Impact of Bivalent BA.4/5 BNT162b2 COVID-19 Vaccine on Acute Symptoms, Quality of Life, Work Productivity and Activity Levels among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy
Abstract
:1. Background
2. Methods
2.1. Study Design and Participants
2.2. Study Cohorts
2.3. Baseline Characteristics and Patient-Reported Outcome Measures
2.4. Acute Symptoms
2.5. Health-Related Quality of Life (HRQoL)
2.6. Work Productivity and Activity Impairment
2.7. Fatigue
3. Statistical Analysis
4. Results
4.1. Baseline Characteristics
4.2. Acute Symptoms
4.3. Health-Related Quality of Life
4.4. PROMIS Fatigue
4.5. Work Productivity and Activity Impairment
5. Discussion
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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All | BNT162b2 | Unvaccinated | p a | |
---|---|---|---|---|
Total n (%) | 643 (100.0) | 316 (49.1) | 327 (50.9) | |
Age, years, mean (SD) | 46.5 (15.9) | 50.8 (16.0) | 42.3 (14.7) | <0.001 |
Age group, n (%) | <0.001 | |||
18–29 | 109 (17.0) | 33 (10.4) | 76 (23.2) | |
30–49 | 257 (40.0) | 111 (35.1) | 146 (44.6) | |
50–64 | 167 (26.0) | 93 (29.4) | 74 (22.6) | |
≥65–74 | 110 (17.0) | 79 (25.0) | 31 (9.5) | |
Gender, n (%) | 0.185 | |||
Female | 452 (70.3) | 212 (67.1) | 240 (73.4) | |
Male | 185 (28.8) | 101 (32.0) | 84 (25.7) | |
Unknown | 6 (0.9) | 3 (1.0) | 3 (0.9) | |
Race/Ethnicity, n (%) | <0.001 | |||
White or Caucasian (not Hispanic or Latino) | 374 (58.2) | 204 (64.6) | 170 (52.0) | |
Black or African American | 57 (8.9) | 19 (6.0) | 38 (11.6) | |
Hispanic | 99 (15.4) | 33 (10.4) | 66 (20.2) | |
Asian | 63 (9.8) | 36 (11.4) | 27 (8.3) | |
Patient Refused/Other | 50 (7.7) | 24 (7.6) | 26 (8.0) | |
US Geographic Region, n (%) | 0.013 | |||
Northeast | 88 (13.7) | 51 (16.1) | 37 (11.3) | |
South | 260 (40.4) | 108 (34.2) | 152 (46.5) | |
Midwest | 141 (21.9) | 76 (24.1) | 65 (19.9) | |
West | 154 (24.0) | 81 (25.6) | 73 (22.3) | |
Social vulnerability index, Mean (SD) b | 0.45 (0.2) | 0.39 (0.2) | 0.50 (0.2) | 0.000 |
Previously Tested Positive, n (%) | 0.051 | |||
No | 338 (52.6) | 177 (56.0) | 161 (49.2) | |
Yes | 268 (41.7) | 119 (37.7) | 149 (45.6) | |
Missing | 37 (5.8) | 20 (6.3) | 17 (5.3) | |
Number of comorbidities, Mean (SD) | 0.40 (0.8) | 0.47 (0.8) | 0.34 (0.8) | 0.043 |
At least 1 comorbidity, n (%) | 165 (25.7) | 96 (30.4) | 69 (21.1) | 0.007 |
Asthma or Chronic Lung Disease, n (%) | 33 (5.1) | 20 (6.3) | 13 (4.0) | 0.176 |
Cirrhosis of the liver, n (%) | 2 (0.3) | 0 (0.0) | 2 (0.6) | 0.499 |
Immunocompromised Conditions or Weakened Immune System c, n (%) | 2 (0.3) | 1 (0.3) | 1 (0.3) | 1.000 |
Diabetes, n (%) | 39 (6.1) | 23 (7.3) | 16 (4.9) | 0.205 |
Heart Conditions or Hypertension, n (%) | 104 (16.2) | 60 (19.0) | 44 (13.5) | 0.057 |
Overweight or obesity, n (%) | 80 (12.4) | 44 (13.9) | 36 (11.0) | 0.263 |
Paxlovid prescription, n (%) | 0.000 | |||
No | 493 (76.7) | 222 (70.3) | 271 (82.9) | |
Yes | 148 (23.0) | 92 (29.1) | 56 (17.1) | |
Missing | 2 (0.3) | 2 (0.6) | 0 (0.0) |
All | BNT162b2 | Unvaccinated | p a | p b | |
---|---|---|---|---|---|
Index day (time of testing) | |||||
n | 643 (100.0) | 316 (49.1) | 327 (50.9) | ||
Mean number of symptoms (SD) | 5.3 (2.3) | 5.0 (2.3) | 5.7 (2.2) | 0.001 | 0.002 |
Median (Q1, Q3) | 5 (4.0, 7.0) | 5 (3.0, 7.0) | 6 (4.0, 7.0) | 0.000 | |
Number of ARI symptoms, n (%) | 0.007 | ||||
1–2 | 75 (11.7) | 45 (14.2) | 30 (9.2) | ||
3–5 | 271 (42.1) | 146 (46.2) | 125 (38.2) | ||
6+ | 297.2 (46.2) | 125 (39.5) | 172 (52.6) | ||
Systemic symptoms, n (%) | 574 (89.3) | 273 (86.4) | 301 (92.0) | 0.021 | 0.037 |
Fever | 268 (41.7) | 119 (37.7) | 149 (45.6) | 0.042 | 0.037 |
Chills | 332 (51.6) | 140 (44.3) | 192 (58.7) | 0.000 | 0.201 |
Muscle or Body Aches | 297 (46.2) | 125 (39.6) | 172 (52.6) | 0.001 | 0.030 |
Headache | 417 (64.9) | 191 (60.4) | 226 (69.1) | 0.021 | 0.010 |
Fatigue | 424 (65.9) | 202 (63.9) | 222 (67.9) | 0.289 | 0.164 |
Respiratory symptoms, n (%) | 627 (97.5) | 310 (98.1) | 317 (96.9) | 0.345 | 0.359 |
Shortness of Breath or Difficulty Breathing | 101 (15.7) | 48 (15.2) | 53 (16.2) | 0.723 | 0.568 |
Cough | 491 (76.4) | 237 (75.0) | 254 (77.7) | 0.425 | 0.401 |
Sore Throat | 390 (60.7) | 191 (60.4) | 199 (60.9) | 0.915 | 0.571 |
New/Recent Loss of Taste or Smell | 89 (13.8) | 37 (11.7) | 52 (15.9) | 0.124 | 0.185 |
Congestion or Runny Nose | 525 (81.6) | 258 (81.6) | 267 (81.7) | 0.999 | 0.908 |
GI symptoms, n (%) | 92 (14.3) | 37 (11.7) | 55 (16.8) | 0.064 | 0.500 |
Nausea or Vomiting | 25 (3.9) | 10 (3.2) | 15 (4.6) | 0.351 | 0.670 |
Diarrhea | 80 (12.4) | 33 (10.4) | 47 (14.4) | 0.131 | 0.443 |
Week 1 | |||||
n | 566 | 285 (50.4) | 281 (49.6) | ||
Mean number of symptoms (SD) | 2.6 (1.8) | 2.5 (1.6) | 2.7 (1.9) | 0.129 | 0.368 |
Median, Q1–Q3 | 2 (1.0, 3.0) | 2 (1.0, 3.0) | 2 (1.0, 4.0) | 0.242 | |
Number of ARI symptoms | 0.158 | ||||
1–2 | 340 (60.0) | 179 (62.8) | 161 (57.1) | ||
3–5 | 189 (33.3) | 94 (33.0) | 95 (33.7) | ||
6+ | 37 (6.5) | 12 (4.3) | 25 (8.9) | ||
Missing | 1 (0.2) | 0 (0.0) | 1 (0.4) | ||
Systemic symptoms, n (%) | 332 (58.6) | 156 (54.7) | 176 (62.4) | 0.064 | 0.127 |
Fever | 15 (2.7) | 3 (1.1) | 12 (4.3) | 0.017 | 0.037 |
Chills | 21 (3.7) | 10 (3.5) | 11 (3.9) | 0.798 | 0.902 |
Muscle or Body Aches | 87 (15.4) | 34 (11.9) | 53 (18.9) | 0.022 | 0.072 |
Headache | 129 (22.8) | 50 (17.5) | 79 (28.1) | 0.003 | 0.034 |
Fatigue | 286 (50.5) | 139 (48.8) | 147 (52.3) | 0.400 | 0.497 |
Respiratory symptoms, n (%) | 418 (73.7) | 212 (74.4) | 206 (73.0) | 0.718 | 0.798 |
Shortness of Breath or Difficulty Breathing | 95 (16.8) | 44 (15.4) | 51 (18.1) | 0.388 | 0.670 |
Cough | 284 (50.2) | 141 (49.5) | 143 (50.9) | 0.736 | 0.644 |
Sore Throat | 79 (14.0) | 39 (13.7) | 40 (14.2) | 0.850 | 0.951 |
New/Recent Loss of Taste or Smell | 76 (13.4) | 37 (13.0) | 39 (13.9) | 0.754 | 0.907 |
Congestion or Runny Nose | 247 (43.6) | 132 (46.3) | 115 (40.9) | 0.196 | 0.298 |
GI symptoms, n (%) | 46 (8.1) | 24 (8.4) | 22 (7.8) | 0.787 | 0.471 |
Nausea or Vomiting | 3 (0.5) | 1 (0.4) | 2 (0.7) | 0.554 | 0.689 |
Diarrhea | 43 (7.6) | 23 (8.1) | 20 (7.1) | 0.669 | 0.561 |
Week 2 | |||||
n | 530 | 269 (50.8) | 261 (49.2) | ||
Mean number of symptoms (SD) | 1.9 (1.3) | 1.9 (1.3) | 2.0 (1.4) | 0.133 | 0.465 |
Median, Q1–Q3 | 1 (1.0, 3.0) | 1 (1.0, 2.0) | 1 (1.0, 3.0) | 0.270 | |
Number of ARI symptoms | 0.284 | ||||
1–2 | 397 (74.9) | 209 (77.7) | 188 (72.0) | ||
3–5 | 120 (22.6) | 55 (20.4) | 65 (24.9) | ||
6–8 | 13 (2.5) | 5 (1.9) | 8 (3.1) | ||
Systemic symptoms, n (%) | 254 (47.9) | 125 (46.5) | 129 (49.4) | 0.496 | 0.638 |
Fever | 7 (1.3) | 2 (0.7) | 5 (1.9) | 0.237 | 0.289 |
Chills | 12 (2.3) | 5 (1.9) | 7 (2.7) | 0.524 | 0.613 |
Muscle or Body Aches | 80 (15.1) | 36 (13.4) | 44 (16.9) | 0.264 | 0.391 |
Headache | 79 (14.9) | 33 (12.3) | 46 (17.6) | 0.083 | 0.224 |
Fatigue | 218 (41.1) | 108 (40.1) | 110 (42.1) | 0.640 | 0.780 |
Respiratory symptoms, n (%) | 271 (51.1) | 134 (49.8) | 137 (52.5) | 0.538 | 0.299 |
Shortness of Breath or Difficulty Breathing | 51 (9.6) | 22 (8.2) | 29 (11.1) | 0.252 | 0.474 |
Cough | 184 (34.7) | 93 (34.6) | 91 (34.9) | 0.943 | 0.731 |
Sore Throat | 44 (8.3) | 17 (6.3) | 27 (10.3) | 0.093 | 0.100 |
New/Recent Loss of Taste or Smell | 29 (5.5) | 17 (6.3) | 12 (4.6) | 0.384 | 0.310 |
Congestion or Runny Nose | 125 (23.6) | 64 (23.8) | 61 (23.4) | 0.909 | 0.979 |
GI symptoms, n (%) | 31 (5.9) | 14 (5.2) | 17 (6.5) | 0.521 | 0.860 |
Nausea or Vomiting | 3 (0.6) | 2 (0.7) | 1 (0.4) | 0.580 | 0.476 |
Diarrhea | 29 (5.5) | 13 (4.8) | 16 (6.1) | 0.511 | 0.655 |
Week 4 | |||||
n | 505 | 260 (51.5) | 245 (48.5) | ||
Mean number of symptoms (SD) | 0.9 (1.3) | 0.7 (1.2) | 1.1 (1.4) | 0.002 | 0.033 |
Median, Q1–Q3 | 0 (0.0, 1.0) | 0 (0.0, 1.0) | 1 (0.0, 2.0) | 0.000 | |
Number of ARI symptoms | 0.009 | ||||
0 | 272 (53.8) | 159 (61.2) | 113 (45.9) | ||
1–2 | 178 (35.2) | 80 (30.8) | 98 (39.8) | ||
3–5 | 46 (9.1) | 17 (6.5) | 29 (11.8) | ||
6–8 | 9 (1.8) | 4 (1.5) | 5 (2.0) | ||
Missing | 1 (0.0) | 0 (0.0) | 1 (0.0) | ||
Systemic symptoms, n (%) | 167 (33.0) | 67 (25.8) | 100 (40.7) | 0.000 | 0.005 |
Fever | 5 (1.0) | 2 (0.8) | 3 (1.2) | 0.606 | 0.658 |
Chills | 6 (1.2) | 3 (1.2) | 3 (1.2) | 0.942 | 0.992 |
Muscle or Body Aches | 42 (8.3) | 17 (6.5) | 25 (10.2) | 0.136 | 0.229 |
Headache | 67 (13.3) | 30 (11.5) | 37 (15.1) | 0.238 | 0.576 |
Fatigue | 123 (24.4) | 46 (17.7) | 77 (31.4) | 0.000 | 0.003 |
Respiratory symptoms, n (%) | 138 (27.3) | 61 (23.5) | 77 (31.3) | 0.048 | 0.027 |
Shortness of Breath or Difficulty Breathing | 50 (9.9) | 22 (8.5) | 28 (11.4) | 0.265 | 0.516 |
Cough | 93 (18.4) | 43 (16.5) | 50 (20.4) | 0.262 | 0.201 |
Sore Throat | 21 (4.2) | 6 (2.3) | 15 (6.1) | 0.032 | 0.057 |
New/Recent Loss of Taste or Smell | 18 (3.6) | 8 (3.1) | 10 (4.1) | 0.543 | 0.691 |
Congestion or Runny Nose | N/A | ||||
GI symptoms, n (%) | 30 (5.9) | 12 (4.6) | 18 (7.3) | 0.198 | 0.409 |
Nausea or Vomiting | 18 (3.6) | 7 (2.7) | 11 (4.5) | 0.276 | 0.521 |
Diarrhea | 15 (3.0) | 5 (1.9) | 10 (4.1) | 0.153 | 0.212 |
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Di Fusco, M.; Sun, X.; Anatale-Tardiff, L.; Yehoshua, A.; Coetzer, H.; Alvarez, M.B.; Allen, K.E.; Porter, T.M.; Puzniak, L.; Lopez, S.M.C.; et al. Impact of Bivalent BA.4/5 BNT162b2 COVID-19 Vaccine on Acute Symptoms, Quality of Life, Work Productivity and Activity Levels among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy. Vaccines 2023, 11, 1669. https://doi.org/10.3390/vaccines11111669
Di Fusco M, Sun X, Anatale-Tardiff L, Yehoshua A, Coetzer H, Alvarez MB, Allen KE, Porter TM, Puzniak L, Lopez SMC, et al. Impact of Bivalent BA.4/5 BNT162b2 COVID-19 Vaccine on Acute Symptoms, Quality of Life, Work Productivity and Activity Levels among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy. Vaccines. 2023; 11(11):1669. https://doi.org/10.3390/vaccines11111669
Chicago/Turabian StyleDi Fusco, Manuela, Xiaowu Sun, Laura Anatale-Tardiff, Alon Yehoshua, Henriette Coetzer, Mary B. Alvarez, Kristen E. Allen, Thomas M. Porter, Laura Puzniak, Santiago M. C. Lopez, and et al. 2023. "Impact of Bivalent BA.4/5 BNT162b2 COVID-19 Vaccine on Acute Symptoms, Quality of Life, Work Productivity and Activity Levels among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy" Vaccines 11, no. 11: 1669. https://doi.org/10.3390/vaccines11111669