Myocarditis after BNT162b2 Vaccination in Israeli Adolescents

Witberg, Guy; Magen, Ori; Hoss, Sara; Talmor‐Barkan, Yeela; Richter, Ilan; Wiessman, Maya; Aviv, Yaron; Grinberg, Tzlil; Shiyovich, Arthur; Schamroth-Pravda, Nili; Auster, Oren; Dagan, Noa; Birk, Einat; Balicer, Ran D.; Kornowski, Ran

doi:10.1056/nejmc2207270

Cited by 16 publications

(17 citation statements)

References 4 publications

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“…A previous Nordic study reported increased risk in ages ≥12 years,[39] as have adolescent studies,[10, 27, 40] particularly after the second dose. [41] This was not observed in clinical trials,[5, 7–9] nor in a Malaysian study.…”

Section: Discussionmentioning

confidence: 96%

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Adverse Events Following SARS-CoV-2 mRNA Vaccination in Adolescents: A Norwegian Nationwide Register-Based Study

Larsen,

Gunnes,

Gran

et al. 2023

Preprint

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BackgroundVaccination of older adolescents against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) started in the spring of 2021 and continued with younger adolescents throughout the summer and fall. We assessed risks of adverse events following immunization (AEFI) in adolescents aged 12–19 years following SARS-CoV-2 vaccination with a messenger RNA (mRNA) vaccine in Norway.Materials and MethodsThe study sample included 496,432 adolescents born in 2002–2009, residing in Norway, and unvaccinated against SARS-CoV-2 at the beginning of the age-specific waves of vaccination in 2021. The exposures under study were first- and second-dose SARS-CoV-2 mRNA vaccinations vs. no dose. We applied Poisson regression and self-controlled case series (SCCS) analysis to estimate incidence rate ratios (IRRs) of 17 preselected outcomes, with associated 95% confidence intervals (CIs), between vaccinated and unvaccinated subjects using predefined post-vaccination risk windows.ResultsMost outcome-specific numbers of cases were low. There were no statistically significant associations between first-dose vaccination and any of the outcomes. In the main Poisson regression, second-dose vaccination was associated with increased risks of anaphylactic reaction (adjusted IRR [aIRR]: 10.05; 95% CI: 1.22–82.74), lymphadenopathy (aIRR: 2.33; 95% CI: 1.46–3.72), and myocarditis and pericarditis (aIRR: 5.27; 95% CI: 1.98–14.05). We also observed increased incidence of acute appendicitis outside the 14-day risk window. When expanding the risk window to 42 days in a post-hoc analysis, there was increased incidence of acute appendicitis following both first-dose vaccination (aIRR: 1.39; 95% CI: 1.09–1.78) and second-dose vaccination (aIRR: 1.43; 95% CI: 1.07–1.91). Results of the SCCS analysis were similar to the Poisson regression.ConclusionsIn general, potential AEFI were rare among adolescents. We found increased risks of anaphylactic reaction, lymphadenopathy, and myocarditis and pericarditis following second-dose vaccination. There were also indications of increased acute appendicitis risk when applying longer risk windows.

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Section: Discussionmentioning

confidence: 96%

“…Other studies reporting increased post-vaccination myocarditis risk similarly report no vaccine-arrhythmia association,[10, 27, 42] while a Malaysian study report increased risk. [30] Post-vaccination myocarditis might be milder,[40, 43] resulting in fewer arrhythmias, or arrhythmias might be less common in adolescents.…”

Section: Discussionmentioning

confidence: 99%

Adverse Events Following SARS-CoV-2 mRNA Vaccination in Adolescents: A Norwegian Nationwide Register-Based Study

Larsen,

Gunnes,

Gran

et al. 2023

Preprint

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“…A follow-up study of adolescents in Israel indicated that BNT162b2 vaccine-induced myocarditis in adolescents seems to be a rare adverse event, occurring predominantly in male individuals after the second dose of the vaccine. The clinical course seems to be mild and benign over a six-month follow-up period, and cardiac imaging findings suggest a favorable long-term prognosis 61 and, although some patients still had minor cardiac abnormalities, they occurred at a significantly lower rate than after SARS-CoV-2 infection. 62 , 63 …”

Section: Safety and Adverse Events Of Covid-19 Vaccines For Children ...mentioning

confidence: 92%

COVID-19 vaccination in children: a public health priority

Lima

Leite

2023

Jornal de Pediatria

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“…The rate of myocarditis was 4.8 cases per 10000 vaccinated adolescents using mRNA products in the Israeli population. All cases were mild and hemodynamically stable, and only some of them needed short hospitalization [ 18 ]. Other, such as anaphylactic shock, was also described, but the frequency of the event, in some trials, did not differ from the placebo group [ 19 ].…”

Section: Introductionmentioning

confidence: 99%

Impact of Improper Storage of ChAdOx1-S (AstraZeneca) Vaccine on Its Efficacy and Safety

2022

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Background: In May 2021, there was an incident regarding giving patients AstraZeneca vaccines stored improperly. They were stored at room temperature (21 degrees centigrade) for 18 h, 12 h longer than the producer recommends. Aim of the study: The paper aims to contribute to the body of knowledge concerning the efficacy and safety of the ChAdOx1-S (AstraZeneca) vaccine concerning the requirements for cold supply chain specification. Patients and methods: Improperly stored vaccines were given to 44 patients, and 39 of them decided to take part in the study. The Control group consisted of 56 people vaccinated on the same days by the same medical teams, using properly stored medicines. Results: The concentration of anti-S1 SARS-CoV-2 Spike protein IgG antibodies did not differ significantly between the groups. Examined group median 70 kU/L (20;100). Control group median 66 kU/L (32.75;100), p = 0.751. We did not observe any COVID-19 infections in either the control or examined group for half a year after the incident. People from each group reported that local and systemic adverse events occurred directly after the first and second doses. In the control group, one case of spontaneously subsiding face edema and joint pain was observed. There were no severe or fatal adverse events. There were no significant differences between the groups, besides the fatigue, after the second dose. Conclusion: AstraZeneca vaccine ChAdOx1-S stored at 21 degrees centigrade for 18 h before vaccination has the same safety profile (p < 0.05) and the same efficacy (p < 0.05) as the vaccines stored in conditions recommended by the producer.

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Myocarditis after BNT162b2 Vaccination in Israeli Adolescents

Cited by 16 publications

References 4 publications

Adverse Events Following SARS-CoV-2 mRNA Vaccination in Adolescents: A Norwegian Nationwide Register-Based Study

Adverse Events Following SARS-CoV-2 mRNA Vaccination in Adolescents: A Norwegian Nationwide Register-Based Study

COVID-19 vaccination in children: a public health priority

Impact of Improper Storage of ChAdOx1-S (AstraZeneca) Vaccine on Its Efficacy and Safety

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