Comparison of Clinical and Demographic Factors Among Participants Who Developed COVID-19 Infection ≥1 Month After Completion of SARS-CoV-2 Vaccine Series vs Participants Who Did Not Develop COVID-19 Infection ≥1 Month After Vaccination
| . | All Patients n . | COVID-19 Infection . | No COVID-19 Infection . | P Value . |
|---|---|---|---|---|
| Total number of patients | 2849 | 48 | 2801 | — |
| COVID infection prior to vaccination | 128 | 0 (0) | 128 (5) | .130 |
| COVID infection after starting vaccine series or <1 mo after completing vaccine series | 18 | 0 (0) | 18 (1) | .577 |
| Age, y | 44.5 | 43.6 ± 15.2 | 44.5 ± 14.9 | .672 |
| <18 y | 22 | 1 (2) | 21 (1) | |
| 18–39 y | 1189 | 23 (48) | 1166 (42) | |
| 40–64 y | 1288 | 17 (35) | 1271 (45) | |
| ≥65 y | 350 | 7 (15) | 343 (12) | |
| Female | 2070 | 32 (67) | 2038 (73) | .348 |
| Current smoker | 50 | 0 (0) | 50 (2) | .350 |
| Region | .028 | |||
| Northeast | 675 | 6 (13) | 669 (24) | |
| South | 851 | 22 (46) | 829 (30) | |
| Midwest | 699 | 14 (29) | 685 (24) | |
| West | 623 | 6 (13) | 617 (22) | |
| Highest grade | .407 | |||
| >12th grade | 36 | 1 (2) | 35 (1) | |
| 12th grade or GED | 60 | 2 (4) | 58 (2) | |
| Some college | 328 | 7 (15) | 321 (11) | |
| College | 1169 | 24 (50) | 1145 (41) | |
| Graduate school | 1255 | 14 (29) | 1241 (44) | |
| Unknown | 1 | 0 (0) | 1 (0) | |
| Disease type | .670 | |||
| Crohn’s disease | 1921 | 32 (67) | 1889 (67) | |
| Ulcerative colitis | 886 | 16 (33) | 870 (31) | |
| Missing/IBD-U | 42 | 0 (0) | 42 (1) | |
| Type of vaccine (first dose) | .483 | |||
| BNT162b2 | 1639 | 28 (58) | 1611 (58) | |
| mRNA-1273 | 1068 | 16 (33) | 1052 (38) | |
| Ad26.COV2.S | 138 | 4 (8) | 134 (5) | |
| Unknown | 4 | 0 (0) | 4 (0) | |
| IBD medication at baseline vaccinationa | ||||
| No medical therapy | 239 | 1 (2) | 238 (8) | .112 |
| Systemic steroids | 128 | 4 (8) | 124 (4) | .196 |
| Anti-TNF monotherapy | 1018 | 20 (42) | 998 (36) | .387 |
| Anti-TNF combination therapyb | 286 | 6 (13) | 280 (10) | .567 |
| Thiopurine | 225 | 4 (8) | 221 (8) | .910 |
| Methotrexate | 16 | 0 (0) | 16 (1) | .600 |
| Mesalamine or sulfasalazine | 632 | 13 (27) | 619 (22) | .410 |
| Budesonide | 114 | 3 (6) | 111 (4) | .423 |
| Vedolizumab | 324 | 5 (10) | 319 (11) | .833 |
| Ustekinumab | 406 | 9 (19) | 397 (14) | .368 |
| Tofacitinib | 42 | 0 (0) | 42 (1) | .393 |
| Participants with antibody level | 2006 | 31 | 1975 | — |
| Anti-RBD antibody level | 30.4 | 7.1 (2.7-21.0) | 17.0 (7.1-33.0) | .004 |
| . | All Patients n . | COVID-19 Infection . | No COVID-19 Infection . | P Value . |
|---|---|---|---|---|
| Total number of patients | 2849 | 48 | 2801 | — |
| COVID infection prior to vaccination | 128 | 0 (0) | 128 (5) | .130 |
| COVID infection after starting vaccine series or <1 mo after completing vaccine series | 18 | 0 (0) | 18 (1) | .577 |
| Age, y | 44.5 | 43.6 ± 15.2 | 44.5 ± 14.9 | .672 |
| <18 y | 22 | 1 (2) | 21 (1) | |
| 18–39 y | 1189 | 23 (48) | 1166 (42) | |
| 40–64 y | 1288 | 17 (35) | 1271 (45) | |
| ≥65 y | 350 | 7 (15) | 343 (12) | |
| Female | 2070 | 32 (67) | 2038 (73) | .348 |
| Current smoker | 50 | 0 (0) | 50 (2) | .350 |
| Region | .028 | |||
| Northeast | 675 | 6 (13) | 669 (24) | |
| South | 851 | 22 (46) | 829 (30) | |
| Midwest | 699 | 14 (29) | 685 (24) | |
| West | 623 | 6 (13) | 617 (22) | |
| Highest grade | .407 | |||
| >12th grade | 36 | 1 (2) | 35 (1) | |
| 12th grade or GED | 60 | 2 (4) | 58 (2) | |
| Some college | 328 | 7 (15) | 321 (11) | |
| College | 1169 | 24 (50) | 1145 (41) | |
| Graduate school | 1255 | 14 (29) | 1241 (44) | |
| Unknown | 1 | 0 (0) | 1 (0) | |
| Disease type | .670 | |||
| Crohn’s disease | 1921 | 32 (67) | 1889 (67) | |
| Ulcerative colitis | 886 | 16 (33) | 870 (31) | |
| Missing/IBD-U | 42 | 0 (0) | 42 (1) | |
| Type of vaccine (first dose) | .483 | |||
| BNT162b2 | 1639 | 28 (58) | 1611 (58) | |
| mRNA-1273 | 1068 | 16 (33) | 1052 (38) | |
| Ad26.COV2.S | 138 | 4 (8) | 134 (5) | |
| Unknown | 4 | 0 (0) | 4 (0) | |
| IBD medication at baseline vaccinationa | ||||
| No medical therapy | 239 | 1 (2) | 238 (8) | .112 |
| Systemic steroids | 128 | 4 (8) | 124 (4) | .196 |
| Anti-TNF monotherapy | 1018 | 20 (42) | 998 (36) | .387 |
| Anti-TNF combination therapyb | 286 | 6 (13) | 280 (10) | .567 |
| Thiopurine | 225 | 4 (8) | 221 (8) | .910 |
| Methotrexate | 16 | 0 (0) | 16 (1) | .600 |
| Mesalamine or sulfasalazine | 632 | 13 (27) | 619 (22) | .410 |
| Budesonide | 114 | 3 (6) | 111 (4) | .423 |
| Vedolizumab | 324 | 5 (10) | 319 (11) | .833 |
| Ustekinumab | 406 | 9 (19) | 397 (14) | .368 |
| Tofacitinib | 42 | 0 (0) | 42 (1) | .393 |
| Participants with antibody level | 2006 | 31 | 1975 | — |
| Anti-RBD antibody level | 30.4 | 7.1 (2.7-21.0) | 17.0 (7.1-33.0) | .004 |
Values are n, n (%), mean ± SD, or median (interquartile range).
Abbreviations: COVID-19, coronavirus disease 2019; IBD-U, inflammatory bowel disease–unclassified; RBD = receptor binding domain; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; TNF, tumor necrosis factor.
aNumbers do not add to total n as patients may be taking more than 1 medication class.
bIncluding azathioprine, 6-mercaptopurine, or methotrexate.
Comparison of Clinical and Demographic Factors Among Participants Who Developed COVID-19 Infection ≥1 Month After Completion of SARS-CoV-2 Vaccine Series vs Participants Who Did Not Develop COVID-19 Infection ≥1 Month After Vaccination
| . | All Patients n . | COVID-19 Infection . | No COVID-19 Infection . | P Value . |
|---|---|---|---|---|
| Total number of patients | 2849 | 48 | 2801 | — |
| COVID infection prior to vaccination | 128 | 0 (0) | 128 (5) | .130 |
| COVID infection after starting vaccine series or <1 mo after completing vaccine series | 18 | 0 (0) | 18 (1) | .577 |
| Age, y | 44.5 | 43.6 ± 15.2 | 44.5 ± 14.9 | .672 |
| <18 y | 22 | 1 (2) | 21 (1) | |
| 18–39 y | 1189 | 23 (48) | 1166 (42) | |
| 40–64 y | 1288 | 17 (35) | 1271 (45) | |
| ≥65 y | 350 | 7 (15) | 343 (12) | |
| Female | 2070 | 32 (67) | 2038 (73) | .348 |
| Current smoker | 50 | 0 (0) | 50 (2) | .350 |
| Region | .028 | |||
| Northeast | 675 | 6 (13) | 669 (24) | |
| South | 851 | 22 (46) | 829 (30) | |
| Midwest | 699 | 14 (29) | 685 (24) | |
| West | 623 | 6 (13) | 617 (22) | |
| Highest grade | .407 | |||
| >12th grade | 36 | 1 (2) | 35 (1) | |
| 12th grade or GED | 60 | 2 (4) | 58 (2) | |
| Some college | 328 | 7 (15) | 321 (11) | |
| College | 1169 | 24 (50) | 1145 (41) | |
| Graduate school | 1255 | 14 (29) | 1241 (44) | |
| Unknown | 1 | 0 (0) | 1 (0) | |
| Disease type | .670 | |||
| Crohn’s disease | 1921 | 32 (67) | 1889 (67) | |
| Ulcerative colitis | 886 | 16 (33) | 870 (31) | |
| Missing/IBD-U | 42 | 0 (0) | 42 (1) | |
| Type of vaccine (first dose) | .483 | |||
| BNT162b2 | 1639 | 28 (58) | 1611 (58) | |
| mRNA-1273 | 1068 | 16 (33) | 1052 (38) | |
| Ad26.COV2.S | 138 | 4 (8) | 134 (5) | |
| Unknown | 4 | 0 (0) | 4 (0) | |
| IBD medication at baseline vaccinationa | ||||
| No medical therapy | 239 | 1 (2) | 238 (8) | .112 |
| Systemic steroids | 128 | 4 (8) | 124 (4) | .196 |
| Anti-TNF monotherapy | 1018 | 20 (42) | 998 (36) | .387 |
| Anti-TNF combination therapyb | 286 | 6 (13) | 280 (10) | .567 |
| Thiopurine | 225 | 4 (8) | 221 (8) | .910 |
| Methotrexate | 16 | 0 (0) | 16 (1) | .600 |
| Mesalamine or sulfasalazine | 632 | 13 (27) | 619 (22) | .410 |
| Budesonide | 114 | 3 (6) | 111 (4) | .423 |
| Vedolizumab | 324 | 5 (10) | 319 (11) | .833 |
| Ustekinumab | 406 | 9 (19) | 397 (14) | .368 |
| Tofacitinib | 42 | 0 (0) | 42 (1) | .393 |
| Participants with antibody level | 2006 | 31 | 1975 | — |
| Anti-RBD antibody level | 30.4 | 7.1 (2.7-21.0) | 17.0 (7.1-33.0) | .004 |
| . | All Patients n . | COVID-19 Infection . | No COVID-19 Infection . | P Value . |
|---|---|---|---|---|
| Total number of patients | 2849 | 48 | 2801 | — |
| COVID infection prior to vaccination | 128 | 0 (0) | 128 (5) | .130 |
| COVID infection after starting vaccine series or <1 mo after completing vaccine series | 18 | 0 (0) | 18 (1) | .577 |
| Age, y | 44.5 | 43.6 ± 15.2 | 44.5 ± 14.9 | .672 |
| <18 y | 22 | 1 (2) | 21 (1) | |
| 18–39 y | 1189 | 23 (48) | 1166 (42) | |
| 40–64 y | 1288 | 17 (35) | 1271 (45) | |
| ≥65 y | 350 | 7 (15) | 343 (12) | |
| Female | 2070 | 32 (67) | 2038 (73) | .348 |
| Current smoker | 50 | 0 (0) | 50 (2) | .350 |
| Region | .028 | |||
| Northeast | 675 | 6 (13) | 669 (24) | |
| South | 851 | 22 (46) | 829 (30) | |
| Midwest | 699 | 14 (29) | 685 (24) | |
| West | 623 | 6 (13) | 617 (22) | |
| Highest grade | .407 | |||
| >12th grade | 36 | 1 (2) | 35 (1) | |
| 12th grade or GED | 60 | 2 (4) | 58 (2) | |
| Some college | 328 | 7 (15) | 321 (11) | |
| College | 1169 | 24 (50) | 1145 (41) | |
| Graduate school | 1255 | 14 (29) | 1241 (44) | |
| Unknown | 1 | 0 (0) | 1 (0) | |
| Disease type | .670 | |||
| Crohn’s disease | 1921 | 32 (67) | 1889 (67) | |
| Ulcerative colitis | 886 | 16 (33) | 870 (31) | |
| Missing/IBD-U | 42 | 0 (0) | 42 (1) | |
| Type of vaccine (first dose) | .483 | |||
| BNT162b2 | 1639 | 28 (58) | 1611 (58) | |
| mRNA-1273 | 1068 | 16 (33) | 1052 (38) | |
| Ad26.COV2.S | 138 | 4 (8) | 134 (5) | |
| Unknown | 4 | 0 (0) | 4 (0) | |
| IBD medication at baseline vaccinationa | ||||
| No medical therapy | 239 | 1 (2) | 238 (8) | .112 |
| Systemic steroids | 128 | 4 (8) | 124 (4) | .196 |
| Anti-TNF monotherapy | 1018 | 20 (42) | 998 (36) | .387 |
| Anti-TNF combination therapyb | 286 | 6 (13) | 280 (10) | .567 |
| Thiopurine | 225 | 4 (8) | 221 (8) | .910 |
| Methotrexate | 16 | 0 (0) | 16 (1) | .600 |
| Mesalamine or sulfasalazine | 632 | 13 (27) | 619 (22) | .410 |
| Budesonide | 114 | 3 (6) | 111 (4) | .423 |
| Vedolizumab | 324 | 5 (10) | 319 (11) | .833 |
| Ustekinumab | 406 | 9 (19) | 397 (14) | .368 |
| Tofacitinib | 42 | 0 (0) | 42 (1) | .393 |
| Participants with antibody level | 2006 | 31 | 1975 | — |
| Anti-RBD antibody level | 30.4 | 7.1 (2.7-21.0) | 17.0 (7.1-33.0) | .004 |
Values are n, n (%), mean ± SD, or median (interquartile range).
Abbreviations: COVID-19, coronavirus disease 2019; IBD-U, inflammatory bowel disease–unclassified; RBD = receptor binding domain; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; TNF, tumor necrosis factor.
aNumbers do not add to total n as patients may be taking more than 1 medication class.
bIncluding azathioprine, 6-mercaptopurine, or methotrexate.
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