BARDA Exercises $261 Million Dollar Option for Innovative Anthrax Vaccine
Emergent BioSolutions AV7909 anthrax vaccine being added to the Strategic National Stockpile
Emergent BioSolutions announced today that the Biomedical Advanced Research and Development Authority (BARDA) has exercised a contract option valued at $261 million to procure doses of the AV7909 anthrax vaccine.
This announcement on July 31, 2019, calls for delivery of the AV7909 anthrax vaccine to the Strategic National Stockpile (SNS) over 12 months.
AV7909 is designed to offer a 2-dose schedule that elicits a rapid immune response especially advantageous during an anthrax event.
This contract option includes a 5-year base period of performance to develop AV7909 for post-exposure prophylaxis of anthrax disease and to deliver an initial 3 million doses to the SNS, as well as contract options for procurement of up to an additional 50 million vaccine doses.
Robert G. Kramer Sr., president, and chief executive officer of Emergent BioSolutions, said in a press release, “Emergent continues its longstanding history of successfully meeting the U.S. government’s anthrax preparedness strategy."
“We look forward to maintaining the BioThrax capability for pre-exposure vaccination for military and other high-risk personnel.”
The vaccine candidate AV7909 is being developed for post-exposure prophylaxis of disease resulting from suspected or confirmed Bacillus anthracis exposure, in conjunction with the recommended course of antimicrobial therapy.
AV7909 is a combination of BioThrax and CPG 7909, an adjuvant.
CPG 7909 is a synthetic short DNA sequence that has been shown to be an effective vaccine adjuvant, which increases the speed and the degree of the immune response to Protective Antigen (PA), the major vaccine antigen.
Several Phase 1 and Phase 2 clinical studies have investigated the safety, efficacy, and stability profile of AV7909. The lot consistency, safety, and immunogenicity of AV7909 are currently being evaluated in a Phase 3 trial, which is expected to complete in late 2020.
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Anthrax is a serious infectious disease caused by gram-positive, rod-shaped bacteria known as Bacillus anthracis. Although it is rare, people can get sick with anthrax if they come in contact with infected animals or contaminated animal products, says the CDC.
The type of illness a person develops depends on how anthrax enters the body. Typically, anthrax gets into the body through the skin, lungs, or gastrointestinal system. All types of anthrax can eventually spread throughout the body and cause death if they are not treated with antibiotics.
Contract HHSO100201600030C for the advanced development and delivery of AV7909 is funded by BARDA, a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats.