HQ Team
July 21, 2023: Emergent BioSolutions Inc., a US developer of vaccines for infectious diseases, announced its anthrax vaccine has been approved by the FDA for people between 18 and 65 years.
The company’s Cyfendus vaccine is a component of the US government’s preparedness efforts against anthrax, said Paul Williams, Emergent’s senior vice president, of products business.
It remains a high-priority national security threat due to its ability to be easily disseminated, lethality, and potential for major public health impact, he said.
The efficacy of the Cyfendus vaccine for post-exposure prophylaxis, or as a means to prevent or control the spread of an infection or disease, was based solely on studies in animal models of inhalational anthrax.
The medicine has to be administered with antibacterial drugs, according to a company statement.
20 years in making
Dr Kelly Warfield, Emergent’s senior vice president, of science and development said the vaccine was 20 years in the making.
Emergent collaborated with the Biomedical Advanced Research and Development Authority and early support from the Defense Advanced Research Projects Agency and the National Institute of Allergy and Infectious Diseases (NIAID).
In December 2018, Cyfendus vaccine was approved for pre-emergency use authorization package submitted to the FDA. The following year, the US government began procuring this product for national preparedness efforts.
Emergent’s anthrax franchise include the BioThrax vaccine, as well as two treatments, Anthrasil, which is an Anthrax Immune globulin intravenous, and raxibacumab, a monoclonal antibody therapy.
Two doses
Cyfendus, demonstrated that by using an additional adjuvant, two doses administered over 14 days elicited protective levels of an immune response.
This can be especially important in response to a large-scale public health emergency involving anthrax, according to the statement.
Anthrax is an infectious disease caused by bacillus anthracis. It occurs naturally in soil and commonly affects domestic and wild animals around the world.
People can get sick with anthrax if they come in contact with infected animals or contaminated animal products.
