Guidelines to Assure the Quality, Safety and Efficacy of Recombinant Human Papillomavirus Virus-Like Particle Vaccines
The World Health Organization convened two meetings in Geneva in 2006 where scientific experts, regulatory professionals, and other stakeholders met to develop guidelines for prophylactic human papillomavirus (HPV) vaccines. This technical document is intended to provide background and guidance to national regulatory authorities and vaccine manufacturers on the production, quality control, and evaluation of the safety and efficacy of recombinant HPV virus-like particle vaccines. It includes recommendations for manufacturing, clinical and nonclinical evaluation, and regulatory guidelines.
Author(s): World Health Organization Expert Committee on Biological Standardization
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