COVID 19 Vaccine for Adolescents. Concern about Myocarditis and Pericarditis

Calcaterra, Giuseppe; Mehta, J. L.; Gregorio, Cesare de; Butera, Gianfranco; Neroni, Paola; Fanos, Vassilios; Bassareo, Pier Paolo

doi:10.3390/pediatric13030061

Cited by 23 publications

(23 citation statements)

References 17 publications

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“…Our results indicated that post-COVID-19 vaccine myocarditis and pericarditis adverse events were more prevalent in young males 18-29 years old. Actually, a recent opinion [ 34 ] in the journal Pediatric Reports raised concerns about mRNA vaccines for adolescents, and questioned why cardiac adverse events have higher incidence in male adolescents after receiving the second dose of the vaccine and what mechanisms are contributing to these adverse events. Our data also showed that the number of myocarditis and pericarditis adverse events was higher for Pfizer/BioNTech vaccine followed by Moderna’s and then Janssen’s (based on the available data described herein).…”

Section: Discussionmentioning

confidence: 99%

Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients

et al. 2021

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Myocarditis and pericarditis have been linked recently to COVID-19 vaccines without exploring the underlying mechanisms, or compared to cardiac adverse events post-non-COVID-19 vaccines. We introduce an informatics approach to study post-vaccine adverse events on the systems biology level to aid the prioritization of effective preventive measures and mechanism-based pharmacotherapy by integrating the analysis of adverse event reports from the Vaccine Adverse Event Reporting System (VAERS) with systems biology methods. Our results indicated that post-vaccine myocarditis and pericarditis were associated most frequently with mRNA COVID-19 vaccines followed by live or live-attenuated non-COVID-19 vaccines such as smallpox and anthrax vaccines. The frequencies of cardiac adverse events were affected by vaccine, vaccine type, vaccine dose, sex, and age of the vaccinated individuals. Systems biology results suggested a central role of interferon-gamma (INF-gamma) in the biological processes leading to cardiac adverse events, by impacting MAPK and JAK-STAT signaling pathways. We suggest that increasing the time interval between vaccine doses minimizes the risks of developing inflammatory adverse reactions. We also propose glucocorticoids as preferred treatments based on system biology evidence. Our informatics workflow provides an invaluable tool to study post-vaccine adverse events on the systems biology level to suggest effective mechanism-based pharmacotherapy and/or suitable preventive measures.

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Section: Discussionmentioning

confidence: 99%

Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients

et al. 2021

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“…However, if sponsors do not generate the evidence needed for safe and effective use of their product in all relevant populations, the burden of medical uncertainty is laid upon the groups not represented in the drug development program [ 22 ]. The relevance of this with respect to COVID-19 vaccines is clearly exemplified by the recent observation that suggest a disproportionate higher frequency of post-vaccination myocarditis in adolescents and young adults than in the average adult population [ 23 ].…”

Section: Discussionmentioning

confidence: 98%

Status of Planned and Ongoing Paediatric Trials Investigating COVID-19 Vaccines: A Cross-Sectional Study of Paediatric Clinical Trials Planned in Agreed PIPs and/or Registered in Clinical Trial Databases

Christiansen

Thirstrup

Hallgreen

2022

Ther Innov Regul Sci

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Background The immune system matures throughout childhood; therefore, evidence about the safety and efficacy of vaccines for the prevention of COVID-19 in the paediatric population is important. Efficacy and safety have not been established for COVID-19 vaccines in a large part of the paediatric population at the time of the initial approval for use in adults. This study aims to provide an overview of planned and ongoing paediatric clinical trials investigating the safety and/or efficacy of COVID-19. Methods We identified all paediatric clinical trials investigating the safety and/or efficacy of COVID-19 vaccines in clinicaltrials.gov and clinicaltrialregister.eu, as well as all clinical trials planned in agreed PIPs (Paediatric Investigational Plans) as of 11 June 2021. Information about the study design, the paediatric age groups that they included, and the primary and secondary safety and efficacy outcomes were collected, together with expected timelines for the studies. Results 21 clinical trials were identified through the clinical trial registries and 19 clinical trials were specified in 6 agreed PIPs, 5 of these trials were also in the trial registers. All PIPs stipulated development of the COVID-19 vaccines for the full paediatric population, with a deferral. The earliest expected completion date of a PIPs is March 2024. The majority (14/21) of registered trials are randomised double-blinded studies. All investigated safety, 20 have a surrogate efficacy outcome (immunogenicity), of these 7 also measure clinical efficacy (COVID-19 infections). 18 studies were initiated, of these, all but one is still ongoing and one in adolescents has been finalised. Conclusion Even though several trials have been planned in agreed PIPs, the registered paediatric clinical trials identified are most often not part of a PIP.

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“…The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines, with the fact sheets to be provided before vaccination; in addition, CDC has developed patient and provider education materials about the possibility of myocarditis and symptoms of concern, to ensure prompt recognition and management of myocarditis [ 173 , 176 ]. Importantly, none of the patients fulfilled the criteria for multi-system inflammatory syndrome or Kawasaki-like disease and there was no evidence of acute SARS-CoV-2 infection [ 184 ].…”

Section: Possible Side Effects Of Covid-19 Vaccines In Children and Young Peoplementioning

confidence: 99%

The COVID-19 pandemic in children and young people during 2020-2021: A complex discussion on vaccination

et al. 2021

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COVID 19 Vaccine for Adolescents. Concern about Myocarditis and Pericarditis

Cited by 23 publications

References 17 publications

Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients

Shedding the Light on Post-Vaccine Myocarditis and Pericarditis in COVID-19 and Non-COVID-19 Vaccine Recipients

Status of Planned and Ongoing Paediatric Trials Investigating COVID-19 Vaccines: A Cross-Sectional Study of Paediatric Clinical Trials Planned in Agreed PIPs and/or Registered in Clinical Trial Databases

The COVID-19 pandemic in children and young people during 2020-2021: A complex discussion on vaccination

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