Pediatric Off-Label COVID-19 Vaccination: The Concerns of Healthcare Professionals in Pakistan
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Setting
2.2. Sample Size Calculation
2.3. Survey Instrument
2.4. Tool Administration and Scoring
2.5. Data Analysis
2.6. Ethical Approval
3. Results
3.1. Demographic Characteristics
3.2. Respondents’ Knowledge towards Off-Label COVID-19 Vaccination in Children
3.3. Respondents’ Attitude towards Off-Label COVID-19 Vaccination in Children
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
References
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Baseline Characteristics | Frequency (%) |
---|---|
Age (years) | 38.6 ± 7.5 |
Gender | |
Male | 152 (31.8) |
Female | 325 (68.1) |
Profession | |
Physicians | 209 (43.8) |
Pharmacists | 112 (23.4) |
Dentists | 28 (5.8) |
Nurses | 96 (20.1) |
Other HCPs | 32 (6.7) |
Working Organization | |
Private sector | 348 (72.9) |
Public sector | 129 (27) |
Practice area | |
Primary patient care | 225 (47.1) |
Secondary patient care | 57 (11.9) |
Tertiary patient care | 195 (40.8) |
Working Experience | |
1–5 years | 188 (39.4) |
6–10 years | 149 (31.2) |
11–15 years | 54 (11.3) |
>15 years | 86 (18) |
Knowledge Item | Correct Response n (%) | Age | Gender | Profession | Work Organization | Practice Area | Work Experience |
---|---|---|---|---|---|---|---|
Off-label vaccination in children | |||||||
Definition/general understanding | 369 (77.3) | 0.019 | 0.014 | 0.012 | <0.001 | 0.01 | |
Any example (other than COVID-19 vaccine) | 267 (55.9) | 0.02 | |||||
COVID-19 vaccines | |||||||
Any example of vaccine | 385 (80.7) | 0.006 | 0.004 | ||||
Benefits | 359 (75.2) | <0.001 | 0.003 | <0.001 | 0.017 | ||
Safety and efficacy | 316 (66.2) | 0.002 | 0.01 | ||||
COVID-19 vaccines in children | |||||||
FDA * and AAP ** caution for COVID-19 vaccine off-label use | 302 (63.3) | 0.005 | 0.008 | 0.003 | 0.001 | ||
Administration of COVID-19 vaccines | |||||||
Age-appropriate vaccination | 294 (61.6) | 0.001 | 0.009 | 0.001 | <0.001 | ||
Formulation specification | 255 (53.4) | <0.001 | 0.005 | 0.06 | <0.001 | ||
Dosing specification | 318 (66.6) | 0.03 | |||||
Monitoring requirements | 329 (68.9) | 0.001 | <0.001 | ||||
Co-administration of other vaccines in the same visit | 330 (69.1) | 0.001 | |||||
Adverse drug reactions of COVID-19 vaccines | |||||||
Examples | 379 (79.4) | ||||||
Severity of adverse reactions | 377 (79) | ||||||
Developmental or fertility problem | 346 (72.5) | ||||||
Risk for myocarditis and pericarditis | 289 (60.5) | <0.001 | 0.016 | 0.02 | |||
Post-vaccination scenarios | |||||||
Chances of getting COVID-19 | 326 (68.3) | ||||||
Chances of spreading COVID-19 to others | 312 (65.4) | 0.003 | |||||
Severity of disease if get COVID-19 | 386 (80.9) |
VAX Scale | n (%) | Negative Attitude | Age | Gender | Profession | Work Organization | Practice Area | Work Experience |
---|---|---|---|---|---|---|---|---|
Questions 1–3 (concerns about trusting vaccines) | 297 (62.2) | Low | 0.434 | 0.005 * | 0.012 * | 0.007 * | 0.159 | 0.691 |
118 (24.7) | Intermediate | |||||||
62 (12.9) | High | |||||||
Questions 4–6 (concerns about unpredictable effects) | 127 (26.6) | Low | 0.667 | 0.46 | 0.004 * | 0.352 | 0.342 | <0.001 * |
233 (48.8) | Intermediate | |||||||
117 (24.5) | High | |||||||
Questions 7–9 (concerns about commercial profits) | 281 (58.9) | Low | 0.112 | 0.001 * | 0.776 | 0.081 | 0.153 | 0.452 |
147 (30.8) | Intermediate | |||||||
49 (10.2) | High | |||||||
Questions 10–12 (preference to natural immunity) | 125 (26.) | Low | 0.671 | 0.211 | 0.137 | <0.001 * | 0.486 | 0.091 |
249 (52.2) | Intermediate | |||||||
103 (21.5) | High | |||||||
Agreement with COVID-19 vaccines off-label use in children under 12 years of age | 13 (2.7) | Low | 0.66 | 0.891 | 0.305 | 0.017 | 0.723 | 0.164 |
210 (44) | Intermediate | |||||||
254 (53.2) | High |
To What Extent Do You Agree or Disagree with the Following Statements? | Strongly Agree/Agree n (%) | Neutral n (%) | Disagree/Strongly Disagree n (%) |
---|---|---|---|
COVID-19 vaccines can be used off-label in children under 12 | 127 (26.6) | 38 (7.9) | 312 (65.4) |
Off-label use of COVID-19 vaccines is an ethically permitted decision on a case-by-case basis | 186 (38.9) | 82 (17.1) | 209 (43.8) |
Off-label COVID-19 vaccination in children increases the probability of more rapid and effective protection against the SARS-CoV-2 virus | 166 (34.8) | 140 (29.3) | 171 (35.8) |
Off-label vaccination during a pandemic is an approach to protect patients after evaluating the associated risks and benefits | 152 (31.8) | 104 (21.8) | 221 (46.3) |
HCPs should consider prescribe/administer pediatric off-label COVID-19 vaccines | 97 (20.3) | 53 (11.1) | 327 (68.5) |
Pediatric off-label COVID-19 immunization is subject to the same legal and ethical standards as other cases of off-label usage | 158 (33.1) | 61 (12.7) | 258 (54) |
Administering vaccinations to minors under the age of 12 may result in consequences, including legal liability for providers | 404 (84.6) | 22 (4.6) | 51 (10.6) |
Emerging clinical studies will provide evidence on the most effective and safe dose and administration schedule for children | 435 (91.1) | 11 (2.3) | 31 (6.4) |
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Share and Cite
Shakeel, S.; Nesar, S.; Nizami, G.N.; Iqbal, Z.; Emad, S.; Wasim, Q.; Mumtaz, T.; Jamshed, S.; Usmani, M.S.; Hussain, R. Pediatric Off-Label COVID-19 Vaccination: The Concerns of Healthcare Professionals in Pakistan. Vaccines 2022, 10, 1236. https://doi.org/10.3390/vaccines10081236
Shakeel S, Nesar S, Nizami GN, Iqbal Z, Emad S, Wasim Q, Mumtaz T, Jamshed S, Usmani MS, Hussain R. Pediatric Off-Label COVID-19 Vaccination: The Concerns of Healthcare Professionals in Pakistan. Vaccines. 2022; 10(8):1236. https://doi.org/10.3390/vaccines10081236
Chicago/Turabian StyleShakeel, Sadia, Shagufta Nesar, Ghazala Noor Nizami, Zafar Iqbal, Shaista Emad, Quratulain Wasim, Tayyaba Mumtaz, Shazia Jamshed, Muhammad Salahuddin Usmani, and Rabia Hussain. 2022. "Pediatric Off-Label COVID-19 Vaccination: The Concerns of Healthcare Professionals in Pakistan" Vaccines 10, no. 8: 1236. https://doi.org/10.3390/vaccines10081236