Adverse events post-BNT162b2 vaccination in Japanese children

Area of Science:

• Pediatric Infectious Diseases
• Vaccinology
• Public Health

Background:

• Low BNT162b2 vaccination rates in Japanese children due to adverse event (AE) concerns.
• Limited data on AE incidence and risk factors post-vaccination in Japanese pediatric populations.

Purpose of the Study:

• To determine the incidence of adverse events (AEs) following BNT162b2 vaccination in Japanese children.
• To identify risk factors associated with AEs in this demographic.

Main Methods:

• Prospective study of 1016 Japanese children (6 months-11 years) receiving BNT162b2 vaccine across 12 institutions.
• AEs recorded within 7 days post-vaccination via an online reporting system.
• Data analyzed for incidence and correlation with demographic and medical factors.

Main Results:

• Fever incidence: 6.2% (dose 1), 14.1% (dose 2), 18.0% (dose 3).
• No severe AEs (myocarditis, anaphylaxis, seizures) observed.
• Increased AE risk associated with older age, female sex, higher dose, prior vaccination, specific medical histories, and parental AEs.

Conclusions:

• BNT162b2 vaccination demonstrated a favorable safety profile in Japanese children.
• Low AE rates and identified risk factors can improve vaccine confidence and uptake.
• Enhanced COVID-19 vaccination coverage in children is crucial for disease control.