ABSTRACT
Introduction: The COVID-19 pandemic determined a necessary reorganization of pharmacovigilance resources and strategies, particularly after vaccines authorization. Enhanced monitoring and quality of ICSRs is crucial for the causality assessment of the adverse events following immunization (AEFI) occurred in the COVID-19 vaccinated population [1]. Objective(s): To evaluate the effectiveness of enhanced Italian Pharmacovigilance activities during the first year of COVID-19 vaccination campaign on the quality of the ICSRs. Method(s): The Italian PharmacoVigilance System is a network connecting the Italian Medicine Agency (AIFA) to local health authorities [2]. The collected ICRSs were prioritized by seriousness, special interest and disproportionality and harmonized for coding and key information requirements. Further follow up information were requested to reporters from Local/Regional PhV Representatives or AIFA. Targeted templates tailored on Brighton Collaboration Group case definitions were implemented for adverse events of special interest (AESI) [3]. The percentage of completed ICSRs by fields and the rate of evaluable causality assessments by WHO causality assessment tool for AEFI [4] were used as indicators for descriptive analysis of effectiveness. Completeness of ICSRs was evaluated for the following AESI: anaphylaxis, Guillain-Barre syndrome, peripheral facial palsy, vaccine-induced thrombotic thrombocytopenia, myocarditis and pericarditis. Result(s): Between 26 December 2020 and 26 December 2021, 117.920 ICSRs were reported (98.717 not serious and 19.055 serious). Overall, patients' demographic field were updated in 35% of ICSRs, with a total of 97,6% of cases with valid age and sex data. Suspected medicinal products section was modified in 11% of ICSRs with 91% of cases reporting batch number and administration date. Follow up was obtained in 26% of ICSRs (7% after AIFA request). Available information on seriousness and outcome was reported in 97,6% of cases. Time-to-onset was assessable in 95,2% of cases. Overall, causality assessment was applicable in 15.731/19055 (83%) of serious reports, only 751/15.731 (4,8%) of which was unclassifiable. Follow up information was not obtained in 831/3887 cases related to selected AESI (21%). Complete clinical data were available in the remaining 3056/3887 ICSRs (79%) and were used for BCG classification as cases (38%) or not cases (62%). Conclusion(s): A harmonized approach to ICSR enhanced surveillance and management through a structured Pharmacovigilance network was effective in improving the quality of AEFI reports related to COVID-19 vaccines, resulting in a high percentage of cases with complete information.
ABSTRACT
Introduction: During large-scale vaccination campaign against COVID-19, the Italian Medicines Agency (AIFA) in collaboration with the Regional Centres of Pharmacovigilance have carried out a closely monitoring of Individual Case Safety Reports (ICSRs) about Adverse Event Following Immunisation (AEFIs) related to COVID- 19 vaccines and have assured a constant communication through public monthly reports1. During the first months of the vaccination campaign, a signal of rare events of thrombosis associated with thrombocytopenia2, particularly in young women, was detected by health authorities associated with the viral vector vaccines ChAdOx1- S and Ad26.COV2-S. Objective(s): To present a comprehensive assessment of thrombotic and thromboembolic events associated with thrombocytopenia following COVID-19 immunisation with viral vector vaccines recorded in the Italian National Pharmacovigilance Network database Methods: We selected all ICSRs reported from 27 December 2020 to 26 December 2021 containing Preferred Terms (PT) related to platelet count reduction associated with PT related to thrombotic and thromboembolic events (clinical symptoms and/or diagnostic tests). All cases of thrombotic and thromboembolic events reporting thrombocytopenia in the narrative description of the report were also reviewed. The selected ICRSs were submitted to the independent evaluation of three pharmacovigilance experts who blindly classified into 5 levels of diagnostic certainty, according to the definition provided by the Brighton Collaboration Group (BCG)3. Disagreement were resolved by plenary discussion. Result(s): 12,166,236 doses of ChAdOx1-S and 1,500,746 of Ad26.COV2-S have been administered in Italy during the considered interval with overall 23,358/117,947 ICSRs related to ChAdOx1-S (19.8 %) and 1,580/117,947 related to Ad26.COV2-S (1.3 %). A total of 134 reports after vaccination with adenoviral vaccines were identified according to the inclusion criteria, of which 107 cases were defined as thrombotic thrombocytopenia (95 following ChAdOx1-S and 12 after Ad26.COV2-S). 27 reports were defined as ''not case'' (level 5, Brighton) on the basis of clinical examination or investigation, or because of the presence of heparin as a concomitant drug. Furthermore, 3 reports were excluded because of a hereditary thrombophilia or a previous history of other thrombotic episodes. Seventy-seven cases were classifiable as BCG levels 1, 2, and 3 (definite, probable and possible cases, respectively) with an overall reporting rate at about 1 case per approximately 200,000 doses administered. Women aged 30 to 49 years showed the highest reporting rates. Conclusion(s): In Italy, the rates of thrombotic thrombocytopenia following COVID-19 immunisation with viral vector vaccines are in line with those reported in other Countries.
ABSTRACT
Introduction: The COVID-19 pandemic determined a necessary reorganization of pharmacovigilance resources and strategies, particularly after vaccines authorization. Enhanced monitoring and quality of ICSRs is crucial for the causality assessment of the adverse events following immunization (AEFI) occurred in the COVID-19 vaccinated population [1]. Objective: To evaluate the effectiveness of enhanced Italian Pharmacovigilance activities during the first year of COVID-19 vaccination campaign on the quality of the ICSRs. Methods: The Italian PharmacoVigilance System is a network connecting the Italian Medicine Agency (AIFA) to local health authorities [2]. The collected ICRSs were prioritized by seriousness, special interest and disproportionality and harmonized for coding and key information requirements. Further follow up information were requested to reporters from Local/Regional PhV Representatives or AIFA. Targeted templates tailored on Brighton Collaboration Group case definitions were implemented for adverse events of special interest (AESI) [3]. The percentage of completed ICSRs by fields and the rate of evaluable causality assessments by WHO causality assessment tool for AEFI [4] were used as indicators for descriptive analysis of effectiveness. Completeness of ICSRs was evaluated for the following AESI: anaphylaxis, Guillain-Barre syndrome, peripheral facial palsy, vaccine-induced thrombotic thrombocytopenia, myocarditis and pericarditis. Results: Between 26 December 2020 and 26 December 2021, 117.920 ICSRs were reported (98.717 not serious and 19.055 serious). Overall, patients' demographic field were updated in 35% of ICSRs, with a total of 97,6% of cases with valid age and sex data. Suspected medicinal products section was modified in 11% of ICSRs with 91% of cases reporting batch number and administration date. Follow up was obtained in 26% of ICSRs (7% after AIFA request). Available information on seriousness and outcome was reported in 97,6% of cases. Time-to-onset was assessable in 95,2% of cases. Overall, causality assessment was applicable in 15.731/19055 (83%) of serious reports, only 751/15.731 (4,8%) of which was unclassifiable. Follow up information was not obtained in 831/3887 cases related to selected AESI (21%). Complete clinical data were available in the remaining 3056/3887 ICSRs (79%) and were used for BCG classification as cases (38%) or not cases (62%). Conclusion: A harmonized approach to ICSR enhanced surveillance and management through a structured Pharmacovigilance network was effective in improving the quality of AEFI reports related to COVID-19 vaccines, resulting in a high percentage of cases with complete information.
ABSTRACT
Introduction: During large-scale vaccination campaign against COVID-19, the Italian Medicines Agency (AIFA) in collaboration with the Regional Centres of Pharmacovigilance have carried out a closely monitoring of Individual Case Safety Reports (ICSRs) about Adverse Event Following Immunisation (AEFIs) related to COVID19 vaccines and have assured a constant communication through public monthly reports1. During the first months of the vaccination campaign, a signal of rare events of thrombosis associated with thrombocytopenia2, particularly in young women, was detected by health authorities associated with the viral vector vaccines ChAdOx1S S Ad26.COV2-S. Objective: To present a comprehensive assessment of thrombotic and thromboembolic events associated with thrombocytopenia following COVID-19 immunisation with viral vector vaccines recorded in the Italian National Pharmacovigilance Network database Methods: We selected all ICSRs reported from 27 December 2020 to 26 December 2021 containing Preferred Terms (PT) related to platelet count reduction associated with PT related to thrombotic and thromboembolic events (clinical symptoms and/or diagnostic tests). All cases of thrombotic and thromboembolic events reporting thrombocytopenia in the narrative description of the report were also reviewed. The selected ICRSs were submitted to the independent evaluation of three pharmacovigilance experts who blindly classified into 5 levels of diagnostic certainty, according to the definition provided by the Brighton Collaboration Group (BCG)3. Disagreement were resolved by plenary discussion. Results: 12,166,236 doses of ChAdOx1-S and 1,500,746 of Ad26.COV2-S have been administered in Italy during the considered interval with overall 23,358/117,947 ICSRs related to ChAdOx1-S (19.8 %) and 1,580/117,947 related to Ad26.COV2-S (1.3 %). A total of 134 reports after vaccination with adenoviral vaccines were identified according to the inclusion criteria, of which 107 cases were defined as thrombotic thrombocytopenia (95 following ChAdOx1-S and 12 after Ad26.COV2-S). 27 reports were defined as "not case" (level 5, Brighton) on the basis of clinical examination or investigation, or because of the presence of heparin as a concomitant drug. Furthermore, 3 reports were excluded because of a hereditary thrombophilia or a previous history of other thrombotic episodes. Seventy-seven cases were classifiable as BCG levels 1, 2, and 3 (definite, probable and possible cases, respectively) with an overall reporting rate at about 1 case per approximately 200,000 doses administered. Women aged 30 to 49 years showed the highest reporting rates. Conclusion: In Italy, the rates of thrombotic thrombocytopenia following COVID-19 immunisation with viral vector vaccines are in line with those reported in other Countries.
ABSTRACT
Introduction: The Istituto Superiore di Sanita and the Agenzia Italiana del Farmaco coordinate the project TheShinISS-Vax, Flu, a post-marketing "active" surveillance of influenza vaccines. We report the results of the investigation using the Self- Controlled Case Series (SCCS) design on influenza vaccine and Guillain-Barre syndrome in vaccinated population aged over than 6 months, during the influenza vaccine campaign 2020-2021 in Italy. Materials and methods: A SCCS multi-regional study was carried out using linked data from Regional Health Care Registries of Valle d'Aosta, Friuli Venezia Giulia, Emilia-Romagna, Toscana, Lazio, Campania, and Puglia. Relative incidence of Guillain-Barre syndrome was estimated, comparing the exposure risk periods (0-41 days from the vaccination day, subdivided in six intervals) with the unexposed period.