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Anaphylaxis After Immunization of Children and Adolescents in Germany
Doris Oberle1, Jutta Pavel, Thorsten Rieck
1From the *Department Safety of Medicinal Products and Medical Devices, Federal Institute for Vaccines and Biomedicines, Paul-Ehrlich-Institut, Langen, Germany; †Immunization Unit, Robert Koch Institute, Berlin, Germany; ‡Charité-University Medicine Berlin, Berlin, Germany; and §Pediatric Infectious Diseases and Pulmonology, University Children's Hospital Mannheim, Heidelberg University, Germany.
Insights
Anaphylaxis following immunization in children is rare, with an estimated annual frequency of 6.8 per million. The AS03 adjuvanted A/H1N1 influenza vaccine showed a higher associated risk compared to other vaccines.
Area of Science:
- Pediatric Allergy and Immunology
- Vaccine Safety Surveillance
- Public Health Epidemiology
Background:
- Anaphylaxis is a severe, life-threatening allergic reaction.
- Understanding post-immunization anaphylaxis incidence in children is crucial for public health.
- Germany has surveillance systems for monitoring adverse events following immunization.
Purpose of the Study:
- To estimate the annual frequency of anaphylaxis after immunization in individuals under 18 years old in Germany requiring hospitalization.
- To identify potential risk factors or specific vaccines associated with post-immunization anaphylaxis.
Main Methods:
- Utilized data from the German surveillance unit for rare pediatric diseases and the Paul-Ehrlich-Institut (June 2008-May 2010).
- Applied Brighton collaboration case definition criteria (Level 1-3) for hospitalized anaphylaxis cases.
- Employed capture-recapture methods to estimate annual frequency.
Main Results:
- 22 eligible cases of post-immunization anaphylaxis were identified in individuals aged 0-17 years.
- The estimated annual frequency of anaphylaxis after vaccination (excluding specific vaccines) was 6.8 per million (95% CI: 6.1-10.9).
- The AS03 adjuvanted A/H1N1 pandemic influenza vaccine was most frequently associated with anaphylaxis.
Conclusions:
- Anaphylaxis following immunization in children and adolescents is a rare event.
- The AS03 adjuvanted A/H1N1 pandemic influenza vaccine may be associated with an increased risk of anaphylaxis.
- Continued surveillance of vaccine safety in pediatric populations is warranted.
Background:
Anaphylaxis is a life-threatening event. The aim of this study was to estimate the annual frequency of anaphylaxis after immunization in individuals younger than 18 years in Germany leading to hospitalization.
Methods:
All suspected cases of postvaccination anaphylaxis involving individuals aged 0-17 years reported to the German surveillance unit for rare pediatric diseases (Erhebungseinheit für seltene pädiatrische Erkrankungen in Deutschland) from June 2008 through May 2010, and all suspected cases of anaphylaxis as an adverse event following immunization in the same age group reported to the Paul-Ehrlich-Institut during the observational period were classified according to the Brighton collaboration case definition. Only hospitalized cases of anaphylaxis fulfilling Brighton collaboration case definition level 1-3 criteria were eligible. Estimates for the annual frequency were calculated by using capture-recapture methods.
Results:
A total of 22 reports were eligible. Median age of the affected individuals (13 males, 9 females) was 7.0 years (range: 2 months to 17 years). Anaphylaxis occurred most frequently after administration of AS03 adjuvanted A/H1N1 pandemic influenza vaccine (n = 8). The annual frequency of anaphylaxis after vaccination (excluding pandemic influenza vaccine as well as monovalent measles and rubella vaccines) was estimated to be 6.8 (95% confidence interval: 6.1-10.9). The estimated incidence of anaphylaxis after administration of specific vaccines ranged from 0.4 to 127.6 cases per 1,000,000 doses administered.
Conclusions:
This study confirms that anaphylaxis after immunization in children and adolescents is a rare event. AS03 adjuvanted A/H1N1 pandemic influenza vaccine seems to be associated with a higher risk of anaphylaxis when compared with other vaccines.
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