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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.

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 post-licensure 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.

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.

•CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months.•The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group.•In the per protocol population vaccine efficacy was 43% after 3 doses, p=0.20 and 45%, p=0.08 after 2 doses.•We conclude the vaccine was safe and immunogenic and although the efficacy did not reach significance, the results are consistent with a previous study in adult women (Pass et al NEJM 360:1191, 2009) using the same formulation. Cytomegalovirus (CMV) is a leading cause of congenital infection and an important target for vaccine development. CMV seronegative girls between 12 and 17 years of age received CMV glycoprotein B (gB) vaccine with MF59 or saline placebo at 0, 1 and 6 months. Blood and urine were collected throughout the study for evidence of CMV infection based on PCR and/or seroconversion to non-vaccine CMV antigens. 402 CMV seronegative subjects were vaccinated (195 vaccine, 207 placebo). The vaccine was generally well tolerated, although local and systemic adverse events were significantly more common in the vaccine group. The vaccine induced gB antibody in all vaccine recipients with a gB geometric mean titer of 13,400EU; 95%CI 11,436, 15,700, after 3 doses. Overall, 48 CMV infections were detected (21 vaccine, 27 placebo). In the per protocol population (124 vaccine, 125 placebo) vaccine efficacy was 43%; 95%CI: −36; 76, p=0.20. The most significant difference was after 2 doses, administered as per protocol; vaccine efficacy 45%, 95%CI: −9; 72, p=0.08. The vaccine was safe and immunogenic. Although the efficacy did not reach conventional levels of significance, the results are consistent with a previous study in adult women (Pass et al. N Engl J Med 2009;360:1191) using the same formulation.

•COVID-19 during pregnancy imposes a risk of severe disease and adverse birth outcomes.•Data about the safety of vaccination against COVID-19 for pregnant women is limited.•COVID-19 vaccination coverage among pregnant persons is suboptimal.•We found no safety concerns for COVID-19 vaccination during pregnancy.•Our findings support authorized or approved COVID-19 vaccines for pregnant persons. Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49–15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56–2.12). Animal studies showed consistent results with studies in pregnant persons. We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.

Background Despite vaccine availability, Pertussis remains a global public health challenge, especially among infants. The Eastern Mediterranean Region (EMR) presents a diverse epidemiological landscape with varying vaccination coverages and healthcare infrastructures. This systematic review aimed to assess the burden of pertussis in infants < 1 year of age in the EMR and evaluate the use and impact of pertussis vaccination during pregnancy. Methods Following PRISMA guidelines, we conducted a systematic search of Scopus, Embase, CINAHL Ultimate, and PubMed from inception until April 30, 2024. Studies included reported on pertussis burden in infants or maternal vaccination. Data extraction and quality assessment were performed in duplicate, focusing on incidence, age distribution, disease severity, and vaccination uptake and impact when data were available. Results Thirty-six studies were included, the majority from Iran ( N  = 11), Morocco ( N  = 5), Tunisia ( N  = 5), and Oman ( N  = 3), with underrepresentation of other EMR countries. The incidence of PCR-confirmed pertussis among children with suspected pertussis varied significantly, from 6.7% to 8.9% (Morocco 2018–2019) to 50.4% and 51.6% (Palestine 2004–2008) among children < 12 and < 6 months, respectively, and between 16.3% (Tunisia 2007–2016) to 73.0% (Morocco 2013–2015) in children < 2 months. Age distribution data indicated the highest burden was in infants < 2 months regardless of the population studied. High hospitalization rates and severe complications, including seizures and the need for ventilatory support, were frequently reported in infants < 6 months of age. Only one study from Saudi Arabia addressed maternal pertussis vaccination, reflecting low vaccine uptake and awareness among pregnant women. Conclusions This review underscores the substantial burden of pertussis among infants in the EMR and the lack of data on maternal immunization. The findings emphasize the need for enhanced surveillance and targeted public health interventions to reduce disease incidence. Future research should prioritize underrepresented countries to ensure comprehensive data for informed public health strategies. Trial registration PROSPERO (CRD42024573471)

This is a Brighton Collaboration case definition of the term “Sensorineural Hearing Loss” 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 Lassa Fever and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and define levels of diagnostic certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network.

The variability of terms and definitions of Adverse Events Following Immunization (AEFI) represents a missed opportunity for optimal monitoring of safety of immunization in pregnancy. In 2014, the Brighton Collaboration Foundation and the World Health Organization (WHO) collaborated to address this gap. Two Brighton Collaboration interdisciplinary taskforces were formed. A landscape analysis included: (1) a systematic literature review of adverse event definitions used in vaccine studies during pregnancy; (2) a worldwide stakeholder survey of available terms and definitions; (3) and a series of taskforce meetings. Based on available evidence, taskforces proposed key terms and concept definitions to be refined, prioritized, and endorsed by a global expert consultation convened by WHO in Geneva, Switzerland in July 2014. Using pre-specified criteria, 45 maternal and 62 fetal/neonatal events were prioritized, and key terms and concept definitions were endorsed. In addition recommendations to further improve safety monitoring of immunization in pregnancy programs were specified. This includes elaboration of disease concepts into standardized case definitions with sufficient applicability and positive predictive value to be of use for monitoring the safety of immunization in pregnancy globally, as well as the development of guidance, tools, and datasets in support of a globally concerted approach. There is a need to improve the safety monitoring of immunization in pregnancy programs. A consensus list of terms and concept definitions of key events for monitoring immunization in pregnancy is available. Immediate actions to further strengthen monitoring of immunization in pregnancy programs are identified and recommended.

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries.

Background Lassa fever (LF), caused by the Lassa virus (LASV), is a zoonotic viral hemorrhagic disease endemic to West Africa, primarily transmitted through rodent excreta and infected bodily fluids. It poses significant public health challenges due to its high morbidity and mortality rates, particularly among at-risk populations like pregnant persons and children. Despite decades of research, vaccine development has been hindered by the virus’s genetic diversity and complex epidemiology. While several vaccine candidates have been developed, none have received regulatory approval. Given the rapidly evolving vaccine landscape, a living systematic review (LSR) was selected to enable real-time evidence synthesis. This protocol outlines a living systematic review (LSR) to evaluate the safety, efficacy, effectiveness, and immunogenicity of LASV vaccines, providing evidence to guide public health interventions and vaccine recommendations. Methods We will conduct a biweekly updated LSR and meta-analysis, systematically searching databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries from January 2014 onward to identify studies of LASV vaccines in pregnant persons, children, and adolescents. All study designs, including randomized trials, cohort studies, case–control studies, and case reports, will be eligible. Pairs of reviewers will independently assess eligibility, extract data, and evaluate the risk of bias. Primary outcomes include vaccine safety, efficacy, and effectiveness in pregnant persons (including neonatal outcomes), children, and adolescents, while secondary outcomes assess immunogenicity and reactogenicity. Data on adult populations will also be included, and results on this group will be reported as available. We will conduct paired meta-analyses, including prespecified subgroup and sensitivity analyses. We will use the grading of recommendations assessment, development, and evaluation approach to evaluate the certainty of evidence. Discussion This LSR offers a dynamic framework to generate timely evidence on LASV vaccines for vulnerable populations. By integrating findings into an interactive Microsoft Power BI dashboard, stakeholders can access and utilize real-time updates to inform public health strategies. Despite challenges like study heterogeneity and vaccine platform variability, subgroup and sensitivity analyses will mitigate these issues. This review aims to support clinical trial designs, guide policy, and improve health outcomes in Lassa fever-endemic regions. Study registration Two protocols were registered in the International Prospective Register of Systematic Reviews (PROSPERO) database: CRD42024514513 and CRD42024516754.