Vaccines

Through great effort and long anticipation, a newly developed World Health Organization (WHO) Recommendations to assure the quality, safety and efficacy of recombinant hepatitis E vaccines was finally adopted by WHO Expert Committee on Biological Standardization (ECBS) in the first week of November 2018. The final version of the document is now posted on WHO website of biologicals and will be published in WHO Technical Report Series (TRS) in due time next year (2019).

Participants were drawn from academia, national regulatory authorities (NRAs), national control laboratories (NCLs) and Industry to draft and develop this important document, including the team from National Institute of Diagnostics and Vaccine Development in Infectious Diseases (NIDVD), XMU and Xiamen Innovax Biotech Co., Ltd. (INNOVAX).  

INNOVAX is the producer of Hecolin®, the only available hepatitis E vaccine today.

These WHO Recommendations provide guidance to NRAs and manufacturers on the

manufacturing process, and on nonclinical and clinical aspects, to assure the quality, safety

and efficacy of recombinant hepatitis E vaccines.

This document will now enable licensing, subsequent prequalification and use of hepatitis E vaccines in Gavi support areas and HE outbreak setting to prevent HEV infection. This opens the door for INNOVAX to accomplish its commitment to increasing the availability of high quality innovative vaccines to combat infectious diseases globally.

Find more information at WHO website of biologicals:  http://www.who.int/biologicals/WHO_ECBS/en/