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The NIAID of the NIH completed the Clinical Study Report (CSR) of a Phase 2 clinical trial of the BiondVax’s M-001 universal influenza vaccine candidate. The trial in 120 adult volunteers was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). As indicated when the preliminary trial data was published earlier this year, both primary objectives of the trial, to assess the safety and T cell immune responses to M 001, were achieved. The CSR concludes that “M-001 was safe in this study” and that “M-001 induced significant polyfunctional T cell responses.”

BiondVax Pharmaceuticals is a biopharmaceutical company developing a universal influenza vaccine (M-001) designed to protect individuals from all strains of influenza. The company’s strategy for commercializing M-001 involves testing it in a pivotal Phase 3 program as a standalone influenza vaccine to assess its clinical efficacy. The ongoing Phase 3 trial is being conducted in Europe following feedback about the trial design and approval to initiate it from the European Medicines Agency (EMA). The EMA also stated that “a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza like illness (ILI) could suffice for an approval”.

Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, commented, “We are grateful for the opportunity to collaborate with NIAID and thank them for their professionalism and partnership. We also are grateful to the investigators and their teams, and to the 120 volunteers who participated in this trial. It is exciting that data from this Phase 2 trial conducted in the U.S. confirm safety and cellular immune response results, as have six previously completed clinical trials of M-001.”

The NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application (IND), and NIAID’s Division of Microbiology and Infectious Diseases (DMID) has submitted the final CSR to the FDA. NIAID has communicated to BiondVax that the study’s lead investigator may prepare a manuscript for publication sometime in the future.

The published data are available at The trial was supported through NIAID awards #HHSN272201300016I, HHSN272201300015I, HHSN272201300020I, and HHSN272201300021I.

Instead of relying on people to get vaccinated every year, BiondVax is getting closer to a universal flu vaccine, a flu vaccine that would last through multiple seasons.

“It will be a game-changer,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health. “It also would very likely be a much more effective vaccine than the ones we have to make each year, hoping that we guess accurately as to what the influenza virus that season will be.”

For a universal flu vaccine to work, it has to target certain parts of the virus that don’t change much from season to season, and that’s no easy task.

There’s even a possibility it might not work.

“We’ll know probably by the end of 2020, the beginning of 2021, whether or not we do have a successful universal flu vaccine,” Fauci said.

In parallel, BiondVax’s pivotal, clinical efficacy, Phase 3 trial in Europe is ongoing. The trial, which is assessing M-001’s ability to provide clinical protection from circulating influenza strains, is being conducted in more than 12,400 volunteers aged 50+ (with half aged 65+) over two flu seasons in seven countries. Results of the pivotal Phase 3 trial are expected by the end of 2020.

While the development of M-001 is not directly related to the current coronavirus outbreak, what the COVID19 pandemic shows is that an effective universal influenza vaccine could help to alleviate the overall burden on healthcare systems around the world, thereby making it easier to handle novel viral outbreaks, such as SARS-CoV-2. In the current environment, an effective universal influenza vaccine could both reduce the number of individuals experiencing influenza-like illnesses, thus making it easier to identify those suffering from the novel coronavirus, and reduce the rates of hospitalization for those suffering from influenza, thus freeing up valuable hospital resources

About BiondVax

BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit

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