Challenges and Opportunities for Signal Detection During Public Health Emergencies: An Historical Re-evaluation of the Disproportionality Analysis of the ADR Reporting of Anti-COVID-19 Monoclonal Antibodies in Vigibase

DOI record: { "DOI": "10.1007/s40264-026-01705-2", "ISSN": [ "0114-5916", "1179-1942" ], "URL": "http://dx.doi.org/10.1007/s40264-026-01705-2", "alternative-id": [ "1705" ], "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "12 February 2026" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "6 July 2026" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "22 July 2026" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Conflicts of Interest", "name": "Ethics", "order": 1, "value": "Marco Tuccori is an Editorial Board member of\n Drug Safety\n . Marco Tuccori was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Gianluca Trifirò is an Editorial Board member of\n Drug Safety\n . Gianluca Trifirò was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Over the last three years, Gianluca Trifirò has served on advisory boards/seminars funded by Egualia, Biogen, GSK, Fidia, Sanofi, Eli Lilly, Novo Nordisk, Bayer, Pfizer, AlfaSigma and Takeda on topics not related to content of this paper. He is also the scientific coordinator of the academic spin-off “INSPIRE srl”, which over the past three years has conducted or is conducting observational studies and other scientific activities funded by Sanofi, Gruenenthal, PTC Therapeutics, Kyowa Kirin, Novo Nordisk, and Molteni Farmaceutici. INSPIRE has also organized an annual multi-sponsor symposium over the past three years on the role of RWE in supporting drug policy, funded by several pharmaceutical companies. Additionally, Gianluca Trifirò is currently a consultant for Viatris in a legal case concerning a topic not related to the content of this paper. All the above-mentioned activities are not related to the topic of the manuscript. The other authors have no conflict of interest to disclose." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "UMC Statement", "name": "Ethics", "order": 2, "value": "VigiBase, the WHO global database of ICSRs, is the source of our information. The information comes from a variety of sources, and the probability that the suspected adverse event is drug related is not the same in all cases; the information does not represent the opinion of the UMC or WHO." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Data Availability", "name": "Ethics", "order": 3, "value": "The datasets generated and/or analyzed in the current study are available in the VigiBase repository. The data presented in this study are obtainable on request from the corresponding author." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Ethical Approval", "name": "Ethics", "order": 4, "value": "The analysis used data from VigiBase, which is an anonymized database and consent for publication is not applicable." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Consent to Participate", "name": "Ethics", "order": 5, "value": "Not applicable." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Consent for Publication", "name": "Ethics", "order": 6, "value": "Not applicable." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Author Contributions", "name": "Ethics", "order": 7, "value": "MT and GT conceived and designed the study. NL and CB wrote the first draft of the manuscript, supervised by MT. NL, CB, FC, UM and EA performed the search and collected the data. FS performed the analyses. FC, EA, FM, UM, ER, EP, DF, JA, PDN, AS, ET, GT and MT reviewed the manuscript critically for important intellectual content. All authors read and approved the final manuscript." }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "label": "Code Availability", "name": "Ethics", "order": 8, "value": "The cleaned dataset used in the analysis and the code for the analysis is available from the corresponding author upon reasonable request." } ], "author": [ { "affiliation": [], "family": "Luxi", "given": "Nicoletta", "role": [ { "role": "author", "vocabulary": "crossref" } ], "sequence": "first" }, { "affiliation": [], "family": "Bellitto", "given": "Chiara", "role": [ { "role": "author", "vocabulary": "crossref" } ], "sequence": "additional" }, { "affiliation": [], "family": "Ciccimarra", "given": "Francesco", "role": [ { "role": "author", "vocabulary": "crossref" } ], "sequence": "additional" }, { "affiliation": [], "family": "Scapini", "given": "Fabio", "role": [ { "role": "author", "vocabulary": "crossref" } ], "sequence": "additional" }, { "affiliation": [], "family": "Arzenton", "given": 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