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Potency of pertussis component in the DTP vaccine--an overview of three decade study in Poland

Anna Gzyl1, Ewa Augustynowicz, Daniel Rabczenko

  • 1Department of Sera and Vaccines Evaluation, National Institute of Hygiene, Chocimska Str 24, 00-791 Warsaw, Poland. agzyl@pzh.gov.pl

Biologicals : Journal of the International Association of Biological Standardization
|November 13, 2004
PubMed

Insights

Pertussis (whooping cough) vaccine potency in Poland has declined since 1992, potentially explaining the rise in childhood cases. Changes in vaccine production and testing correlate with reduced potency and efficacy.

Area of Science:

  • Immunology
  • Vaccinology
  • Public Health

Background:

  • Poland, like other highly immunized nations, is experiencing a resurgence of pertussis (whooping cough) cases.
  • This increase is concerning given high vaccination rates.

Purpose of the Study:

  • To investigate potential fluctuations in the potency of the pertussis component of diphtheria-tetanus-pertussis (DTP) vaccines produced in Poland.
  • To assess the impact of changes in vaccine production and potency testing procedures on vaccine efficacy.

Main Methods:

  • Analysis of Kendrick test results for DTP vaccine lots over a 30-year period.
  • Comparison of vaccine potency based on production periods, manufacturers, vaccine strain composition, and reference preparations.

Main Results:

  • A significant downtrend in pertussis vaccine potency was observed starting in 1992.
  • Reduced potency from 1992-1997 correlated with lower International Units per dose (IOU/dose).
  • Variations in vaccine strain composition and reference vaccines influenced potency estimations.

Conclusions:

  • Changes in vaccine production and testing procedures have impacted DTP vaccine potency.
  • The DTP vaccine produced between 1992-1997 may have had lower relative efficacy.
  • This reduced efficacy could contribute to the observed increase in pertussis cases among Polish children aged 5-15.

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