Surveillance Of Adverse Events Research Articles

Active surveillance of immunization adverse effects: a multicentre, open-label, three-arm randomized uncontrolled trial in Ethiopia.

Participant-centred active adverse event following immunization (AEFI) surveillance can offer real-time vaccine safety data and help in signal detection. This study aimed to evaluate the effectiveness of participant-centred active adverse events (AEs) surveillance following measles immunization in Gedeo Zone health facilities in Ethiopia. An open-label, multicentred, three-arm randomized uncontrolled trial was conducted from 1 June to 21 October 2023. After assessing enrolment eligibility, the study participants were randomized into three groups (short message service [SMS], telephone interview, and diary card). They were expected to report AEs in children 1week after receiving immunization. Binary and multivariable logistic regression and χ2 tests were used to analyse the data. Among the 396 participants randomized into the three groups, 80.8% (320 participants) reported back about their children's AE status. Participants in the telephone interview group exhibited a substantially superior response rate (93.2% of 132 participants; p<0.00001) compared with the SMS (71.2%) and diary card (78%) groups. The likelihood of reporting the status of AEs experienced by children was lower by 77% (adjusted odds ratio 0.23 [95% confidence interval 0.1 to 0.52], p-value <0.00001) in the diary card group compared with the telephone interview group. In this study, a telephone interview was found to be the best method for AEFI reporting. Participant-centred active AE surveillance could potentially permit more rapid identification of emerging safety signals. Trial registration: https://clinicaltrials.gov/ct2/show/NCT05803538.

#2572 Sodium-glucose transport protein 2 (SGLT-2) inhibitors in diabetic and non-diabetic kidney transplant recipients

Abstract Background and Aims The beneficial effects of administering sodium-glucose transport protein 2 (SGLT2i) inhibitors in patients with Chronic Kidney Disease, with or without Type 2 Diabetes (T2D), has been proven in large randomized controlled trials. Nevertheless, there is limited data considering Kidney Transplant Recipients (KTRs) with or without albuminuria. The purpose of this study was to evaluate the safety and efficacy of administering SGLT2i to KTRs in association to their kidney function and albuminuria. Method In this retrospective study we examined the effects of treatment with SGLT2i on kidney function (eGFR calculated with CKD-EPI formula), albuminuria (24h urine collection) and fasting serum glucose levels of KTRs. We included KTRs with T2D or without T2D and confirmed albuminuria (ACR &amp;gt;30 mg/gCr) in two consecutive ACR measurements. Kidney function and albuminuria monitoring was performed one month post-treatment initiation and in three month intervals thereafter. Moreover, immunosuppression trough levels were measured in each visit and active surveillance for adverse events was performed. Results Twenty-four KTRs (20 males) with a mean eGFR of 51.1 ± 14.2 ml/min/1.73 m2 were included in this study. Nine patients had T2D. Treatment was initiated 10 ± 5.4 years post transplant and all KTRs received dapagliflozin. Mean follow-up was 9 ± 2 months. Kidney function was non-significantly decreased directly after SGLT2i initiation and remained stable until the end of follow up (51.1 ± 14.2 vs. 51.4 ± 13.8 ml/min/1.73 m2). Overall, we found a significant reduction of albuminuria (371 ± 460 vs 235 ± 294 mg/24 h, p = 0.015). When KTRs were examined separately based on their diabetes status (KTRs with T2D vs. no T2D) we found that only those with T2D showed a significant decrease in albuminuria (450.4 ± 548 vs. 259.8 ± 332.5 mg/24 h, p = 0.008) at the end of follow up. Furthermore, a significant reduction of morning fasting glucose (106.4 ± 19.6 vs 99.9 ± 16.6 mg/dl, p = 0.0006) was noted. Trough levels of immunosuppression agents (tacrolimus, everolimus or cyclosporine) did not show any significant change after the initiation of SGLT2i and two patients had to discontinue the treatment, due to one episode of pyelonephritis and detection of funguria. Conclusion Prescription of SGTL2i in KTRs with T2D and albuminuria, seems to be a reliable option with significant efficacy on the decrease of albuminuria with minimal adverse effects.

An analysis of suicidal and self-injurious behavior reports with antiseizure medications in the FDA adverse event database

BackgroundPharmacovigilance systems such as the FDA Adverse Event Reporting System (FAERS), are established models for adverse event surveillance that may have been missed during clinical trials. We aimed to analyze twenty-five anti-seizure medications (ASMs) in FAERS to assess for increased reporting of suicidal and self-injurious behavior. MethodsTwenty-five ASMs were analyzed: brivaracetam, cannabidiol, carbamazepine, clobazam, clonazepam, diazepam, eslicarbazepine, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, phenobarbital, phenytoin, pregabalin, primidone, rufinamide, stiripentol, tiagabine, topiramate, valproate, vigabatrin, zonisamide. Reports of “suicidal and self-injurious behavior” were collected from January 1, 2004, to December 31, 2020, using OpenVigil 2.1 tool with indication as “Epilepsy”. Relative reporting ratio, proportional reporting ratio, and reporting odds ratio were calculated utilizing all other drug reports for epilepsy patients as a control. ResultsSignificant relative operating ratio, ROR (greater than 1, p<0.05) were observed for diazepam (2.909), pregabalin (2.739), brivaracetam (2.462), gabapentin (2.185), clonazepam (1.649), zonisamide (1.462), lacosamide (1.333), and levetiracetam (1.286). ConclusionsOf the 25 ASMs that were analyzed in this study, 4 (16%) were identified to have been linked with a likely true adverse event. These drugs included diazepam, brivaracetam, gabapenetin, and pregabalin. Although several limitations are present with the FAERS database, it is imperative to closely monitor patient comorbidities for increased risk of suicidality with the use of several ASMs.

Discussion on Medical Device Adverse Event Surveillance

With the continuous development of medical technology and the wide application of medical devices, the risk of medical device adverse events is gradually increasing. In order to ensure the safety and effectiveness of medical devices, timely detection and treatment of adverse events of medical devices, and to protect the safety and rights of patients, the state continuously strengthens the monitoring of adverse events of medical devices. This paper firstly introduces the domestic and foreign medical device adverse event related regulations, it introduces the form of medical device adverse event monitoring work in China, compares and analyzes the data of medical device adverse events in recent years, and puts forward some problems in medical device adverse event monitoring work, in order to continuously improve the control and management of the risk level of medical devices, and ensure the clinical use of medical devices and patient safety.

Surveillance for adverse events following immunization with DTaP-containing combination vaccines in Linping, China, 2019-2022.

The DTaP-Hib and DTaP-IPV/Hib combination vaccine can be used as a substitute for the diphtheria, tetanus, and acellular pertussis combined vaccine (DTaP). We aimed to evaluate the safety of multi-component vaccines containing DTaP by analyzing the reporting rates and characteristics of adverse events following immunization (AEFIs) in Linping District during the years 2019 to 2022. We obtained data of AEFI and vaccination from the National AEFI Surveillance System of China and Zhejiang Municipal Immunization Information Management System, respectively, during 2019-2022 for a descriptive, epidemiological analysis. The total number of AEFI reported following vaccinations with DTaP-containing combination vaccines was 802 in Linping District from 2019 to 2022. The overall reporting rates of AEFIs following DTaP, DTaP-Hib, and DTaP-IPV/Hib vaccinations were 445.72 (537 cases), 536.29 (45 cases), and 306.13 (220 cases) per 100,000 doses in Linping District from 2019 to 2022, respectively. Only one case of a serious AEFI following DTaP vaccination, with a reporting rate of 0.83 per 100,000 doses. The composition ratio of vaccine product-related reactions for DTaP, DTaP-Hib, and DTaP-IPV/Hib were 99.81, 97.78, and 100.00%, respectively. The composition ratio of coincidental events for DTaP and DTaP-Hib were 0.19 and 2.22%, respectively. The reporting rates of total AEFIs for DTaP-IPV/Hib were lower than for DTaP. The reporting rate of local induration for DTaP-Hib was lower than for DTaP, and the reporting rates of local redness & swelling and local induration for DTaP-IPV/Hib were both lower than for DTaP. DTaP-IPV/Hib had a higher proportion of AEFIs in first quarter compared to DTaP. The reporting rate after the second dose of DTaP-Hib was higher than that of DTaP, and the reporting rates of AEFIs after the first dose and third dose of DTaP-IPV/Hib were lower than DTaP. The reported AEFIs to multi-component vaccines containing DTaP components during 2019-2022 in Linping District were mainly mild vaccine reactions. DTaP-containing combination vaccines demonstrated a good safety profile.

Intussusception and Other Adverse Event Surveillance after Pilot Introduction of Rotavirus Vaccine in Nam Dinh and Thua Thien Hue Provinces-Vietnam, 2017-2021.

Rotavin-M1 (POLYVAC) was licensed in Vietnam in 2012. The association of Rotavin-M1 with intussusception, a rare adverse event associated with rotavirus vaccines, and with adverse events following immunization (AEFI) have not been evaluated and monitored under conditions of routine use. From February 2017 to May 2021, we conducted a pilot introduction of Rotavin-M1 into the routine vaccination program in two provinces. Surveillance for intussusception was conducted at six sentinel hospitals. AEFI reports at 30 min and 7 days after vaccination were recorded. Among 443 children <12 months of age admitted for intussusception, most (92.3%) were children ≥ 6 months. Of the 388 children who were age-eligible to receive Rotavin-M1, 116 (29.9%) had received ≥1 dose. No intussusception cases occurred in the 1-21 days after dose 1 and one case occurred on day 21 after dose 2. Among the 45,367 children who received ≥1 dose of Rotavin-M1, 9.5% of children reported at least one AEFI after dose 1 and 7.3% after dose 2. Significantly higher AEFI rates occurred among children given Rotavin-M1 with pentavalent vaccines (Quinvaxem®, ComBE Five®) compared to Rotavin-M1 without pentavalent vaccines. There was no association between intussusception and Rotavin-M1. The vaccine was generally safe when administered alone and when co-administered with other vaccines.

Interdisciplinary Learning Health System Response to Public Vaccine Concerns.

In Victoria, Australia, jurisdictional vaccine safety service is conducted by SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community). SAEFVIC developed a public Vaccine Safety Report (saefvic.online/vaccinesafety) to present key surveillance information. This study applies an interdisciplinary learning health system approach to evaluate the report, taking into consideration public expressions of concern on social media.

Vaccination coverage and adverse events following a reactive vaccination campaign against hepatitis E in Bentiu displaced persons camp, South Sudan.

Hepatitis E (HEV) genotypes 1 and 2 are the common cause of jaundice and acute viral hepatitis that can cause large-scale outbreaks. HEV infection is associated with adverse fetal outcomes and case fatality risks up to 31% among pregnant women. An efficacious three-dose recombinant vaccine (Hecolin) has been licensed in China since 2011 but until 2022, had not been used for outbreak response despite a 2015 WHO recommendation. The first ever mass vaccination campaign against hepatitis E in response to an outbreak was implemented in 2022 in Bentiu internally displaced persons camp in South Sudan targeting 27,000 residents 16-40 years old, including pregnant women. We conducted a vaccination coverage survey using simple random sampling from a sampling frame of all camp shelters following the third round of vaccination. For survey participants vaccinated in the third round in October, we asked about the onset of symptoms experienced within 72 hours of vaccination. During each of the three vaccination rounds, passive surveillance of adverse events following immunisation (AEFI) was put in place at vaccination sites and health facilities in Bentiu IDP camp. We surveyed 1,599 individuals and found that self-reported coverage with one or more dose was 86% (95% CI 84-88%), 73% (95% CI 70-75%) with two or more doses and 58% (95% CI 55-61%) with three doses. Vaccination coverage did not differ significantly by sex or age group. We found no significant difference in coverage of at least one dose between pregnant and non-pregnant women, although coverage of at least two and three doses was 8 and 14 percentage points lower in pregnant women. The most common reasons for non-vaccination were temporary absence or unavailability, reported by 60% of unvaccinated people. Passive AEFI surveillance captured few mild AEFI, and through the survey we found that 91 (7.6%) of the 1,195 individuals reporting to have been vaccinated in October 2022 reported new symptoms starting within 72 hours after vaccination, most commonly fever, headache or fatigue. We found a high coverage of at least one dose of the Hecolin vaccine following three rounds of vaccination, and no severe AEFI. The vaccine was well accepted and well tolerated in the Bentiu IDP camp community and should be considered for use in future outbreak response.

Long term follow up and outcomes of Covid-19 vaccine associated myocarditis in Victoria, Australia: A clinical surveillance study

BackgroundMyocarditis and myopericarditis are well described adverse events of special interest (AESI) following COVID-19 vaccinations. Although reports are reassuring regarding initial clinical outcomes, information about longer term outcomes remains limited. We aimed to further this knowledge and report outcomes to 6 months post diagnosis from a single population cohort. MethodsReports of myocarditis following COVID-19 vaccination were followed up by SAEFVIC (Surveillance of Adverse Events Following Vaccination in the Community), the state-wide vaccine safety service for Victoria, Australia. Confirmed myocarditis cases (Brighton Collaboration Criteria levels 1–3) were followed up via surveys at 1, 3 and 6 months post symptom onset. Responses received between 22 February 2021 and 30 September 2022 were analysed. Results87.5 % (N = 182) of eligible participants completed at least 1 survey report. 377 reports were analysed. 76.9 % of completed reports were from male patients. The median age of patients was 21 years [IQR: 16 to 32].54.8 % (n = 74) of survey reports at 6 months, reported ongoing symptoms. At all follow-up time points, females were significantly more likely to have ongoing symptoms. At 6 months, 51.9 % of male respondents reported symptom resolution compared to 22.6 % of female patients (p = 0.002). Females were also more likely to continue medication and have ongoing exercise restrictions. However, males were significantly more likely to have higher initial peak troponin results and abnormal initial cardiac imaging investigations. ConclusionsThere appears to be a significant proportion of patients who experience ongoing symptoms to 6 months post onset amongst patients that experience these AESI. Male patients were more likely to report earlier and more complete symptom recovery, despite significantly higher average initial peak troponin. This difference in phenotypic presentation in females compared to males warrants further investigation and there is a need for longer term follow up data.

Development and Validation of an Electronic Adverse Event Model for Patient Safety Surveillance in Interventional Radiology

BackgroundComprehensive adverse event (AE) surveillance programs in interventional radiology (IR) are rare. Our aim was to develop and validate a retrospective electronic surveillance model to identify outpatient IR procedures that are likely to have an AE, to support patient safety and quality improvement. MethodsWe identified outpatient IR procedures performed in the period from October 2017 to September 2019 from the Veterans Health Administration (n = 135,283) and applied electronic triggers based on posyprocedure care to flag cases with a potential AE. From the trigger-flagged cases, we randomly sampled n = 1,500 for chart review to identify AEs. We also randomly sampled n = 600 from the unflagged cases. Chart-reviewed cases were merged with patient, procedure, and facility factors to estimate a mixed-effects logistic regression model designed to predict whether an AE occurred. Using model fit and criterion validity, we determined the best predicted probability threshold to identify cases with a likely AE. We reviewed a random sample of 200 cases above the threshold and 100 cases from below the threshold from October 2019 to March 2020 (n = 20,849) for model validation. ResultsIn our development sample of mostly trigger-flagged cases, 444 of 2,096 cases (21.8%) had an AE. The optimal predicted probability threshold for a likely AE from our surveillance model was >50%, with positive predictive value of 68.9%, sensitivity of 38.3%, and specificity of 95.3%. In validation, chart-reviewed cases with AE probability >50% had a positive predictive value of 63% (n = 203). For the period from October 2017 to March 2020, the model identified approximately 70 IR cases per month that were likely to have an AE. ConclusionsThis electronic trigger-based approach to AE surveillance could be used for patient-safety reporting and quality review.

Monitoring of adverse drug reactions during seasonal malaria chemoprevention campaigns in children aged 3–59 months in Burkina Faso

Seasonal malaria chemoprevention (SMC) by mass administration of sulfadoxine pyrimethamine + amodiaquine (SPAQ) reduces the burden of malaria in children aged 3-59 months. The occurrence of adverse drug reaction (ADR) may affect the success of this intervention. There are few studies of SMC adverse event surveillance in sub-Saharan Africa, particularly in Burkina Faso, a highly endemic country. Our main objective was to characterize the ADRs reported during SMC campaigns in Burkina Faso. Secondly, we evaluated the performance of the pharmacovigilance integrated into the SMC program in order to support safe administration of SMC. This was a retrospective descriptive study of SMC individual case safety reports recorded in VigiBase® in Burkina Faso from 2014 to 2021. We used the P-method for the analysis of preventable serious adverse drug reactions and WHO criteria for assessing the performance of pharmacovigilance integrated into the SMC program. A total of 1,105 SMC individual case safety reports were registered in VigiBase® for 23,311,453 doses of SPAQ given between 2014 and 2021. No pharmacovigilance signal was detected. The number of serious cases was 101, of which 23 (22.8%) were preventable. In 38.1% of children, the occurrence of ADRs led to discontinuation of SMC treatment. Vomiting was the most frequently reported adverse drug reaction (48.0%). The proportion of children whose treatment was discontinued due to vomiting was 42.7%, while the proportion of treatment discontinuation for other ADRs was 32.8% (p = 0.01). The SMC program contributed at 46.2% to the national pharmacovigilance database. The reporting rate was 0.03 per 1,000 exposed children in 2021. The median completeness score of the ICSRs was 0.7 (IQR: 0.5-0.7), and the median time to register the ICSRs in VigiBase® was 204 (IQR: 143-333) days. Post-drug administration vomiting may interfere with the purpose of SMC. Measures to manage this adverse drug reaction should be taken to improve the success of the SMC program. Based on the information on reporting time and reporting rate, spontaneous reporting should be supported by active surveillance, including cohort event monitoring, in Burkina Faso.

Progress in Immunization Safety Monitoring - Worldwide, 2020-2022.

Effective surveillance of adverse events following immunization (AEFIs) primarily relies on the collaboration of two partners: national regulatory authorities (NRAs) and national expanded programs on immunization (EPIs). In December 2020, the World Health Organization (WHO) Global Advisory Committee for Vaccine Safety recommended a new case-based indicator of national capacity to monitor immunization safety: at least one serious AEFI reported per 1 million total population per year. To achieve this indicator, WHO-affiliated countries and territories (WHO countries) rely upon data generated from functional AEFI surveillance systems. This report describes 2020-2022 global, regional, and national progress in use of the newly introduced immunization safety monitoring indicator and progress on joint AEFI reporting from national EPIs and NRAs. Among WHO countries, 51 (24%) of 214 implemented the new indicator in 2020, 111 (52%) of 214 implemented it in 2021, and 92 (43%) of 215 in 2022. In 2020, 41 (19%) WHO countries reported AEFI data jointly from EPIs and NRAs; this increased to 55 (26%) in 2021 and 57 (27%) in 2022. These findings, resulting in part from the intensified support for COVID-19 vaccination, demonstrate that national AEFI surveillance systems increasingly support the timely use and sharing of case-based immunization safety data, but work is still needed to strengthen global vaccine safety monitoring.

Treatment of Congenital Hypotransferrinemia Patients with Human Apotransferrin Resolves Anemia and Reduces Iron Accumulation

Introduction Congenital hypotransferrinemia is a very rare inherited and life-threatening disorder (MIM#209300) characterized by systemic iron overload and anemia. The deficiency of serum transferrin leads to inadequate iron supply to erythroid bone marrow, resulting in microcytic hypochromic anemia. This triggers hepcidin downregulation, causing increased iron absorption and production of non-transferrin bound iron (NTBI), leading to iron overload in various organs and tissues. Currently, there is no targeted therapy for this disease. Method In an open-label phase II/III study, four children (age 0-7 years) and one adult (20 years) with congenital hypotransferrinaemia were treated with purified plasma-fractionated human apotransferrin for nearly 10 years. All patients received an initial intravenous dose of 75 mg/kg every 8 weeks for 6 months, followed by 75 mg/kg every 4 weeks for additional 6 months, and in the subsequent years apotransferrin was administered every 4 weeks but the dose was adjusted to 75-150 mg/kg based on clinical judgement of physician according to patient condition. Prior to the start of the study two patients already received replacement therapy, i.e., human apotransferrin or plasma. Serum transferrin and serum iron were determined before every infusion. Primary objective was to investigate the effect of apotransferrin treatment on anemia and iron overload. Hemoglobin, hematocrit, and erythrocytes as markers of anemia were measured every 8 weeks. Iron overload was monitored by measuring serum ferritin every 8 weeks and yearly iron quantification in liver and heart through MRI. Labile Plasma Iron (LPI) was measured before and after infusion (starting after 2 years of treatment). The need for additional treatment for anemia or iron overload was defined as a secondary outcome. Safety and clinical tolerance were evaluated by adverse event surveillance and laboratory measurements. Results Baseline serum transferrin levels were significantly below the normal range in all patients (&amp;lt;10-189 mg/L; normal range: 1800-3500 mg/L). Treatment with human apotransferrin increased serum transferrin and serum iron levels in all patients. Fifteen minutes after the first infusion, transferrin levels ranged from 1340-2415 mg/L, but declined to values just above baseline before the next infusion (dosing interval 8 weeks). During the study period serum transferrin concentrations were affected by dose adjustments; however, trough levels of transferrin remained below the normal range throughout the study (range 200-800 mg/L). Despite subnormal trough levels, apotransferrin infusion led to rapid increase of hemoglobin (Figure 1), hematocrit, and erythrocyte levels up to normal values. The two patients who were already treated before the study, showed normal levels at baseline that were maintained. In all patients hematologic parameters remained stable throughout the study. Ferritin levels were elevated at baseline and decreased to normal ranges in 1.2 to 7.3 years, with a maximum decrease ranging from 82% to 97% of baseline. MRI examinations revealed liver iron overload at baseline which normalized in all patients after apotransferrin treatment, in most cases after 3 to 4 years (Figure 2). No myocardial iron overload was observed at baseline and during the follow-up. Pre-infusion LPI was found in all five patients, however in three patients the values were undetectable on most occasions. Immediately after infusion with apotransferrin, in none of the patients LPI was present anymore. Throughout the study no additional use of plasma/blood products or iron chelators was needed. Apotransferrin infusions were well tolerated. No serious adverse events were reported. No loss of clinical response to treatment was detected over time. Conclusion Treatment with human apotransferrin in patients with congenital hypotransferrinemia demonstrated good long-term clinical efficacy. Apotransferrin infusions increased hematopoiesis, reduced iron overload in organs, and eliminated the need for additional medication. The therapy was well-tolerated and showed good clinical safety. Human apotransferrin holds promise as the mainstay treatment option for congenital hypotransferrinemia.

The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial

BackgroundIncorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform new solutions for removing treatment barriers like medication nonadherence. This study evaluated whether implementing a patient-reported outcome data collection and adverse event surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform.MethodsWe used iterative plan-study-do-act cycles to evaluate how this data collection and surveillance tool—a short prompt for patients to provide information on treatment satisfaction and side effects—impacted treatment continuation, the outcome of interest. We tested two cycles in n = 2,000 patients receiving care for erectile dysfunction on a telehealth platform as a randomized controlled trial, and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.ResultsCompared to patients in the control group, patients in the intervention group were more likely to refill their prescription over the duration of the study period (75% vs. 71%, Kaplan Meier log-rank test, p = 0.04). Receiving standardized counseling as part of the AE response system was positively associated with treatment continuation (p = 0.0005).ConclusionsPrompting patients to report side effects and outcomes outside of routine clinical visits has the potential to improve quality of care in virtual treatment.Trial registrationThis trial has been retrospectively registered as a clinical trial (ClinicalTrials.gov Identifier: NCT05895539, registered June 8, 2023).

Enhancing Pharmacovigilance in Côte d'Ivoire: Impact of GSK's Training and Mentoring Pilot Project in the Abidjan Region.

Pharmacovigilance (PV) in sub-Saharan Africa relies on passive surveillance but underreporting of adverse events (AEs) by health care professionals (HCPs) is a major challenge. A PV enhancement project was implemented to address this in Côte d'Ivoire. To improve safety surveillance of medicines through PV training and mentoring of HCPs in selected health care facilities (HCFs). This collaborative project between national PV stakeholders, GSK, and PATH was implemented from September 2018 to February 2020 in Abidjan region, Côte d'Ivoire. Trained PV focal points provided training and regular mentoring of HCPs. Key performance indicator (KPI) categories for AE reporting were the volume of AE reports, efficiency of report transmission and data entry, quality of reports, and quality of the central (Vigilance Unit) response to AE reports. Overall, 1427 HCPs at 91 HCFs were trained. In the 8 months before implementation, 33 AE reports were received versus 85 after 3 months and 361 after 18 months of implementation (71 [83.5%] and 278 [77.0%], respectively, from Abidjan). The KPIs with the highest proportions were: AE reports received centrally (100%), complete AE reports (69.0%), AE reports entered into the local PV database within 48h (99.6%), and AE reports entered into the global database, VigiBase (86.7%). Report notification within 72h, causality assessment, and serious AE reporting had proportions below 20%; feedback to reporters was provided for only 0.4% of reports. Regular PV trainings and mentoring improved AE reporting in Côte d'Ivoire but further enhancement is required to improve passive safety surveillance.

Adverse events following immunization (AEFIs) with anti-meningococcus type B vaccine (4CMenB): Data of post-marketing active surveillance program. Apulia Region (Italy), 2019–2023

The four-component recombinant-DNA anti-meningococcus B vaccine (4CMenB) has been approved by the European Medicines Agency in 2013. In Italy, 4CMenB is recommended since 2017 for use in infants under one year of age. Due to the strong evidence of increased risk of fever after administration, surveillance of adverse events following immunization (AEFIs) is a priority for 4CMenB.This cross-sectional prospective study aims at investigating 4CMenB’s safety profile. The study population is represented by infants under twelve months of age vaccinated with 4CMenB in selected ambulatories in Apulia, a region in South-Eastern Italy, from October 1st, 2020, to March 31st, 2023. Parents were provided with a post-vaccination diary covering up to seven days after immunization and were contacted one week after the vaccination day. Information about AEFIs was collected, and reactions were classified following World Health Organization guidelines. For serious AEFIs, causality assessment was carried out. AEFI risk determinants were investigated via logistic regression.A total of 4,773 diaries were completed, with 78.13 % of them (3,729/4,773) containing one or more AEFI reports. Systemic reactions such as malaise, drowsiness/insomnia and fatigue were the most common ones, followed by fever and local pain, tenderness, redness and swelling.Twenty-three cases of serious AEFIs were reported. Following causality assessment, 78.26 % of serious adverse events (18/23) were deemed to have a consistent causal association with the administration of 4CMenB (reporting rate: 0.38 %). Three infants were hospitalized following vaccination, but no cases of death or permanent/severe impairment were reported. Prophylactic paracetamol administration showed a significant protective effect against the risk of manifesting fever within the first 24 h after administration (OR: 0.75; p < 0.005).Our data confirms existing evidence regarding the safety of 4CMenB vaccination in babies under 2 years of age, but also highlight a significant risk of fever after vaccination. Prophylactic paracetamol administration could represent a protective factor against fever, especially during the first 24 h after vaccination.

Adverse reactions after Covid-19 vaccination in persons affected by leprosy: A scoping review.

Leprosy reactions are the main pathway leading to severe nerve damage and disability. These reactions can occur at any time. The coronavirus disease 2019 (Covid-19) pandemic led to a catastrophic loss of human life and has had a devastating impact on persons affected by leprosy. To achieve deep insight into the subject of adverse reactions acquired after Covid vaccinations in persons affected by leprosy through a literature review. A scoping review was conducted in the studies published between July 2021 and June 2022 using the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Reviews (PRISMA-ScR) checklist. Using the search strategy, a total of 130 articles were found, of which five were relevant to the study. The adverse reactions were acquired mostly in males [9 (81.8%)]; the majority of them belong to borderline tuberculoid [4 (36.4%)], and most of them were released from treatment (multi-drug therapy) [7 (63.6%)]. Surveillance and management of adverse events following immunization (AEFI) are essential; even minor AEFI should be reported and documented in a line list.

A sentinel surveillance of adverse events and breakthrough infections following COVID-19 precautionary dose among south Indian healthcare workers

Background: Adverse events following immunization (AEFI) is defined as any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. Break-through infections are referred to as antigen or SARS-CoV-2 RNA positivity of respiratory specimens more than 14 days after receiving all recommended doses. Aim: The study was conducted to identify adverse events and break-through infections following the precautionary dose of the COVID-19 vaccine among healthcare workers. Methodology: The study was designed as a cohort event monitoring; all healthcare professionals who received COVID-19 precautionary dose from the study site were included in the study. The study population was actively followed for any adverse event following immunization (AEFI) through telephonic contact (within 30 days of post-vaccination). Reported adverse events were carefully scrutinized and evaluated by the AEFI investigation team of the study site. Results: Out of 1232 vaccine beneficiaries, a total of 359 (29.14%) individuals were reported with 385 AEFIs. Of which 138 (38.44%) individuals were laboratory-confirmed (RTPCR positive) breakthrough cases. Less severity and low morbidity were observed among all the breakthrough cases. According to the WHO’s new causality assessment algorithm, 183 (47.53%) events were vaccine product-related and 202 (52.46%) were co-incidental events. Conclusion: There was a prevailing outbreak of COVID-19 infection in the study site, which resulted in many breakthrough infections soon after immunization. Initially, all breakthrough infections were misleading as vaccine-related events, where this study helped to break the concerns among the study population.

Active surveillance for adverse events of influenza vaccine safety in elderly cancer patients using self-controlled tree-temporal scan statistic analysis

Both cancer patients and the elderly are at high risk of developing flu complications, so influenza vaccination is recommended. We aimed to evaluate potential adverse events (AEs) following influenza vaccination in elderly cancer patients using the self-controlled tree-temporal scan statistic method. From a large linked database of Korea Disease Control and Prevention Agency vaccination data and the National Health Insurance Service claims data, we identified cancer patients aged over 65 who received flu vaccines during the 2016/2017 and 2017/2018 seasons. We included all the outcomes occurring on 1–84 days post-vaccination and evaluated all temporal risk windows, which started 1–28 days and ended 2–42 days. Patients who were diagnosed with the same disease during a year prior to vaccination were excluded. We used the hierarchy of ICD-10 to identify statistically significant clustering. This study included 431,276 doses of flu vaccine. We detected signals for 1 set: other dorsopathies on 1–15 days (attributable risk 16.5 per 100,000, P = 0.017). Dorsopathy is a known AE of influenza vaccine. No statistically significant clusters were found when analyzed by flu season. Therefore, influenza vaccination is more recommended for elderly patients with cancer and weakened immune systems.

A prospective cohort study protocol: monitoring and surveillance of adverse events following heterologous booster doses of Oxford AstraZeneca COVID-19 vaccine in previous recipients of two doses of Sinopharm or Sputnik V vaccines in Iran

BackgroundRegarding the paucity of evidence on the side effects of the booster dose of Oxford AstraZeneca vaccine in vaccinated people with Sinopharm or Sputnik V, we aimed to set up a cohort event monitoring (CEM) study to capture adverse events occurring in individuals who will receive the booster doses of AstraZeneca (either the first or second booster dose) following being vaccinated with Sinopharm or sputnik V vaccines in Iran.MethodsThe present study is an active COVID-19 vaccine safety surveillance through an observational prospective cohort study that will be conducted in vaccination centers in Iran. The study will be conducted in twelve provinces of Iran. Study sites are vaccination centers where the AstraZeneca vaccine is administered to the cohort population. The study population includes all individuals who have received two doses of Sinopharm or Sputnik V vaccines and either the first or second booster dose of AstraZeneca according to the national guidelines for immunization in Iran in 2023. We are planning to include 30,000 eligible people in this study. Each individual will be followed up for 13 weeks after either the first or second booster dose of the AstraZeneca vaccine. Furthermore, convenience sampling is used to include participants in the present study. Participation in the study will be strictly voluntary.DiscussionWith the planned study we will provide a valid epidemiological evidence to improve the understanding of the safety of the booster dose of the AstraZeneca and to better evaluate the effectiveness of public health interventions. This could help policy makers in managing the COVID-19 pandemic according to scientific evidence.