Ahmadizar, Fariba http://orcid.org/0000-0002-6261-9445
Luxi, Nicoletta
Raethke, Monika
Schmikli, Sandor
Riefolo, Fabio
Saraswati, Putri Widi
Bucsa, Camelia
Osman, Alhadi
Liddiard, Megan
Maques, Francisco Batel
Petrelli, Giuliana
Sonderlichová, Simona
Thurin, Nicolas H.
Villalobos, Felipe
Trifirò, Gianluca
Sturkenboom, Miriam
Moretti, Ugo
Bellitto, Chiara
Ciccimarra, Francesco
Gonella, Laura Augusta
Arzenton, Elena
Chiamulera, Cristiano
Lora, Riccardo
Bellantuono, David
Sabaini, Alberto
Firenze, Alberto
Zodda, Donatella
Guidotti, Fabrizia
Zappone, Maria
Alagna, Bernardo
Cutroneo, Paola Maria
Minore, Claudia
Costantino, Claudio
Vitale, Francesco
D’Alessandro, G.
Morreale, Ilaria
Marsala, Laura
Farinella, Desirè
Bavetta, Silvana
Fantini, Maria Pia
Reno, Chiara
Raschi, Emanuel
Poluzzi, Elisabetta
Sapigni, Ester
Potenza, Anna Maria
Podetti, Debora
Nikitina, Victoria
Ricciardelli, Rita
Mogheiseh, Nazanin
Croce, Silvia
Paltrinieri, Barbara
Castellani, Sofia
Sangiorgi, Elisa
Selleri, Margherita
Lucchesi, Simona
Catucci, Giuseppe
Savini, Denis
Sacripanti, Chiara
Faccioli, Marco
Romio, Maria Silvia
Rossi, Laura
Radici, Simonetta
Negri, Giovanna
Fares, Lidia
Ajolfi, Chiara
Fadda, Antonella
Chiarello, Antonella
Pieraccini, Fabio
Gavioli, Barbara
Palazzi, Simonetta
Tuccori, Marco
Vannacci, Alfredo
Bonaiuti, Roberto
Ravaldi, Claudia
Lombardi, Niccolò
Crescioli, Giada
Gori, Francesco
Tessari, Roberto
Zandonà, Emanuela
Zanoni, Giovanna
Senna, Gianenrico
Crivellaro, Maria Angiola
Cancian, Mauro
Venturini, Francesca
Ferri, Marina
Leonardi, Luca
Orzetti, Sabrina
Caccin, Elisabetta
Baldo, Paolo
Capuano, Annalisa
Rafaniello, Concetta
Ferrajolo, Carmen
Pagliaro, Claudia
Mercaldo, Mariangela
di Giorgio, Annalisa
Tari, Michele
Manna, Sonia
Farina, Giuseppina
Di Mauro, Cristina
De Carlo, Ilenia
Senesi, Ilenia
Pileggi, Claudia
Palleria, Caterina
Gallelli, Luca
De Sarro, Giovambattista
de Sarro, Caterina
Verduci, Chiara
Papadopoli, Rosa
Trabace, Luigia
Morgese, Mariagrazia
Schiavone, Stefania
Tucci, Paolo
Bove, Maria
Lapi, Francesco
Cricelli, Claudio
Racagni, Giorgio
Tonolo, Silvia
Fava, Giusi
Giuffrida, Sandro
Amato, Vincenza
Gambera, Marco
Montresor, Valentina
Mastropasqua, Dario
,
Article History
Accepted: 27 March 2023
First Online: 27 April 2023
Declarations
:
: The research leading to these results was conducted as part of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network, a public academic partnership coordinated by Utrecht University, The Netherlands, in collaboration with the VAC4EU network. The project has received partial support from the European Medicines Agency (EMA) under the Framework service contract nr EMA/2018/23/PE. The content of this paper expresses the opinion of the authors. It may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties. The French part of this research, named EVANESCO, was identified as a “national research priority” (<i>priorité nationale de recherche)</i> by the <i>Comité ad-hoc de pilotage national des essais thérapeutiques et autres recherches sur le COVID-19</i> (CAPNET), and received a complementary funding from the <i>Ministère de la Santé et des Solidarités</i> and the <i>Ministère de l’Enseignement supérieur, de la Recherche et de l’Innovation.</i>
: Miriam Sturkenboom is head of a department that conducts studies for regulatory agencies and pharmaceutical companies, with research grants to the institution; this includes Pfizer, Janssen and AstraZeneca. All studies are conducted using the ENCePP code of conduct. 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's program on pharmacovigilance, pharmacoepidemiology and real-world evidence which has received a non-conditional grant from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until October 2020, which has received funding for conducting observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He is also the 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.). None of these listed activities is related to the topic of the manuscript. Fariba Ahmadizar is the principal investigator of a Janssen COVID-19 vaccine safety study. None of the other authors has any conflicts of interest that are directly relevant to the content of this article.
: Netherlands: EC ref number NW2021-04. France: CNIL ref. no. MLD/MFI/AR218727, EC ref. no. 2020-A03554-35. Italy: PARERE N. 463 del Registro delle Sperimentazioni 2020/2021. Portugal: EC ref. no. 74/2021. Romania: EC ref. no. AVZ6; 08/11/2021 and 246; 30/06/2021. Slovakia: Trieda SNP 1,040 11 Kosice; 1/12/2021. Spain: 21/208-PCV; 29/09/2021. The UK: EC ref. no. 21/HRA/2077.
: Written informed consent was obtained from participants, parents or legal guardians.
: Not applicable.
: Original data will be available upon request, including coding of medicinal products and adverse events to standardised dictionaries.
: The code used to retrieve the dates of the reports from EudraVigilance will be made available on reasonable request.
: All authors contributed to the study's conception and design. Material preparation, data collection and analysis were performed by [Nicoletta Luxi], [Monika Raethke]. The first manuscript draft was written by [Fariba Ahmadizar], and all authors commented on previous versions. All authors read and approved the final version.