NRx Pharmaceuticals announced it is kicking off a Phase IIb trial for Israel’s BriLife coronavirus vaccine in the country of Georgia.
“The vaccines are shipping as we speak,” NRx chairman Prof. Jonathan Javitt told The Jerusalem Post.
The vaccine was developed by the Israel Institute for Biological Research (IIBR). Last month, the institute signed an agreement with Nasdaq-traded NRx to help fast-track the vaccine, which has been plagued by delays for more than a year.
The original hope was to have the vaccine available by this summer. Javitt told the Post that the goal is to launch a Phase III trial by October. That trial will be across multiple countries, including Georgia and Ukraine, and will include up to 30,000 people.
According to a release by NRx, the purpose of the Phase IIb study is to “confirm the vaccine’s ability to generate an immune response against the COVID-19 Delta variant, prior to entering Phase III trials in multiple nations.”
“As the Delta and subsequent variants continue to threaten the immunity generated by first-generation vaccines, we hope that this new vector-based approach may offer enhanced immunity,” Javitt said.
Around 300 people are expected to participate in the intramuscular or traditional injection arm of the trial. The trial will also incorporate a potential intradermal vaccination option where a small quantity of vaccine is placed into the skin instead of a traditional needle injection into a muscle. About 100 people should be involved in that arm.
The trial is being conducted with oversight from the Senator Richard Lugar Center for Public Health Research in Tbilisi.
“IIBR will accompany the process and will continue to provide scientific knowledge in order to complete the trials,” a spokesperson for the Defense Ministry was quoted as saying in the release.
The Defense Ministry declined a request for an added comment by the Post.
NRx has exclusive worldwide development, manufacturing, and marketing rights for BriLife. The company has committed to supplying Israel with any required doses of the vaccine if and when it is completed.
At the same time, Israel is completing its own Phase II trials at hospitals across the country, led by Sheba Medical Center in Tel Hashomer. Javitt said the Phase IIa trial is done, and Israel is close to finishing enrollment in its own Phase IIb trial.
IIBR operates under the auspices of the Prime Minister’s Office and works closely with the Defense Ministry. BriLife is a Hebrew play on words: the “bri” is the first part of the Hebrew word for health; the “il” stands for Israel and “life.”
BriLife is a vector-based vaccine. The vaccine takes the vesicular stomatitis virus (VSV) and genetically engineers it so that it will express the spike protein of the novel coronavirus on its envelope.
Once injected, it does not cause a disease by itself. VSV does not infect humans; instead, the body recognizes the spike protein that is expressed on the envelope and begins to develop an immunological response.
Javitt said that the BriLife vaccine is different from the mRNA vaccines made by Pfizer and Moderna in that it presents the entire COVID-19 spike protein to the body’s immune system. Also, because it is a self-propagating, live-virus vaccine, it can be updated to address new variants.
“Our reason for embarking on this project, even though there are already COVID vaccines in the world, is that we believe the BriLife vaccine may have better ability to deal with variants of the COVID virus than original first-generation vaccines,” Javitt said. “Of course, until we do the clinical research, we have no way to know if that aspiration is true.”