Course: Comparative Safety of the BNT162b2 Messenger RNA COVID-19 Vaccine vs Other Approved Vaccines in Children Younger Than 5 Years
CME Credits: 1.00
Released: 2022-10-18
Key Points
Question Is the BNT162b2 SARS-CoV-2 vaccine safe in children younger than 5 years?Findings In this cohort study based on a survey of guardian-reported safety profiles of BNT162b2 in 7806 children, higher dosages of BNT162b2 were significantly associated with injection-site reactions. Compared with approved non–SARS-CoV-2 vaccines, BNT162b2 was associated with significantly more frequent injection-site, musculoskeletal, dermatologic, or otolaryngologic symptoms but fewer general symptoms and fever after vaccination.
Meaning In this study, the overall frequency of adverse events after vaccination with BNT162b2 was comparable with the frequency of adverse events after vaccination with approved non–SARS-CoV-2 vaccines in children younger than 5 years.
Abstract
Importance SARS-CoV-2 vaccines are authorized for use in most age groups. The safety of SARS-CoV-2 vaccines is unknown in children younger than 5 years.Objective To retrospectively evaluate the safety of the BNT162b2 vaccine used off-label in children younger than 5 years compared with the safety of non–SARS-CoV-2 vaccines in the same sample.
Design, Setting, and Participants This investigator-initiated retrospective cohort study included parents or caregivers who registered children for SARS-CoV-2 vaccination in outpatient care facilities in Germany. The study was performed as an authenticated online survey. A total of 19,000 email addresses were contacted from vaccination registration databases between April 14 and May 9, 2022. Inclusion criteria were child age younger than 5 years at the first BNT162b2 vaccination and use of a correct authentication code to prove invitation.
Exposures Off-label BNT162b2 vaccination and on-label non–SARS-CoV-2 vaccinations.
Main Outcomes and Measures Reported short-term safety data of 1 to 3 doses of 3 to 10 ?g BNT162b2 in children from birth to younger than 60 months are presented. Coprimary outcomes were the frequencies of 11 categories of symptoms after vaccination with bivariate analyses and regression models adjusting for age, sex, weight, and height.
Results The study included 7806 children (median age, 3 years [IQR, 2-4 years]; 3824 [49.0%] female) who were followed up of for a mean (SD) of 91.4 (38.8) days since first BNT162b2 vaccination (survey response rate, 41.1%). A 10-?g dosage was more frequently associated with local injection-site symptoms compared with lower dosages. In the active-comparator analysis, the probability of any symptoms (odds ratio [OR], 1.62; 95% CI, 1.43-1.84), local symptoms (OR, 1.68; 95% CI, 1.38-2.05), musculoskeletal symptoms (OR, 2.55; 95% CI, 1.32-4.94), dermatologic symptoms (OR, 2.18; 95% CI, 10.7-4.45), or otolaryngologic symptoms (OR, 6.37; 95% CI, 1.50-27.09) were modestly elevated after BNT162b2 compared with non–SARS-CoV-2 vaccines, whereas the probabilities of general symptoms (OR, 0.77; 95% CI, 0.63-0.95) and fever (OR, 0.42; 95% CI, 0.32-0.55) were lower after BNT162b2. Symptoms requiring hospitalization (n?=-10) were reported only at BNT162b2 dosages above 3 ?g.
Conclusions and Relevance In this cohort study, the symptoms reported after BNT162b2 administration were comparable overall to those for on-label non–SARS-CoV-2 vaccines in this cohort of children younger than 5 years. The present data may be used together with prospective licensure studies of BNT162b2 efficacy and safety and could help guide expert recommendations about BNT162b2 vaccinations in this age group.
Educational Objective
To identify the key insights or developments described in this article
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