The USFDA recently approved the Anthrax Vaccine adsorbed and adjuvanted for post-exposure prophylaxis of anthrax in cases suspected or confirmed of exposure to Bacillus anthracis in the age group of 18-65 years. The vaccine induces antibodies against the antigen that protects by neutralizing the cytotoxic toxins and edema toxins caused by the bacteria. This approval is backed by a pivotal phase three clinical trial that evaluated the immunogenicity and safety of the vaccine after administration of two doses intramuscularly in healthy adults, while the efficacy is based on the findings of studies in animal models.
Other evidence that supported the approval is a phase two trial where non-interference between the vaccine and antibacterial drugs was established, and few non-clinical studies identified the antibodies that can neutralize the toxins produced by Bacillus anthracis. Drug details…
