BNT162b2 Vaccine-Associated Myo/Pericarditis in Adolescents: A Stratified Risk-Benefit Analysis.

ABSTRACT

BACKGROUND: Male patients ages 12-17 years have an elevated risk of mRNA vaccination-associated myo/pericarditis. A risk-benefit analysis of first and second doses of mRNA vaccination in adolescent boys by health status and history of SARS-CoV-2 infection has not been performed. METHODS: Using the Vaccine Adverse Event Reporting System (VAERS), we identified BNT162b2 [Pfizer-BioNTech] myo/pericarditis occurrence according to CDC criteria. Main outcomes were as follows 1) post-vaccination myo/pericarditis crude incidence in adolescents aged 12-15 and 16-17; and 2) two risk-benefit analyses by age, sex, comorbidity, variant and history of infection. RESULTS: Cases of myo/pericarditis (n = 253) included 129 after dose 1 and 124 after dose 2; 86.9% were hospitalized. Incidence per million after dose two in male patients aged 12-15 and 16-17 was 162.2 and 93.0, respectively. Weighing post-vaccination myo/pericarditis against COVID-19 hospitalization during delta, our risk-benefit analysis suggests that among 12-17-year-olds, two-dose vaccination was uniformly favourable only in nonimmune girls with a comorbidity. In boys with prior infection and no comorbidities, even one dose carried more risk than benefit according to international estimates. In the setting of omicron, one dose may be protective in nonimmune children, but dose two does not appear to confer additional benefit at a population level. CONCLUSIONS: Our findings strongly support individualized paediatric COVID-19 vaccination strategies which weigh protection against severe disease vs. risks of vaccine-associated myo/pericarditis. Research is needed into the nature and implications of this adverse effect as well as immunization strategies which reduce harms in this overall low-risk cohort.