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.
RADNOR, Pa., Aug. 23, 2021 /PRNewswire/ -- 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™ 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™ vaccine (technical name VSV ΔG22) 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. About NRx Pharmaceuticals NRx is led by executives who have held senior roles at Allergan, J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired by Prof Jonathan Javitt, MD, MPH, who has held leadership roles in six biotechnology startup companies with public exits and been appointed to advisory roles in four US Presidential Administrations. The NRx board includes Dr. Sherry Glied, former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the US FDA, Chaim Hurvitz, former director of Teva and President of the Teva International Group, and General H.R. McMaster, Ph.D. (US Army, Ret.) the 26th United States National Security Advisor. Cautionary Note Regarding Forward-Looking Statements The company assumes no obligation to revise any forward-looking statement, whether as a result of new information, future events or otherwise. Accordingly, you should not place reliance on any forward-looking statement, and all forward-looking statements are herein qualified by reference to the cautionary statements set forth above. CORPORATE CONTACT: INVESTOR RELATIONS 2 VSV Delta G
SOURCE NRx Pharmaceuticals |
||
Company Codes: NASDAQ-NMS:NRXP |