1. Serum Troponin I Assessments in 5- to 30-Year-Olds After BNT162b2 Vaccination.
- Author
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Albertson, Timothy, Hansen, Caitlin, Bihari, Smiti, Gayed, Juleen, Xu, Xia, Simón-Campos, J, Dever, Michael, Cardona, Jose, Mitha, Essack, Baker, Jeffrey, Keep, Georgina, Oladipupo, Islamiat, Mensa, Federico, Feng, Ye, Ma, Hua, Koury, Kenneth, Mather, Susan, Ianos, Claudia, Anderson, Annaliesa, Türeci, Özlem, Şahin, Uǧur, Gruber, William, Gurtman, Alejandra, Sabharwal, Charu, and Kitchin, Nicholas
- Subjects
BNT162b2 ,COVID-19 ,Clinical trials ,Myocarditis ,Pericarditis ,Safety ,Troponin I ,Vaccines - Abstract
INTRODUCTION: Rare myocarditis and pericarditis cases have occurred in coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccine recipients. Troponin levels, a potential marker of myocardial injury, were assessed in healthy participants before and after BNT162b2 vaccination. METHODS: Vaccine-experienced 12- to 30-year-olds in phase 3 crossover C4591031 Substudy B (NCT04955626) who had two or three prior BNT162b2 30-μg doses were randomized to receive BNT162b2 30 μg followed by placebo, or placebo followed by BNT162b2 30 µg, 1 month apart. A participant subset, previously unvaccinated against COVID-19, in the phase 3 C4591007 study (NCT04816643) received up to three vaccinations (BNT162b2 10 μg or placebo [5- to 11-year-olds]) or open-label BNT162b2 30 μg (12- to 15-year-olds). Blood samples collected pre-vaccination, 4 days post-vaccination, and 1-month post-vaccination (C4591031 Substudy B only) were analyzed. Frequencies of elevated troponin I levels (male, > 35 ng/l; female, > 17 ng/l) were assessed. RESULTS: Percentages of 12- to 30-year-olds (n = 1485) in C4591031 Substudy B with elevated troponin levels following BNT162b2 or placebo receipt were 0.5% and 0.8% before vaccination, 0.7% and 1.0% at day 4, and 0.7% and 0.5% at 1 month, respectively. In Study C4591007 (n = 1265), elevated troponin I levels were observed in 0.2, 0.4, and 0.2% of 5- to 11-year-old BNT162b2 recipients at baseline and 4 days post-dose 2 and 3, respectively; corresponding values in 12- to 15-year-olds were 0.4, 0.4, and 0.7%. No 5- to 11-year-old placebo recipients had elevated troponin levels. No myocarditis or pericarditis cases or deaths were reported. CONCLUSIONS: Among 5- to
- Published
- 2024