Short term safety of BNT162b2 (Pfizer-BioNTech) SARS-CoV-2 vaccine among children aged 5-11 years, a nationwide parental survey.

ABSTRACT

PURPOSE: SARS-CoV-2 vaccine safety is of major interest worldwide, and transparent information about potential side effects is essential to decrease vaccine hesitancy. The aim of this study was to assess SARS-CoV-2 BNT162b2 vaccine short-term side effects among children aged 5-11 years. METHODS: An observational, cross sectional study of vaccine side-effects using electronic surveys sent to parents one week post administration of BNT162b2 vaccine to their child in a large health maintenance organization in Israel. RESULTS: First dose and second dose surveys were filled for 5,842 and 6,126 children, respectively, with a response rate of 32.1% and 24.8%. Local side effects were reported by 68.7% and 69.1% of the first and second survey respondents, and general side effects were reported by 20.8% and 34.5% of them. The symptoms most frequently reported were fatigue, headache and myalgia. Duration of symptoms lasted three days or less among 86.5% and 81.5% of first and second dose survey respondents. Most respondents (92%) reported that their child did not need any medical consultation following vaccination. CONCLUSIONS: We found further support for the BNT162b2 SARS-CoV-2 vaccine short- term safety among children aged 5-11 years. With ongoing pandemic and future booster COVID-19 vaccines, these findings can encourage vaccine confidence for parents and providers.