Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Ahmadizar, Fariba; Luxi, Nicoletta; Raethke, Monika; Schmikli, Sandor L.; Riefolo, Fabio; Saraswati, Putri Widi; Bucşa, Camelia; Osman, Alhadi Khogali; Liddiard, Megan; Maques, Francisco Batel; Petrelli, Giuliana; Sonderlichová, Simona; Thurin, Nicolas; 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, G; 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 M.; Mercaldo, Mariangela; Giorgio, Annalisa Di; Tari, Michele; Manna, Sonia; Farina, Giuseppina; Mauro, Cristina Di; Carlo, Ilenia De; Senesi, Ilenia; Pileggi, Claudia; Palleria, Caterina; Gallelli, Luca; Sarro, Giovambattista De; Sarro, Caterina de; Verduci, Chiara; Papadopoli, Rosa; Trabace, Luigia; Morgese, Mariagrazia; Schiavone, Stefania; Tucci, Paolo; Bové, María; Lapi, Francesco; Cricelli, Claudio; Racagni, Giorgio; Tonolo, Silvia; Fava, Giusi; Giuffrida, Sandro; Amato, Vincenza; Gambera, Marco; Montresor, Valentina; Mastropasqua, Dario

doi:10.1007/s40264-023-01304-5

Cited by 8 publications

(4 citation statements)

References 6 publications

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“…Two specific and harmonized web-based apps were developed for data collection, the Lareb-managed Intensive Monitoring (LIM) and Research Online (RO), which were built specifically for vaccinee-reported outcomes, and questionnaires were translated into local languages [ 17 , 18 ].…”

Section: Methodsmentioning

confidence: 99%

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Ciccimarra,

Luxi,

Bellitto

et al. 2024

Vaccines

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In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVID-19 vaccination cycle, as well as the administration of booster doses of different vaccine brands, in people with prior SARS-CoV-2 infection, as compared to prior infection-free matched cohorts of vaccinees. A web-based prospective study was conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries in the period February 2021–February 2023. A baseline questionnaire and up to six follow-up questionnaires collected data on the vaccinee’s characteristics, as well as solicited and unsolicited adverse reactions. Overall, 3886 and 902 vaccinees with prior SARS-CoV-2 infection and having received the first dose or a booster dose, respectively, were included in the analysis. After the first dose or booster dose, vaccinees with prior SARS-CoV-2 infection reported at least one ADR at a higher frequency than those matched without prior infection (3470 [89.6%] vs. 2916 [75.3%], and 614 [68.2%] vs. 546 [60.6%], respectively). On the contrary side, after the second dose, vaccinees with a history of SARS-CoV-2 infection reported at least one ADR at a lower frequency, compared to matched controls (1443 [85.0%] vs. 1543 [90.9%]). The median time to onset and the median time to recovery were similar across all doses and cohorts. The frequency of adverse reactions was higher in individuals with prior SARS-CoV-2 infection who received Vaxzevria as the first dose and Spikevax as the second and booster doses. The frequency of serious ADRs was low for all doses and cohorts. Data from this large-scale prospective study of COVID-19 vaccinees could be used to inform people as to the likelihood of adverse effects based on their history of SARS-CoV-2 infection, age, sex, and the type of vaccine administered. In line with pivotal trials, the safety profile of COVID-19 vaccines was also confirmed in people with prior SARS-CoV-2 infection.

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Section: Methodsmentioning

confidence: 99%

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Ciccimarra,

Luxi,

Bellitto

et al. 2024

Vaccines

Self Cite

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“…CEM was extensively used to monitor the safety of COVID-19 vaccines in both HIC and LMIC. It is notable that the aims of the use of this design have been variable across publications, from describing and comparing the overall reactogenicity of the different covid-19 vaccines [32] , [33] , to characterizing safety profiles in subpopulations, such as children and pregnant women [34] , [35] , and even for “signal detection” [36] , [37] . However, the rarity of serious adverse events after vaccination challenges the ability of CEM to identify any pre-specified AESI or unexpected safety signals which typically occur in the range of 1/10,000 to 1/100,000.…”

Section: The Need For More Advanced Safety Surveillance To Support Th...mentioning

confidence: 99%

Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally

ShamaeiZadeh,

Jaimes,

Knoll

et al. 2024

Vaccine: X

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“…Post-authorization surveillance programs were therefore necessary to provide realworld evidence regarding the safety of COVID-19 vaccines in the pediatric population [69,70,80,81]. These programs included, in the United States, the vaccine adverse event reporting system (VAERS), a passive vaccine safety surveillance system managed by the CDC and FDA, and, in Europe, the EudraVigilance surveillance systems, an international spontaneous reporting database maintained by the European Medicines Agency (EMA).…”

Section: Surveillance Data (Post-authorization Monitoring)mentioning

confidence: 99%

Clinical Syndromes Related to SARS-CoV-2 Infection and Vaccination in Pediatric Age: A Narrative Review

Mastrolia,

De Cillia,

Orlandi

et al. 2023

Medicina

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This narrative review aims to report the main clinical manifestations, therapeutic strategies, outcomes, and complications of acute SARS-CoV-2 infection in childhood and to summarize the data relating the SARS-CoV-2 vaccination efficacy and safety in pediatric age. SARS-CoV-2 infection mostly occurs asymptomatically in the pediatric population, while multisystem inflammatory syndrome in children (MIS-C) represents the most severe coronavirus disease 2019 (COVID-19)-related illness, a life-threatening event with a high morbidity rate. After the development of SARS-CoV-2 vaccines and their subsequent approval in children, the rate of infection as well as the number of its related complications have shown a drastic decrease. Fully vaccinated children are protected from the risk of developing a severe disease and a similar protective role has been observed in the reduction of complications, in particular MIS-C. However, long-lasting immunity has not been demonstrated, booster doses have been required, and reinfection has been observed. With regards to vaccine safety, adverse events were generally mild to moderate in all age groups: local adverse events were the most commonly reported. Nevertheless, a potential association between SARS-CoV-2 vaccine and the subsequent development of inflammatory manifestations has been suggested. Myocarditis has rarely been observed following vaccination; it appeared to be more frequent among adolescent males with a mild clinical course leading to a complete recovery. SARS-CoV-2 vaccine-related MIS-C cases have been described, although a univocal definition and an exact time interval with respect to vaccination has not been reported, thus not establishing a direct causal link. Current evidence about COVID-19 vaccination in children and adolescents suggest that benefits outweigh potential risks. Long-term data collection of the post-authorization safety surveillance programs will better define the real incidence of SARS-CoV-2 vaccine-related complications in the pediatric population.

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Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Cited by 8 publications

References 6 publications

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally

Clinical Syndromes Related to SARS-CoV-2 Infection and Vaccination in Pediatric Age: A Narrative Review

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