FDA Clearance Given to Intranasal Anthrax Vaccine

Published Online: Tuesday, October 29th, 2019
Officials from the FDA have cleared an investigational new drug (IND) application for BW-1010 (BlueWillow Biologics), according to the company. The drug would be the company’s next-generation anthrax vaccine candidate.
A Phase 1 clinical study is expected to begin enrollment this year, with funding by the National Institute of Allergy and Infectious Diseases. The vaccine combines a novel intranasal NanoVax system with recombinant protective antigen (rPA) for anthrax. The new drug’s platform employs a proprietary oil-in-water nanoemulsion adjuvant that provokes both systemic and mucosal immunity. This combination enables protection against challenging respiratory infections, like anthrax.
Anthrax is listed as a Category A priority pathogen by NIAID, which means that the disease poses the highest possible risk to national security and public health. The anthrax-causing bacteria can cause severe illness or death when entering the body through inhalation, ingestion, or cuts in the skin.
The currently licensed injectable vaccine requires 3 immunizations, along with antimicrobial therapy as a medical countermeasure following potential anthrax exposure.
BlueWillow receives FDA clearance to begin phase 1 study of its intranasal anthrax vaccine [news release]. Ann Arbor, MI; PR Newswire: October 23, 2019. https://prnmedia.prnewswire.com/news-releases/bluewillow-receives-fda-clearance-to-begin-phase-1-study-of-its-intranasal-anthrax-vaccine-300943726.html.  Accessed October 23, 2019.

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