Safety of the BNT162b2 mRNA COVID-19 Vaccine in Children below 5 Years (CoVacU5) – an Investigator-Initiated Retrospective Cohort Study
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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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SciScore for 10.1101/2022.05.17.22275005: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Inclusion criteria were having registered in a database for at least one dose of BNT162b2 that was administered before reaching the age of 5 years, and informed consent of a parent/legal representative to participate in the survey of the current study.
IRB: The present study protocol was approved by the Ethics Committee of the University of Rostock, Germany (ID: A 2022-0065).Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analyses were performed using MATLAB R2020a and STATA version 15. Chi-Square or Fisher’s exact tests were used to compare … SciScore for 10.1101/2022.05.17.22275005: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Inclusion criteria were having registered in a database for at least one dose of BNT162b2 that was administered before reaching the age of 5 years, and informed consent of a parent/legal representative to participate in the survey of the current study.
IRB: The present study protocol was approved by the Ethics Committee of the University of Rostock, Germany (ID: A 2022-0065).Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Statistical analyses were performed using MATLAB R2020a and STATA version 15. Chi-Square or Fisher’s exact tests were used to compare categorical variables over pre-defined strata of age groups and BNT162b2 dosage. MATLABsuggested: (MATLAB, RRID:SCR_001622)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The present study contains some limitations. First, the study relies on retrospective self-reported data by proxy, which i) may not directly reflect what a child had experienced and ii) underlies a risk of recall bias i.e. not recalling some not life-threatening symptoms several months later. However, the extensive public debate about SARS-CoV-2 vaccinations including their potential side effects, the off-label use investigated, and the study results showing dosage-dependent associations between vaccination and local reactions in ≥24 to <60 months old children suggest that symptoms were adequately reported. The retrospective design did not allow for a structured real-time documentation of symptoms nor an estimation of causality and severity to infer the frequency of vaccine-related serious adverse reactions, but such data should be expected from the ongoing prospective manufacturer-sponsored BNT162b2 studies (5). As vaccinations themselves were not directly part of the study, the study relied on vaccination information as reported by the respondents. However, a potential risk of manipulation by individual respondents was minimized by dispensing study participation codes only via vaccinating centers/initiatives, and the availability of BNT162b2 lot numbers. Moreover, potential duplicate entries were identified by overlap in demographic data and were removed. The reported post-vaccination symptoms could potentially be unrelated to the vaccine. To mitigate this problem, a non-BN...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
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- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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