“The Korea Disease Control and Prevention Agency (KDCA) announced on the 8th that the world’s first ‘recombinant protein anthrax vaccine (Baritrac)’ developed with domestic technology has obtained a pharmaceutical item approval from the Ministry of Food and Drug Safety to prepare for public health crises such as bioterrorism.”
“The newly approved anthrax vaccine uses the protective antigen (PA) protein of the anthrax bacteria as its main component, improving safety issues that could arise from existing commercial vaccines. Developed under the supervision of KDCA with cooperation from GC Pharma, this is the world’s first case of a recombinant anthrax vaccine being commercialized as a pharmaceutical product.”
“Since 1997, the KDCA has been conducting foundational research for vaccine development starting with the discovery of candidate substances for the anthrax vaccine. GC Pharma carried out vaccine process development and clinical trials, applying for the pharmaceutical item approval in October 2023, and received the final approval after a stringent review process.”
“With the approval of the domestically developed anthrax vaccine, the reliance on imported anthrax vaccines can be replaced, significantly reducing vaccine import costs. Moreover, in cases like bioterrorism, sufficient quantities can be produced and secured instantly, contributing to the establishment of national vaccine sovereignty through a stable vaccine supply.”
“Clinical trial results on healthy adults confirmed that the vaccine group generated significant antibodies capable of neutralizing anthrax toxins, with no acute or severe adverse cases reported. Minor adverse symptoms showed no difference between the vaccine group and placebo group, confirming the vaccine’s efficacy and safety.”
“Anthrax bacteria have a very high fatality rate when infecting humans, making it infeasible to conduct Phase 3 clinical trials to verify vaccine efficacy on a large population.”
“In response, KDCA conducted alternative animal testing instead of Phase 3 trials under the ‘Special Act on the Promotion and Emergency Supply of Public Health Crisis Response Medical Products,’ applying the animal rule to prove vaccine efficacy. The tests confirmed a high level of anthrax toxin-neutralizing antibodies and high survival rates against anthrax spore attacks, demonstrating outstanding effectiveness.”
“Lee Young-mi, the head of the KDCA, stated, ‘Having a domestically developed vaccine is crucial for responding to bioterrorism infectious diseases. The localization of the anthrax vaccine allows for rapid and active responses to national public health crises such as bioterrorism and is expected to significantly contribute to strengthening global health security beyond infection response.'”
“Furthermore, she added, ‘We will continuously pursue the development of domestic vaccines for various infectious diseases, and strive to lead the growth of the biopharmaceutical industry alongside vaccine fields such as mRNA (messenger RNA) vaccines, and prepare thoroughly for the production and stockpiling of the anthrax vaccine in anticipation of national crises.'”