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 (HHS) announced last week.
The development work will be done through a 30-month, $31 million agreement between HHS’ Biomedical Advanced Research and Development Authority (BARDA) and Emergent BioSolutions Inc. of Gaithersburg, Maryland.
BARDA will provide funding and technical assistance for the advanced development of NuThrax, (anthrax vaccine adsorbed with CPG 7909 adjuvant), also known as AV7909, 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,” explained BARDA Director Robin Robinson, Ph.D. “If it works, this vaccine may help achieve better preparedness at a lower cost.”
“Emergent looks forward to working with BARDA to advance the development of NuThrax towards a Phase 3 study. We are committed to addressing the U.S. government’s desire for a next generation anthrax vaccine with an enhanced product profile that includes requiring fewer doses, eliciting a higher immune response, and dispensing the need for cold chain with a dry formulation,” said Adam Havey, executive vice president and president biodefense division of Emergent BioSolutions.
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 U.S. Food and Drug Administration 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’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.
