The Biomedical Advanced Research and Development Authority (BARDA) will begin procuring Emergent BioSolutions’ anthrax vaccine into the Strategic National Stockpile (SNS) to strengthen U.S. preparedness in the event of a public health threat, the company said on Wednesday.
Emergent BioSolutions plans to deliver its vaccine, AV7909, which is an anthrax vaccine adsorbed with CPG 7909 adjuvant, for delivery into the SNS in the second half of 2019. AV7909 is designed to elicit a faster immune response than the currently available anthrax vaccine. The company’s AV7909 development and procurement contract with BARDA, valued at up to $1.5 billion, was signed in 2016.
“Emergent is proud of achieving this important milestone that further enables the government’s response capability for a large-scale emergency involving anthrax,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions. “Our investigational next generation anthrax vaccine candidate AV7909 is designed to offer a two-dose schedule that elicits a rapid immune response. We are now one step closer to delivering the initial three million doses of AV7909 into the SNS.”
Emergent submitted an application for AV7909 in December 2018 to the U.S. Food and Drug Administration (FDA) for the potential emergency use in the event of a public health emergency involving Bacillus anthracis, a bacteria that can cause a serious infectious disease. The pre-Emergency Use Authorization submission package calls for the delivery of an initial three million doses of AV7909 to the Strategic National Stockpile. The SNS is the nation’s largest supply of potentially life-saving pharmaceuticals and medical supplies for use in a public health emergency.
“Emergent is pleased to respond to BARDA’s procurement of AV7909 for delivery into the Strategic National Stockpile representing the initiation of the planned anthrax vaccine transition from BioThrax to AV7909,” Robert Kramer Sr., president and chief executive officer of Emergent BioSolutions, said.
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 made up of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant, the immunostimulatory oligodeoxynucleotide compound CPG 7909. The addition of CPG 7909 to AVA has been shown in clinical studies to accelerate and enhance the immune response, the company said. The vaccine is currently in a Phase 3 trial, which is expected to be completed in late 2020.
Jenkins said the action marks an important advancement in the company’s goal to protect public health through its decade-long partnership with BARDA, which is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.