Journal of Statistics: Advances in Theory and ApplicationsAuthor'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
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.
surveillance, vaccines, Covid-19, statistics, health services.
