BriLife (IIBR-100) Vaccine Description
The Brilife (IIBR-100) vaccine candidate contains a recombinant vesicular stomatitis virus (VSV), an animal virus that does not cause disease in humans. The spike protein was replaced with that of SARS-CoV-2 that “results in rapid and potent induction of neutralizing antibodies against the SARS-CoV-2 coronavirus.”
Brilife (VSV ΔG) is a vector-based vaccine that takes VSV and genetically engineers to express the spike protein of the SARS-CoV-2 beta coronavirus on its envelope. The human body recognizes the spike protein expressed on the envelope and begins to develop an immunological response.
The vaccine differs from other COVID-19 vaccines by presenting the entire COVID-19 spike protein to the body's immune system. The spike protein complex from variants may be added to the BriLife vaccine as new variants are discovered. The BriLife™ vaccine also differs from other COVID-19 vaccine approaches. It is a self-propagating, live-virus vaccine that may be updated to address new variants of COVID-19 more rapidly than some other vaccine platforms.
In its collaboration with NRx, announced on July 12, 2021, the Israel Institute for Biological Research (IIBR) will provide technical assistance while receiving customary royalty and milestone payments for its intellectual property. NRx has further committed to supplying all required doses of the vaccine for the population of Israel. The initiative was led by NRx Chairman and CEO Jonathan Javitt and NRx Director Chaim Hurvitz, who chairs CH Health, an Israeli Private Equity group.
NRx has committed to supplying all required doses of the vaccine for the population of Israel.
BriLife (IIBR-100) Vaccine History
On June 19, 2020, a non-peer-reviewed study concluded the vaccine 'generated rVSV-ΔG-spike, a recombinant replication-competent VSV-based vaccine candidate expressing the SARS-CoV-2 spike protein. The rVSV-ΔG-spike resembles the SARS-CoV-2 in spike expression properties, antigenicity, and ability to induce neutralizing antibody production. Moreover, single-dose vaccination of hamsters with rVSV-ΔG-spike elicits a safe, effective, and sufficient neutralizing antibody response against the SARS-CoV-2 challenge.
The IIBR-100 vaccination protected SARS-CoV-2 inoculation, manifested in the rapid return to normal physiological parameters lung protection and rapid viral clearance. These results pave the way for further examination of rVSV-ΔGspike in clinical trials as a vaccine against SARS-CoV-2.'
“Our final goal is 15 million doses for the residents of the State of Israel and our close neighbors,” said Prof. Shmuel Shapira, director of the Israel Institute for Biological research, reported to local media on October 26, 2020. Sheba Medical Center and Hadassah Medical Center stated they were chosen for a COVID-19 vaccine's initial trials. Both of these Israeli hospitals were selected because they have large facilities for clinical research.
On November 27, 2020, Jerusalem Post reported, “We are pleased to announce that the first phase of the clinical research trial of the coronavirus vaccine was a success,” said the director of the clinical research unit at Hadassah, Prof. Yossi Karko.
“As a physician and public health professional, I am inspired by the privilege of collaborating with an institution whose scientific roots date to Jonas Salk and the fight against Polio,” said Prof Jonathan C Javitt, M.D., MPH, CEO, and Chairman of NRx, who has been involved in the fight against Coronaviruses since the 2002 SARS epidemic, in a press statement issued on July 12, 2021. “In its first year, the COVID pandemic has killed four million people worldwide, constituting the worst public health catastrophe since the 1918 Influenza epidemic. As the virus mutates and challenges the immunity we have built through first-generation vaccines, we are excited to expand our focus on COVID by including a vaccine platform that has potential to scale at high speed and low cost.”
Prof Jonathan Javitt added on August 9, 2021, "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."
The Israel Institute for Biological research (IIBR) was established in 1952 as a governmental research institute founded by scientists from the IDF Science Corps and academic organizations under Isreal's Prime Minister's Office. IIBR is located in the city of Ness Ziona, Israel.
NRx (www.nrxpharma.com) (Nasdaq: NRXP) 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 and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services, and the Medical Countermeasures program of the US Department of Defense.
BriLife (IIBR-100) Vaccine Cell Line
BriLife (IIBR-100) Vaccine uses the following cell lines: Design and Development of BriLife (IIBR-100): BHK hamster cells, Vero monkey cells; Production: Vero Monkey Cells; Confirmatory Lab Tests: Plaque reduction; immunofluorescence, Vero monkey cells.
BriLife (IIBR-100) Vaccine Indication
Brilife (IIBR-100) is indicated to prevent COVID-19 infection with the new coronavirus known as SARS-CoV-2. However, no pediatric, oncology or pregnancy vaccine efficacy has been disclosed.
BriLife (IIBR-100) Vaccine Dosage
Media reported on August 23, 2021, 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.
BriLife (IIBR-100) Vaccine News
October 3, 2021 - In an interview with The Jerusalem Post, the father of Israel’s BriLife coronavirus vaccine, Prof. Shmuel Shapira, predicted that when the country’s vaccine is ready, “it will be better” than what its citizens have today.
September 18, 2021 - JPost reported the BriLife vaccine Phase II clinical trial was closed, according to Eytan Ben-Ami, head of early phase clinical trials at Sheba Medical Center. The data from the trial of more than 700 people should be analyzed in October 2021.
September 10, 2021 - NRX Pharmaceuticals, Inc. Form S-1 (Form 8-K) relevant excerpts - The BriLife vaccine has demonstrated a statistically significant increase in COVID-neutralizing antibody - a sign of immunity to SARS-CoV-2 - compared to placebo in Phase 2a trials conducted in Israel and is currently completing Phase 2b dose-ranging trials in Israel and Georgia.'
September 8, 2021 - NRx Pharmaceuticals to Participate in H.C. Wainwright 23rd Annual Global Investment Conference on September 13-15, 2021.
September 1, 2021 - Local media reported Tamir Pardo, a former head of the Mossad, joined the board of directors of NeuroRX, which plans to bring the BriLife COVID-19 vaccine to market.
August 24, 2021 - NRx Pharmaceuticals (Nasdaq: NRXP) announced it had completed its previously announced private placement. The gross proceeds from the private placement were $30 million before deducting placement agent fees and other offering expenses.
August 23, 2021 - NRx announced today Israeli media reported 230 volunteers who received the highest dosage of the Brilife 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 in the High Dose BriLife Investigational Vaccine Trial who received lower doses of the BriLife vaccine have been advised to get a booster vaccination with either Pfizer or Moderna vaccines, as those lower dosages do not appear to offer sufficient long-term protection.
August 15, 2021 - The Israeli Defense Ministry announced that over 1,000 vials of Israel’s BriLife coronavirus vaccine were delivered to Georgia to launch an expansion of phase 2 clinical trial, as reported by The Jerusalem Post.
August 9, 2021 - NRx Pharmaceuticals announced it is initiating a phase 2b dose-confirmatory clinical trial of the BriLife™ vaccine against COVID-19 in the Nation of Georgia. The purpose of the study is to confirm the vaccine's ability to generate an immune response against the COVID-19 Delta variant before entering phase 3 trials in multiple nations. The phase 2b program 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.
July 12, 2021 - NRx Pharmaceuticals (Nasdaq: NRXP), a clinical-stage pharmaceutical company, announced today that it had signed a Memorandum Of Understanding with the Government of Israel to license exclusive worldwide development, manufacturing, and marketing rights to a novel Coronavirus vaccine developed by the Israel Institute for Biological Research. NRx has Arranged for Rapid Phase 2b/3 Testing in Israel, the Nation of Georgia, and Ukraine with Support of the National Governments, Health Ministries, and Cromos, LLC.
May 12, 2021 - A team from Hadassah Hebrew University Medical Center in Jerusalem explores the possibility of starting a Phase III trial of the BriLife Covid-19 vaccine in Argentina.
May 11, 2021 - Local media reported the Chief of Staff and the Argentina Minister of Health met with experts from Israel to analyze "the possibility of being strategic partners in the development of the candidate vaccine" of that country against the coronavirus.
May 4, 2021 - Haaretz reported that Israel’s Biological Research is considering restarting its ongoing clinical trial. According to sources, it became apparent from the first and second phases of the clinical trials on the two-shot Israeli BriLife vaccine that it would be possible to forgo the second shot if patients were given a higher dose in a single injection. The Nes Tziona-based institute plans to move its clinical trials from Israel to Argentina.
April 22, 2021 - The Jerusalem Post reported the Phase II trial for the experimental BriLife vaccine paused for two months while scientists prepared a higher dose of the vaccine.
March 15, 2021 - Jerusalem’s Hadassah-University Medical Center signed a letter of intent to carry out at least part of the Phase III trial of Israel’s BriLife vaccine candidate in Brazil, a top Hadassah doctor has told The Jerusalem Post.
March 4, 2021 - Local media reported Hadassah Director-General Prof. Zeev Rotstein has called on Defense Minister Benny Gantz to allow Israelis who participated in the trial of the Israeli coronavirus vaccine to receive a green passport.
January 14, 2021 - Volunteers flock to Phase II trials for Israel’s BriLife COVID-19 vaccine. The Ness Ziona-based Israel Institute for Biological Research (IIBR), which operates under the Defense Ministry, developed the BriLife vaccine. Unlike Pfizer and Moderna, the IIBR vaccine uses recombinant vesicular stomatitis virus, an animal virus that does not cause disease in humans. It is similar to the model of a separate vaccine proven to be successful against the deadly Ebola virus.
January 5, 2021 - Local media reported the first person to receive a dose of BriLife vaccine's expanded Phase II trial was inoculated at Barzilai Medical Center in Ashkelon. Volunteers had already been inoculated at Sheba Medical Center, Tel Hashomer, and Hadassah-University Medical Center, where the Phase I trial took place.
December 29, 2020 - As the Phase II trial for Israel’s Brilife vaccine got underway at Sheba Medical Center, Dr. Eytan Ben Ami, overseeing the testing, admitted that Israel’s move toward COVID-19 safety is creating new challenges. Israel is racing to become the first country in the world with herd immunity. Some 10 million doses of Pfizer and Moderna vaccines are reportedly scheduled to arrive in the coming months.
December 14, 2020 - The Israeli Health Ministry has approved the Phase II clinical trial launch for the Israel Institute of Biological Research’s coronavirus vaccine candidate, Brilife. The trial begins at Sheba Medical Center, Tel Hashomer, and then expanded to other medical centers across the country.
November 30, 2020 - Speaking at the Knesset on Monday, Israel Institute for Biological Research head Dr. Shmuel Shapira said that “we should have been in Phase III, and now we will only reach it by April."
November 27, 2020 - Hadassah-University Medical Center and Sheba Medical Center reported that they had administered the Brilife coronavirus vaccine candidate to 80 volunteers, thus completing the Phase I clinical trial.
November 14, 2020 - Hadassah-University Medical Center has vaccinated 23 people against the novel coronavirus using the Israel Institute for Biological Research’s coronavirus vaccine candidate Brilife, the hospital said Friday. “All 23 participants in their 20s to 50s have had the vaccine in the last two weeks and are feeling well,” said Prof. Yossi Karko, director of the Center for Clinical Research at Hadassah. “They have not suffered from any unusual side effects or medical problems following the vaccine, other than temporary sensitivity at the site of injection – as expected.”
November 8, 2020 - Four women selected to participate in the human trial of "Brilife," the Israeli Institute for Biological Research's coronavirus vaccine, were vaccinated at Hadassah University Medical Center in Jerusalem Ein Kerem. All four women were in their 20s - 30s and had been medically tested and found suitable to participate in the trial.
November 1, 2020 - The human trial of Brilife, its coronavirus vaccine candidate, launched by injecting two people – one at Hadassah-University Medical Center in Jerusalem's Ein Kerem and one at Sheba Medical Center at Tel Hashomer.
October 26, 2020 - Testing the BriLife vaccine developed at Israel Institute for Biological Research on healthy volunteers has begun at Hadassah and Sheba medical centers.
October 20, 2020 - Israel names its coronavirus vaccine candidate: Brilife.
June 21, 2020 - ISRAEL21c reported that a single dose of the IIBR’s recombinant VSV-∆G-spike vaccine “results in rapid and potent induction of neutralizing antibodies against SARS-CoV-2” in Syrian golden hamsters in a successful preclinical trial. It was also tested successfully in mice, rabbits, and pigs, paving the way to human trials.
BriLife (IIBR-100) Vaccine Clinical Trials
BriLife (IIBR-100) continues in clinical trials.
This Phase IIb/3, prospective, randomized, comparator-controlled, observer-blind, multi-center non-inferiority study was last updated in September 2021. Subjects will receive two intramuscular (IM) injections of the IIBR-100 (prime-boost) separated by 28 days consisted of 1 ml replicating viral rVSV SARS-CoV-2-S vaccine or active comparator. The injection will be performed at Day 0 and Day 28±2d in the deltoid muscle and will be followed through 12 months post-last vaccination.