The Biomedical Advanced Research and Development Authority (BARDA) is conducting research on market availability and capabilities for advanced development and manufacturing of next-generation anthrax vaccines.
The effort supports BARDA’s understanding of the current and future marketplace for planning purposes towards the possible procurement of Post-Exposure Prophylaxis (PEP) vaccines in the event of an anthrax biothreat event.
Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillius anthracis, whichcan cause human disease via gastrointestinal, cutaneous, or inhalation routes. The anthrax vaccine Biothrax® is currently licensed for PEP, however, it requires a three-dose vaccine regimen over 28 days to confer protection.
This three-dose requirement enhances the difficulty in delivery and adherence to the regimen amongst a civilian population in the event of a mass exposure. As such, BARDA is seeking a next-generation vaccine capable of reducing the number of vaccinations needed to confer protection post-exposure.
Characteristics of a new vaccine suitable for a PEP indication include rapid onset of protective immunity in one or two doses and capability for use in conjunction with antibiotics after exposure.
Improvements such as protection against all forms of anthrax, protection in special populations (children, elderly, and the immunocompromised), and elimination of cold chain storage would be considered additional enhancements for an ideal candidate.
Further details are available via Solicitation Number: BARDA-2016-Next-Generation-Anthrax-Vaccine-(01A). The RFI deadline is March 23, 2016.