A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5–17 Years) Living in Saudi Arabia
Abstract
:1. Introduction
2. Materials and Methods
2.1. Sample Size
2.2. Study Design & Tool
2.3. Statistical Analysis
3. Results
3.1. Relationship with Dose
3.2. Relationship with Gender
3.3. Relationship with Past COVID-19 Infection
3.4. Relationship with History of Allergy and AEFI with Previous Vaccines
3.5. COVID-19 Infection after Vaccination
3.6. Adverse Event Characteristics in Group A (5–11 Years)
3.7. Adverse Event Characteristics in Group B (12–17 Years)
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variables | Group A (n = 136) | Group B (n = 249) | Total (n = 385) |
---|---|---|---|
Region of residence | |||
Asir region | 13 (3.3%) | 6 (2.4%) | 19 (5%) |
Eastern region | 33 (24.3%) | 38 (15.3%) | 71 (18.4%) |
Makkah region | 6 (4.4%) | 23 (9.2%) | 29 (7.5%) |
Riyadh region | 56 (41.2%) | 157 (63%) | 213 (55.3%) |
Qasim region | 18 (13.2%) | 24 (9.6%) | 42 (10.9%) |
Others | 10 (7.4%) | 1 (0.4%) | 11 (2.9%) |
Mean Age ± SD (in years) | 8.58 ± 2.06 | 14.26 ± 1.74 | 12.25 ± 3.29 |
Gender | |||
Male | 84 (61.8%) | 101 (40.6%) | 185 (48.1%) |
Female | 52 (38.2%) | 148 (59.4%) | 200 (51.9%) |
No: of doses of COVID-19 vaccine received | |||
One | 41 (30.1%) | 19 (7.6%) | 60 (15.6%) |
Two | 95 (69.9%) | 230 (92.4%) | 325 (84.4%) |
COVID-19 infection before vaccination | |||
Yes | 19 (14%) | 28 (11.2%) | 47 (12.2%) |
Maybe | 7 (5.1%) | 8 (3.2%) | 15 (3.9%) |
COVID-19 infection after vaccination | N = 95 | N = 230 | N = 325 |
Yes | 11 (11.6%) | 34 (14.8%) | 45 (13.8%) |
Maybe | 3 (3.2%) | 7 (3%) | 10 (3.1%) |
History of allergy | |||
Yes | 15 (11%) | 17 (6.8%) | 32 (8.3%) |
Maybe | 5 (3.7%) | - | 5 (1.3%) |
Type of allergy | |||
Dust allergy | 17 (12.5%) | 16 (6.4%) | 33 (8.6%) |
Pet allergy | 2 (1.5%) | - | 2 (0.5%) |
Allergy to antibiotics | 1 (0.7%) | 1 (0.4%) | 2 (0.5%) |
Family history of allergy | |||
Yes | 22 (16.2%) | 17 (6.8%) | 39 (10.1%) |
Maybe | 6 (4.4%) | 8 (3.2%) | 14 (3.6%) |
Comorbidities | |||
Asthma | 7 (5.14%) | 4 (1.6%) | 11 (2.9%) |
Eczema | - | 1 (0.4%) | 1 (0.3%) |
Adrenal insufficiency | - | 1 (0.4%) | 1 (0.3%) |
Unwanted events during past routine immunization | |||
Yes | 3 (2.2%) | 14 (5.6%) | 18 (4.4%) |
Maybe | - | 7 (2.8%) | 7 (1.8%) |
Variables | Group A | Group B | Total |
---|---|---|---|
Total number of events reported, n | |||
After 1st dose | 93 | 233 | 326 |
After 2nd dose | 45 | 144 | 189 |
Number of patients reporting AE after 1st dose ***, n | N = 136 | N = 249 | N = 385 |
None | 56 (41.2%) | 92 (36.9%) | 148 (38.4%) |
One AE | 68 (50%) | 84 (33.7%) | 152 (39.4%) |
More than one AE | 12 (8.8%) | 73 (29.3%) | 85 (22%) |
Number of patients reporting AE after 1st dose *, n | N = 95 | N = 230 | N = 325 |
None | 56 (58.9%) | 129 (56.1%) | 185 (56.9%) |
One AE | 33 (24.3%) | 58 (25.2%) | 91 (28%) |
More than one AE | 6 (4.4%) | 43 (18.7%) | 49 (15.1%) |
Gender of patients reporting at least one AE after 1st dose, n/N # | |||
Male | 51/84 (60.7%) | 75/101 (74.3%) ** | 126/185 (68.1%) * |
Female | 29/52 (55.8%) | 82/148 (55.4%) | 111/200 (55.5%) |
Gender of patients reporting at least one AE after 2nd dose, n/N # | |||
Male | 23/62 (37.1%) | 45/90 (50%) | 68/152 (44.7%) |
Female | 16/33 (48.5%) | 56/140 (40%) | 72/173 (41.6%) |
Cases with history of COVID-19 infection reporting at least one AE, n/N $ | |||
After 1st dose | 10/19 (57.9%) | 28/28 (100%) | 8/47 (80.9%) |
After 2nd dose *** | 3/13 (23.1%) | 21/23 (91.3%) | 24/36 (66.7%) |
Predictors of AE | Odd’s Ratio | 95% CI Upper Limit-Lower Limit | p-Value |
---|---|---|---|
Dose AE 1st/2nd | 2.12 | 1.57–2.86 | <0.001 |
Age AE after 1st dose AE after 2nd dose | 0.84 0.89 | 0.55–1.28 0.55–1.44 | 0.42 0.64 |
Gender (Male/female) AE after 1st dose AE after 2nd dose | 0.171 1.136 | 1.13–2.56 0.73–1.76 | 0.01 0.57 |
Prior COVID-19 AE after 1st dose AE after 2nd dose | 2.95 2.98 | 1.38–6.3 1.44–6.2 | 0.05 0.003 |
Allergy AE after 1st dose AE after 2nd dose | 0.71 0.48 | 0.36–1.41 0.22–1.08 | 0.36 0.08 |
AEFI with routine vaccination AE after 1st dose AE after 2nd dose | 1.56 0.48 | 0.63–3.85 0.19–1.21 | 0.34 0.12 |
AE-Related Variables in Group A | Pain, Redness, and Swelling at the Site of Injection | Fever < 102 °F | Fever > 102 °F | |||
---|---|---|---|---|---|---|
1st Dose (n = 136) | 2nd Dose (n = 95) | 1st Dose (n = 136) | 2nd Dose (n = 95) | 1st Dose (n = 136) | 2nd Dose (n = 95) | |
Number of events, N | 62 | 33 | 29 | 6 | 1 | 6 |
Onset within, (n/N) | ||||||
1–3 days | 62/62 | 33/33 | 29/29 | 6/6 | 1/1 | 6/6 |
4–7 days | - | - | - | - | - | - |
Duration, (n/N) | ||||||
1–4 days | 61/62 | 30/33 | 29/29 | 6/6 | - | - |
4–7 days | 1/62 | 3/33 | - | - | 1/1 | 6/6 |
Intervention, (n/N) | ||||||
No treatment | 45/62 | 24/33 | 14/29 | - | - | - |
Treatment at home | 17/62 | 9/33 | 15/29 | 6/6 | 1/1 | 6/6 |
Utilization of health resources, (n/N) | ||||||
None | 61/62 | 30/33 | 29/29 | - | - | - |
Medical consultation (non-urgent) | 1/62 | 3/33 | 0/29 | 6/6 | 1/1 | 6/6 |
Outcome, % | ||||||
Recovered | 100% | 100% | 100% | 100% | 100% | 100% |
Unknown | - | - | - | - | - | - |
Severity, (n/N) | ||||||
Mild | 45/62 | 24/33 | 14/29 | - | - | - |
Moderate | 17/62 | 9/33 | 15/29 | 6/6 | 1/1 | 6/6 |
Seriousness | None | None | None | None | None | None |
AE-Related Variables in Group B | Pain, Redness, and Swelling at the Site of Injection | Fever < 102 °F | Fever > 102 °F | |||
---|---|---|---|---|---|---|
1st Dose (n = 249) | 2nd Dose (n = 230) | 1st Dose (n = 249) | 2nd Dose (n = 230) | 1st Dose (n = 249) | 2nd Dose (n = 230) | |
Number of events, N | 108 | 66 | 102 | 70 | 20 | 8 |
Onset within, n/N 1–3 days 4–7 days | 108/108 - | 66/66 - | 102/102 - | 70/70 - | 20/20 - | 8/8 - |
Duration, n/N 1–4 days 4–7 days | 105/108 3/108 | 66/66 - | 102/102 - | 70/70 - | 17 3 | 8/8 - |
Intervention, n/N No treatment Treatment at home | 39/108 69/108 | 37/66 29/66 | 56/102 46/102 | 21/70 49/70 | - 20/20 | - 8/8 |
Utilization of health resources, n/N | ||||||
None Medical consultation (non-urgent) | 91/108 17/108 | 58/66 8/66 | 96/102 6/102 | 70/70 - | 9/20 11/20 | - 8/8 |
Outcome, % Recovered Unknown | 100% - | 100% - | 100% - | 100% - | 100% - | 100% - |
Severity, n/N Mild Moderate | 39/108 69/108 | 37/66 29/66 | 56/102 46/102 | 21/70 49/70 | - 17/20 | - 8/8 |
Seriousness | None | None | None | None | None | None |
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Share and Cite
Ahsan, M.; Shaik, R.A.; Mallick, A.K.; Banawas, S.S.; Alruwaili, T.A.M.; Alanazi, Y.A.; Alzahrani, H.S.; Ahmad, R.K.; Ahmad, M.S.; AlAnazi, F.H.; et al. A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5–17 Years) Living in Saudi Arabia. Vaccines 2023, 11, 207. https://doi.org/10.3390/vaccines11020207
Ahsan M, Shaik RA, Mallick AK, Banawas SS, Alruwaili TAM, Alanazi YA, Alzahrani HS, Ahmad RK, Ahmad MS, AlAnazi FH, et al. A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5–17 Years) Living in Saudi Arabia. Vaccines. 2023; 11(2):207. https://doi.org/10.3390/vaccines11020207
Chicago/Turabian StyleAhsan, Marya, Riyaz Ahamed Shaik, Ayaz K. Mallick, Saeed S. Banawas, Thamer A. M. Alruwaili, Yousef Abud Alanazi, Hayat Saleh Alzahrani, Ritu Kumar Ahmad, Mohammad Shakil Ahmad, Faisal Holil AlAnazi, and et al. 2023. "A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5–17 Years) Living in Saudi Arabia" Vaccines 11, no. 2: 207. https://doi.org/10.3390/vaccines11020207
APA StyleAhsan, M., Shaik, R. A., Mallick, A. K., Banawas, S. S., Alruwaili, T. A. M., Alanazi, Y. A., Alzahrani, H. S., Ahmad, R. K., Ahmad, M. S., AlAnazi, F. H., Alfhaid, F., Aljulifi, M. Z., Mehta, V., Almhmd, A. E., Daham, A. S. D. A., & Alruwaili, M. M. M. (2023). A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5–17 Years) Living in Saudi Arabia. Vaccines, 11(2), 207. https://doi.org/10.3390/vaccines11020207