AV7909 Anthrax Vaccine Description

Emergent BioSolutions Inc. AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) is a combination of BioThrax® (also called anthrax vaccine, adsorbed or AVA) and CPG 7909, a synthetic short DNA sequence that is an effective vaccine adjuvant, which increases the speed and the degree of the immune response to Protective Antigen, the major vaccine antigen.

That the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for AV7909. The Prescription Drug User Fee Act goal date for the FDA's decision is April 2023. The BLA submission was completed under contract HHSO100201600030C for the advanced development and delivery of AV7909, funded by the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services (HHS). AV7909 is evaluated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs.

ICON plc announced on October 6, 2022, that it had been selected by BARDA to execute an anthrax vaccine clinical trial that will inform operational logistics and use of AV7909 should an anthrax emergency occur. The trial will enroll healthy adults and be conducted in the United States starting in early 2023.

Emergent BioSolutions (NYSE: EBS) offers specialized products to healthcare providers and governments to address public health threats and emerging infectious diseases. Corporate Headquarters is located at 400 Professional Drive, Suite 400, Gaithersburg, MD 20879.

AV7909 Indication

AV7909 is indicated for post-exposure prophylaxis of anthrax disease. The anthrax vaccine is also recommended for unvaccinated people of all ages who have been exposed to anthrax. These people should get three doses of the anthrax vaccine and recommended antibiotic drugs.

AV7909 Dosage

AV7909 offers a two-dose schedule that elicits a rapid immune response especially advantageous during an anthrax event. It is given as an intramuscular injection. The number of injections and doses of vaccines is being evaluated in ongoing clinical trials.

AV7909 News

August 1, 2022 - Emergent BioSolutions Inc. reported for Q2 2022, revenues from Anthrax vaccines increased by $44.1 million compared to Q2 2021, primarily driven by the timing of deliveries to the U.S. government, specifically the Strategic National Stockpile. Previously, the Company received an AV7909 contract modification in September 2021 valued at approximately $399 million to deliver AV7909 doses through March 2023.

June 24, 2022 - "Over the last 20 years, Emergent has partnered with the U.S. government to lead this program from early- to advanced-stage development," commented Kelly Warfield, senior vice president of research and development at Emergent BioSolutions. "As we progress toward licensure of AV7909, which is designed to follow a two-dose immunization schedule and elicit a faster immune response, we redouble our efforts to support the government's overall preparedness and response strategy for large-scale emergencies involving anthrax and other threats to public health."

February 24, 2022 - Emergent BioSolutions reported financial reports for the fourth quarter and year ended December 31, 2021. She initiated the rolling submission to the U.S. FDA of the Biologics License Application for AV7909, the Company's investigational anthrax vaccine candidate.

July 30, 2019 - The Biomedical Advanced Research and Development Authority would begin procuring Emergent BioSolutions' anthrax vaccine into the Strategic National Stockpile to strengthen U.S. preparedness in the event of a public health threat. BARDA has exercised its first contract option valued at $261 million to procure doses of the AV7909 vaccine.

AV7909 Clinical Trials

Clinical Trial NCT03877926: VELOCITY: An Anthrax Vaccine Clinical Study

• A Phase 3, a multicenter, randomized, double-blind, parallel-group trial designed to evaluate the lot consistency (using three consecutively manufactured lots), immunogenicity, and safety of AV7909 administered in healthy adults for an indication of postexposure prophylaxis (PEP) of anthrax
• AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant.
• AVA drug substance is identical in composition and manufacturing process to commercial BioThrax.
• CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant. It is designed to induce an enhanced immune response.