Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Sample Characteristics
3.2. Adverse Events 0–3 and 4–7 Days after Vaccination
3.3. Impact on Routine Activities and Medical Review
4. Discussion
5. 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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Spikevax | Nuvaxovid | |||
---|---|---|---|---|
Characteristic | Dose 1 n/N (%) | Dose 2 n/N (%) | Dose 1 n/N (%) | Dose 2 n/N (%) |
All respondents | 10,948/26,254 (41.7%) | 12,585/19,611 (64.2%) | 1088/2972 (36.6%) | 1079/1884 (57.3%) |
Sex 1 | ||||
Female | 5553/11,615 (47.8%) | 5394/7817 (69.0%) | 624/1518 (41.1%) | 579/946 (61.2%) |
Male | 3732/10,557 (35.4%) | 4263/7314 (58.3%) | 335/1084 (30.9%) | 313/619 (50.6%) |
Other | 18/30 (60.0%) | 12/15 (80.0%) | <5 (100.0%) | <5 (100.0%) |
Missing data | 4052 | 4465 | 369 | 318 |
Age (years) 1 | ||||
Median (IQR) | 39 (26, 55) | 35 (21, 49) | 43 (33, 56) | 43 (34, 55) |
Missing data | 13 | 9 | 10 | 8 |
Indigenous status 1 | ||||
Aboriginal | 276/733 (37.7%) | 287/529 (54.3%) | 21/61 (34.4%) | 20/41 (48.8%) |
Non-Aboriginal | 10,405/24,907 (41.8%) | 12,028/18,652 (64.5%) | 1037/2858 (36.3%) | 1031/1804 (57.2%) |
Missing data | 614 | 430 | 53 | 39 |
Anaphylaxis history | ||||
No | 10,618/25,634 (41.4%) | 12,242/19,145 (63.9%) | 1008/2833 (35.6%) | 1007/1781 (56.5%) |
Yes | 330/620 (53.2%) | 343/466 (73.6%) | 80/139 (57.6%) | 72/103 (69.9%) |
Underlying medical condition | ||||
No | 9046/22,634 (40.0%) | 11,129/17,510 (63.6%) | 834/2374 (35.1%) | 896/1566 (57.2%) |
Yes | 1902/3620 (52.5%) | 1456/2101 (69.3%) | 254/598 (42.5%) | 183/318 (57.5%) |
Spikevax | Nuvaxovid | |||
---|---|---|---|---|
Characteristic | Dose 1 n/N (%) | Dose 2 n/N (%) | Dose 1 n/N (%) | Dose 2 n/N (%) |
Missed work, study, or routine activities 1 | N = 26,254 | N = 19,611 | N = 2972 | N = 1884 |
3493/26,220 (13.3%) | 6849/19,583 (35.0%) | 383/2971 (12.9%) | 471/1882 (25.0%) | |
Missing | 34 | 28 | 1 | 2 |
Number of days missed from routine activities 1 | N = 3493 | N = 6849 | N = 383 | N = 471 |
Less than a day | 326/3484 (9.4%) | 470/6836 (6.9%) | 35/378 (9.3%) | 30/471 (6.4%) |
One day | 1462/3484 (42.0%) | 3032/6836 (44.4%) | 126/378 (33.3%) | 187/471 (39.7%) |
Two days | 1179/3484 (33.8%) | 2358/6836 (34.5%) | 130/378 (34.4%) | 139/471 (29.5%) |
Three or more days | 517/3484 (14.8%) | 976/6836 (14.3%) | 87/378 (23.0%) | 115/471 (24.4%) |
Missing data | 9 | 13 | 5 | 0 |
Medical review sought | N = 26,254 | N = 19,611 | N = 2972 | N = 1884 |
493/26,254 (1.9%) | 931/19,611 (4.8%) | 81/2972 (2.7%) | 73/1884 (3.9%) | |
Highest level medical review obtained 1 | N = 493 | N = 931 | N = 81 | N = 73 |
ED | 113/450 (25.1%) | 182/869 (20.9%) | 20/75 (26.7%) | 11/72 (15.3%) |
GP or Aboriginal HCW | 201/450 (44.7%) | 409/869 (47.1%) | 39/75 (52.0%) | 40/72 (55.6%) |
Phone | 136/450 (30.2%) | 278/869 (32.0%) | 16/75 (21.3%) | 21/72 (29.2%) |
Missing data | 43 | 62 | 6 | 1 |
Symptom resolution by day 3 1,2 | N = 6585 | N = 7362 | N = 655 | N = 683 |
4443/6559 (67.7%) | 4479/7334 (61.1%) | 311/653 (47.6%) | 306/680 (45.0%) | |
Missing data | 26 | 28 | 2 | 3 |
Symptom resolution by day 8 1,2 | N = 6585 | N = 7362 | N = 655 | N = 683 |
4800/6499 (73.9%) | 5385/6708 (80.3%) | 357/629 (56.8%) | 422/633 (66.7%) | |
Missing data | 86 | 654 | 26 | 50 |
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Reynolds, R.; Tay, E.; Dymock, M.; Deng, L.; Glover, C.; Lopez, L.K.; Huang, Y.A.; Cashman, P.; Leeb, A.; Marsh, J.A.; et al. Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia. Vaccines 2024, 12, 971. https://doi.org/10.3390/vaccines12090971
Reynolds R, Tay E, Dymock M, Deng L, Glover C, Lopez LK, Huang YA, Cashman P, Leeb A, Marsh JA, et al. Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia. Vaccines. 2024; 12(9):971. https://doi.org/10.3390/vaccines12090971
Chicago/Turabian StyleReynolds, Renee, Evelyn Tay, Michael Dymock, Lucy Deng, Catherine Glover, Laura K. Lopez, Yuanfei Anny Huang, Patrick Cashman, Alan Leeb, Julie A. Marsh, and et al. 2024. "Short-Term Active Safety Surveillance of the Spikevax and Nuvaxovid Priming Doses in Australia" Vaccines 12, no. 9: 971. https://doi.org/10.3390/vaccines12090971