Recommendations to assure the quality, safety and efficacy of recombinant Hepatitis E vaccines, Annex 2, TRS No 1016

Overview

The WHO Strategic Advisory Group of Experts on Immunization (SAGE) issued a position paper in 2015 which reviewed existing evidence on the burden of hepatitis E and on the safety, immunogenicity, efficacy and cost-effectiveness of a hepatitis E vaccine that was first licensed in China. This vaccine contains the HEV open reading frame 2 (ORF2) capsid protein, corresponding to amino acids 368–606 of ORF2, manufactured in Escherichia coli using recombinant technology. The WHO Global Advisory Committee on Vaccine Safety (GACVS) had reviewed this same hepatitis E vaccine in 2014 and concluded that it had an acceptable safety profile. In 2016, WHO published its Global health sector strategy on viral hepatitis 2016–2021, which addresses hepatitis A, B, C and E. Hepatitis E is probably the most neglected of the four. This strategy document highlights the urgent need to address all viral hepatitis, including hepatitis E for which only one vaccine is approved anywhere in the world and for which no effective therapies exist.

The document encompasses recombinant hepatitis E vaccines for prophylactic use based on the ORF2 capsid protein. The document should be read in conjunction with other relevant WHO guidance, especially on the nonclinical and clinical evaluation of vaccines. Other WHO guidance should also be considered, including – as appropriate to the vaccine – guidance on the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks and on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines.

Full version of  WHO Technical Report Series No. 1016