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Abscesses complicating DTP vaccination
Abstract:
Reports of abscesses after the use of diphtheria and tetanus toxoids and pertussis vaccine (DTP vaccine) from two different lots (No. 1 and 2) of a single manufacturer (manufacturer A) prompted an investigation into the rates of abscess formation following the use of DTP vaccine from several different manufacturers. A total of 74 abscesses for lot 1, 16 for lot 2, and three for other DTP products was uncovered. The overall rate after lots 1 and 2 was 1.1 per 1,000 doses administered compared with 0.01 per 1,000 doses for DTP vaccine from other manufacturers (P less than .0001). Faulty technique, site and route of inoculation, microbiologic contamination, and hypersensitivity were ruled out as likely explanations for the increase in abscesses among recipients of DTP vaccine from manufacturer A. Use of a single needle to withdraw vaccine from the vial and to inoculate the vaccinees, combined with high aluminum adjuvant content in the implicated vaccine, may have led to an increased rate of abscess formation.
Insights
Certain diphtheria and tetanus toxoids and pertussis vaccines (DTP) from manufacturer A caused significantly more abscesses. This study investigated DTP vaccine abscess rates, finding higher risks with specific lots due to potential manufacturing or formulation issues.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Abscess formation post-vaccination is a rare but concerning adverse event.
- Initial reports indicated an unusual number of abscesses linked to specific diphtheria and tetanus toxoids and pertussis vaccine (DTP) lots from manufacturer A.
Purpose of the Study:
- To investigate and compare the rates of abscess formation associated with DTP vaccines from different manufacturers and lots.
- To identify potential factors contributing to increased abscess rates observed with specific DTP vaccine batches.
Main Methods:
- Retrospective analysis of reported abscess cases following DTP vaccination.
- Comparative rate calculation between DTP vaccine lots from manufacturer A and other manufacturers.
- Exclusion of common causes like faulty technique, contamination, or hypersensitivity.
Main Results:
- Manufacturer A's DTP vaccine lots 1 and 2 showed significantly higher abscess rates (1.1 per 1,000 doses) compared to other DTP products (0.01 per 1,000 doses).
- A total of 93 abscesses were linked to manufacturer A's implicated lots.
- Factors such as shared needles and high aluminum adjuvant content were hypothesized as potential causes.
Conclusions:
- Specific lots of DTP vaccine from manufacturer A were associated with a markedly increased risk of abscess formation.
- The high aluminum adjuvant content and potential issues with vaccine preparation (e.g., needle reuse) may explain the elevated abscess rates.