The Biomedical Advanced Research and Development Authority (BARDA) exercised its first $261 million contract option with Emergent BioSolutions Inc. to procure its next-generation anthrax vaccine known as AV7909 for delivery into the Strategic National Stockpile (SNS) over 12 months, the company said on Tuesday.
Emergent entered into an up to $1.5 billion development and procurement contract with BARDA in 2016 for AV7909, Emergent’s vaccine to treat anthrax disease. It includes delivering an initial 3 million doses to the SNS over a five-year base period, as well as contract options for procurement of up to an additional 50 million doses. BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
“As a company uniquely focused on addressing public health threats, we have been committed, for the last 20 years, to the government’s ongoing objective of maintaining anthrax vaccines in the SNS sufficient to protect 25 million lives,” Robert Kramer Sr., president and chief executive officer of Emergent BioSolutions, said.
AV7909 is being developed as a medical countermeasure in the event of a public health emergency involving exposure to anthrax, or Bacillus anthracis. Kramer said the company will remain responsive to the needs of the government as it transitions away from Emergent’s BioThrax anthrax vaccine to AV7909.
“AV7909 expands the government’s anthrax preparedness capabilities,” Abbey Jenkins, senior vice president and vaccines business unit head at Emergent, said. “AV7909 is designed to offer a two-dose schedule that elicits a rapid immune response especially advantageous during an anthrax event, while BioThrax vaccine will continue to serve a critical purpose through its general use prophylaxis indication.”
Kramer added that Emergent would maintain the BioThrax capability for pre-exposure vaccination for military and other high-risk personnel.
AV7909 is comprised of Anthrax Vaccine Adsorbed (AVA) in combination with an adjuvant. Two phases of 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 that is expected to be completed in late 2020, the company said.