Surveillance of adverse events following the introduction of 13-valent pneumococcal conjugate vaccine in infants, and comparison with adverse events following 7-valent pneumococcal conjugate vaccine, in Victoria, Australia

Abstract

The 13-valent pneumococcal vaccine (PCV13) replaced the 7-valent vaccine (PCV7) on the Australian National Immunization Program (NIP) in 2011. Post-marketing surveillance of adverse events following immunization (AEFI) is crucial for detecting potential safety signals and maintaining confidence in the NIP. This study describes all AEFI reported to Surveillance of Adverse Events following Vaccination in the Community (SAEFVIC), Melbourne, Australia, following both the primary series of PCV13 (children <7 months) and the catch-up dose (12 months-35 months) in its first year of inclusion on the NIP. AEFI reporting rates per 100,000 doses of vaccine administered were compared for the PCV13 prima..