Comparison of acellular pertussis-based combination vaccines by Japanese control tests for toxicities and laboratory models for local reaction

Two batches each of diphtheria–tetanus–acellular pertussis vaccine (DTaP) and that combined with inactivated polio vaccine purchased from the U.S.A., European and Asian markets were compared with Japanese DTaPs by Japanese control tests for DTaP and laboratory models for local reaction. All the imported vaccines met Japanese criteria for toxicities of acellular pertussis vaccine except for the toxicity to mouse weight gain (body weight decreasing (BWD) toxicity). When injecting into mouse footpad, rabbit back skin and mouse quadriceps muscle, the imported vaccines induced much severer inflammation and tissue injury comparing to Japanese DTaPs irrespective of animal species, injection site and injection volume suggesting that these vaccines may induce stronger local reactogenicity.