Adverse events following immunization associated with coronavirus disease 2019 (COVID-19) vaccines: A descriptive analysis from VigiAccess

Yamoah, Peter; Mensah, Kofi Boamah; Attakorah, Joseph; Padayachee, Neelaveni; Oosthuizen, Frasia; Bangalee, Varsha

doi:10.1080/21645515.2022.2109365

Cited by 12 publications

(6 citation statements)

References 30 publications

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“…With regard to sex distribution, several studies have shown sex differences in adverse events spontaneously reported in pharmacovigilance databases, showing a higher proportion of ICSRs related to female patients [ 16 , 17 ]. This sex difference in terms of ICSRs is still appreciable even in the case of COVID-19 vaccination cases as observed in recent studies, except for the cases of myocarditis and pericarditis which occur predominantly in young males [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study

et al. 2023

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Although the safety profiles of mRNA COVID-19 vaccines (mRNA-1273 and BNT162b2) were evaluated in pre-authorization clinical trials, real-world data allow us to better define their benefit/risk ratio in the paediatric population. The current study aimed to evaluate the safety profiles of mRNA COVID-19 vaccines in children by analysing the pharmacovigilance data of the European spontaneous reporting system database EudraVigilance (EV) in the period from January 1st, 2021, to October 1st, 2022. During our study period, overall 4838 ICSRs related to mRNA COVID-19 vaccines referring to 5–11-year-old subjects were retrieved from EV, of which 96.9% were related to BNT162b2 and 49.3% were related to males. A total of 12,751 Adverse Events Following Immunization (AEFIs) were identified, of which 38.7% were serious. The most frequently reported AEFIs were pyrexia, headache, and vomiting. Only 20 Individual Case Safety Reports (ICSRs) reported Multisystem Inflammatory Syndrome (MIS) as an AEFI, all related to BNT162b2. The majority of MIS cases were females, and six cases were completely resolved at the time of reporting. Our results show a favourable risk–benefit profile for all mRNA COVID-19 vaccines in this paediatric sub-population, supporting their use in children. Considering the peculiarity and fragility of children, continuous safety monitoring of COVID-19 vaccines is required.

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Section: Discussionmentioning

confidence: 99%

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study

et al. 2023

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“…Of these patients, almost 70% were female. In line with this finding, Peter Yamoah et al reported that COVID-19 vaccine-induced AEFIs were more frequently observed in women than men and in patients of the age group 18-64 years [10]. Other studies reported similar difference in AEFIs distribution by gender [11,12].…”

Section: Discussionmentioning

confidence: 72%

“…According to this analysis, we found a difference in IgG level for different DMTs (ANOVA test, p < 0.001). Significant differences were found for the comparison interferon Beta 1-a vs. ocrelizumab (10,315; p < 0.001) and interferon Beta 1-a vs. fingolimod (9573; p < 0.001). As reported by Pitzalis M et al [18], who evaluated the SARS-CoV-2 response after the second dose of the COVID-19 vaccine among 912 Sardinian MS patients and 63 healthy controls, humoral response to BNT162b2 was significantly influenced by these specific DMTs.…”

Section: Discussionmentioning

confidence: 97%

Three Doses of COVID-19 Vaccines: A Retrospective Study Evaluating the Safety and the Immune Response in Patients with Multiple Sclerosis

Maniscalco¹,

Cesare²,

Liguori

et al. 2023

JCM

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Since the beginning of the mass immunization of patients with multiple sclerosis (MS), many data on the efficacy and safety of COVID-19 vaccines have been produced. Considering that MS is an autoimmune disease and that some disease-modifying therapies (DMTs) could decrease the antibody response against COVID-19 vaccines, we carried out this retrospective study with the aim to evaluate the safety of these vaccines in terms of AEFI occurrence and the antibody response after MS patients had received the third dose. Two hundred and ten patients (64.8% female; mean age: 46 years) received the third dose of the mRNA-based COVID-19 vaccine and were included in the study. Third doses were administered from October 2021 to January 2022. The majority of patients (n = 193) were diagnosed with RRMS and EDSS values were ≤3.0 in 72.4% of them. DMTs most commonly used by included patients were interferon Beta 1-a, dimethyl fumarate, natalizumab and fingolimod. Overall, 160 patients (68.8% female) experienced 294 AEFIs, of which about 90% were classified as short-term, while 9.2% were classified as long-term. The most commonly reported following the booster dose were pain at the injection site, flu-like symptoms, headache, fever and fatigue. Regarding the immune response, consistently with literature data, we found that patients receiving ocrelizumab and fingolimod had lower IgG titer than patients receiving other DMTs.

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“…WHO-VigiAccess was launched by the WHO in 2015 to provide public access to information in VigiBase ® , the WHO global database of reported potential side effects of medicinal products. Data mining of the WHO-VigiAccess database would provide previously unknown drug-AE associations and some wellestablished clinical ones (Yamoah et al, 2022). The present study was conducted to assess the post-market adverse events associated with TNFɑ inhibitors in the WHO-VigiAccess database.…”

Section: Discussionmentioning

confidence: 99%

Application of Data Mining in Pharmaceutical Research

Pan,

Zhao,

Jia

et al. 2024

Frontiers Research Topics

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Frontiers is more than just an open access publisher of scholarly articles: it is a pioneering approach to the world of academia, radically improving the way scholarly research is managed. The grand vision of Frontiers is a world where all people have an equal opportunity to seek, share and generate knowledge. Frontiers provides immediate and permanent online open access to all its publications, but this alone is not enough to realize our grand goals. Frontiers journal seriesThe Frontiers journal series is a multi-tier and interdisciplinary set of openaccess, online journals, promising a paradigm shift from the current review, selection and dissemination processes in academic publishing. All Frontiers journals are driven by researchers for researchers; therefore, they constitute a service to the scholarly community. At the same time, the Frontiers journal series operates on a revolutionary invention, the tiered publishing system, initially addressing specific communities of scholars, and gradually climbing up to broader public understanding, thus serving the interests of the lay society, too. Dedication to qualityEach Frontiers article is a landmark of the highest quality, thanks to genuinely collaborative interactions between authors and review editors, who include some of the world's best academicians. Research must be certified by peers before entering a stream of knowledge that may eventually reach the public -and shape society; therefore, Frontiers only applies the most rigorous and unbiased reviews. Frontiers revolutionizes research publishing by freely delivering the most outstanding research, evaluated with no bias from both the academic and social point of view. By applying the most advanced information technologies, Frontiers is catapulting scholarly publishing into a new generation. What are Frontiers Research Topics?Frontiers Research Topics are very popular trademarks of the Frontiers journals series: they are collections of at least ten articles, all centered on a particular subject. With their unique mix of varied contributions from Original Research to Review Articles, Frontiers Research Topics unify the most influential researchers, the latest key findings and historical advances in a hot research area.

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Adverse events following immunization associated with coronavirus disease 2019 (COVID-19) vaccines: A descriptive analysis from VigiAccess

Cited by 12 publications

References 30 publications

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study

Three Doses of COVID-19 Vaccines: A Retrospective Study Evaluating the Safety and the Immune Response in Patients with Multiple Sclerosis

Application of Data Mining in Pharmaceutical Research

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