Regulatory Decision Summary for PreHevbrio
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to gain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for PreHevbrio, submitted by VBI Vaccines Inc., for the following indication:
- PreHevbrio (3-antigen, recombinant Hepatitis B vaccine) is indicated for active immunization against infection caused by all known subtypes of hepatitis B virus in adults. It can be expected that hepatitis D will also be prevented by immunization with PreHevbrio as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
After evaluation of the submitted data package, Health Canada authorized the indication below:
- PreHevbrio (3-antigen, recombinant Hepatitis B vaccine) is indicated for active immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. It can be expected that hepatitis D will also be prevented by immunization with PreHevbrio as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Why was the decision issued?
Two phase 3 pivotal studies (Sci-B-Vac-001 and Sci-B-Vac-002) were submitted in support of PreHevbrio marketing authorization. The total number of volunteers enrolled was 4,445 adults from 18 to ≥ 65 years old. The studies demonstrated non-inferiority of PreHevbrio when compared to Engerix B (another hepatitis B vaccine).
Safety data from the studies demonstrates an acceptable safety profile for PreHevbrio. Although PreHevbrio was moderately more reactogenic than Engerix-B, the vast majority of reactions were mild or moderate in severity and resolved quickly.
There were no serious adverse events (SAE) considered causally related to PreHevbrio.
An updated Risk Management Plan (RMP) for PreHevbrio was reviewed by Health Canada and considered acceptable.
The chemistry and manufacturing information submitted for PreHevbrio has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
In conclusion, the benefit risk assessment for PreHevbrio is favorable and supports the use of PreHevbrio in subjects aged 18 years and older. A Notice of Compliance (NOC) was issued.
For further details about PreHevbrio, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| PREHEVBRIO | 02533286 | VBI VACCINES INC. | HEPATITIS B SURFACE ANTIGEN (RECOMBINANT) 10 MCG / ML |