E An Update On VBI Vaccines Inc: What's Happened And What It Means

Because the drug is already approved in fifteen countries, and based on the fact that it's one of two standard of care infant administration hepatitis B vaccines in Israel (50% of babies get Sci-B-Vac, the other 50% get Engerix), there's a wealth of safety and efficacy data available already. It's been used as a real world vaccine in more than 300,000 patients, and there's a wealth of clinically evaluated safety and efficacy data that includes more than 20 clinical trials, spread across more than 3,000 patients.

The hope was that VBI would be able to collate this data and use it as supportive of safety and efficacy in its registration applications to the respective regulatory entities in its target approval regions. If this was the case, a confirmatory efficacy study would be all that would be required to complete the application, and it would essentially mean that VBI could skip the early to mid stage clinical trial requirements of the standard approval pathway.

At the time of my previous coverage of this one, it was unclear whether this would play out as hoped.

Since that coverage, VBI has updated markets as to the progress of its regulatory pathways in both Canada and Europe, and these updates are supportive of the above discussed shortened development pathway.

First, the company announced that, on the back of discussions with the EMA, a phase III study, combined with the already available data, would be enough to support a registration application in Europe.  A few weeks, later, VBI put out a second release, detailing an almost identical situation in Canada.

Alongside both releases, management outlined the fact that it expects one phase III study will be enough to cover both applications, and that it is working to bring the program in the US up to speed with that of Canada and Europe parallel to its efforts in the two latter regions.

The takeaway here, then, is that VBI's hepatitis B program is progressing exactly in line with expectations. The next major catalyst is confirmation from the FDA that this is the case, which will bring the US in line with Europe and Canada, and will pave the way for initiation of the pivotal trial that's required to get the drug into these markets. 

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Bill Myers 1 year ago Member's comment

Thanks for the update.