GC Biopharma has achieved a significant milestone in vaccine development with the Korean Ministry of Food and Drug Safety's approval of BARYTHRAX, marking the world's first recombinant protein-based anthrax vaccine. The vaccine, jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA), received approval on April 8, 2024, following an application submitted on October 31, 2023.
Revolutionary Vaccine Technology
BARYTHRAX represents a major advancement in anthrax vaccine technology by utilizing protective antigen proteins produced through genetic recombination techniques. Unlike traditional vaccines made by attenuating Bacillus anthracis or culturing non-pathogenic strains, which may contain residual toxin components, BARYTHRAX eliminates this risk entirely.
The vaccine works by targeting the protective antigen, which acts as a gateway for two Bacillus anthracis toxins - lethal factor and edema factor - to enter host cells. By utilizing protective antigen proteins, the vaccination trains and stimulates an immune response to neutralize anthrax effectively.
Clinical Trial Results and Safety Profile
In phase II clinical trials, healthy adult subjects who received BARYTHRAX generated sufficient antibodies to neutralize anthrax toxins while reporting no acute or severe adverse events. The vaccine has also overcome a key limitation of recombinant protein vaccines - the reduction in immunogenicity within the shelf life - thereby improving vaccine stability.
Due to the highly lethal nature of Bacillus anthracis, phase 3 human clinical trials would be unethical. Under Korea's "Animal Rule" from The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis, animal trials were conducted as a substitute for phase 3 clinical studies. In the animal efficacy study, vaccinated subjects maintained high levels of neutralizing antibodies even after 6 months following the fourth dose, with high survival rates against Bacillus anthracis spore challenge.
Addressing Critical Public Health Needs
Anthrax, caused by Bacillus anthracis, is classified as a class-1 infectious disease capable of surviving extreme conditions and spreading easily through airborne transmission. If untreated, its fatality rate can reach up to 97 percent, making it a significant threat as a potential biological weapon.
"As demonstrated during the COVID-19 pandemic, infectious diseases can spread rapidly and cause massive damage in a short period of time. This underscores the importance of securing proactive response capabilities at the national level," said Kim Gab-jung, director general of the KDCA's department of disease diagnosis and analysis.
Strategic Impact and Market Potential
The approval enables South Korea to achieve self-sufficiency in anthrax vaccine production for the first time, ending its reliance on imports of Biothrax, the US-made anthrax vaccine produced by Emergent BioSolutions Inc. Until now, South Korea had depended entirely on imported vaccines for its national stockpile.
Beyond domestic stockpiling, the KDCA and GC Biopharma expect overseas demand for BARYTHRAX from countries without the capability to produce their own anthrax vaccines. Global demand is expected to rise, particularly given recent outbreaks in various regions. In 2023, Zambia reported more than 600 cases, while Uganda confirmed 251 in 2024. Laos, Thailand, and the Democratic Republic of the Congo have also reported fatalities in recent years.
Development Investment and Timeline
The KDCA began basic research on anthrax vaccines in 1997, with GC Biopharma joining the development effort in 2002. Together, they invested a combined 30 billion won ($22 million) in the project over more than two decades.
"This achievement underscores our commitment to localizing critical medicines for public health and national security," said Eun-chul Huh, President and CEO of GC Biopharma. "GC Biopharma will continue leading efforts to ensure stable supplies of essential medical products, as we have been doing with other vaccines and blood products since our founding."
Future Outlook
"To replace existing anthrax vaccine products on the market, we will focus on further improving product competitiveness and strengthening marketing activities to export Barythrax," said Lee Jae-woo, chief development officer at GC Biopharma's Development Division. The company views the anthrax vaccine as part of its social contribution efforts, complementing its profitable varicella and influenza vaccine portfolio.
With BARYTHRAX becoming Korea's 39th novel drug, the approval represents a significant step toward strengthening the country's overall public health security and biosafety preparedness capabilities.
