Keywords
Eventos adversos
Vacunación
Pfizer BioNTech®
Abstract
Objective: To describe the events supposedly attributable to immunization with the Pfizer-BioNTech® COVID-19 vaccine in children aged 5 to 17 years in the state of Puebla, Mexico.
Methods: Observational, cross-sectional and descriptive study carried out based on the analysis of reports of events supposedly attributable to immunization in children aged 5 to 17 years, who received the vaccine with the BNT162b2 mRNA platform for COVID-19, since January. to December 2022. Percentages, frequencies, averages, standard deviations and medians were used for statistical analysis. The Statistical Package for the Social Sciences 23 program was implemented.
Results: 1,993,373 doses of the BNT162b2 vaccine were administered. 52 events presumed to be attributable to vaccination or immunization were reported. An annual rate of 2.6 per 100,000 doses applied was estimated. The age distribution recorded a median of 10.50 years (SD: 3.53). There were 56% women and 44% men; The most frequent symptoms were: dizziness, nausea, vomiting and pain at the vaccine application site. 2 cases of seizures and 1 of flaccid paralysis were reported.
Conclusions: The safety of vaccines against SARS-CoV-2 requires an improvement in strategies for epidemiological surveillance (passive and active), with a more robust approach to guarantee safe vaccination.
Keywords: Adverse effects; Adverse events; Vaccination; Pfizer BioNTech®.
References
Chung E, Chow EJ, Wilcox NC, et al. Comparison of Symptoms and RNA Levels in Children and Adults With SARS-CoV-2 Infection in the Community Setting. JAMA Pediatr 2021; 175 (10): e212025. doi: 10.1001/jamapediatrics.2021.2025
Madewell ZJ, Yang Y, Longini IM, et al. Factors Associated With Household Transmission of SARS-CoV-2: An Updated Systematic Review and Meta-analysis. JAMA Netw Open 2021; 4 (8): e2122240. doi: 10.1001/jamanetworkopen.2021.22240
Ghasemiyeh P, Mohammadi-Samani S, Firouzabadi N, et al. A focused review on technologies, mechanisms, safety, and efficacy of available COVID-19 vaccines. Int Immunopharmacol 2021; 100: 108162. doi: 10.1016/j.intimp.2021.108162
Fleming-Dutra KE, Britton A, Shang N, et al. Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance. JAMA 2022; 327 (22): 2210-2219. doi: 10.1001/jama.2022.7493
Walter EB, Talaat KR, Sabharwal C, et al. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med 2022; 386 (1): 35-46. doi:10.1056/NEJMoa2116298
Bhandari B, Rayamajhi G, Lamichhane P, Shenoy AK. Adverse Events following Immunization with COVID-19 Vaccines: A Narrative Review. Biomed Res Int 2022; 2022: 2911333. doi: 10.1155/2022/2911333
Manual de vigilancia de eventos supuestamente atribuibles a la vacunación o inmunización en la Región de las Américas. Washington, D.C.: Organización Panamericana de la Salud; 2021. Licencia: CC BY-NC-SA 3.0 IGO. https://doi.org/10.37774/9789275323861.
CIOMS.WHO: Working Group on Vaccine Pharmacovigilance. https://cioms.ch/working_groups/vaccine-pharmacovigilance/
Centro Nacional para la Salud de la Infancia y la Adolescencia: Manual de Eventos Supuestamente Atribuibles a la Vacunación o Inmunización (ESAVI). https://www.gob.mx/salud/censia/documentos/manual-de-eventos-supuestamente-atribuibles-a-la-vacunacion-o-inmunizacion-esavi
García-Grimshaw M, Ceballos-Liceaga SE, Hernández-Vanegas LE, et al. Neurologic adverse events among 704,003 first-dose recipients of the BNT162b2 mRNA COVID-19 vaccine in Mexico: A nationwide descriptive study. Clin Immunol 2021; 229: 108786. doi: 10.1016/j.clim.2021.108786
Núñez I, García-Grimshaw M, Castillo Valencia CY, et al. Seizures following COVID-19 vaccination in Mexico: A nationwide observational study. Epilepsia 2022; 63 (10): e144-e149. doi: 10.1111/epi.17390
Toledo-Salinas C, Scheffler-Mendoza SC, Castano-Jaramillo LM, et al. Anaphylaxis to SARS-CoV-2 Vaccines in the Setting of a Nationwide Passive Epidemiological Surveillance Program. J Clin Immunol 2022; 42 (8): 1593-1599. doi: 10.1007/s10875-022-01350-1
WM A. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA 2013; 310 (20): 2191-2194. doi: 10.1001/jama.2013.281053
Copaescu AM, Rosa-Duque JS, Phillips EJ. What have we learned about the allergenicity and adverse reactions associated with the severe acute respiratory syndrome coronavirus 2 vaccines: One year later. Ann Allergy Asthma Immunol 2022; 129 (1): 40-51. doi: 10.1016/j.anai.2022.03.030
Wu Q, Dudley MZ, Chen X, et al. Evaluation of the safety profile of COVID-19 vaccines: a rapid review. BMC Med 2021; 19 (1): 173. doi: 10.1186/s12916-021-02059-5
Alamer E, Alhazmi A, Qasir NA, et al. Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12-18 Years in Saudi Arabia. Vaccines (Basel) 2021; 9 (11): 1297. doi: 10.3390/vaccines9111297
Guo W, Deguise J, Tian Y, et al. Profiling COVID-19 Vaccine Adverse Events by Statistical and Ontological Analysis of VAERS Case Reports. Front Pharmacol. 2022; 13: 870599. doi: 10.3389/fphar.2022.870599
Piechotta V, Siemens W, Thielemann I, 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): 379-391. doi: 10.1016/S2352-4642(23)00078-0
Zinzi A, Gaio M, Liguori V, et al. Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study. Vaccines (Basel) 2023; 11 (2): 401. doi: 10.3390/vaccines11020401
Bloise S, Marcellino A, Frasacco B, 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 (Basel) 2022; 10 (8): 1224. doi: 10.3390/vaccines10081224
Bhandari B, Rayamajhi G, Lamichhane P, Shenoy AK. Adverse Events following Immunization with COVID-19 Vaccines: A Narrative Review. Biomed Res Int 2022; 2022: 2911333. doi: 10.1155/2022/2911333
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright (c) 2024 Revista Alergia México