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BARDA Exercises First Option in Transition from BioThrax to AV7909 Anthrax Vaccine

The Biomedical Advanced Research and Development Authority (BARDA) has exercised its first contract option with Emergent BioSolutions to procure doses of AV7909 (anthrax vaccine adsorbed with adjuvant) for delivery into the Strategic National Stockpile (SNS) over 12 months.

This contract option was exercised under the company’s 2016 development and procurement contract with BARDA, valued at up to $1.5 billion, that includes a five-year base period of performance to develop AV7909 for post-exposure prophylaxis of anthrax disease and to deliver an initial three million doses to the SNS, as well as contract options for procurement of up to an additional 50 million doses.

This exercise of the contract option through a modification is the first such option for procurement of doses to follow the initial deliveries of doses under the base contract. The action is valued at $261 million.

“As the government initiates the transition from BioThrax® (Anthrax Vaccine Adsorbed) to AV7909 in the SNS, Emergent remains responsive to their needs,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “We look forward to initiating deliveries of AV7909 under both the base contract and this contract option in the near-term as well as 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 comprised of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant. 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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