Israeli Vaccine to Launch Phase 2b/3 Trial after Top Safety Score

NRx Pharmaceuticals has been working on the BriLife vaccine for COVID-19 and was informed on Monday that the Data Safety Monitoring Board, which is overseeing the vaccine’s phase 2 trial, had gotten positive results in the safety analysis. Therefore, the company announced that it would now take its plans of initiating a phase 2b/3 trial of the vaccine forward. The company disclosed that they were expecting a report in the next few days. The World Health Organization (WHO) and the European Medicines Agency have provided guidance to NRx in regard to the design of its upcoming trial. 

The trial will be run in Israel, along with the country of Georgia and they would add other locations in the United States and the European Union after inoculating the initial volunteers of the 2b phase. Professor Jonathan Javitt, the CEO of NRx said that they were looking forward to conduct a multi-nation trial for their vaccine at a time when new variants are challenging the immunity that has been developed through the roll out of the first-generation vaccines. The trial will compare BriLife to a vaccine that has already been approved, which is referred to as a non-inferiority study. 

The company revealed that there had been increased interest in participation in the study after the neutralizing antibody tests conducted by the Israeli Institute of Biological Research indicated that the vaccine was effective against the Delta variant. Currently, they are evaluating the vaccine against the Omicron variant as well. Moderna and Pfizer have produced the mRNA vaccines, but the BriLife vaccine is vector-based. This means that it genetically engineers the vesicular stomatitis virus (VSV), which enables it to express the spike protein of COVID-19 on its envelope. The vaccine does not cause a disease once it has been injected, as the VSV does not inflict any harm in human beings.

The spike protein that’s expressed on the envelope is recognized by the body and it starts developing an immunological response. According to the company, BriLife will be able to lead to a more robust immune response because it presents the whole spike protein complex to the immune system in the body. Furthermore, it can even present several variants of the spike protein of the coronavirus simultaneously, as opposed to vaccines that either provide a single variant or even just a portion of the spike protein’s single variant. 

In addition, the BriLife vaccines also binds to the nasal cavity and lung’s specific cells that are targeted by the coronavirus. As per NRx, this could allow the vaccine to develop a level of tissue immunity that could prevent vaccinated individuals from contracting and spreading the disease. Even though the traditional injection will initially be used for delivering the vaccine, it is possible that it could be developed as a nasal spray as well, considering that it binds to cells lining the respiratory tract. Javitt said that they were ‘optimistic’ about the vaccine being durable against new variants as they surface and long-lived in the immunity it provides.