VBI Vaccines Gets UK MHRA Approval for Its PreHevbri Adult Hepatitis B Vaccine
The UK’s Medicines and Healthcare products Regulatory Agency has approved VBI Vaccines’ PreHevbri three-antigen vaccine for immunization of adults against infection by all known subtypes of the hepatitis B virus.
The approval was supported by positive safety and immunization data from two phase 3 studies. VBI said it also expects the vaccine to protect against hepatitis D, which does not occur in the absence of hepatitis B infection.
PreHevbri will be available in the UK by early next year, the company said.
The vaccine gained EU marketing authorization in April and was approved late last year by the FDA, branded as PreHevbrio.
June 7, 2022
