BiondVax Publishes Regulatory Approval Strategy for Novel Universal Flu Vaccines in Future Virology Journal

Monday, March 13, 2017 Drug News
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NESS ZIONA, Israel, March 13, 2017 /PRNewswire/ --

BiondVax Pharmaceuticals Ltd. (NASDAQ:

BVXV, TASE: BVXV),  a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, reports the publication this week of an article by BiondVax-affiliated authors titled, "Strategy for
approving a universal flu vaccine
" in the peer reviewed journal Future Virology.

The article proposes a process for regulatory and marketing approval for next-generation influenza vaccines such as M-001. Current flu vaccines are strain-specific, and existing regulatory approval pathways are not directly applicable to M-001's unique method of action, which is designed to protect against current and future seasonal and pandemic flu strains.

The authors propose a step-wise regulatory strategy in which the novel vaccine is initially approved for use prior to flu season and followed, when available, by currently recommended strain-specific vaccines. Applied in this manner, human clinical trials have shown M-001 broadens and enhances the action of current flu vaccines. This is of particular importance for the elderly who, despite high seasonal flu vaccination rates suffer disproportionately from flu illness. Ultimately, based on clinical efficacy trials, M-001 will be approved as a standalone flu vaccine, potentially replacing existing seasonal strain-based vaccines.

Dr. Tamar Ben-Yedidia, BiondVax's Chief Scientist and the article's lead author, commented, "In many ways, our universal flu vaccine candidate is blazing a trail. Heeding messages from European and American regulatory experts, we have identified what we believe to be the safest and most efficient path for bringing M-001 to the market. Publication in a peer-reviewed journal is a strong sign of support for our plans."

The Future Virology article is available for free to registered users via Infectious Diseases Hub at

The article complements a recently published article in Vaccine which discusses M-001's mechanism of action. (

About BiondVax Pharmaceuticals Ltd 

BiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit

Forward Looking Statements 

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the uncertainty of the regulatory approval process, the results of the current Phase 2 and contemplated Phase 3 trials, general business conditions in the industry, changes in regulatory and legal compliance environments in which BiondVax engages, the adequacy of available cash resources to fund product development and commercialization, and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.  

For further information, please contact: Joshua E. Phillipson Business Development +972-8-930-2529 x5105

SOURCE BiondVax Pharmaceuticals Ltd.


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