Volume no :28, Issue no: 1, September (2023)

CRITIC ASSESSMENT ON OBSERVED VS EXPECTED VACCINE-RELATED MORTALITY SHOWN IN THE 10th AIFA REPORT ON COVID-19 VACCINE SURVEILLANCE IN ITALY

Author's: Michela Baccini, Bruno Cheli, Rachele Foschi, Alessio Iodice, Lorenzo Melacarne, Barbara Pinto and Eugenio Serravalle
Pages: [1] - [10]
Received Date: April 17, 2023
Submitted by:
DOI: http://dx.doi.org/10.18642/jsata_7100122279

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.

Despite the release of two public notes stating the problem highlighted by the authors of this paper [3-4] and a direct communication to the Italian Ministry of Health, AIFA never took note of its mistakes and did not make any amendments.

In this paper, we briefly focus on the methods AIFA used to perform this comparison and on the data of the 5th and 10th Reports on the Surveillance of COVID-19 vaccines. We also describe these errors discussing their implications.

Keywords

surveillance, vaccines, Covid-19, statistics, health services.