Recommendations for Diphtheria, tetanus, pertussis and combined vaccines, Annex 5, TRS No 927

Overview

These amendments should be read in conjunction with the introduction to the Requirements for diphtheria, tetanus, pertussis and combined vaccines published in WHO Technical Report Series, No. 800, 1990 (Annex 2).

Diphtheria and tetanus vaccines are among the most frequently used vaccines worldwide and have been remarkably successful products. Their use has resulted in a significant decrease in the incidence of these diseases in both the industrialized world and in developing countries. Nevertheless, some difficulties exist in the global harmonization of potency testing procedures, even when International Standards are used, and different approaches have been taken by different countries. Some follow WHO and European Pharmacopoeia procedures, whereas others follow the National Institutes of Health (NIH) procedures used in the USA, with or without modifications. 

The following amendments have thus been made to Annex 2, WHO Technical Report Series, No. 800, 1990. These include:

1. The updating of sections on International Reference Preparations for Diphtheria vaccine (adsorbed) and Tetanus vaccine (adsorbed);

2. The division of the sections on potency for Diphtheria vaccine (adsorbed) and for Tetanus vaccine (adsorbed) into two subsections to clearly distinguish the recommendations for licensing from those for routine batch release;

3. Simplification of the routine testing for batch release and use of fewer animals than used for licensing; 6952 ECE TEXT 139 8/21/05, 10:57 140 E

4. Amendment of the recommendations for diphtheria and tetanus potency testing in the diphtheria, tetanus, pertussis combined vaccine section to bring them in line with the changes outlined (in 2 and 3) above.

No changes have yet been made to the pertussis section of the Requirements for pertussis vaccines published in Technical Report Series, No 800, 1990 (annex 2).

Full version of the WHO Technical Report Series N° 927