A Qualitative Study to Assess Challenges Faced During AEFI Surveillance

Area of Science:

• Public Health
• Pharmacovigilance
• Vaccine Safety

Background:

• India's National Regulatory Authority ensures vaccine safety.
• Post-licensure monitoring is crucial for detecting rare adverse events following immunization (AEFI).

Purpose of the Study:

• To qualitatively assess the existing AEFI surveillance system in a metropolitan city in Maharashtra.
• To identify challenges and areas for improvement in AEFI reporting and management.

Main Methods:

• Cross-sectional observational qualitative study.
• Focus group discussions (FGDs) with healthcare workers and stakeholders.
• Thematic analysis using grounded theory and ATLAS ti 5.7.1 software.

Main Results:

• Both active and passive surveillance methods were employed, improving reporting and early detection of AEFIs.
• Lack of proper training for private sector doctors was identified.
• Reporting rates were influenced by factors including clinical seriousness, temporal proximity, awareness, fear of blame, time constraints, and reporting responsibility.

Conclusions:

• Mandatory training for private practitioners and collaboration with community health volunteers (CHVs) for active AEFI surveillance are recommended.
• Online reporting platforms and improved counseling for mothers on paracetamol use are suggested.
• Enhanced convergence among national regulators (CDSCO, PvPI) and AEFI surveillance programs is needed for faster, more effective vaccine safety management.