Participants in High Dose BriLife™ Investigational Vaccine Trial for COVID-19 Advised Booster Not Necessary
NRx Pharmaceuticals (NRXP) reported that participants in the high-dose BriLife vaccine trial for COVID-19 have been informed they do not require a booster dose, as their immunity remains robust six months post-second dose. In contrast, those who received lower doses are advised to get a booster from Pfizer or Moderna. CEO Prof. Jonathan Javitt indicated preparations for a Phase 2b/3 protocol submission for BriLife are underway. The vaccine is a self-propagating, live-virus variant designed to adapt against evolving COVID-19 strains.
- High-dose BriLife vaccine trial participants do not need a booster dose due to sustained immunity.
- Phase 2b/3 protocol submission for BriLife is being prepared, indicating ongoing development.
- Participants with lower doses of BriLife require a Pfizer or Moderna booster, suggesting inadequate long-term protection.
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.
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 Pharmaceuticals (NRx) draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. In July 2021, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID vaccine developed by the Israel Institute for Biological Research.
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
This announcement of NRx Pharmaceuticals, Inc. includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may include, but are not limited to, statements regarding our financial outlook, product development, business prospects, and market and industry trends and conditions, as well as the company's strategies, plans, objectives, and goals. These forward-looking statements are based on current beliefs, expectations, estimates, forecasts, and projections of, as well as assumptions made by, and information currently available to, the company's management.
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:
Jack Hirschfield
Head of External Affairs, NRx
jhirschfield@nrxpharma.com
512-674-5163
INVESTOR RELATIONS
John Mullaly
LifeSci Advisors
jmullaly@lifesciadvisors.com
617-429-3548
2 VSV Delta G
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SOURCE NRx Pharmaceuticals
FAQ
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