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Comparative analysis of adverse events following immunization with DTaP vaccine in children before and after

Tiane Liu1, Qinghua Chen1, Chunmei Ye1

  • 1Department of Expanded Program on Immunization, Hangzhou Linping District Center for Disease Control and Prevention (Hangzhou Linping District Health Supervision Institute), Hangzhou, Zhejiang, China.

Human Vaccines & Immunotherapeutics
|July 20, 2026
PubMed

Insights

Adjusting the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine schedule did not increase adverse events. Local induration decreased, and the primary series showed improved safety, though the fifth dose requires monitoring.

Area of Science:

  • Pediatrics
  • Immunology
  • Public Health

Background:

  • The diphtheria, tetanus, and acellular pertussis (DTaP) vaccine schedule is critical for childhood immunization.
  • Previous schedules involved four doses, while newer recommendations include a fifth dose.
  • Understanding the safety profile of adjusted DTaP schedules is essential for public health.

Purpose of the Study:

  • To evaluate the impact of shifting from a four-dose to a five-dose DTaP immunization schedule on adverse events following immunization (AEFIs).
  • To compare AEFI reporting rates, symptom patterns, and dose-specific differences before and after the schedule adjustment.

Main Methods:

  • Utilized surveillance data from Linping District for 2024 (pre-adjustment) and 2025 (post-adjustment).
  • Compared AEFI reporting rates and characteristics between the two schedules using chi-square tests and rate ratios (RR).
  • Conducted sensitivity analyses to assess dose-specific effects and overall safety trends.

Main Results:

  • Overall AEFI reporting rates remained statistically unchanged (482.27 vs. 457.32 per 100,000 doses; RR=0.95).
  • Local induration significantly decreased overall (RR=0.57), particularly moderate induration (RR=0.61).
  • The primary series (doses 1-4) in the adjusted schedule showed a trend toward improved safety (RR=0.82), while the fifth dose had the highest AEFI rate but consisted of mild reactions.

Conclusions:

  • DTaP schedule adjustment to a five-dose regimen did not elevate overall AEFI rates.
  • The adjusted schedule demonstrated a potential safety benefit, with a significant reduction in local induration.
  • The fifth dose of DTaP warrants continued surveillance due to its higher AEFI reporting rate, although reactions are typically mild.

Keywords:
Diphtheria, tetanus, and acellular pertussis vaccineadverse events following immunizationimmunization schedulesurveillancevaccine safety

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