Scientific Publications by FDA Staff

Vaccine 2011 Sep 2;29(38):6432-6

WHO Working Group discussion on revision of the WHO recommendations for the production and control of poliomyelitis vaccines (oral): TRS Nos. 904 and 910. Report of Meeting held on 20-22 July 2010, Geneva, Switzerland.

Martin J, Milne C, Minor P, Chumakov K, Baca-Estrada M, Caruana JF, Zhou T

Oral poliomyelitis vaccine (OPV) is a critical part of the polio eradication programme. A high number of doses are administered each year with an impact on billions of citizens worldwide. It is therefore essential that written standards concerning OPV are up to date and widely available. The World Health Organization (WHO) publishes technical guidance on the quality, safety and efficacy of vaccines intended to assist national regulatory authorities (NRAs), national control laboratories (NCLs) and manufacturers. As part of its programme, on 20-22 July 2010 WHO convened a working group meeting to initiate the revision of the WHO recommendations on the production and control of OPV as presently outlined in the Technical Reports Series (TRS) issues Nos. 904 and 910 [1,2]. The attendees included experts from academia, NRAs/NCLs and industry involved in the study, manufacture, and authorization and testing/release of OPV from countries around the world including representatives from China, the European Union, Indonesia, Japan, Mexico, and the USA. The objective was to review the state of knowledge concerning production and control of OPV, with a focus on neurovirulence testing, to determine how the existing guidelines should be updated and what recommendations should be made for the future. The outcomes of this meeting will be taken into consideration in future revision of the WHO TRS.