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COVID-19 vaccine safety and side effects in children aged 5-11 years: a cross-sectional study

M A Nurhani1, H M S Farah1, N M A Ili1

  • 1Hospital Tuanku Ja'afar, Jalan Rasah, Seremban, Negeri Sembilan, Ministry of Health Malaysia.

The Medical Journal of Malaysia
|November 30, 2023
PubMed

Insights

The Pfizer-BioNTech COVID-19 vaccine showed good tolerability in children, with most side effects being mild and short-lived. This supports vaccine safety for pediatric populations, including those with co-morbidities.

Area of Science:

  • Pediatric Infectious Diseases
  • Vaccinology
  • Public Health

Background:

  • The COVID-19 pandemic necessitated rapid vaccine development and deployment, including for pediatric populations.
  • Assessing the safety and tolerability of vaccines in children is critical for public trust and informed decision-making.
  • The Pfizer-BioNTech (BNT162b2) vaccine is a key tool in global vaccination efforts.

Purpose of the Study:

  • To evaluate the safety and side effect profile of the Pfizer-BioNTech (BNT162b2) vaccine in children.
  • To determine the proportion of children experiencing postvaccination side effects.
  • To identify factors associated with the occurrence of side effects in pediatric vaccine recipients.

Main Methods:

  • A cross-sectional study design was employed.
  • Data were collected from 195 children vaccinated between February 3 and May 8, 2022.
  • Parent or legal guardian completed self-administered questionnaires regarding side effects.

Main Results:

  • 31.8% of vaccinated children reported side effects, most commonly injection site pain (29.7%), fever (15.9%), and localized inflammation (10.8%).
  • No severe adverse events like anaphylaxis or myocarditis were reported.
  • Children with underlying co-morbidities showed a higher proportion of side effects; no significant differences were noted based on age, weight, allergies, or premedication.

Conclusions:

  • The BNT162b2 vaccine demonstrated good tolerability in the pediatric population studied.
  • Reported side effects were predominantly mild and self-limiting.
  • Findings support the safety of COVID-19 vaccination in children and inform healthcare providers, parents, and policymakers, particularly for high-risk groups.
Abstract

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