CYFENDUS™ Anthrax Vaccine

Emergent BioSolutions Inc. CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted) is a combination of BioThrax® (also called anthrax vaccine, adsorbed or AVA) and CPG 7909, a synthetic short DNA sequence as a vaccine adjuvant to increases the speed and the degree of the immune response to Protective Antigen. The U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for AV7909 in June 2022. 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 Administration Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). The Company announced the FDA's Approval ((STN: 125761/0) on July 20, 2023, as a two-dose anthrax vaccine for Post-Exposure Prophylaxis (PEP) Use.

CYFENDUS was 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. The approval of the CYFENDUS vaccine is symbolic of Emergent's longstanding partnership with the U.S. government and our shared commitment to helping protect public health," said Dr. Kelly Warfield, Emergent's senior vice president of science and development, in a press release.

On November 17, 2023, the U.S. Centers for Disease Control and Prevention (CDC) published updated Guidelines for the Prevention and Treatment of Anthrax regarding preferred prevention and treatment regimens for naturally occurring anthrax. Healthcare providers can use the updated guidelines in this report to prevent and treat anthrax and guide emergency preparedness officials and planners as they develop and update plans for a wide-area aerosol release of B. anthracis. Although data indicated that the polyclonal antitoxin AIGIV should not be coadministered with AVA, noninterference was demonstrated between raxibacumab and AVA, allowing their coadministration. No data were available on the coadministration of obiltoxaximab and AVA.

BARDA awarded a $75 million option to acquire CYFENDUS according to Emergent's existing contract (HHSO100201600030C) on November 28, 2023. Deliveries are expected to begin in 2023 and be completed by the first quarter 2024. In 2016, BARDA and Emergent extended their partnership to support clinical development and manufacturing efforts for the AV7909 vaccine.

Emergent BioSolutions (NYSE: EBS) offers specialized products to healthcare providers and governments to address public health threats and emerging infectious diseases. Corporate Headquarters is at 400 Professional Drive, Suite 400, Gaithersburg, MD 20879. The Middle East and Africa anthrax treatment market is projected to register a CAGR of 8.6% from 2022 to 2029. 

CYFENDUS Vaccine 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.

CYFENDUS Vaccine Dosage

AV7909 offers a two-dose schedule that elicits a rapid immune response, which is 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.

CYFENDUS Vaccine Efficacy

The efficacy of the CYFENDUS™ vaccine for post-exposure prophylaxis is based on studies in animal models of inhalational anthrax.

CYFENDUS Vaccine Safety Information

Safety Information: Do not take CYFENDUS™ vaccine if you are allergic to CYFENDUS™ vaccine, BioThrax®, or any vaccine ingredient. Allergic reactions: Appropriate medical treatment and supervision must be available after receiving the CYFENDUS™ vaccine to manage possible serious allergic reactions. Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to CYFENDUS™ vaccine. Pregnancy: CYFENDUS™ vaccine can cause fetal harm when administered to a pregnant individual. The most common adverse reactions reported were tenderness, pain, warmth, itching, swelling, redness, bruising, arm motion limitations, muscle aches, tiredness, headache, and fever.

CYFENDUS News

December 11, 2023 - The World Health Organization confirmed Kenya, Malawi, Uganda, Zambia, and Zimbabwe are experiencing anthrax outbreaks in 2023.

November 28, 2023 - Paul Williams, senior vice president products head at Emergent, stated, "This (BARDA) procurement helps ensure the nation has sufficient anthrax vaccine and aligns with Emergent's longstanding commitment to strengthen public health preparedness."

July 20, 2023 - "CYFENDUS™ vaccine is a component of the U.S. government's preparedness efforts against anthrax, which remains a high-priority national security threat due to its ability to be easily disseminated, lethality, and potential for major public health impact," said Paul Williams, Emergent's senior vice president, products business. "The approval of the CYFENDUS™ vaccine demonstrates what effective public-private partnerships can achieve for national security. Emergent will continue to work closely with the U.S. government to transition this product to post-approval procurement while ensuring an uninterrupted supply of this important vaccine."

May 7, 2023 - Anthrax cases were confirmed in India.

December 12, 2022 - Anthrax outbreak investigation in Tengwe, Mashonaland West Province, Zimbabwe, 2022.

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.

CYFENDUS (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.