Advanced development is underway on an improved anthrax vaccine that could provide protection in fewer doses than the currently licensed anthrax vaccine and so may be more cost-effective to stockpile, Dr. Nicole Lurie, assistant secretary for preparedness and response for the U.S. Department of Health and Human Services announced.
The development work will be done through a 30-month, $31 million agreement between HHS and Emergent BioSolutions Inc. of Gaithersburg, Md.
The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS, will provide funding and technical assistance for NuThrax, including non-clinical studies, product development, and manufacturing to support phase 3 safety studies with larger groups than previous studies.
“Anthrax remains a national health security threat, and we’re striving to develop an anthrax vaccine that affords immunity sooner and with fewer doses,” explains BARDA director Robin Robinson, PhD. “If it works, this vaccine may help achieve better preparedness at a lower cost.”
NuThrax is enhanced with CPG 7909 to stimulate the immune system. Studies conducted to date with NuThrax indicate that two doses are sufficient to protect against anthrax.
Nuthrax is a modified formulation of BioThrax, an anthrax vaccine manufactured by Emergent that requires three doses to protect against anthrax. BioThrax is licensed by the Food and Drug Administration (FDA) for use prior to exposure to anthrax and could be used after exposure with emergency use authorization from the FDA. BioThrax is stockpiled in the Centers for Disease Control and Prevention (CDC)’s Strategic National Stockpile, and BARDA is supporting additional work under Project BioShield to apply for label expansion for post-exposure use.
Early development of NuThrax was sponsored by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) and the Department of Defense. This early work included manufacturing process development, critical non-clinical studies, and completion of phase 1 and 2 clinical studies.
NuThrax represents the successful transition of a vaccine from early development under NIAID into advanced development under BARDA and resulted from more than six years of collaboration on the vaccine’s development between the two HHS agencies.
The new project is part of BARDA’s comprehensive, integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases.
Source: U.S. Department of Health and Human Services