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As APEXXNAR contains the same 13 serotype-specific capsular polysaccharide conjugates and the same vaccine excipients as Prevenar 13®, the adverse reactions already identified for Prevenar 13 have been adopted for APEXXNAR.1
No new adverse reactions were identified as compared to Prevenar 13.1
Adverse experiences that have been spontaneously reported during the postmarketing use of Prevenar 13, may also occur with APEXXNAR.1
Safety with concomitant vaccine administration in adults1
When APEXXNAR was administered to adults aged ≥ 65 years together with the third (booster) dose of a COVID-19 mRNA vaccine (nucleoside modified), the tolerability profile generally resembled that of the COVID-19 mRNA vaccine (nucleoside modified) administered alone. There were a few differences in the safety profile when compared to administration of APEXXNAR alone. In the phase 3 trial B7471026, pyrexia (13.0%) and chills (26.5%) were reported as 'very common' with co-administration. There was also one report of dizziness in the co-administration group.1
Conjugate vaccines like APEXXNAR are designed to deliver long-lasting immunity.1,2
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Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
Adverse events should also be reported to Pfizer Medical Information on 1800 633 363
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PP-UNP-IRL-0176. January 2023