Safety of the BNT162b2 mRNA COVID-19 Vaccine in Children below 5 Years (CoVacU5) – an Investigator-Initiated Retrospective Cohort Study

  1. Nicole Töpfner
  2. Wolfgang C G von Meißner
  3. Christoph Strumann
  4. Denisa Drinka
  5. David Stuppe
  6. Maximilian Jorczyk
  7. Jeanne Moor
  8. Johannes Püschel
  9. Melanie Liss
  10. Emilie von Poblotzki
  11. Reinhard Berner
  12. Matthias B. Moor
  13. Cho-Ming Chao
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Abstract

Background

The safety of SARS-CoV-2 vaccines is unknown in children aged <5 years. Here, we retrospectively evaluated the safety of BNT162b2 vaccine used off-label in children of this age group in Germany.

Methods

An investigator-initiated retrospective cohort study (CoVacU5) included parents or caregivers having children aged <5 years registered for SARS-CoV-2 vaccination in outpatient care facilities in Germany. Reported short-term safety data of 1-3 doses of 3-10µg BNT162b2 in children aged 0 to <60 months are presented. Co-primary outcomes were the frequencies of 11 categories of symptoms post-vaccination with bivariate analyses and regression models adjusting for age, sex, weight and height. On-label non-SARS-CoV-2 vaccines served as controls in an active-comparator design.

Results

The study included 7806 of 19,000 registered children representing a 41% response rate. 338 children received the first dose of BNT162b2 at age 0-<12 months, n=1272 at age 12-24 months and n=5629 at age ≥24 to <60 months. A 10µg dosage was more frequently associated with injection-site symptoms compared to lower dosages. The probability of any symptoms (OR: 1.62 [95% confidence interval (CI): 1.36-1.94]), injection-site, musculoskeletal, dermatological or otolaryngological symptom categories were modestly elevated after BNT12b2 compared to non-SARS-CoV-2 vaccines, whereas the probabilities of general symptoms (OR: 0.74 [95% CI: 0.64-0.85]) and fever (OR: 0.43 [95% CI: 0.35-0.51]) were lower after BNT162b2. Symptoms requiring hospitalization (n=10) were reported only at BNT162b2 dosages higher than 3µg.

Conclusions

The symptoms reported after BNT162b2 administration were overall comparable to on-label non-SARS-CoV-2 vaccines in this cohort of children aged <5 years. (German Clinical Trials Register ID: DRKS00028759).

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