ABSTRACT
Introduction: The vaccinovigilance Italian group was established since 2014 (1), with members from AIFA, Italian National Institute of Health (ISS), Ministry of Health (MH), Pharmacovigilance Regional Centers (PVRC) and Regional Prevention (RP). Signal detection of vaccines, annual reports on vaccine surveillance and supporting documents for pharmacovigilance activity are the main core of the group activities (2). During pandemic, enhanced surveillance was conducted to better characterize safety profile of the new anti- COVID-19 vaccines. Objective(s): We reported the enhanced surveillance for anti-COVID- 19 vaccines, managed by the AIFA in collaboration with ISS, MH, PVRC and RP. Method(s): Actions implemented for the enhanced surveillance: daily control of the RNF and follow-up requests, periodic publication of reports, interactive graphs on web site updated monthly, meetings of signal detection for anti-COVID-19 vaccines on a monthly basis. Result(s): From the first month of the vaccination campaign (27/12/ 2020-26/01/2021) a report on the course of safety surveillance was made publicly available (3). Until 26/09/2022 the report was published on a monthly basis, then, considering the downward trend in report submission and the greater knowledge of the vaccine safety profile, we moved to a quarterly frequency. The 10th report is referred to an observation period of one year from the start of the vaccination campaign with 117.920 reports submitted to RNF and 108.530.987 administered doses. In this annual report, there are specific focuses developed with the contribution of the regions, tailored on reproductive health, pediatric population and adverse events of special interest such as anaphylaxis, Guillain Barre syndrome, myocarditis/ pericarditis, Bell paralysis and thrombosis with thrombocytopenia syndrome. The report was presented in live streaming on the AIFA YouTube channel. Regarding the signal detection within the group, it was performed monthly since September 2021;the work was distributed among regions on the basis of vaccines and MedDRA System Organ Class (SOC). As a result of the analysis two signals were validated by AIFA. The signal CLS-Elasomeran was confirmed by the lead member state and determined the update of the Product Information (4). Conclusion(s): Despite the high number of reports, coordination with the territory and continuous and enhanced surveillance, supported by an integrated group with different expertise (epidemiologist, pharmacist, medical doctors), have proved to be effective in safety monitoring of COVID vaccines.
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 vaccinovigilance Italian group was established since 2014 (1), with members from AIFA, Italian National Institute of Health (ISS), Ministry of Health (MH), Pharmacovigilance Regional Centers (PVRC) and Regional Prevention (RP). Signal detection of vaccines, annual reports on vaccine surveillance and supporting documents for pharmacovigilance activity are the main core of the group activities (2). During pandemic, enhanced surveillance was conducted to better characterize safety profile of the new antiCOVID-19 vaccines. Objective: We reported the enhanced surveillance for anti-COVID19 vaccines, managed by the AIFA in collaboration with ISS, MH, PVRC and RP. Methods: Actions implemented for the enhanced surveillance: daily control of the RNF and follow-up requests, periodic publication of reports, interactive graphs on web site updated monthly, meetings of signal detection for anti-COVID-19 vaccines on a monthly basis. Results: From the first month of the vaccination campaign (27/12/ 2020-26/01/2021) a report on the course of safety surveillance was made publicly available (3). Until 26/09/2022 the report was published on a monthly basis, then, considering the downward trend in report submission and the greater knowledge of the vaccine safety profile, we moved to a quarterly frequency. The 10th report is referred to an observation period of one year from the start of the vaccination campaign with 117.920 reports submitted to RNF and 108.530.987 administered doses. In this annual report, there are specific focuses developed with the contribution of the regions, tailored on reproductive health, pediatric population and adverse events of special interest such as anaphylaxis, Guillain Barre syndrome, myocarditis/ pericarditis, Bell paralysis and thrombosis with thrombocytopenia syndrome. The report was presented in live streaming on the AIFA YouTube channel. Regarding the signal detection within the group, it was performed monthly since September 2021;the work was distributed among regions on the basis of vaccines and MedDRA System Organ Class (SOC). As a result of the analysis two signals were validated by AIFA. The signal CLS-Elasomeran was confirmed by the lead member state and determined the update of the Product Information (4). Conclusion: Despite the high number of reports, coordination with the territory and continuous and enhanced surveillance, supported by an integrated group with different expertise (epidemiologist, pharmacist, medical doctors), have proved to be effective in safety monitoring of COVID vaccines.
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.