tetano
Editor, Senior Moderator
Emerg Microbes Infect
. 2022 Mar 7;1-17.
doi: 10.1080/22221751.2022.2050952. Online ahead of print.
Adverse Events of Special Interest Following the Use of BNT162b2 in Adolescents: A Population-Based Retrospective Cohort Study
Francisco Tsz Tsun Lai PhD[SUP] 1 2 [/SUP], Gilbert T Chua MBBS[SUP] 3 4 [/SUP], Edward Wai Wa Chan MPH[SUP] 1 5 [/SUP], Lei Huang MSc[SUP] 1 5 [/SUP], Mike Yat Wah Kwan MSc[SUP] 4 6 [/SUP], Tiantian Ma PhD[SUP] 1 5 [/SUP], Xiwen Qin PhD[SUP] 1 5 [/SUP], Celine Sze Ling Chui PhD[SUP] 5 7 8 [/SUP], Xue Li PhD[SUP] 1 5 9 [/SUP], Eric Yuk Fai Wan PhD[SUP] 1 5 10 [/SUP], Carlos King Ho Wong PhD[SUP] 1 5 9 [/SUP], Esther Wai Yin Chan PhD[SUP] 1 5 [/SUP], Ian Chi Kei Wong PhD[SUP] 1 5 11 [/SUP], Patrick Ip MPH[SUP] 3 4 [/SUP]
Affiliations
Abstract
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.
Keywords: Chinese; Coronavirus; Immunization; Reactogenicity; SARS-CoV-2.
. 2022 Mar 7;1-17.
doi: 10.1080/22221751.2022.2050952. Online ahead of print.
Adverse Events of Special Interest Following the Use of BNT162b2 in Adolescents: A Population-Based Retrospective Cohort Study
Francisco Tsz Tsun Lai PhD[SUP] 1 2 [/SUP], Gilbert T Chua MBBS[SUP] 3 4 [/SUP], Edward Wai Wa Chan MPH[SUP] 1 5 [/SUP], Lei Huang MSc[SUP] 1 5 [/SUP], Mike Yat Wah Kwan MSc[SUP] 4 6 [/SUP], Tiantian Ma PhD[SUP] 1 5 [/SUP], Xiwen Qin PhD[SUP] 1 5 [/SUP], Celine Sze Ling Chui PhD[SUP] 5 7 8 [/SUP], Xue Li PhD[SUP] 1 5 9 [/SUP], Eric Yuk Fai Wan PhD[SUP] 1 5 10 [/SUP], Carlos King Ho Wong PhD[SUP] 1 5 9 [/SUP], Esther Wai Yin Chan PhD[SUP] 1 5 [/SUP], Ian Chi Kei Wong PhD[SUP] 1 5 11 [/SUP], Patrick Ip MPH[SUP] 3 4 [/SUP]
Affiliations
- PMID: 35254219
- DOI: 10.1080/22221751.2022.2050952
Abstract
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.
Keywords: Chinese; Coronavirus; Immunization; Reactogenicity; SARS-CoV-2.