KDCA and Green Cross Achieve World's First Self-Sufficiency in Recombinant Protein Anthrax Vaccine Production

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The Korea Disease Control and Prevention Agency (KDCA) announced on the 8th that the world's first domestically developed recombinant protein anthrax vaccine (Baritrax Injection) has received pharmaceutical product approval from the Ministry of Food and Drug Safety to prepare for public health crises such as bioterrorism.

The newly approved anthrax vaccine is a safer vaccine that improves upon issues found in existing commercial vaccines by using the protective antigen (PA) protein of Bacillus anthracis as its main component. It was developed under the leadership of the KDCA in collaboration with Green Cross Corporation, marking the world's first case of commercializing an anthrax vaccine using genetic recombination technology as a pharmaceutical product.

The KDCA began foundational research for vaccine development starting in 1997 by identifying anthrax vaccine candidate substances. Together with Green Cross Corporation, they conducted vaccine process development and clinical trials, applying for pharmaceutical product approval in October 2023, and after a rigorous review process, obtained final product approval.

With the approval of the domestically developed anthrax vaccine, the previously fully imported anthrax vaccine can now be replaced with a domestically self-sufficient vaccine, significantly reducing vaccine import costs. Additionally, in emergencies such as bioterrorism, sufficient quantities can be immediately produced and secured, contributing to the establishment of national vaccine sovereignty through stable vaccine supply.

Clinical trial results on healthy adults confirmed that the anthrax vaccine group produced a significant amount of antibodies capable of neutralizing anthrax toxins, with no occurrence of acute or severe adverse events. Mild adverse symptoms showed no difference between the vaccine group and the placebo group, confirming the vaccine’s efficacy and safety.

Because Bacillus anthracis has a very high fatality rate upon infection in humans, conducting phase 3 clinical trials to verify vaccine protection effects on a large number of people is not feasible.

Therefore, under the "Special Act on the Promotion of Development and Emergency Supply of Medical Products for Public Health Crisis Response," the KDCA applied the Animal Rule to substitute phase 3 clinical trials with animal experiments that can demonstrate vaccine efficacy. The results showed sustained high levels of anthrax toxin-neutralizing antibodies and high survival rates against anthrax spore attacks, proving excellent effectiveness.

Jiyoungmi, Commissioner of the KDCA, stated, "Possessing a domestically developed vaccine is very important for responding to bioterrorism infectious diseases," adding, "Through the localization of the anthrax vaccine, rapid and proactive responses will be possible in national public health crises such as bioterrorism, and it is expected to greatly contribute to strengthening global health security beyond infectious disease response."

She also said, "We will continue to promote domestic vaccine development for various infectious diseases, strive to lead the growth of the biopharmaceutical industry in the vaccine field including mRNA (messenger ribonucleic acid) vaccines, and prepare without delay for the production and stockpiling of the anthrax vaccine in preparation for national crisis situations."