Abstract
Introduction: Immunization is a highly effective public health strategy that protects against vaccine-preventable diseases; however, adverse events following immunization (AEFI) may occur. As AEFIs after BCG vaccination are not uncommon and immune responses in preterm infants differ from those born at term.
Objectives: This study aimed to evaluate AEFIs following BCG in term and preterm neonates.
Methodology: Hospital based observational study was conducted in a tertiary care center from July-December 2025. Babies of either sex, under the age of 3 months visiting the hospital’s immunization center for BCG Vaccine as per the National Immunization Program (NIP) were included in the study. A total of 120 babies were enrolled using purposive sampling and were divided into two groups with 60 in each term and preterm group. Parents were contacted at various time points via telephone / whatsApp / viber for questioning about post vaccination adverse events.
Results: Majority of the respondents were male (61.7%) in term group and female (51.7%) in the preterm group. The mean birth weight for preterm infants was significantly lower compared with the term infants (1945 ± 470 grams vs 3134 ± 409 grams, p <0.001). Inoculation site, ulceration, redness, and scar formation were commonly found among the babies in both groups within 20 weeks. No adverse effect of BCG vaccination was noticed except one preterm infant (1.7%) developing an abscess.
Conclusion: AEFI following BCG vaccination were rare and comparable between term and preterm infants, suggesting a favorable safety profile of the vaccine in both groups.
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