Adverse events following pediatric immunization in an Indian city

Area of Science:

• Pediatric vaccine safety research
• Immunization adverse event surveillance
• Public health in developing nations

Background:

• Adverse events following immunization (AEFI) are critical for maintaining public trust in vaccines.
• Vaccine safety surveillance is particularly important in understudied populations, such as India.
• Understanding AEFI in children aged 0-12 years is essential for optimizing vaccine benefit-risk profiles.

Purpose of the Study:

• To assess vaccine safety in the pediatric population (0-12 years) in India.
• To identify and analyze adverse events following immunization (AEFI).
• To investigate potential sex-specific differences in AEFI incidence.

Main Methods:

• A prospective observational study conducted across 3 primary healthcare centers and 2 tertiary care hospitals.
• Enrolled 826 children over a 6-month period (April 2016 - September 2016).
• Utilized the World Health Organization causality assessment instrument to analyze AEFI and assessed sex-specific differences.

Main Results:

• Pentavalent vaccines were associated with the highest cumulative adverse events (62.04%), followed by bacille Calmette-Guérin (BCG) vaccine (22.99%).
• A total of 826 children were enrolled, with detected adverse events analyzed for causality.
• No statistically significant association was found between the incidence of adverse events and the children's sex.

Conclusions:

• Vaccine safety surveillance is crucial in developing countries to uphold public confidence in vaccination programs.
• The study identified specific vaccines with higher AEFI rates in children.
• Findings suggest no sex-specific differences in the incidence of adverse events following immunization in the studied pediatric population.