KDCA and Green Cross Apply for World’s First 'Recombinant Protein Anthrax Vaccine' Approval

The Korea Disease Control and Prevention Agency (KDCA) announced on the 1st that, in collaboration with GC Green Cross, it has applied for product approval from the Ministry of Food and Drug Safety to commercialize the world's first 'recombinant protein anthrax vaccine (GC1109)' developed with domestic technology as a counter-terrorism medical product.

Anthrax is a zoonotic infectious disease caused by Bacillus anthracis that affects both humans and livestock. If not treated early, anthrax has a fatality rate of up to 97%. Bacillus anthracis forms spores that can survive for long periods in harsh environments and can be easily dispersed in the air when loaded onto missiles, making it a representative biological terrorism pathogen that can be developed as a biological weapon and misused for terrorism. According to a report by the World Trade Organization (WTO), if 50 kg of anthrax spores were dispersed 2 km ahead of an area inhabited by 500,000 people, it is estimated that 125,000 patients would occur and 95,000 would die. After the 9/11 terrorist attacks in 2001, anthrax spores were used in biological terrorism through mail across the United States. At that time, 22 people were infected, and 5 of them died.

The KDCA and GC Green Cross have been developing the anthrax vaccine since 2002. The anthrax vaccine is the world's first case developed as a safer recombinant protein anthrax vaccine by using the protective antigen (PA) protein of Bacillus anthracis as the main component, improving on the problems of existing vaccines (possibility of side effects caused by trace residual anthrax bacterial toxin factors).

Clinical trials conducted on healthy adults confirmed that the anthrax vaccine group produced sufficient antibodies capable of neutralizing anthrax toxins. Furthermore, no acute or severe adverse events occurred, and mild adverse symptoms showed no difference between the vaccine group and the placebo group.

Because Bacillus anthracis has a high fatality rate when infecting humans, conducting phase 3 clinical trials to confirm vaccine protective effects against anthrax infection in a large number of people was difficult. Therefore, under the 'Special Act on the Promotion of Development and Emergency Supply of Medical Products for Public Health Crisis Response,' an alternative animal experiment for phase 3 clinical trials applying the Animal Rule to prove vaccine efficacy was conducted. This test evaluates long-term immunogenicity and protective ability against anthrax spore challenge by survival rate using an animal (rabbit) model. High anthrax toxin-neutralizing antibody levels were maintained even 6 months after the fourth vaccine dose, and high survival rates against anthrax spores were confirmed in the animal model, proving efficacy.

The KDCA expects that through domestic production and development of this anthrax vaccine, vaccine sovereignty will be established, reducing overseas vaccine import costs and enabling stable vaccine supply.

Ji Young-mi, Director of the KDCA, stated, "Once the Ministry of Food and Drug Safety completes product approval, it is expected that domestic production and stockpiling of anthrax vaccines for emergency preparedness will be possible," adding, "The fact that Korea can produce and possess vaccines capable of responding to biological terrorism infectious diseases will play a significant role in reducing the occurrence of biological terrorism."

This content was produced with the assistance of AI translation services.