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[Adverse events from the Pfizer-BioNTech® COVID-19vaccine in children 5-17 years old]
María Del Rocío Hernández Morales1, Margarita Aguirre Barbosa2, Eleazar Mancilla Hernández3
1Servicio de Alergia e Inmunología Clínica. ciaic.puebla@gmail.com.
Insights
Adverse events following Pfizer-BioNTech COVID-19 vaccination in Mexican children (5-17 years) were rare, with a rate of 2.6 per 100,000 doses. Most events were mild, though rare serious events like seizures were noted.
Area of Science:
- Immunology
- Vaccinology
- Pediatric Infectious Diseases
Background:
- The Pfizer-BioNTech COVID-19 vaccine (BNT162b2 mRNA) is widely used in pediatric populations.
- Monitoring vaccine safety in children is crucial for public health.
- Understanding adverse events following immunization (AEFI) informs vaccination strategies.
Purpose of the Study:
- To describe events supposedly attributable to immunization with the Pfizer-BioNTech COVID-19 vaccine.
- To analyze AEFI in children aged 5 to 17 years in Puebla, Mexico.
- To determine the incidence rate of AEFI in this demographic.
Main Methods:
- Observational, cross-sectional, and descriptive study design.
- Analysis of reported AEFI in children (5-17 years) who received the BNT162b2 mRNA vaccine.
- Statistical analysis included percentages, frequencies, averages, standard deviations, and medians using SPSS 23.
Main Results:
- 1,993,373 doses of BNT162b2 vaccine administered.
- 52 events (rate of 2.6 per 100,000 doses) were presumed attributable to vaccination.
- Most frequent symptoms: dizziness, nausea, vomiting, local pain; rare serious events included 2 seizures and 1 case of flaccid paralysis.
Conclusions:
- The Pfizer-BioNTech COVID-19 vaccine demonstrated a low rate of adverse events in children aged 5-17 years.
- Enhanced epidemiological surveillance strategies are necessary for robust vaccine safety monitoring.
- Continued vigilance is essential to ensure the safety of COVID-19 vaccination programs in pediatric populations.
Objetives:
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.
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