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

@entity1 @entity1200 @entity69291
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 @entity1200 ( @entity1200 ) is crucial for detecting potential safety signals and maintaining confidence in the NIP. This study describes all @entity1200 reported to Surveillance of Adverse Events following Vaccination in the Community (SAEFVIC), Melbourne, Australia, following both the primary series of PCV13 ( @entity1 <7 months) and the catch-up dose (12 months-35 months) in its first year of inclusion on the NIP. @entity1200 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 @entity1200 following @entity69291 in the 12 months post introduction. There was no difference in the total number of @entity1200 cases reported between the vaccines but 7 @entity1200 categories were reported at a significantly higher rate following PCV13 compared with PCV7. No difference in reporting rate was observed for serious @entity1200 (p = 0.25). Post-hoc analysis of a further 12 months of PCV13 data revealed that all 7 @entity1200 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 @entity1200 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 @entity1200 that would require further investigation at this time.
