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Article History

Accepted: 26 April 2022

First Online: 13 June 2022

Declarations

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: Open access funding provided by Università degli Studi di Verona within the CRUI-CARE Agreement.

: Gianluca Trifirò has served in the last three years on advisory boards/seminars funded by SANOFI, Eli Lilly, AstraZeneca, AbbVie, Servier, Mylan, Gilead, Amgen; he was the scientific director of a Master program on pharmacovigilance, pharmacoepidemiology and real-world evidence which has received non-conditional grant from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until Oct 2020, which has received funding for conducting observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He is also scientific coordinator of the academic spin-off "INSPIRE srl" which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.). All the above-mentioned activities are not related to the topic of the manuscript. Carmen Ferrajolo declares that she is a member and vice-chief of academic Spin-off "INSPIRE SRL– INnovative Solutions for medical Prediction and big data Integration in REal world setting SRL which has received funding for conducting observational studies from various pharmaceutical companies. All the above-mentioned activities are not related to the topic of the manuscript. The other authors have no conflicts of interest to disclose.

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: GT, NL, AG contributed to the conception and the design of the article. NL and AG performed the literature search for the allergic reaction data from observational studies. PMC, CF, UM, GP performed the search through the spontaneous reporting databases. GS and FF performed the literature search for the identification of risk factors from the real-world setting data. MC and LG described the role of PEGylation. GZ and AA reviewed the literature and summarized the recommendation from the scientific societies and health authorities. PB and EO searched and reviewed the literature for COVID-19 in high-risk groups. All authors reviewed the results and approved the final version of the manuscript. GT approved this version to be published.