Association between mRNA COVID-19 vaccine boosters and mortality in Japan: The VENUS study

Figures & data

Figure 1. Study flow chart.

COVID-19: coronavirus disease.

Table 1. Characteristics of the matched cases and controls.

	18–64 years		≥65 years
	Cases	Controls	Cases	Controls
Characteristic	n = 431	n = 2,155	n = 12,166	n = 60,830
Age, years
Median (IQR)	57.0 (49.0, 61.0)	56.0 (49.0, 61.0)	84.0 (78.0, 90.0)	84.0 (78.0, 90.0)
Sex
Men	251 (58.2%)	1,255 (58.2%)	6,110 (50.2%)	30,550 (50.2%)
Women	180 (41.8%)	900 (41.8%)	6,056 (49.8%)	30,280 (49.8%)
Charlson comorbidity index
Median (IQR)	2.0 (0.0, 6.0)	0.0 (0.0, 1.0)	3.0 (2.0, 5.0)	2.0 (1.0, 4.0)
Myocardial infarction	20 (4.6%)	26 (1.2%)	712 (5.9%)	2,399 (3.9%)
Congestive heart failure	82 (19.0%)	100 (4.6%)	5,210 (42.8%)	18,469 (30.4%)
Peripheral vascular disease	37 (8.6%)	81 (3.8%)	1,929 (15.9%)	8,939 (14.7%)
Cerebrovascular disease	51 (11.8%)	89 (4.1%)	4,129 (33.9%)	15,059 (24.8%)
Dementia	9 (2.1%)	10 (0.5%)	3,506 (28.8%)	9,369 (15.4%)
Chronic pulmonary disease	86.0 (20.0%)	205 (9.5%)	3,523 (29.0%)	13,620 (22.4%)
Rheumatic disease	15 (3.5%)	39 (1.8%)	653 (5.4%)	2,478 (4.1%)
Peptic ulcer disease	115 (26.7%)	187 (8.7%)	3,159 (26.0%)	12,173 (20.0%)
Mild liver disease	103 (23.9%)	228 (10.6%)	2,356 (19.4%)	9,983 (16.4%)
Diabetes without chronic complications	132 (30.6%)	350 (16.2%)	4,958 (40.8%)	21,873 (36.0%)
Diabetes with chronic complications	39 (9.0%)	90 (4.2%)	1,015 (8.3%)	4,193 (6.9%)
Hemiplegia or paraplegia	10 (2.3%)	11 (0.5%)	301 (2.5%)	574 (0.9%)
Renal disease	43 (10.0%)	28 (1.3%)	1,642 (13.5%)	4,406 (7.2%)
Any malignancy	128 (29.7%)	89 (4.1%)	3,176 (26.1%)	9,444 (15.5%)
Moderate or severe liver disease	15 (3.5%)	5 (0.2%)	156 (1.3%)	173 (0.3%)
Metastatic solid tumor	68 (15.8%)	10 (0.5%)	830 (6.8%)	821 (1.3%)
AIDS/HIV	1 (0.2%)	1 (0.0%)	10 (0.1%)	29 (0.0%)

IQR, interquartile rang.

Table 2. Mortality risk after mRNA COVID-19 vaccination in the 18–64-years-old population.

	Cases, n = 431	Controls, n = 2,155	Adjusted OR (95% CI)
0–21 days before the index date
Unvaccinated	409 (94.9%)	1,954 (90.7%)	Reference
First dose	7 (1.6%)	56 (2.6%)	0.67 (0.27, 1.65)
Second dose	6 (1.4%)	59 (2.7%)	0.38 (0.14, 1.01)
Third dose	7 (1.6%)	58 (2.7%)	0.62 (0.24, 1.62)
Fourth dose	2 (0.5%)	28 (1.3%)	0.38 (0.08, 1.84)
Fifth dose	0 (0.0)	0 (0.0)	-
0–42 days before the index date
Unvaccinated	397 (92.1%)	1,831 (85.0%)	Reference
First dose	7 (1.6%)	58 (2.7%)	0.61 (0.25, 1.50)
Second dose	12 (2.8%)	119 (5.5%)	0.39 (0.19, 0.81)
Third dose	11 (2.6%)	104 (4.8%)	0.36 (0.16, 0.84)
Fourth dose	4 (0.9%)	43 (2.0%)	0.38 (0.12, 1.22)
Fifth dose	0 (0.0%)	0 (0.0%)	-
0–21 days before the index date
Unvaccinated	409 (94.9%)	1,954 (90.7%)	Reference
Any doses	22 (5.1%)	201 (9.3%)	0.52 (0.31, 0.87)
0–42 days before the index date
Unvaccinated	397 (92.1%)	1,831 (85.0%)	Reference
Any doses	34 (7.9%)	324 (15.0%)	0.42 (0.27, 0.65)

COVID-19, coronavirus disease; OR, odds ratio; CI, confidence interval.

Table 3. Mortality risk after mRNA COVID-19 vaccination in the ≥65-years-old population.

	Cases, n = 12,166	Controls, n = 60,830	Adjusted OR 95% CI
0–21 days before the index date
Unvaccinated	11,512 (94.6%)	52,738 (86.7%)	Reference
First dose	128 (1.1%)	1,633 (2.7%)	0.29 (0.24, 0.35)
Second dose	162 (1.3%)	1,786 (2.9%)	0.31 (0.26, 0.38)
Third dose	188 (1.5%)	2,010 (3.3%)	0.36 (0.31, 0.43)
Fourth dose	108 (0.9%)	1,509 (2.5%)	0.30 (0.25, 0.37)
Fifth dose	68 (0.6%)	1,154 (1.9%)	0.26 (0.20, 0.33)
0–42 days before the index date
Unvaccinated	10,828 (89.0%)	46,944 (77.2%)	Reference
First dose	200 (1.6%)	1,670 (2.7%)	0.39 (0.33, 0.47)
Second dose	359 (3.0%)	3,471 (5.7%)	0.31 (0.27, 0.36)
Third dose	403 (3.3%)	3,926 (6.5%)	0.32 (0.28, 0.36)
Fourth dose	271 (2.2%)	3,017 (5.0%)	0.33 (0.29, 0.38)
Fifth dose	105 (0.9%)	1,802 (3.0%)	0.20 (0.16, 0.25)
0–21 days before the index date
Unvaccinated	11,512 (94.6%)	52,738 (86.7%)	Reference
Any doses	654 (5.4%)	8,092 (13.3%)	0.31 (0.28, 0.34)
0–42 days before the index date
Unvaccinated	10,828 (89.0%)	46,944 (77.2%)	Reference
Any doses	1,338 (11.0%)	13,886 (22.8%)	0.31 (0.29, 0.33)

COVID-19, coronavirus disease 2019; OR, odds ratio; CI, confidence interval.

Data availability statement

Data cannot be made available for privacy or ethical reasons.