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Developing Countries Vaccine Manufacturers Network (DCVMN) is an alliance of vaccine developers, manufacturers, and marketing authorization holders (MAHs) from low- and middle-income countries (LMICs) that plays a vital role in ensuring equitable, inclusive, accountable, and timely access to affordable, high-quality vaccines in these countries. Besides research and development, this network promotes manufacturing and global supply chains for effective strengthening of regulatory and pharmacovigilance activities. Traditionally, vaccine safety surveillance systems in LMICs rely on spontaneous reporting. However, especially in resource-limited settings, robust passive surveillance is lacking, and active vaccine safety surveillance (AVSS) can complement passive surveillance by actively collecting adverse events at sentinel sites or via formally designed observational (non-interventional) studies. The rapid introduction of novel vaccines during the COVID-19 pandemic with rather limited safety information at deployment accelerated the need for comprehensive AVSS in LMICs to detect potential safety concerns that may not have been identified in pre-licensure trials. In this context, national regulatory agencies (NRAs) and the World Health Organization (WHO) prequalification team requested risk management plans (RMPs) in line with Pharmacovigilance Planning guideline. The submitted RMPs contained the companies' commitments to pharmacovigilance activities encompassing both post-approval routine surveillance (passive) and additional active surveillance activities. These AVSS activities were either committed voluntarily by the manufacturers/MAHs or imposed by the NRA/WHO prequalification in case of important identified or potential risks, or important missing information. Unlike passive surveillance, AVSS relies on various epidemiological methodologies that require resources and expertise. DCVMN initiated a "learn-by-doing" project to support manufacturers/MAHs in performing AVSS. This project focused on improving the understanding of AVSS and its tools, investigated the support needs, opportunities, challenges, and barriers to performing AVSS activities in LMICs, and proposed solutions that could be used to mitigate the main challenges in performing AVSS activities in these countries., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: KH is an independent vaccine safety expert consulting for DCVMN and CEPI. Patricia Mouta Nunes de Oliveira reports article publishing charges and writing assistance were provided by DCVMN International. Patricia Mouta Nunes de Oliveira reports a relationship with Immunobiological Technology Institute that includes: employment. PMNO is an employee of Bio-Manguinhos, a public vaccine producer in Brazil If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2025 Elsevier Ltd. All rights reserved.)

Background: Children presenting enuresis are more likely to be asthmatics. The association between enuresis and sleep-disordered breathing has already been demonstrated and several studies have shown at least partial improvement of two thirds or more of the cases of enuresis adenoidectomy. Studies have already described associations between enuresis and allergies but do not assess the repercussions of allergy treatment in enuretics., Objective: This study aims to evaluated whether asthma treatment alters the course of enuresis and whether there is any predictive factor associated with this improvement., Materials and Methods: Twenty patients (5 - 12 years old) with uncontrolled enuresis and asthma, received treatment for asthma. Children were also assessed for the presence of rhinitis and other allergies. The control of asthma was confirmed by a validated questionnaire and primary enuresis by clinical history and wet night diaries. Patients received only asthma treatment., Results: At least partial improvement of enuresis was observed in 55% of the patients with an increase in 64.4% in the number of dry nights at the end of the study (p=0.01). The "presence of other allergies" and "obstruction seen in nasal endoscopy" positively influenced the improvement of urinary symptoms (OR = 3.350; CI 0.844-13.306) and (OR=1.272; CI 0.480-3.370), respectively., Discussion: Until now, only patients presenting upper airway obstruction were known to benefit from the improvement of urinary symptoms when undergoing treatment for their respiratory problems. In our study, we found at least partial improvement in enuresis in 55% of our patients, with only clinical asthma treatment., Conclusion: Controlling asthma in children with primary enuresis resulted in a significant increase in dry nights., Competing Interests: None declared., (Copyright® by the International Brazilian Journal of Urology.)

We describe 5 cases of yellow fever vaccine-associated viscerotropic disease (YEL-AVD) in 2 familial clusters during the 2017-2018 yellow fever (YF) vaccination campaign in São Paulo state, Brazil. The first case was that of a 40-year-old white man who died of icterohemorrhagic syndrome, which was confirmed to be YEL-AVD by using real-time reverse transcription PCR to detect 17DD YF vaccine in the liver. Ten years previously, his brother died of a clinically similar disease without a confirmed diagnosis 9 days after YF vaccination. The second cluster included 3 of 9 siblings in whom hepatitis developed in the first week after receiving fractionated doses of YF vaccine. Two of them died of hemorrhagic diathesis and renal and respiratory failure, and 17DD-YF vaccine was detected in serum samples from all patients and in the liver in 1 case. Genetic factors might play a substantial role in the incidence of YEL-AVD.

Yellow fever virus (YFV) live attenuated vaccine can, in rare cases, cause life-threatening disease, typically in patients with no previous history of severe viral illness. Autosomal recessive (AR) complete IFNAR1 deficiency was reported in one 12-yr-old patient. Here, we studied seven other previously healthy patients aged 13 to 80 yr with unexplained life-threatening YFV vaccine-associated disease. One 13-yr-old patient had AR complete IFNAR2 deficiency. Three other patients vaccinated at the ages of 47, 57, and 64 yr had high titers of circulating auto-Abs against at least 14 of the 17 individual type I IFNs. These antibodies were recently shown to underlie at least 10% of cases of life-threatening COVID-19 pneumonia. The auto-Abs were neutralizing in vitro, blocking the protective effect of IFN-α2 against YFV vaccine strains. AR IFNAR1 or IFNAR2 deficiency and neutralizing auto-Abs against type I IFNs thus accounted for more than half the cases of life-threatening YFV vaccine-associated disease studied here. Previously healthy subjects could be tested for both predispositions before anti-YFV vaccination., Competing Interests: Disclosures: A. Homma reported, "Our institution is a non-profit producer of the yellow fever vaccine. We are public institution, part of our Ministry of Health, and provide vaccine only for National Immunization Program and UNICEF, PAHO Revolving Fund, GAVI, and WHO. We are very much interested to know all relevant scientific issues involved with our vaccine." J.L. Casanova reported a patent to application number 63/055,155, filed July 22, 2020 pending. No other disclosures were reported., (© 2021 Bastard et al.)

Vaccination against measles, mumps, and rubella (MMR) and yellow fever (YF) with live attenuated viruses can rarely cause life-threatening disease. Severe illness by MMR vaccines can be caused by inborn errors of type I and/or III interferon (IFN) immunity (mutations in IFNAR2 , STAT1 , or STAT2 ). Adverse reactions to the YF vaccine have remained unexplained. We report two otherwise healthy patients, a 9-yr-old boy in Iran with severe measles vaccine disease at 1 yr and a 14-yr-old girl in Brazil with viscerotropic disease caused by the YF vaccine at 12 yr. The Iranian patient is homozygous and the Brazilian patient compound heterozygous for loss-of-function IFNAR1 variations. Patient-derived fibroblasts are susceptible to viruses, including the YF and measles virus vaccine strains, in the absence or presence of exogenous type I IFN. The patients' fibroblast phenotypes are rescued with WT IFNAR1 Autosomal recessive, complete IFNAR1 deficiency can result in life-threatening complications of vaccination with live attenuated measles and YF viruses in previously healthy individuals., (© 2019 Hernandez et al.)