Since the beginning of the vaccination campaign against SARS-CoV-2, reports of postvaccination adverse events (ADRs) have raised concerns in the population, fueling doubts about vaccine safety and, consequently, producing vaccine hesitation. The Italian national system of surveillance for drugs and vaccines is regulated by the Italian Medicines Agency (AIFA) both for the control functions at the national level and for participation in EU activities through the National Pharmacovigilance Network (RNF). AIFA represents the national public entity responsible for guaranteeing the efficacy, safety, and appropriateness of medicines for human use in Italy, as well as for regulating their diffusion over the national territory. Since February 2021, AIFA regularly published reports on COVID-19 vaccinations in Italy. In particular, in the 5th and 10th reports, released on June 10th, 2021, and February 9th, 2022, respectively, AIFA carried out a comparative analysis between observed and expected deaths following vaccination, the results of which reassured about vaccination safety [1-2]. Unfortunately, the analysis was affected by biases which the scientific community did not notice or did not point out.
Critic assessment on observed vs expected vaccine-related mortality shown in the 10th AIFA report on COVID-19 vaccine surveillance in Italy
Bruno Cheli;Rachele Foschi;Alessio Iodice;Barbara Pinto
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2023-01-01
Abstract
Since the beginning of the vaccination campaign against SARS-CoV-2, reports of postvaccination adverse events (ADRs) have raised concerns in the population, fueling doubts about vaccine safety and, consequently, producing vaccine hesitation. The Italian national system of surveillance for drugs and vaccines is regulated by the Italian Medicines Agency (AIFA) both for the control functions at the national level and for participation in EU activities through the National Pharmacovigilance Network (RNF). AIFA represents the national public entity responsible for guaranteeing the efficacy, safety, and appropriateness of medicines for human use in Italy, as well as for regulating their diffusion over the national territory. Since February 2021, AIFA regularly published reports on COVID-19 vaccinations in Italy. In particular, in the 5th and 10th reports, released on June 10th, 2021, and February 9th, 2022, respectively, AIFA carried out a comparative analysis between observed and expected deaths following vaccination, the results of which reassured about vaccination safety [1-2]. Unfortunately, the analysis was affected by biases which the scientific community did not notice or did not point out.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
