BiondVax Pharmaceuticals Ltd (BVXV)

[midastouch017]

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

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 https://www.id-hub.com/2017/03/09/strategy-approving-universal-flu-vaccine/.

The article complements a recently published article in Vaccine which discusses M-001's mechanism of action. (http://www.biondvax.com/2017/01/back-to-the-future-study-published-in-vaccine-journal-indicates-biondvaxs-universal-flu-vaccine-candidate-may-cover-strains-which-dont-yet-exist/).