Peer-reviewed article
PaedVacCOVID - safety of the BNT162b2 vaccine against the SARS-CoV-2 in children with and without comorbidities aged 5 to 11 years
Sarah Holzwarth, Kimiya Saadat, Maximilian Jorczyk, Svenja Dreßen, Sarah Kotsias-Konopelska et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study evaluated the safety of the BNT162b2 COVID-19 vaccine in 793 children aged 5 to 11 years in Germany, comparing 179 children with chronic health conditions to 614 healthy children. Overall safety was high in both groups, but children with comorbidities reported more side effects across several categories including psychological, pulmonary, gastrointestinal, neurological and skin symptoms. The researchers note that higher symptom reporting could reflect either greater physical susceptibility or greater health awareness in children with existing conditions.
Key points
- Overall safety of BNT162b2 was high in both children with and without comorbidities
- Children with comorbidities reported significantly higher rates of psychological side effects (3.56 times higher), pulmonary symptoms (7.14 times higher), and gastrointestinal symptoms (2.35 times higher)
- Neurological side effects were 1.74 times more common and dermatological side effects 2.28 times more common in children with comorbidities
- Data collected via online questionnaire at median 17 days after vaccination
- Authors recommend safety evaluation of mRNA COVID-19 vaccines in children with comorbidities should be mandatory for pharmaceutical companies
Limitations
This is a self-reported survey study without clinical verification of symptoms, so reported side effects may be influenced by recall bias or parental health awareness rather than actual physiological differences. The study cannot determine causality or distinguish between vaccine-related effects and symptoms from underlying comorbidities.
Abstract
BACKGROUND: Little is known about specific safety aspects in children with significant comorbidities receiving the mRNA vaccine BNT162b2, as approval studies did not address this population. This study's purpose is to evaluate safety and adverse events in these children compared to healthy children. METHODS: In this prospective, multicentre, industry-independent cohort study, caregivers whose children received BNT162b2 were asked to participate in an online questionnaire. Potential side effects were evaluated in ten organ related categories. Frequency of symptoms was compared in both cohorts by bivariate analysis. RESULTS: From a total of 1,294 responses to the questionnaire, 793 data sets were included into the analysis (179 children with comorbidities and 614 healthy children). Responses were given at a median of 17 days after vaccination. Overall, safety of BNT162b2 was high in both cohorts. Psychological (OR: 3.56, [95% CI: 1.461 to 8.629]), pulmonary (OR: 7.14, [95% CI: 2.039 to 21.48]), gastrointestinal (OR: 2.35, [95% CI: 1.231 to 4.665]), neurological (OR: 1.74, [95% CI: 1.078 to 2.796]) and dermatological (OR: 2.28, [95% CI: 1.220 to 4.172]) side effects were increased in children with comorbidities over healthy controls. CONCLUSION: The higher rate of reported post-vaccination symptoms could either be due to a higher susceptibility for symptomatic effects following immune stimulation, or due to a trained awareness to health-related symptoms. The data emphasizes the importance to evaluate safety of the new mRNA COVID-19 vaccines not only in healthy children but also in children with comorbidities. To perform such evaluation should be made mandatory for pharmaceutical enterprises.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
Problem
Lack of safety data for mRNA COVID-19 vaccines in children aged 5-11 with chronic health conditions
- Intervention
- BNT162b2 mRNA COVID-19 vaccination
- Population
- Children aged 5 to 11 years in Germany, 179 with comorbidities and 614 healthy children
Key finding
Overall safety was high in both cohorts
Holzwarth et al. · OpenAlex · 11 Nov 2024