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The informed consent could not be obtained since this retrospective study used exclusively data which are routinely gathered by the Italian Regions to inform policy decisions and more\u00a0effective public services and included in large regional health care registry. The need for the informed consent was waived by the ethics committee.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics and permissions"}},{"value":"The Istituto Superiore di Sanit\u00e0 received funding from AIFA (Italian Medicines Agency) for this study in the framework of the collaboration agreement \u2018Efficacia real world e sicurezza dei vaccini anti Covid-19: studio di coorte e Self-Controlled Case Series\u2019 (effectiveness and safety of COVID-19 vaccines: cohort and self-controlled case series studies). AIFA is the Italian national regulatory body for drugs and vaccines and a public organization. All authors are independent from the funder. The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The informed consent could not be obtained since this retrospective study used exclusively data which are routinely gathered by the Italian Regions to inform policy decisions and more effective public services and included in large regional health care registry. The ethics committee waived the requirement for informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Financial interests:\u00a0Authors C.M., M.M., M.C., V.B., N.M., E.S., A.P., G.Z., M.Z., G. Monaco, O.L., S.D.Z., S.S., F.M., G. Marano, F.M.I., R.D.C., G. Traversa and S.S.A. declare they have no financial interests. Author G. Trifir\u00f2 participated to advisory boards and seminars on topics not related to the content of this paper and sponsored by the following pharmaceutical companies: MSD, Eli Lilly; Sanofi; Amgen; Novo Nordisk; Sobi; Gilead; Celgene; Daikii Sankyo. He is Scientific coordinator of the UNIVR academic spin-off INSPIRE that carried out observational studies\/systematic reviews on topics not related to the content of this paper and which were funded by PTC Pharmaceutics, Kiowa Kirin, Shonogi, Shire, Chiesi and Daiichi Sankyo. Non-financial interests:\u00a0Authors C.M., M.M., M.C., V.B., G. Trifir\u00f2, N.M., E.S., A.P., G.Z., M.Z., G. Monaco, O.L., S.D.Z., S.S., F.M., G. Marano, F.M.I., R.D.C., G. Traversa and S.S.A. declare none. G. Trifir\u00f2 is an Editorial Board member of <i>Drug Safety.<\/i> G. Trifir\u00f2 was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"1) C.M., M.M., M.C., V.B., G. Trifir\u00f2 and S.S.A.: made substantial contributions to the conception or design of the work; C.M., M.M., M.C., V.B., G. Trifir\u00f2, N.M., E.S., A.P., G.Z., M.Z., G. Monaco, O.L., S.D.Z., S.S., F.M., G. Marano, F.M.I., R.D.C., G. Traversa and S.S.A.: the acquisition, analysis and interpretation of data; M.M., M.C., V.B., R.D.C. and S.S.A.: the creation of new software used in the work; 2) C.M., M.M., M.C. and S.S.A.: drafted the work. C.M., M.M., M.C., V.B., G. Trifir\u00f2, G. Marano, F.M.I., R.D.C., G. Traversa and S.S.A. revised it critically for important intellectual content; 3) C.M., M.M., M.C., V.B., G. Trifir\u00f2, N.M., E.S., A.P., G.Z., M.Z., G. Monaco, O.L., S.D.Z., S.S., F.M., G. Marano, F.M.I., R.D.C., G. Traversa and S.S.A.: approved the version to be published; and 4) C.M., M.M., M.C., V.B., G. Trifir\u00f2, N.M., E.S., A.P., G.Z., M.Z., G. Monaco, O.L., S.D.Z., S.S., F.M., G. Marano, F.M.I., R.D.C., G. Traversa and S.S.A.: read and approved the final version, and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}},{"value":"Data from this study cannot be shared publicly for legal and ethical reasons. This work is carried out in accordance with Article 9 of Regulation (EU) 2016\/679, which prohibits the processing of personal data revealing data relating to the health of the data subject. The study protocol, as approved by the Ethical Committee, explicitly establishes that data shall be exclusively stored at the Istituto Superiore di Sanit\u00e0, acting as the Data Controller, and it does not foresee any provisions for public sharing of the minimum dataset. The minimum dataset, for the reasons set out above, may be made available anonymously to researchers upon reasonable request from the scientific secretary of the \u2018National ethics committee for clinical trials of public research bodies (EPR) and other national public institutions\u2019 (CEN) at the Istituto Superiore di Sanit\u00e0 (ISS) via email (segreteria.comitatoetico@iss.it).","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}},{"value":"Not available.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}}]}}