WHO consultation on clinical evaluation of vaccines, 17-18 July 2014, WHO Headquarters, Geneva, Switzerland.
A World Health Organization (WHO) consultation on guidelines for National Regulatory Authorities (NRAs) and vaccine manufacturers on clinical evaluation of vaccines was held from 17 to 18 July 2014, to review key scientific challenges that regulators have been facing since the establishment of the WHO Guidelines on Clinical Evaluation of Vaccines. The guidelines, adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2001, have served as the basis for setting or updating national requirements for the evaluation and licensing of a broad range of vaccines as well as for WHO vaccine prequalification. Regulators from Australia, Brazil, China, Canada, Germany, India, Republic of Korea, South Africa, United States of America and the United Kingdom were represented. The International Federation for Pharmaceutical Manufacturers' Association (IFPMA) and the Developing Country Vaccine Manufacturers' Network (DCVMN) provided industry representation. The consultation concluded that the guidelines should be revised to address issues that were raised in the context of vaccines that were the subject of clinical development in the past decade. Although the current guidelines have served well over time, it was recognized that an update would further increase their utility and would help regulators, manufacturers, vaccine developers and academia to respond to the challenging questions regarding the safety, immunogenicity, efficacy and effectiveness of vaccines intended for global use. A summary of the main outcomes of the consultation and proposals for the next steps regarding the guidelines and beyond are provided in this report.
World Health Organization (WHO), Geneva, Switzerland. Electronic address: knezevici@who.int.
Ivana
I
Knezevic
World Health Organization (WHO), Geneva, Switzerland.
Vasee
V
Moorthy
Grimalkin Partners, Silver Spring, MD, United States.
Rebecca
R
Sheets
D002986:Clinical Trials as Topic; D017277:Drug Approval; D004345:Drug Industry / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control; D014612:Vaccines / Q000592:standards*; D014944:World Health Organization
D014612:Vaccines
Clinical trials; Regulatory guidance; Scientific challenges; Vaccines; WHO