Short-term safety of COVID-19 vaccines in the underage population of Buenos Aires
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Keywords
Side Effects, Adverse Reactions, COVID-19, Vaccine, Pediatrics, Pharmacovigilance
Abstract
Introduction: COVID-19 vaccines were developed in record time and only received emergency use authorization. There is still a limited data on the safety of paediatric vaccines for this disease.
Objective: To determine the adverse events attributable to vaccination/immunization (ESAVI) associated with COVID-19 vaccines administered to individuals under 18 years of age.
Methodology: An active pharmacovigilance process was carried out through a prospective, observational, and descriptive study on the short-term safety of paediatric SARS-CoV-2 vaccines. Children older than 6 months and younger than 18 years who had received at least one dose of a SARS-CoV-2 vaccine at Elina de la Serna Hospital in Montes de Oca between February and August 2023 were included. Data were collected via a WhatsApp survey conducted at 24 hours and 7 days post-vaccination. Variables considered included age, place of residence, recorded comorbidities, vaccine type and dose administered, and concomitant vaccinations. Data are presented as percentages, means, or rates, with corresponding confidence intervals.
Results: A total of 545 children were included in the study, with a mean age of 9.6 years (95% CI: 5–13.8). Of the vaccines administered, 46.7% (n=129) were Moderna Pediatric, 32.6% (n=90) Pfizer Bivalent, 14.9% (n=41) Pfizer Pediatric, 4.7% (n=13) Beijing Institute, and 1.1% (n=3) Moderna Bivalent. At the time of vaccination, 12.1% (n=33) of patients had comorbidities. At 24 hours, 58.3% (n=161) of participants reported fever or injection site pain, and 25.4% (n=70) of them still had symptoms at 7 days. Only 2.2% (n=6) reported symptoms that required medical consultation. No hospitalizations or deaths were recorded. The relative risk (RR = 0.79) indicates that those vaccinated with Pfizer Bivalent had a 21% lower risk of presenting symptoms at 24 hours compared to those vaccinated with Moderna Pediatric. The symptoms can be considered mild, as only 4 patients required medical consultation.
Conclusion: COVID-19 vaccination in children showed a low incidence of serious ESAVI in the short-term post-immunization period.
References
2. WHO. COVID-19. WHO, Ginebra, 2020. Available in: https://www.who.int/es/news/item/27-04-2020-who-timeline---covid-19.
3. Ludvigsson JF. Systematic review of COVID-19 in children shows milder cases and a better prognosis than adults. Acta Paediatr. 2020;109(6):1088-95.
4. Watanabe A, Kani R, Iwagami M, Takagi H, Yasuhara J, Kuno T. Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years: A Systematic Review and Meta-analysis. JAMA Pediatr. 2023;177(4):384-94.
5. Russia has launched the world’s first COVID-19 vaccine. Anadolu Agency 11/08/2020. Available in: https://www.aa.com.tr/en/asia-pacific/russia-registers-1st-coronavirus-vaccine-in-the-world/1938105.
6. Mahase E. Covid-19: Russia approves vaccine without large scale testing or published results. BMJ 2020; 370, m3205. doi: 10.1136/bmj.m3205.
7. Logunov D., Dolzhykova I., Shcherblyakov D. et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. The Lancet 2021; 397, 10275: 671 – 681. Available in: doi:10.1016/S0140-6736(21)00234-8
8. Durkee A. AstraZeneca/Oxford Covid-19 Vaccine Gets Emergency Approval. Forbes 2021. WHO. Available en: https://www.forbes.com/sites/alisondurkee/2021/02/15/astrazeneca-oxford-covid-19-vaccine-gets-emergency-approval-from-who/
9. WHO. World Health Organization. Vaccination COVID-19. Report Ginebra, WHO 2023. Available in: https://extranet.who.int/prequal/sites/default/files/document_files/Status_COVID_VAX_08AUgust2023.pdf
10. World Health Organization. Interim recommendations for use of the inactivated COVID-19 vaccine, CoronaVac, developed by Sinovac: interim guidance, WHO. May 2021, World Health Organization. Available in: https://iris.who.int/handle/10665/352472.
11. WHO. Background document on the inactivated vaccine Sinovac-CoronaVac against COVID-19: background document to the WHO Interim recommendations for use of the inactivated COVID-19 vaccine, CoronaVac, developed by Sinovac, Mayo 2021. Geneva: World Health Organization. Available en: https://apps.who.int/iris/handle/10665/341455.
12. MSAL. Comenzó la campaña de vacunación contra COVID-19 en Argentina. Argentina.gob.ar 2020 [citado 14 de enero de 2025]. Available en: https://www.argentina.gob.ar/noticias/comenzo-la-campana-de-vacunacion-contra-covid-19-en-argentina
13. MSAL. Report DI-2022-450-APN-ANMAT#MS, ANMAT validated COMIRNATY de Pfizer-Biontech. against COVID-19. www.argentina.gob.ar. 2022 Available In: https://www.argentina.gob.ar/coronavirus/vacuna/preguntas-frecuentes
14. Infobae. Los ministerios de Salud de todo el país acordaron avanzar con la vacunación de menores de entre 3 y 12 años con la vacuna de Sinopharm Octubre 2021 Available en: https://www. Infobae.com/politica/2021/10/04/los-ministerios-de-salud-de-todo-el-pais-acordaron-avanzar-con-la-vacunacion-de-menores-de-entre-3-y-12-anos-con-la-vacuna-de-sinopharm/
15. MSAL. El Ministerio de Salud comenzará a vacunar contra COVID-19 a niñas y niños desde los 6 meses de edad. Julio 2022. Available en: https://www.argentina.gob.ar/noticias/el-ministerio-de-salud-comenzara-vacunar-contra-covid-19-ninas-y-ninos-desde-los-6-meses-de
16. MSAL. Manual-vacunador-moderna-desde-6-anos.pdf. 2024. Available In: https://www.argentina.gob.ar/coronavirus/vacuna/equipos-salud/lineamientos-manual-vacunador https://www.argentina.gob.ar/sites/default/files/bancos/2021-07/Manual vacunador MODERNA.pdf
17. Cohen R., Thill P. Vaccinating children: The pros and cons. Infectious Diseases Now 2022; 52,8: 9-11. Available en: https://doi.org/10.1016/j.idnow.2022.09.015.
18. UNESCO. 1.3 billion learners are still affected by school or university closures, as educational institutions start reopening around the world. 2021. Available In: https://www.unesco.org/en/articles/13-billion-learners-are-still-affected-school-or-university-closures-educational-institutions-start
19. Wen J, Du X, Li A, Zhang S, Shen S, Zhang Z, Yang L, Sun C, Li J, Zhu S. Dilemmas and options for COVID-19 vaccination in children. Ital J Pediatr. 2023;49(1):103. doi: 10.1186/s13052-023-01513-9.
20. WHO. Interim statement on COVID-19 vaccination for children and adolescents. OMS, Ginebra, 2021. Available en: https://www.who.int/news/item/24-11-2021-interim-statement-on-covid-19-vaccination-for-children-and-adolescents
21. KidCOVE Study Group. Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age | N Engl J of Med.2022; 386:2011-2023 Available In: https://www.nejm.org/doi/full/10.1056/NEJMoa2203315
22. CDC. Centers for disease control and prevention COVID-19. Vacunarse contra el COVID-19. CDC, 2024. Available en: https://espanol.cdc.gov/covid/vaccines/getting-your-covid-19-vaccine.html
23. Montané E, Santesmases J. Reacciones adversas a medicamentos. Med Clínica. 2020;154(5):178-84.
24. Marin GH. Covid-19 Vaccination Advantages of Opting for an Active Pharmacovigilance Model. Epidemiol Int J 2022; 6(1):1-14. Available en: https://medwinpublishers.com/EIJ/covid-19-vaccination-advantages-of-opting-for-an-active-pharmacovigilance-model.pdf
25. MacDonald NE. Vaccine hesitancy: Definition, scope and determinants. SAGE Working Group on Vaccine Hesitancy. Vaccine. 2015;33(34):4161-4.
26. Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, et al. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2021;NEJMoa2116298.
27. Anderson EJ, Creech CB, Berthaud V, Piramzadian A, Johnson KA, Zervos M, et al. Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. N Engl J Med. 2022;387(18):1673-87.
28. Bloise S, Marcellino A, Frasacco B, Gizzone P, Proietti Ciolli C, Martucci V, et al. Cross-Sectional Survey on BNT162b2 mRNA COVID-19 Vaccine Serious Adverse Events in Children 5 to 11 Years of Age: A Monocentric Experience. Vaccines. 2022;10(8):1224.
29. Piechotta V, Siemens W, Thielemann I, Toews M, Koch J, Vygen-Bonnet S, et al. Safety and effectiveness of vaccines against COVID-19 in children aged 5–11 years: a systematic review and meta-analysis. Lancet Child Adolesc Health. 2023;7(6):379-91.
30. MSAL. Infome ESAVI por COVID-19 en Argentina, 2024. Available in: https://www.argentina.gob.ar/sites/default/files/bancos/2023-10/informe-esavi-covid-n20.pdf
31. PAHO. Consolidated regional and global information on events presumed to be attributable to COVID-19 vaccination or immunization (ESAVI) and other updates. Pan American Health Organization, PAHO. WASHINGTON, DC 2023.
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
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Anahi Alvarez Rotondo
Institution: CUFAR (Pharmacology Research Center, FCMLP-UNLP)
Juan Pablo Cocozella
Hospital Elina de la Serna, La Plata, Argentina
Ezequiel Perez
Hospital Elina de la Serna, La Plata
Paola Lopez
Hopsital Elina de la Serna, La Plata.Argentina
Garcia Munitis Pablo
Hospital Elina de la Serna, La Plata, Argentina
Natalia Fernández
Hospital Elina de la Serna, La Plata, Argentina
Florencia Jardel
Hospital Elina de la Serna, La Plata, Argentina