Officials from the FDA have cleared an investigational new drug (IND) application for BlueWillow Biologics' BW-1010 vaccine, 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 (NIAID). 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; October 23, 2019: BlueWillow Biologics. Accessed October 23, 2019.