Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines, Annex 4, TRS No 999

Overview

WHO Guidelines to assure the quality, safety and efficacy of recombinant human papillomavirus (HPV) virus-like particle (VLP) vaccines were first adopted by the WHO Expert Committee on Biological Standardization in 2006 and were based largely on experience gained from clinical trials undertaken on the first two licensed HPV vaccines.

The factors that have prompted this revision include the substantial amount of data accumulated during vaccine implementation, the development of prophylactic vaccines with extended valency and the use of other production methods. In addition, the increasing availability and routine use of HPV VLP vaccines composed of L1 capsid protein and containing at least types 16 and 18 have important implications for trial designs and end-points for clinical evaluation of new prophylactic HPV vaccines. Additional changes have also been made to bring the document into line with other WHO Recommendations, Guidelines and guidance documents published since the 2006 adoption of the WHO Guidelines on recombinant HPV VLP vaccines

The scope of the present document encompasses recombinant HPV VLP vaccines for prophylactic use which contain the L1 capsid protein of one or more HPV types. The document does not cover vaccines targeted to L2 capsid proteins as antigens, as appropriate serological assays have not yet been standardized and clinical vaccine trials have not started.

Full version of  WHO Technical Report Series No. 999