines expressing different antigens (influenza, tuberculosis, malaria, meningococcal B, prostate cancer, MERS-CoV, Chikungunya, Zika and SARS-CoV-2), conducted by the University of Oxford, as well as post marketing surveillance data for the COVID-19 Oxford-AstraZeneca vaccine. Overall, ChAdOx1 vectored vaccines have been well tolerated. Very rarely, thrombosis with thrombocytopenia syndrome (TTS), capillary leak syndrome (CLS), immune thrombocytopenia (ITP), and Guillain-Barre syndrome (GBS) have been reported following mass administration of the COVID-19 Oxford-AstraZeneca vaccine. The benefits of thi COVID-19 vaccination have outweighed the risks of serious adverse events in most settings, especially with mitigation of risks when possible. Extensive immunogenicity clinical evaluation of ChAdOx1 vectored vaccines reveal strong, durable humoral and cellular immune responses to date; studies to refine the COVID-19 protection (e.g., via homologous/heterologous booster, fractional dose) are also underway. New prophylactic and therapeutic vaccines based on the ChAdOx1 vector are currently undergoing preclinical and clinical assessment, including vaccines against viral hemorrhagic fevers, Nipah virus, HIV, Hepatitis B, amongst others.

This deliverable provides the fifth update to the Priority List of potential Adverse events of special interest relevant to COVID-19 vaccine trials. Past updates focused on COVID-19 disease course and complications whereas this one shifts the emphasis to what has been observed for COVID-19 vaccines currently in use. It is limited to countries with pharmacovigilance programs in place that are able to monitor large populations (United States, Canada, Australia, United Kingdom, European Union)., The SPEAC Project is funded in whole by CEPI.

This is a Brighton Collaboration case definition of anosmia to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by two expert reviewers prior to submission.

This deliverable collates into a single document the SPEAC Vaccine-associated enhanced disease 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 guidance (real time investigation, data collection, analysis and presentation). This guide can be used by stakeholders to assess the occurrence of Vaccine-associated enhanced disease in clinical trials or epidemiologic studies. Unlike all other Brighton case definitions, this one cannot be applied to individual case reports in a pharmacovigilance setting. It is designed for use in controlled clinical trials or settings where the frequency of cases can be compared to that seen in naturally infected, unvaccinated individuals., The SPEAC Project is funded in whole by CEPI.

This deliverable replaces an earlier version of the Anaphylaxis Companion Guide (completed Feb 5, 2021) which accompanied the 2007 Anaphylaxis case definition. A new Working Group was formed in 2021 to review and revise the 2007 Anaphylaxis case definition (Anaphylaxis V-1) due to identified issues of the V-1 definition over-calling events with allergic symptoms as anaphylaxis. The new V-2 case definition was completed in September 2022, and this Companion Guide updates the previous one primarily as regards the tools for data abstraction and application to determine level of certainty. No changes were needed for the other sections including risk factors, background rates and ICD9/10-CM & MedDRA codes. This guide should replace the earlier version and can be used by stakeholders to assess the occurrence of anaphylaxis in several settings including as an adverse event following immunization., The SPEAC Project is funded in whole by CEPI.

This deliverable collates into a single document the SPEAC MIS-C/A resources (ICD9/10-CM, MedDRA and SNOMEDCT 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 guidance (real time investigation, data collection, analysis, and presentation). This guide can be used by stakeholders to assess the occurrence of MIS-C/A in several settings including as an adverse event following immunization., The SPEAC project is funded in whole by CEPI.

This deliverable collates into a single document the SPEAC ARDS resources (ICD9/10 CM, MedDRA and SNOMEDCT-US codes, background incidence, risk factors), tools (Case Report & interpretation form, tabular summary of key case definition criteria and algorithm for level of certainty determination, pictorial level of certainty algorithm) and guidance (real time investigation, data collection, analysis and presentation). This guide can be used by stakeholders to assess the occurrence of ARDS in several settings including as an adverse event following immunization., The SPEAC Project is funded in whole by CEPI.

This deliverable collates into a single document the SPEAC Thrombosis and Thromboembolism 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 guidance (real time investigation, data collection, analysis and presentation This guide can be used by stakeholders to assess the occurrence of Thrombosis and Thromboembolism in several settings including as an adverse event following immunization. Note: this guide accompanies the Thrombosis and Thromboembolism case definition specifically. A separate guide will be prepared for Thrombocytopenia Thrombosis Syndrome., The SPEAC project is funded in whole by CEPI.

This is a Brighton Collaboration case definition of thrombosis and thromboembolism to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected expert reviewers prior to submission.

This is a Brighton Collaboration case definition of thrombosis and thromboembolism to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected expert reviewers prior to submission., The SPEAC Project is funded in whole by CEPI.

This is a Brighton Collaboration Case Definition of the term ‘‘Multisystem Inflammatory Syndrome in Children and Adults (MIS-C/A)” to be utilized in the evaluation of adverse events following immunization. The case definition was developed by topic experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for SARS-CoV-2. The format of the Brighton Collaboration was followed, including an exhaustive review of the literature, to develop a consensus definition and defined levels of certainty. The document underwent peer review by the Brighton Collaboration Network and by selected expert external reviewers prior to submission. The comments of the reviewers were taken into consideration and edits incorporated into this final manuscript. 2021 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND.

This deliverable provides the methods and results of the creation of the Priority List of potential Adverse events of special interest relevant to Lassa Fever and MERS vaccine trials., The SPEAC Project is funded in whole by CEPI.

SPEAC has completed a 4th update of the COVID-19 clinical literature covering the period from November 2020 – August 2021. The primary objectives were to review the evidence on the following outcomes: Long COVID (Part 1) Acute cardiac injury other than myocarditis/pericarditis; Maternal, foetal and neonatal outcomes; Paediatric and adult COVID-19 related complications; System-specific COVID-19 complications. For this update, the search focused on meta-analyses and reviews and excluded case reports, case series, studies, guidelines and commentaries. The system specific annexes from previous reports have been updated with the newly published meta-analyses and reviews. New annexes have been added for specific populations: adult, paediatric, pregnant/foetal/neonatal. Based on this review, SPEAC recommends that: Long COVID should not be added to the COVID-19 AESI list at the present time and continued review of the evidence on Long COVID should be a focused activity of the fifth update. Beyond myocarditis and pericarditis, for which Brighton case definitions have been completed, no new case definitions need to be created for the other acute cardiac injuries. No maternal, foetal or neonatal outcomes will be added at this time to the COVID-19 AESI list. No new AESI will be added to the COVID-19 AESI list related to COVID-19 course and complications in children or adults. No new system-specific AESIs will be added to the COVID-19 AESI list. The next update (fifth update due December 2021) will use the same methods as described for this update to focus on new evidence related to Long COVID, Pregnancy and perinatal outcomes, paediatric course and complications and system specific AESIs or those seen in adult populations. The COVID-19 AESI list, as published in the 3rd update of December 2020, remains the same. Summaries are provided in body system specific annexes to the deliverable. As well, all citations in full along with PMID links are included in a spreadsheet that has separate tabs by body system. For pregnancy there are three tabs: one with all citations including PMID links similar to other tabs; a second that provides summaries of all the meta-analyses and systematic reviews included in the 4th update; and a third tab that cross tabulates all studies referenced by any meta-analysis and/or systematic review, against the meta-analyses and systematic reviews included in the fourth update., The SPEAC Project is funded in whole by CEPI.

Inactivated viral vaccines have long been used in humans for diseases of global health threat (e.g., poliomyelitis and pandemic and seasonal influenza) and the technology of inactivation has more recently been used for emerging diseases such as West Nile, Chikungunya, Ross River, SARS and especially for COVID-19. The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group has prepared standardized templates to describe the key considerations for the benefit and risk of several vaccine platform technologies, including inactivated viral vaccines. This paper uses the BRAVATO inactivated virus vaccine template to review the features of an inactivated whole chikungunya virus (CHIKV) vaccine that has been evaluated in several preclinical studies and clinical trials. The inactivated whole CHIKV vaccine was cultured on Vero cells and inactivated by ß-propiolactone.This provides an effective, flexible system for high-yield manufacturing. The inactivated whole CHIKV vaccine has favorable thermostability profiles, compatible with vaccine supply chains. Safety data are compiled in the current inactivated whole CHIKV vaccine safety database with unblinded data from the ongoing studies: 850 participants from phase II study (parts A and B) outside of India, and 600 participants from ongoing phase II study in India, and completed phase I clinical studies for 60 subjects. Overall, the inactivated whole CHIKV vaccine has been well tolerated, with no significant safety issues identified. Evaluation of the inactivated whole CHIKV vaccine is continuing, with 1410 participants vaccinated as of 20 April 2022. Extensive evaluation of immunogenicity in humans shows strong, durable humoral immune responses.

This deliverable collates into a single document the SPEAC Myocarditis and Pericarditis resources (Risk factors, background rates, ICD9/10-CM, MedDRA, SNOMEDCT_US, MeSH 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 guidance (real time investigation, data collection, analysis and presentation). This guide can be used by stakeholders to assess the occurrence of Myocarditis and Pericarditis in several settings including as an adverse event following immunization., The SPEAC Project is funded in whole by CEPI.

Nucleic acid (DNA and RNA) vaccines are among the most advanced vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of nucleic acid vaccines. This will facilitate the assessment by key stakeholders of potential safety issues and understanding of overall benefit-risk. The structured assessment provided by the template can also help improve communication and public acceptance of licensed nucleic acid vaccines.

This study investigated how a continuing education course can contribute to the pedagogical practice of teachers at Full-time Teaching Centers, final years of elementary school, in the State of Goiás. Action research was used, with the course offering, performed in remote format due to the pandemic. The methodological instruments were discourse analysis, chat, conversation wheel and written activities. The results indicate that a training course must consider the offer period, with enough time to solve the difficulties and challenges found throughout the course, as well as the specificity of the target audience and collective learning., El presente estudio investigó cómo un curso de formación continua puede contribuir a la práctica didáctica de los profesores de centros de enseñanza de tiempo completo, últimos años de enseñanza básica del Estado de Goiás. Se empleó la investigación-acción, ofreciendo un curso, realizado de manera remota, debido a la pandemia. Los instrumentos metodológicos fueron: el análisis del discurso, chat, ronda de conversación y actividades escritas. Los resultados indican que un curso de formación debe considerar el período en el que se ofrece, con tiempo suficiente para solucionar las dificultades y desafíos encontrados a lo largo del curso, así como la especificidad del público meta al que se destina el aprendizaje colectivo., Este estudo investigou como um curso de formação continuada pode contribuir para a prática pedagógica de professores dos Centros de Ensino em Período Integral, dos anos finais do ensino fundamental, do Estado de Goiás. Utilizou-se a pesquisa-ação, com o oferecimento de um curso realizado em formato remoto, devido à pandemia. Os instrumentos metodológicos foram: análise do discurso, chat, roda de conversa e atividades escritas. Os resultados indicam que um curso de formação deve considerar o período de oferecimento, com tempo suficiente para solucionar as dificuldades e os desafios encontrados ao longo do curso, assim como a especificidade do público-alvo a que se destina e a aprendizagem coletiva.

Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions. The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/ or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports. Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for postlicensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document. &nbsp

Beginning in February, 2021, multiple European countries (e.g., Austria, Denmark, Norway, Germany, UK) and Australia have reported cases of thrombosis with thrombocytopenia syndrome (TTS) in persons who received the Astra-Zeneca (AZ) COVID-19 vaccine (1-3, 10) and more recently in the US with the Janssen vaccine (11). In May 2021, a draft interim case definition was proposed by the Brighton Collaboration. Since that time, understanding of this condition and its relationship to vaccines has evolved. Recent work by Andreas Greinacher and others now allow revision of the original case definition and level of certainty algorithm.1 The goal of this case definition is to facilitate harmonized studies of this outcome. This supplements guidelines published by WHO provided information on case identification for treatment., The SPEAC Projec is funded in whole by CEPI.

This deliverable describes the methods for the systematic literature search, screening and the extraction of information from published documents, that capture information on incidence rates for any of the AESI in tier 1-4. It also describes how this information can be displayed visually on the Brighton Collaboration website. The approach chosen for the dashboard was to retain as much information as possible, in the underlying extracted data, which are quite heterogeneous in terms of methodology in particular geographic area, age classification, study years as well as age range, case identification and ascertainment processes Maintaining that information in a structured manner will allow the user to select as needed., The SPEAC Project is funded in whole by CEPI.

Auro Vaccines LLC has developed a protein vaccine to prevent disease from Nipah and Hendra virus infection that employs a recombinant soluble Hendra glycoprotein (HeV-sG) adjuvanted with aluminum phosphate. This vaccine is currently under clinical evaluation in a Phase 1 study. The Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template may also helpcontribute to improved public acceptance and communication of licensed protein vaccines.

Thrombosis: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

This is a Brighton Collaboration Case Definition of the term ‘‘Vaccine Associated Enhanced Disease” to be utilized in the evaluation of adverse events following immunization. The Case Definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for SARS-CoV-2 vaccines and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected Expert Reviewers prior to submission.

This deliverable 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 of certainty algorithm) and guidance (real time investigation, data collection, analysis and presentation). This guide can be used by stakeholders to assess the occurrence of aseptic meningitis in several settings including as an adverse event following immunization., The SPEAC Project is funded in whole by CEPI.