TY - JOUR
T1 - WHO Working Group on Technical Specifications for Manufacture and Evaluation of Yellow Fever Vaccines, Geneva, Switzerland, 13-14 May 2009
AU - Ferguson, Morag
AU - Shin Jinho, J.
AU - Knezevic, Ivana
AU - Minor, Philip
AU - Barrett, Alan
N1 - Funding Information:
Dr Ivana Knezevic (QSS/WHO) presented an update on biological standardization and positioned the discussion in terms of the work of QSS and the issues of importance in the area of YF vaccine. The activities of the QSS group within WHO include ensuring that all vaccines are of assured quality through regulatory guidance and the implementation of new WHO standards. Goals of immunization programmes include increasing and sustaining vaccine coverage, reducing morbidity and mortality through the use of vaccines of assured quality, and introducing new vaccines and vaccines from new manufacturers or with modified vaccine production. The strengthening of National Regulatory Authorities (NRA) is also important as NRA functionality forms an essential part of quality assurance of vaccines. The Expert Committee on Biological Standards (ECBS) has played essential roles in WHO's normative function, e.g. establishment of standards, both written and physical. Written standards are produced as a form of guidelines or recommendations and used for the regulation of vaccines worldwide and also for the prequalification of vaccines. The established written standards must be evidence-based and only experts in the field can provide the evidence. The written standards now include nonclinical and clinical issues. The work of ECBS is supported by an Expert Advisory Panel and Collaborating Centres including the WHO International Laboratory for Biological Standards at the National Institute for Biological Standards and Control (NIBSC), the Paul-Ehrlich-Institut (PEI) and the Center for Biologics Evaluation and Research (CBER) of the US Food and Drug Administration (FDA).
PY - 2010/12/6
Y1 - 2010/12/6
N2 - In May 2009, WHO convened a meeting of Working Group on Technical Specifications for Manufacturing and Evaluating Yellow Fever (YF) Vaccines, Geneva, Switzerland to initiate revision of the WHO Recommendations (formerly, Requirements) for YF vaccine published in WHO Technical Report Series number 872 (1998). The Working Group, consisting of experts from academia, industry, national regulatory authorities and national control laboratories, reviewed the latest issues of safety, efficacy and quality of YF vaccines and agreed that (i) the revision should focus on live attenuated YF vaccine virus 17D lineage; and that (ii) nonclinical and clinical guidelines for new vaccines prepared from 17D lineage be developed.
AB - In May 2009, WHO convened a meeting of Working Group on Technical Specifications for Manufacturing and Evaluating Yellow Fever (YF) Vaccines, Geneva, Switzerland to initiate revision of the WHO Recommendations (formerly, Requirements) for YF vaccine published in WHO Technical Report Series number 872 (1998). The Working Group, consisting of experts from academia, industry, national regulatory authorities and national control laboratories, reviewed the latest issues of safety, efficacy and quality of YF vaccines and agreed that (i) the revision should focus on live attenuated YF vaccine virus 17D lineage; and that (ii) nonclinical and clinical guidelines for new vaccines prepared from 17D lineage be developed.
KW - Recommendations
KW - World Health Organization
KW - Yellow fever vaccine
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U2 - 10.1016/j.vaccine.2010.10.070
DO - 10.1016/j.vaccine.2010.10.070
M3 - Article
C2 - 21055492
AN - SCOPUS:78649725860
SN - 0264-410X
VL - 28
SP - 8236
EP - 8245
JO - Vaccine
JF - Vaccine
IS - 52
ER -