Benzinga | Aug 23, 2021 09:36AM EDT

NRx Pharma Highlights Reports In Israeli Media Participants In Its BriLife Vaccine Trial Were Notified By Local Health Authorities That They Did Not Need a Third Booster Dose Of The Vaccine 6 Months After Second Dose

NRx Pharmaceuticals (NRx) (Nasdaq: NRXP), a clinical stage, biopharmaceutical company noted today reports1 in the Israeli media that participants in the BriLife vaccine trial who received the highest dose vaccine were notified by local health authorities they did not need a third, booster dose of the vaccine as their protection remained high, six months after getting a second dose. Trial surveillance continues and this guidance may change in the future.



Participants in High Dose BriLife(tm) Investigational Vaccine Trial for COVID-19 Advised Booster Not Necessary

Media reported 230 volunteers who received the highest dosage of the vaccine, developed by the Israel Institute for Biological Research were notified that they did not need a third dose of the vaccine as their protection remained high, six months after getting a second dose.

Participants who received lower doses of the BriLife vaccine have been advised to get a booster vaccination with Pfizer or Moderna shots, as those lower dosages do not appear to offer sufficient long-term protection.

"These reports, based on medical determinations made at local level suggest potential performance of the BriLife vaccine at a time when ICUs around the world are racing to capacity," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of NRx. "With this new information, and more expected in the coming weeks, we are preparing to submit a phase 2b/3 protocol for BriLife against an established active comparator."

The BriLife vaccine differs from other COVID-19 vaccines by presenting the entire COVID-19 spike protein to the body's immune system. It also differs from other COVID-19 vaccine approaches in that it is a self-propagating, live-virus vaccine in which the spike protein of the vaccine appears to evolve in a manner consistent with the evolution of the SARS-CoV-2 virus in nature. Thus, while variants may arise that support manual enrichment of the vaccine against those specific variants, the vaccine itself may continue to evolve in a manner that provides ongoing protection against variants.

The BriLife(tm) vaccine (technical name VSV ?G22) is based on a previous, FDA-approved vaccine platform that was further optimized by the Israel Institute for Biological Research targeted towards COVID-19.

NRx has signed a Memorandum of Understanding with the Israel Ministry of Defense under which NRx has exclusive worldwide rights to develop and market the BriLife vaccine in exchange for customary royalty and milestone payments.