Table 2.
Characteristic | Received BA.4/5 Bivalent Vaccine (n = 26 961) |
Unvaccinateda (n = 64 846) | 2–4 Original Wild-Type Doses but no Bivalent Vaccineb (n = 216 078) | ||
---|---|---|---|---|---|
No. (%) | No. (%) | P Valuec,d | No. (%) | P Valued,e | |
Age, y | |||||
5–11 | 370 (1.37) | 4702 (7.25) | <.0001f | 2844 (1.32) | <.0001f |
12–17 | 762 (2.83) | 6107 (9.42) | <.0001f | 9460 (4.38) | <.0001f |
≥ 18 | 25 829 (95.80) | 54 037 (83.33) | <.0001f,g | 203 774 (94.31) | <.0001g |
18–49 | 12 404 (46.01) | 44 070 (67.96) | Ref | 134 447 (62.22) | Ref |
50–64 | 6270 (23.26) | 7359 (11.35) | <.0001f | 43 819 (20.28) | <.0001f |
≥65 | 7155 (26.54) | 2608 (4.02) | <.0001f | 25 508 (11.80) | <.0001f |
Mean (SD) | 49.47 (19.06) | 32.60 (15.98) | <.0001 | 41.41 (17.62) | <.0001 |
Gender | |||||
Female | 16 627 (61.67) | 36 734 (56.65) | <.0001 | 131 531 (60.87) | .1579 |
Male | 10 202 (37.84) | 28 019 (43.21) | Ref | 83 810 (38.79) | Ref |
Other | 132 (0.49) | 93 (0.14) | <.0001 | 737 (0.34) | <.0001 |
Race/ethnicity | |||||
Hispanic/any race | 3001 (11.13) | 14 436 (22.26) | <.0001 | 45 654 (21.13) | <.0001 |
Asian/non-Hispanic or Latino | 2551 (9.46) | 1396 (2.15) | <.0001 | 18 588 (8.60) | <.0001 |
Black or African American/non-Hispanic or Latino | 2177 (8.07) | 13 890 (21.42) | <.0001 | 30 643 (14.18) | <.0001 |
Native/non-Hispanic or Latinoh | 148 (0.55) | 792 (1.22) | <.0001 | 1992 (0.92) | <.0001 |
White/non-Hispanic or Latino | 17 818 (66.09) | 29 176 (44.99) | Ref | 105 394 (48.78) | Ref |
Decline to answer | 1266 (4.70) | 5156 (7.95) | <.0001 | 13 807 (6.39) | <.0001 |
Currently pregnant? | |||||
No | 19 710 (73.11) | 46 635 (71.92) | Ref | 158 639 (73.42) | Ref |
Yes | 238 (0.88) | 1148 (1.77) | <.0001 | 2901 (1.34) | <.0001 |
Does not apply | 7013 (26.01) | 17 063 (26.31) | .3877 | 54 538 (25.24) | .1805 |
Recent close contact with someone diagnosed with or presumed to have COVID-19 | <.0001 | ||||
No | 15 220 (56.45) | 37 617 (58.01) | Ref | 124 017 (57.39) | Ref |
Yes | 11 741 (43.55) | 27 229 (41.99) | <.0001 | 92 061 (42.61) | <.0001 |
Chronic conditions reported | |||||
At least 1 | 13 066 (48.46) | 17 444 (26.90) | <.0001 | 82 395 (38.13) | <.0001i |
Chronic lung disease, eg, COPD, moderate to severe asthma, cystic fibrosis, or pulmonary embolism | 1769 (6.56) | 2459 (3.79) | <.0001 | 10 137 (4.69) | <.0001 |
Cirrhosis of the liver | 71 (0.26) | 114 (0.18) | .0012 | 389 (0.18) | .0007 |
Current or former smoker | 2705 (10.03) | 5888 (9.08) | .3628 | 18 929 (8.76) | .0404 |
Diabetes | 2774 (10.29) | 2885 (4.45) | <.0001 | 17 436 (8.07) | <.0001 |
Heart condition | 2166 (8.03) | 2164 (3.34) | <.0001 | 11 080 (5.13) | <.0001 |
High blood pressure | 7243 (26.86) | 7297 (11.25) | <.0001 | 42 430 (19.64) | <.0001 |
Overweight or obesity | 5891 (21.85) | 6220 (9.59) | <.0001 | 35 299 (16.34) | <.0001 |
Kidney failure or end-stage renal disease | 167 (0.62) | 204 (0.31) | <.0001 | 1038 (0.48) | .0061 |
None | 13 895 (51.54) | 47 402 (73.10) | Ref | 133 683 (61.87) | Ref |
Number of condition(s) reported | |||||
0 | 13 895 (51.54) | 47 402 (73.10) | Ref | 133 683 (61.87) | Ref |
1 | 6878 (25.51) | 10 919 (16.84) | <.0001 | 46 490 (21.52) | <.0001 |
2 | 3670 (13.61) | 4209 (6.49) | <.0001 | 22 470 (10.40) | <.0001 |
≥ 3 | 2518 (9.34) | 2316 (3.57) | <.0001 | 13 435 (6.22) | <.0001 |
Symptoms reported | |||||
Low-grade fever, <102°F | 6223 (23.08) | 27 402 (42.26) | <.0001 | 74 229 (34.35) | <.0001 |
Chills | 7064 (26.20) | 25 440 (39.23) | <.0001 | 76 727 (35.51) | <.0001 |
Fatigue | 12 905 (47.87) | 33 163 (51.14) | .0091 | 113 766 (52.65) | <.0001 |
Headache | 12 834 (47.60) | 40 895 (63.06) | <.0001 | 125 015 (57.86) | <.0001 |
Muscle pain | 6962 (25.82) | 27 261 (42.04) | <.0001 | 79 266 (36.68) | <.0001 |
Congestion/runny nose | 17 207 (63.82) | 37 134 (57.26) | <.0001 | 133 819 (61.93) | .0011 |
New loss of taste or smell | 1560 (5.79) | 8238 (12.70) | <.0001 | 20 117 (9.31) | <.0001 |
Sore throat | 16 127 (59.82) | 36 465 (56.23) | <.0001 | 133 272 (61.68) | <.0001 |
New or worsening cough | 17 558 (65.12) | 47 005 (72.49) | <.0001 | 154 282 (71.40) | <.0001 |
Shortness of breath/difficulty breathing, not severe | 3612 (13.40) | 15 873 (24.48) | <.0001 | 41 538 (19.22) | <.0001 |
Diarrhea | 2363 (8.76) | 10 475 (16.15) | <.0001 | 25 845 (11.96) | <.0001 |
Vomiting | 802 (2.97) | 6532 (10.07) | <.0001 | 11 654 (5.39) | <.0001 |
SARS-CoV-2 test type | |||||
PCR | 11 728 (43.50) | 15 583 (24.03) | Ref | 72 179 (33.40) | Ref |
Rapid NAAT | 15 233 (56.50) | 49 263 (75.97) | <.0001 | 143 899 (66.60) | <.0001 |
Wild-type vaccination history | |||||
Unvaccinated | NA | 64 846 (100.00) | NA | NA | NA |
2 doses only | 3501 (12.99) | NA | NA | 107 059 (49.55) | Ref |
≥ 3 doses | 23 460 (87.01) | NA | NA | 109 019 (50.45) | <.0001j |
3 doses only | 16 229 (60.19) | NA | NA | 92 912 (43.00) | <.0001k |
4 doses only | 7231 (26.82) | NA | NA | 16 107 (7.45) | <.0001k |
Months since last wild-type dosel | |||||
2–6 | 3199 (11.87) | NA | NA | 26 025 (12.04) | .2513 |
≥7 | 23 762 (88.13) | NA | NA | 190 053 (87.96) | Ref |
SARS-CoV-2 test status | |||||
Negative | 18 053 (66.96) | 43 429 (66.97) | Ref | 127 697 (59.10) | Ref |
Positive | 8908 (33.04) | 21 417 (33.03) | .7554 | 88 381 (40.90) | <.0001 |
Prior SARS-CoV-2 infection | |||||
No | 18 279 (67.80) | 29 821 (45.99) | Ref | 126 491 (58.54) | Ref |
Yes, > 3 mo agom | 8682 (32.20) | 35 025 (54.01) | <.0001 | 89 587 (41.46) | <.0001 |
Average weekly incidence rate (per 100 000) in participating counties over study period, mean (SD) | 110.40 (57.95) | 108.30 (62.56) | .9698 | 110.10 (60.25) | .8095 |
Average store-specific percent positivity (No. of positive tests in a store, divided by the number of total tests) in participating stores over study period, mean (SD) | 36.74 (29.06) | 36.12 (29.42) | .9780 | 39.51 (29.43) | .0023 |
US census region | |||||
Midwest | 7882 (29.23) | 18 074 (27.87) | <.0001 | 55 026 (25.47) | <.0001 |
Northeast | 3779 (14.02) | 5388 (8.31) | <.0001 | 27 020 (12.50) | <.0001 |
South | 9224 (34.21) | 30 576 (47.15) | Ref | 90 415 (41.84) | Ref |
West | 6076 (22.54) | 10 808 (16.67) | <.0001 | 43 617 (20.19) | <.0001 |
Rural/urban area of pharmacy trade region | |||||
Rural | 5593 (20.74) | 20 650 (31.84) | .0113 | 50 055 (23.17) | .4568 |
Suburban | 18 981 (70.40) | 40 398 (62.30) | .4372 | 147 446 (68.24) | .6422 |
Urban | 2387 (8.85) | 3798 (5.86) | Ref | 18 577 (8.60) | Ref |
Area deprivation index of pharmacy, mean (SD) | 50.52 (28.91) | 65.91 (26.57) | <.0001 | 57.28 (28.54) | <.0001 |
Average store-specific testing volume per 100 persons in pharmacy trade area over study period, mean (SD) | 0.13 (0.15) | 0.27 (0.15) | <.0001 | 0.27 (0.15) | <.0001 |
Abbreviations: COPD, chronic obstructive pulmonary disease; COVID-19, coronavirus disease 2019; NAAT, nucleic acid amplification test; PCR, polymerase chain reaction; Ref, reference; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; VE, vaccine effectiveness; NA, Not Applicable; ICC, intraclass correlation coefficient.
aUnexposed group for absolute VE.
bUnexposed group for relative VE.
c P value for received BA.4/5 bivalent vaccine vs unvaccinated.
d P value for received BA.4/5 bivalent vaccine vs received 2–4 original wild-type doses but no bivalent vaccine.
eStatistical significance was assessed using bivariate generalized estimating equations logistic regression models that clustered on US Census region of pharmacy to account for intraclass correlation coefficient (ICC) by Walgreens pharmacy region.
fComparing categories: 5–11, 12–17, 18–49, 50–64, and ≥65 years.
gComparing categories: ≥ 18 vs <18 years.
hIncludes American Indian, Alaska Native, Native Hawaiian, or Other Pacific Islander.
iComparing categories: any chronic conditions vs no chronic conditions.
jComparing categories: unvaccinated, 2 doses only, ≥3 doses.
kComparing unvaccinated, 2 doses, 3 doses, and 4 doses.
lBecause only month and year are available for vaccine doses, 2–6 months may include some patients who were vaccinated 7 months ago; 7–11 months may include some patients who were vaccinated 6 or 12 months ago.
mHistory of prior COVID-19 infection included the following response options: No; Yes, within the last week; Yes, 1 week to 3 months ago; and Yes, >3 months ago. Those indicating a prior COVID-19 infection within the last week or 1 week to 3 months ago were excluded from the analysis. This variable represents self-reported prior COVID-19 infection >3 months ago (yes vs no).