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.

Correspondence on ‘BNT162b2 vaccine‐associated myo/pericarditis in adolescents’

“…Dear Editor, We would like to share ideas on the publication 'BNT162b2 vaccine-associated myo/pericarditis in adolescents: A Stratified Risk-Benefit Analysis.' 1 Krug et al reported a comprehensive analysis of an original study and concluded that 'Our findings strongly support individualized paediatric COVID-19 vaccination strategies, which weigh protection against severe disease vs. risks of vaccineassociated myo/pericarditis. Research is needed into the nature and implications of this adverse effect and immunization strategies, which reduce harm in this overall low-risk cohort.'…”

“…Research is needed into the nature and implications of this adverse effect and immunization strategies, which reduce harm in this overall low-risk cohort.' 1 We agree that COVID-19 can have negative side effects, with myo/pericarditis being one among them. Krug et al analyzed data from the Vaccine Adverse Event Reporting System (VAERS) in this investigation.…”

The unintended consequences of COVID-19 vaccine policy: why mandates, passports and restrictions may cause more harm than good

“…Some governments have publicly admitted this much; in the words of French President Emmanuel Macron, the aim is to ‘piss off [the unvaccinated] …to the end. This is the strategy.’117 Mandating a third dose for young boys to attend college or university in America has been widely discussed in the US media despite the lack of evidence for substantial clinical benefit,59 118 and with evidence of small but still significant risk of myocarditis that compounds with each dose 119–121. Scandinavian countries have taken a precautionary and voluntary approach in their recommendations to the vaccination of children, with Swedish authorities stating that ‘[because of] a low risk for serious disease for kids, we don’t see any clear benefit with vaccinating them’ 122.…”

What Should We Do after the COVID-19 Vaccination? Vaccine-Associated Diseases and Precautionary Measures against Adverse Reactions

“…Various cardiovascular diseases have been reported to be associated with the COVID-19 vaccine. These include myocarditis and pericarditis [5,20,27,[36][37][38][39][40][41], ACS [5][6][7]36], aortic dissection [5,6,34,35], vasospastic angina [36], Takotsubo cardiomyopathy [42], heart failure [5,7,27], arrhythmia [5,14,27,39,43], and pulmonary embolism [5,44] (Table 1). Stark et al reported the interplay between inflammation cytokines and thrombosis in cardiovascular pathology [45].…”

“…Myocarditi and pericarditis are reported to be more common in young males after the second vac cination. In male patients aged 12-15 and 16-17 years, the reported incidence is 162.2/mil lion and 93.0/million, respectively [40]. Patients with myocarditis/pericarditis usually pre sent 24-72 h post-vaccination [38].…”