Table 2.
Risk of cerebrovascular infarction, myocarditis, and pericarditis after vaccination with a bivalent omicron adapted booster as fourth dose within 28 days in Danish adults aged ≥50 year during 15 September 2022 to 10 December 2022, including by sex, age, and vaccine type
| Outcome by subgroup | Bivalent booster | Reference period | Incidence rate ratio (95% CI) | |||||
|---|---|---|---|---|---|---|---|---|
| Events/person years | Rate/1 000 000* | Events/person years | Rate/1 000 000* | |||||
| Cerebrovascular infarction (including TIA) | ||||||||
| All | 644/127 304 | 387.8 | 9687/1 853 451 | 400.7 | 0.95 (0.87 to 1.05) | |||
| Sex: | ||||||||
| Female | 290/67 794 | 327.9 | 4317/974 392 | 339.6 | 0.91 (0.79 to 1.05) | |||
| Male | 354/59 511 | 456.0 | 5370/879 059 | 468.3 | 0.99 (0.88 to 1.13) | |||
| Age group (years): | ||||||||
| 50-64 | 113/52 983 | 163.5 | 1910/858 398 | 170.6 | 0.96 (0.78 to 1.20) | |||
| 65-79 | 315/55 419 | 435.7 | 4426/728 948 | 465.5 | 0.94 (0.82 to 1.07) | |||
| ≥80 | 216/18 902 | 876.0 | 3351/266 105 | 965.4 | 0.98 (0.83 to 1.15) | |||
| Vaccine type†: | ||||||||
| BNT162b2 with BA.4-5 | 377/84 259 | 343.0 | 9687/1 853 451 | 400.7 | 0.97 (0.86 to 1.09) | |||
| BNT162b2 with BA.1 | 246/38 856 | 485.3 | 9687/1 853 451 | 400.7 | 0.98 (0.85 to 1.12) | |||
| mRNA-1273 with BA.1 | 21/4189 | 384.3 | 9687/1 853 451 | 400.7 | 0.83 (0.54 to 1.29) | |||
| Myocarditis | ||||||||
| All | 9/130 288 | 5.3 | 64/1 893 405 | 2.6 | 2.65 (1.01 to 6.97) | |||
| Sex: | ||||||||
| Female | 6/69 066 | 6.7 | 29/991 433 | 2.2 | 3.89 (1.05 to 14.50) | |||
| Male | 3/61 223 | 3.8 | 35/901 972 | 3.0 | 1.60 (0.36 to 7.07) | |||
| Age group (years): | ||||||||
| 50-64 | 4/53 520 | 5.7 | 30/866 339 | 2.7 | 3.29 (0.75 to 14.46) | |||
| 65-79 | 4/56 889 | 5.4 | 27/747 644 | 2.8 | 1.79 (0.45 to 7.08) | |||
| ≥80 | 1/19 880 | 3.9 | 7/279 421 | 1.9 | 10.13 (0.23 to 437.19) | |||
| Vaccine type†: | ||||||||
| BNT162b2 with BA.4-5 | 6/85 859 | 5.4 | 64/1 893 405 | 2.6 | 3.74 (1.16 to 12.05) | |||
| BNT162b2 with BA.1 | 2/40 146 | 3.8 | 64/1 893 405 | 2.6 | 2.59 (0.52 to 12.94) | |||
| mRNA-1273 with BA.1 | 1/4283 | 17.9 | 64/1 893 405 | 2.6 | 12.39 (1.46 to 105.47) | |||
| Pericarditis | ||||||||
| All | 22/130 215 | 13.0 | 265/1 892 351 | 10.7 | 1.21 (0.72 to 2.03) | |||
| Sex: | ||||||||
| Female | 11/69 036 | 12.2 | 104/991 018 | 8.0 | 1.20 (0.57 to 2.50) | |||
| Male | 11/61 179 | 13.8 | 161/901 332 | 13.7 | 1.22 (0.59 to 2.53) | |||
| Age group (years): | ||||||||
| 50-64 | 8/53 490 | 11.5 | 134/865 857 | 11.9 | 1.09 (0.48 to 2.48) | |||
| 65-79 | 13/56 856 | 17.5 | 96/747 218 | 9.8 | 1.47 (0.71 to 3.05) | |||
| ≥80 | 1/19 869 | 3.9 | 35/279 276 | 9.6 | 0.43 (0.05 to 3.67) | |||
| Vaccine type†: | ||||||||
| BNT162b2 with BA.4-5 | 14/85 811 | 12.5 | 265/1 892 351 | 10.7 | 0.85 (0.43 to 1.71) | |||
| BNT162b2 with BA.1 | 7/40 123 | 13.4 | 265/1 892 351 | 10.7 | 1.12 (0.48 to 2.64) | |||
| mRNA-1273 with BA.1 | 1/4281 | 17.9 | 265/1 892 351 | 10.7 | 1.82 (0.25 to 13.31) | |||
NE=not estimable; TIA=transient cerebral ischaemic attack.
Each outcome was studied separately, therefore slight differences exist in denominators owing to different exclusions. The sum of person years within different strata may not equal the total person years owing to rounding.
Incidence rate per 1 000 000 vaccinated individuals (or individuals for reference period) within 28 days. Supplementary table S13 shows the sex and age subgroup estimates by individual bivalent omicron adapted mRNA booster vaccine types.
BNT162b2 is manufactured by Pfizer-BioNTech and mRNA-1273 is manufactured by Moderna.