Peer-reviewed article
The Long-Term Tolerability of BNT162b2 in Children and Adolescents (the CoVacU18 Study).
Vivien Grieshaber, Christoph Strumann, Sarah Holzwarth, Nicole Toepfner, Wolfgang Carl Gustav von Meißner et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study examined how well children and adolescents tolerated the BNT162b2 COVID-19 vaccine over a long period in Germany. Researchers collected reports from parents or guardians of over 3,200 children about any side effects they experienced after vaccination, with follow-up lasting about 17 months on average. Most children (over 98%) had no serious problems, though common mild effects included arm pain and redness, and some experienced tiredness or fever. A small group reported symptoms lasting three months or longer.
Key points
- Tolerability data collected from 3,228 children (median age 5.7 years) with median observation period of 524 days
- Most common side effects were local reactions: pain (49.7%) and redness (23%); systemic symptoms included fatigue (20.1%), fever (11.4%), and headache (6.5%)
- BNT162b2 was more commonly associated with local and systemic symptoms compared to other vaccines (influenza, etc.)
- 1.3% (41 subjects) reported symptoms persisting ≥90 days, mainly psychological (15), neurological (9), and dermatological (8)
- 45 serious adverse events occurred; female sex and long-term medication use were associated with increased risk
Limitations
This was a retrospective, self-reported survey with potential selection bias—parents of children who experienced side effects may have been more motivated to participate. The study relies on parental recall and reporting rather than clinical evaluation, and results may not represent all vaccinated children.
Abstract
BACKGROUND: The available safety data on the use of the messenger RNA-based COVID-19 vaccine BNT162b2 in persons under age 18 are limited to observation periods of up to six months. METHODS: In a retrospective, cross-sectional study, we evaluated self-reported vaccine tolerability (SRVT) in eleven symptom categories among persons who were under 18 years old when they received at least one dose of the BNT162b2 vaccine in Germany on or after 1 October 2021. Data were collected online from the parents or legal guardians of the vaccinated persons. Individual participation codes enabled authenticated and pseudonymous participation in the survey. In a subgroup, the SRVT of BNT162b2 was compared with that of vaccines against other illnesses than SARS-CoV-2 (e.g., influenza). RESULTS: Tolerability data were obtained from 3228 persons with a median age of 5.7 years; 49.6% were male. The median period of observation was 524 days. The more commonly reported undesired effects of the vaccine, mainly in older subjects, were local reactions- pain (49.7%), redness (23%)-with less common systemic symptoms including fatigue (20.1%), fever (11.4%), general feeling of illness (8.0%), and headache (6.5%). Compared to vaccines against other illnesses, BNT162b2 was more commonly associated with local and systemic symptoms (gastrointestinal, musculo - skeletal, dermatological, neurological, psychological). 41 (1.3%) of the subjects reported that their SRVT persisted for ≥90 days after vaccination with BNT162b2: these symptoms were mainly psychological (15 subjects), neurological (9 subjects), and dermatological (8 subjects). There were 45 serious adverse events; these were associated with female sex (OR = 4.70, 95% confidence interval [2.17; 10.20]) and with long-term medication use (OR = 4.06 [1.53; 10.79]). CONCLUSION: Vaccination with BNT162b2 was reportedly well tolerated by more than 98% of the children and adolescents who received it, although symptoms were more common than after vaccination against other illnesses than SARS-CoV-2. The participants in our study may have had a more positive attitude toward vaccination. On the other hand, a selection bias might exist for participants who experienced vaccination side effects.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
Problem
Limited long-term safety data on BNT162b2 vaccine in children and adolescents under 18 years of age
- Intervention
- BNT162b2 (Pfizer-BioNTech) COVID-19 vaccination with long-term tolerability follow-up
- Population
- Children and adolescents under 18 years old who received at least one dose of BNT162b2 in Germany on or after 1 October 2021; 3,228 participants with median age 5.7 years
Key finding
Over 98% of vaccinated children were reportedly well tolerated