A Cross-Sectional Study to Assess mRNA-COVID-19 Vaccine Safety among Indian Children (5–17 Years) Living in Saudi Arabia

Abstract

The objective of this study is to assess the frequency and severity of adverse events following immunization (AEFI) in Indian children aged 5–17 years who received the Pfizer-BioNTech mRNA COVID-19 vaccine, as well as to investigate for predictors of AEFI. To examine AEFI following the first and second doses of Pfizer’s vaccine, semi-structured questionnaires were distributed as Google forms at Indian schools in Saudi Arabia. The 385 responses included 48.1% male and 51.9% female children, with 136 responses of children aged 5–11 years (group A) and 249 responses from children aged 12–17 years (group B). Overall, 84.4% of children had two shots. The frequency of AEFI was reported to be higher after the first dose than after the second (OR = 2.12, 95% CI = 1.57–2.86). The reported AEFIs included myalgia, rhinitis, local reaction with fever, a temperature of 102 °F or higher, and mild to moderate injection site reactions. While group B frequently reported multiple AEFIs, group A typically reported just one. Local reaction with low grade fever was more frequently reported in group B after the first dose (24.1%) and second dose (15.4%), while local reaction without low grade fever was most frequently observed in group A after the first (36.8%) and second dose (30%). Only prior COVID-19 infection (OR = 2.98, 95% CI = 1.44–6.2) was associated with AEFI after the second dose in the study sample, whereas male gender (OR = 1.71, 95% CI = 1.13–2.6) and prior COVID-19 infection (OR = 2.95, 95% CI = 1.38–6.3) were predictors of AEFI after the first dose. Non-serious myocarditis was reported by only one child. According to the analysis conducted, the Pfizer’s mRNA COVID-19 vaccination was found to be safe in Indian children.

Keywords

• mRNA vaccine
• COVID-19
• adverse events following immunization (AEFI)
• adverse events of special interest (AESI)
• myocarditis