{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:40:49Z","timestamp":1747183249330,"version":"3.40.5"},"reference-count":30,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,8,22]],"date-time":"2023-08-22T00:00:00Z","timestamp":1692662400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Paediatrica"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To provide further evidence on the safety profile of COVID\u201019 vaccines in paediatrics by analysing the spontaneous reports of adverse effects related to these vaccines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Reports related to US paediatric population (from 0 to 17\u2009years) vaccinated with authorised COVID\u201019 vaccines were extracted from Vaccine Adverse Event Reporting System from December 2020 to 17 November 2022. We conducted a descriptive analysis of Adverse Events Following Immunization (AEFI), calculating reporting rate of serious AEFIs and focusing on <jats:italic>myocarditis<\/jats:italic> and <jats:italic>Guillain\u2010Barr\u00e9 Syndrome<\/jats:italic> after mRNA COVID\u201019 vaccines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 52\u2009720 reports were retrieved: 77% (40541)\u2010Pfizer\u2010BioNTech, 19% (10083)\u2010Moderna, a small proportion for other vaccines 4% (2096). Most of AEFIs were non\u2010serious and listed in corresponding SPCs. Of serious AEFIs, 96% were related to the Pfizer\u2010BioNTech vaccine. Roughly 91% (47874) were related to people from 6 to 17\u2009years, a small percentage of 9% (4773) to the younger group (0\u20135\u2009years). In both groups, most of the reports were related to mRNA vaccines and the percentage of AEFIs experienced by females were similar to males.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Data showed that events most frequently reported were non\u2010serious and listed in the corresponding SPCs, extending the evidence of safety of COVID\u201019 vaccines authorised in the United States in children.<\/jats:p><\/jats:sec>","DOI":"10.1111\/apa.16954","type":"journal-article","created":{"date-parts":[[2023,8,23]],"date-time":"2023-08-23T06:40:01Z","timestamp":1692772801000},"page":"2426-2433","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety profile of paediatric COVID\u201019 vaccines: An analysis of the US Vaccine Adverse Event Reporting System"],"prefix":"10.1111","volume":"112","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0089-3043","authenticated-orcid":false,"given":"Victoria","family":"Nikitina","sequence":"first","affiliation":[{"name":"Unit of Pharmacology, Department of Medical and Surgical Sciences Alma Mater Studiorum University of Bologna  Bologna Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7897-2956","authenticated-orcid":false,"given":"Greta","family":"Santi\u00a0Laurini","sequence":"additional","affiliation":[{"name":"Unit of Pharmacology, Department of Medical and Surgical Sciences Alma Mater Studiorum University of Bologna  Bologna Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5710-8077","authenticated-orcid":false,"given":"Nicola","family":"Montanaro","sequence":"additional","affiliation":[{"name":"Alma Mater Studiorum University di Bologna  Bologna Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6253-4014","authenticated-orcid":false,"given":"Domenico","family":"Motola","sequence":"additional","affiliation":[{"name":"Unit of Pharmacology, Department of Medical and Surgical Sciences Alma Mater Studiorum University of Bologna  Bologna Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,8,22]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"Centers for Disease Control.Accessed November 18 2022.https:\/\/www.cdc.gov\/coronavirus\/2019\u2010ncov\/hcp\/clinical\u2010care\/underlyingconditions.html"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0258154"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/jme.2004.009555"},{"volume-title":"Medical Research with Children: Ethics, Law, and Practice: the Report of an Institute of Medical Ethics Working Group on the Ethics of Clinical Research Investigations on Children","year":"1986","author":"Nicholson RH","key":"e_1_2_13_5_1"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1076\/jmep.25.6.723.6129"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2020-0702"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm6915e3"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2020.4573"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.15585\/mmwr.mm7023e1"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30566-3"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2021756"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1542\/hpeds.2020-0123"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)31103-X"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2020.08.003"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(21)00339-X"},{"key":"e_1_2_13_17_1","unstructured":"Centers for Disease Control and Prevention (CDC).COVID\u201019 Vaccination for Children. 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