학술논문
Serum Troponin I Assessments in 5- to 30-Year-Olds After BNT162b2 Vaccination
Document Type
article
Author
Timothy E. Albertson; Caitlin Hansen; Smiti Bihari; Juleen Gayed; Xia Xu; J. Abraham Simón-Campos; Michael E. Dever; Jose F. Cardona; Essack Mitha; Jeffrey B. Baker; Georgina Keep; Islamiat Oladipupo; Federico J. Mensa; Ye Feng; Hua Ma; Kenneth Koury; Susan Mather; Claudia Ana Ianos; Annaliesa S. Anderson; Özlem Türeci; Uǧur Şahin; William C. Gruber; Alejandra Gurtman; Charu Sabharwal; Nicholas Kitchin; the C4591031, C4591007 Clinical Trial Groups
Source
Infectious Diseases and Therapy, Vol 13, Iss 4, Pp 699-714 (2024)
Subject
Language
English
ISSN
2193-8229
2193-6382
2193-6382
Abstract
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