Introduction
Methods
The Lombardy Vaccine Integrated Platform
Cohort selection and covariates
Measuring vaccine harms
Measuring vaccine benefits
Balancing harms and benefits
Results
Study cohort
Baseline characteristics | |
---|---|
Sex | |
Men | 4,715,243 (51.3%) |
Women | 4,468,903 (48.7%) |
Age categories | |
12–15 years | 401,186 (4.4%) |
16–19 years | 387,685 (4.2%) |
20–29 years | 977,758 (10.7%) |
30–39 years | 1,130,699 (12.3%) |
40–49 years | 1,493,328 (16.3%) |
50–59 years | 1,665,591 (18.1%) |
60–69 years | 1,254,101 (13.7%) |
70–79 years | 1,026,382 (11.2%) |
80 + years | 847,416 (9.2%) |
Cardiac comorbidities | |
Arrhythmic myocardiopathy | 237,941 (2.6%) |
Arterial vascular disease | 76,321 (0.8%) |
Familial and non-familial hypercholesterolaemia | 274,477 (3.0%) |
Heart failure | 161,551 (1.8%) |
Hypertension | 1,285,967 (14.0%) |
Ischaemic heart disease | 246,631 (2.7%) |
Non-arrhythmic myocardiopathy | 245,683 (2.7%) |
Valvular heart disease | 69,656 (0.8%) |
Venous vascular disease | 41,184 (0.5%) |
At least one cardiac comorbidity | 2,255,136 (24.5%) |
Vaccine status | |
---|---|
First dose | 7,907,765 (86.1%) |
Oxford-AstraZeneca | 1,223,681 (13.3%) |
Janssen | 289,989 (3.2%) |
Moderna | 1,024,935 (11.2%) |
Pfizer-BioNTech | 5,369,160 (58.5%) |
Second dose | 7,165,379 (78.0%) |
Oxford-AstraZeneca | 1,041,884 (11.3%) |
Moderna | 970,629 (10.6%) |
Pfizer-BioNTech | 5,152,866 (56.1%) |
Third dose (booster) | 1,052,469 (11.5%) |
Moderna | 108,319 (1.2%) |
Pfizer-BioNTech | 944,150 (10.3%) |
Harm-related outcomes
Balancing harms and benefits
Men receiving the Moderna vaccine | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Harms | Age categories | Benefits | ||||||||||
No exposurea | Exposurea | Rate differencec | Number needed to harm (95% CI)e | Number needed to treat (95% CI)e | Rate difference | Exposureb | No exposureb | |||||
# casesc | Incidence ratec | # casesc | Incidence ratec | Incidence rated | # casesd | Incidence rated | # casesd | |||||
12 | 5.8 | 1 | 33.1 | 27.3 | 36,680 (10,854 to − 26,596) | 12–15 years | 20,008 (9980 to − 3,529,828) | 50.0 | 35.0 | 2 | 84.9 | 155 |
32 | 16.3 | 6 | 154.9 | 138.6 | 7213 (3807 to 68,776) | 16–19 years | 9471 (7513 to 12,852) | 105.6 | 11.2 | 1 | 116.8 | 182 |
70 | 14.2 | 14 | 94.8 | 80.6 | 12,414 (7675 to − 32,468) | 20–29 years | 6764 (5790 to 8130) | 147.9 | 41.8 | 16 | 189.7 | 693 |
203 | 5.9 | 14 | 23.7 | 17.8 | 56,106 (33,025 to 186,428) | + 30 years | 911 (890 to 933) | 1097.7 | 206.9 | 389 | 1304.6 | 27,939 |
Women receiving the Moderna vaccine | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Harms | Age categories | Benefits | ||||||||||
No exposurea | Exposurea | Rate differencec | Number needed to harm (95% CI)e | Number needed to treat (95% CI)e | Rate difference | Exposureb | No exposureb | |||||
# casesc | Incidence ratec | # casesc | Incidence ratec | Incidence rated | # casesd | Incidence rated | # casesd | |||||
3 | 1.5 | 0 | 0.0 | – | – | 12–15 years | 27,522 (11,049 to − 56,054) | 36.3 | 38.0 | 2 | 74.3 | 127 |
8 | 4.4 | 1 | 29.9 | 25.5 | 39,184 (11,882 to − 30,193) | 16–19 years | 7285 (5907 to 9506) | 137.3 | 12.8 | 1 | 150.0 | 216 |
18 | 3.9 | 3 | 25.2 | 21.3 | 46,920 (20,044 to − 137,646) | 20–29 years | 4279 (3809 to 4980) | 233.7 | 43.9 | 14 | 277.6 | 908 |
117 | 3.1 | 4 | 6.5 | 3.3 | 298,908 (102,754 to − 328,839) | + 30 years | 1,265 (1228 to 1305) | 790.2 | 216.9 | 454 | 1007.1 | 22,328 |
Men receiving the Pfizer-BioNTech vaccine | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Harms | Age categories | Benefits | ||||||||||
No exposurea | Exposurea | Rate differencec | Number needed to harm (95% CI)e | Number needed to treat (95% CI)e | Rate difference | Exposureb | No exposureb | |||||
# casesc | Incidence ratec | # casesc | Incidence ratec | Incidence rated | # casesd | Incidence rated | # casesd | |||||
12 | 5.8 | 9 | 46.4 | 40.6 | 24,633 (14,069 to 98,9123) | 12–15 years | 16,543 (12,395 to 24,863) | 60.5 | 24.5 | 10 | 84.9 | 155 |
32 | 16.3 | 8 | 36.1 | 19.7 | 50,633 (22,046 to − 170,561) | 16–19 years | 11,741 (9294 to 15,929) | 85.2 | 31.6 | 18 | 116.8 | 182 |
70 | 14.2 | 13 | 25.4 | 11.2 | 89,592 (39,448 to − 330,251) | 20–29 years | 6,395 (5770 to 7174) | 156.4 | 33.3 | 49 | 189.7 | 693 |
203 | 5.9 | 24 | 7.0 | 1.1 | 890,332 (246,731 to − 553,403) | + 30 years | 925 (910 to 940) | 1081.1 | 223.5 | 2,556 | 1304.6 | 27,939 |
Women receiving the Pfizer-BioNTech vaccine | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Harms | Benefits | |||||||||||
No exposurea | Exposurea | Rate difference | Number needed to harm (95% CI)e | Age categories | Number needed to treat (95% CI)e | Rate differencec | Exposureb | No exposureb | ||||
# casesc | Incidence ratec | # casesc | Incidence ratec | Incidence rated | # casesd | Incidence rated | # casesd | |||||
3 | 1.5 | 0 | 0.0 | – | – | 12–15 years | 18,560 (13,691 to 28,810) | 53.9 | 20.4 | 8 | 74.3 | 127 |
8 | 4.4 | 2 | 9.5 | 5.1 | 196,329 (53,937 to − 119,175) | 16–19 years | 10,413 (8071 to 14,658) | 96.0 | 54.0 | 30 | 150.0 | 216 |
18 | 3.9 | 4 | 8.3 | 4.4 | 227,298 (78,616 to − 254,842) | 20–29 years | 4254 (3906 to 4668) | 235.1 | 42.5 | 63 | 277.6 | 908 |
117 | 3.1 | 17 | 4.4 | 1.3 | 772,323 (287,274 to − 1,121,831) | + 30 years | 1214 (1192 to 1237) | 823.5 | 183.6 | 2416 | 1007.1 | 22,328 |
Individuals receiving the Moderna vaccine | ||||
---|---|---|---|---|
Men | Women | |||
Number Needed to Harm | Number Needed to Treat | Age categories | Number Needed to Harm | Number Needed to Treat |
30,252 | 21,876 | 12 to 15 years | – | 33,621 |
6747 | 10,317 | 16 to 19 years | 34,997 | 7861 |
11,086 | 7060 | 20 to 29 years | 41,819 | 4621 |
47,910 | 1085 | ≥ 30 years | 210,530 | 1527 |
Individuals receiving the Pfizer-BioNTech vaccine | ||||
---|---|---|---|---|
Men | Women | |||
Number Needed to Harm | Number Needed to Treat | Age categories | Number Needed to Harm | Number Needed to Treat |
21,557 | 17,800 | 12 to 15 years | – | 21,148 |
34,095 | 13,069 | 16 to 19 years | 122,747 | 10,317 |
48,036 | 6660 | 20 to 29 years | 142,873 | 7060 |
239,663 | 1105 | ≥ 30 years | 370,479 | 1085 |