Acta paediatrica (Oslo, Norway : 1992) · 2026
Update on Selected Adverse Events of Concern Following Immunization With Acellular Pertussis Vaccines, a Narrative Review.
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Nilsson Lennart, Storsaeter Jann
Аннотация
AIM: To provide an update paper on evidence of adverse events of concern following immunization (AEFI) with pertussis vaccines, focusing primarily on acellular (aP) vaccines.
METHODS: Evidence was synthesised from epidemiological studies, systematic reviews over recent decades, expert interpretations in reviews from relevant research teams and well-conducted observational reports across different time periods. A more comprehensive review of the literature was conducted for certain specific AEFIs, including sterile abscesses, macrophagic myofasciitis, reactions to aluminium adjuvants, Guillain-Barré syndrome, acute disseminated encephalomyelitis (ADEM) and anaphylaxis.
RESULTS: Acellular (aP) vaccines are generally associated with mild reactions such as local pain, redness, and transient fever. Moderate reactions, including prolonged crying, hypotonic-hyporesponsive episodes, extensive limb swelling, and aluminium-induced granuloma, occur infrequently and are self-limiting. Severe outcomes such as seizures or encephalopathy have been extensively investigated, with large studies showing no consistent increase above background incidence.
CONCLUSION: Licensed acellular pertussis vaccine combinations demonstrate acceptable safety profiles, with serious adverse events being rare. Continuous pharmacovigilance and balanced, evidence-based communication remain essential to sustain trust in pertussis immunisation programmes.
METHODS: Evidence was synthesised from epidemiological studies, systematic reviews over recent decades, expert interpretations in reviews from relevant research teams and well-conducted observational reports across different time periods. A more comprehensive review of the literature was conducted for certain specific AEFIs, including sterile abscesses, macrophagic myofasciitis, reactions to aluminium adjuvants, Guillain-Barré syndrome, acute disseminated encephalomyelitis (ADEM) and anaphylaxis.
RESULTS: Acellular (aP) vaccines are generally associated with mild reactions such as local pain, redness, and transient fever. Moderate reactions, including prolonged crying, hypotonic-hyporesponsive episodes, extensive limb swelling, and aluminium-induced granuloma, occur infrequently and are self-limiting. Severe outcomes such as seizures or encephalopathy have been extensively investigated, with large studies showing no consistent increase above background incidence.
CONCLUSION: Licensed acellular pertussis vaccine combinations demonstrate acceptable safety profiles, with serious adverse events being rare. Continuous pharmacovigilance and balanced, evidence-based communication remain essential to sustain trust in pertussis immunisation programmes.