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.

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 primary series and PCV7 primary series in the previous year. SAEFVIC received 229 reports describing 406 AEFI following PCV13 vaccine in the 12 months post introduction. There was no difference in the total number of AEFI cases reported between the vaccines but 7 AEFI categories were reported at a significantly higher rate following PCV13 compared with PCV7. No difference in reporting rate was observed for serious AEFI (p = 0.25). Post-hoc analysis of a further 12 months of PCV13 data revealed that all 7 AEFI categories that were initially reported at a significantly higher rate following PCV13 compared to PCV7 in the first 12 months post introduction, were no longer significantly increased in the 13-24 month period. The initial high reporting rate for several common AEFI post PCV13 compared to PCV7 may be explained by heightened awareness of the new vaccine. There were no safety signals detected for rare or serious AEFI that would require further investigation at this time.