Vaccines Safety in Children and in General Population: A Pharmacovigilance Study on Adverse Events Following Anti-Infective Vaccination in Italy

Abstract

Background: The concern for adverse events following immunization (AEFI) and anti-vaccination movements that lacked scientific evidence-based supports may reduce vaccine uptake in the general population. Thus, the aims of the present study were to characterize AEFI in general population (all age groups), in terms of frequency, preventability, and seriousness and to define predictors of their seriousness in children. Methods: A retrospective study was performed on suspected AEFI reports for children and adults who received any form of vaccinations, collected in Tuscany, Italy, between 1 January and 31 December 2017. Patients’ characteristics, suspected vaccines, and AEFI description were collected. Causality and preventability were assessed using WHO and Schumock and Thornton algorithms, respectively. Logistic regression was used to estimate the reporting odds ratios of potential predictors of AEFI seriousness in children. Results: A total of 223 suspected AEFI reports were collected, and the majority of them were defined as non-serious (76.7%). Reports were mostly related to one vaccine, and to a median of two to five strains/toxoids. The total number of simultaneously administered strains/toxoids and the presence of allergens did not correlate with AEFI seriousness. Considering vaccines with a high number of administered doses (≥60,000 doses), the rates estimated for serious AEFI reports were always very low, ranging between 0.01 and 0.2/1,000 doses. Twenty-four vaccines (8,993 doses) were not related to any AEFI. Conclusion: Results of present study showed that AEFI were very rare; the vast majority of them was non-serious and, despite the claims of anti-vaccination movements, the simultaneous administration of vaccines was safe and did not influence the risk of reporting a serious AEFI, particularly in children.

Italian Emergency Department Visits and Hospitalizations for Outpatients’ Adverse Drug Events: 12-Year Active Pharmacovigilance Surveillance (The MEREAFaPS Study)

“…This is an observational retrospective study performed on data retrieved by pharmacovigilance reports of suspected ADE collected between January 1, 2007 and December 31, 2018 in the EDs participating to the MEREAFaPS Study ("Monitoraggio Epidemiologico delle Reazioni e degli Eventi Avversi da Farmaci in Pronto Soccorso" -"Epidemiological Monitoring of Adverse Drug Reactions and Events leading to Emergency Department"), an ongoing multicentre study of active pharmacovigilance (Lombardi et al, 2018;Lombardi et al, 2019). This is the first nationwide pharmacovigilance study performed in Italy with an "active" approach and based on electronic ED medical records containing detailed information on patient populations, thereby allowing consideration of modifying factors such as polypharmacy and comorbidity, as well as sociodemographic characteristics.…”

“…Several studies have been published on ADEs as a cause of ED admissions, but none of those available in the literature has been conducted at national level and for a long observational period (Perrone et al, 2014;Lombardi et al, 2018;Lombardi et al, 2019). Furthermore, few studies evaluated the presence of specific variables among population and/or medication characteristics which can contribute to an ADE as a cause of hospitalization.…”

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database

“…age, sex etc.) and clinical status; (ii) AE, codified using the Medical Dictionary for Regulatory Activities (MedDRA) classification, and described using the preferred terms (PT) and system organ class (SOC) most frequently reported; (iii) AE degree of seriousness, classified according to the World Health Organisation criteria as fatal, life‐threatening, or requiring hospitalisation of the patient, or causing serious/permanent disability, or causing congenital abnormalities, or other clinically relevant conditions (https://apps.who.int/iris/bitstream/handle/10665/67378/WHO_EDM_QSM_2002.2.pdf;jsessionid=EF4F54EFF6FBD634E21D2C075ADCA3C0?sequence=1; 29661234); (iv) AE outcome; (v) ongoing cannabis therapy (i.e. product type, indication, dosage, length of exposure, and administration route); (vi) concomitant medications.…”

A 7-Years Active Pharmacovigilance Study of Adverse Drug Reactions Causing Children Admission to a Pediatric Emergency Department in Sicily

“…An active monitoring system of ADR showed that neonates (< 1 years) have an higher risk of ADR appearance than children (7-14 years) (Menniti-lppolito et al, 2000). Antibacterial for systemic use were reported as the drugs with the highest frequency of ADRs (Carnovale et al, 2014;Ferrajolo et al, 2014;Lombardi et al, 2018) In the recent years, the number of vaccine-hesitant patients as well as the movements against vaccination grew up (Lombardi et al, 2019). Consequently, immunization coverage of children sharply decreased (Signorelli et al, 2017).…”