Key result
BNT162b2 vaccination in adolescents was associated with a low overall absolute risk of adverse events of special interest, with no significantly increased risk except for myocarditis (IRR 29.61 after second dose) and sleeping disturbances.
Why the study?
While evidence suggests an increased risk of myocarditis in adolescents from mRNA COVID-19 vaccines, other potential adverse events remain under-researched.
Does the BNT162b2 vaccine increase the risk of adverse events of special interest, including myocarditis, in adolescents aged 12-18?
Cohort (n=274,881)
Does the BNT162b2 vaccine increase the risk of adverse events of special interest, including myocarditis, in adolescents aged 12-18?
In adolescents, BNT162b2 vaccination is associated with a significantly increased relative risk of myocarditis, particularly after the second dose, though the absolute risk remains low and the overall risk of other adverse events is not elevated.
This is the authors' abstract. We don't add key points for this paper.
Accruing evidence suggests an increased risk of myocarditis in adolescents from messenger RNA COVID-19 vaccines. However, other potential adverse events remain under-researched. We conducted a retrospective cohort study of adolescents aged 12–18 with a territory-wide electronic healthcare database of the Hong Kong population linked with population-based vaccination records and supplemented with age- and sex-specific population numbers. Two age- and sex-matched retrospective cohorts were formed to observe 28 days following the first and second doses of BNT162b2 and estimate the age- and sex-adjusted incidence rate ratios between the vaccinated and unvaccinated. Thirty AESIs adapted from the World Health Organization’s Global Advisory Committee on Vaccine Safety were examined. Eventually, the first-dose cohort comprised 274,881 adolescents (50.25% received the first dose) and the second-dose cohort 237,964 (50.29% received the second dose). Ninety-four (34.2 per 100,000 persons) adolescents in the first-dose cohort and 130 (54.6 per 100,000 persons) in the second-dose cohort experienced ≥1 AESIs. There were no statistically significant differences in the risk of any AESI associated with BNT162b2 except myocarditis [first-dose cohort: incidence rate ratio (IRR) = 9.15, 95% confidence interval (CI) 1.14–73.16; second-dose cohort: IRR = 29.61, 95% CI 4.04–217.07] and sleeping disturbances/disorders after the second dose (IRR = 2.06, 95% CI 1.01–4.24). Sensitivity analysis showed that, with myocarditis excluded as AESIs, no significantly elevated risk of AESIs as a composite outcome associated with vaccination was observed (P = 0.195). To conclude, the overall absolute risk of AESIs was low with no evidence of an increased risk of AESIs except myocarditis and sleeping disturbances/disorders.
Low absolute risk supports adolescent vaccination programs; observational data leaves open causality and need for RCTs on myocarditis.
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Lai et al. (2022) conducted a cohort in Adverse events of special interest (AESI) following COVID-19 vaccination (n=274,881). BNT162b2 vaccine vs. Unvaccinated adolescents was evaluated on Any adverse event of special interest (AESI) after first dose (IRR 1.30, 95% CI 0.87-1.95, p=0.204). BNT162b2 vaccination in adolescents was associated with a low overall absolute risk of adverse events of special interest, with no significantly increased risk except for myocarditis (IRR 29.61 after second dose) and sleeping disturbances.
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