Recommendations for whole-cell pertussis vaccine, Annex 6, TRS No 941

Overview

The WHO Requirements for whole-cell pertussis vaccine were fi rst formulated in 1963 and the requirements for diphtheria and tetanus vaccines were prepared in 1964. Since diphtheria, tetanus and whole cell pertussis (DTwP) vaccines have been commonly used in a combined form, the requirements revised in 1978 contained separate sections on all three components as a followed by a fi nal section that applied to a combination. The last revision of the requirements for diphtheria, tetanus, pertussis and combined vaccines was made in 1989 and published in 1990 (1).

An amendment to the diphtheria and tetanus sections concerning single dilution and in vitro potency assays was adopted by the Expert Committee on Biological Standardization in 2004 (2). The present revision of the requirements for whole-cell pertussis vaccine should therefore be considered as part of the revision of the overall requirements for DTP. In 1998 the title WHO Requirements was changed to WHO Recommendations to better refl ect the nature of these documents. These recommendations for whole-cell pertussis vaccine supersede those published in 1990 (1) and should be read in conjunction with the recommendations for diphtheria and tetanus vaccines when whole-cell pertussis vaccine is part of DTwP combined vaccine (1, 2). Once both the diphtheria and tetanus sections have also been fully revised, it is the intention to combine all three sections into one document.

Full version of the WHO Technical Report Series N° 941