Determining Which of Several Simultaneously Administered Vaccines Increase Risk of an Adverse Event

Introduction Childhood immunization schedules often involve multiple vaccinations per visit. When increased risk of an adverse event is observed after simultaneous (same-day) vaccinations, it can be difficult to ascertain which triggered the adverse event. This methods paper discusses a systematic p...

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Bibliographic Details
Published in:Drug safety 2020-10, Vol.43 (10), p.1057-1065
Main Authors: Wang, Shirley V., Stefanini, Kristina, Lewis, Edwin, Newcomer, Sophia R., Fireman, Bruce, Daley, Matthew F., Glanz, Jason M., Duffy, Jonathan, Weintraub, Eric, Kulldorff, Martin
Format: Article
Language:English
Subjects:
Age
Chicken pox
Children
Diphtheria
Drug Safety and Pharmacovigilance
Hepatitis
Immunization
Measles
Medicine
Medicine & Public Health
Mumps
Original Research Article
Pertussis
Pharmacology/Toxicology
Risk
Rubella
Schedules
Seizures
Simulation
Tetanus
Vaccines
Whooping cough
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Summary:Introduction Childhood immunization schedules often involve multiple vaccinations per visit. When increased risk of an adverse event is observed after simultaneous (same-day) vaccinations, it can be difficult to ascertain which triggered the adverse event. This methods paper discusses a systematic process to determine which of the simultaneously administered vaccine(s) are most likely to have caused an observed increase in risk of an adverse event. Methods We use an example from the literature where excess risk of seizure was observed 1 day after vaccination, but same-day vaccination patterns made it difficult to discern which vaccine(s) may trigger the adverse event. We illustrate the systematic identification process using a simulation that retained the observed pattern of simultaneous vaccination in an empirical cohort of vaccinated children. We simulated “true” effects for diphtheria–tetanus–acellular pertussis (DTaP) and pneumococcal conjugate (PCV) on risk of seizure the day after vaccination. We varied the independent and interactive effects of vaccines (on the multiplicative scale). After applying the process to simulated data, we evaluated risk of seizure 1 day after vaccination in the empirical cohort. Results In all simulations, we were able to determine which vaccines contributed to excess risk. In the empirical data, we narrowed the association with seizure from all vaccines in the schedule to three likely candidates, DTaP, PCV, and/or Haemophilus influenzae type B (HiB) ( p  
ISSN:0114-5916
1179-1942
DOI:10.1007/s40264-020-00967-8