GC Biopharma Pioneers Anthrax Vaccine Approval, Sets New Safety Standards

GC Biopharma Receives MFDS Approval for BARYTHRAX: The First Recombinant Anthrax Vaccine

GC Biopharma, a South Korean biopharmaceutical leader, has celebrated a significant achievement that may change the landscape of vaccine development. On April 9, 2025, the Korean Ministry of Food and Drug Safety (MFDS) granted approval for BARYTHRAX, the world's first recombinant protein-based anthrax vaccine. This development is not only crucial for public health but also for national security, given the severe risks associated with anthrax as a potential bioweapon.

BARYTHRAX, co-developed with the Korea Disease Control and Prevention Agency (KDCA), is now recognized as Korea's 39th novel drug. This milestone comes after a successful application submitted on October 31, 2023, and demonstrates the efficacy and safety of the vaccine. The approval process underscored the urgency of developing effective countermeasures against the Bacillus anthracis bacteria, responsible for anthrax infections, known for their high fatality rates if left untreated.

Anthrax, a class-1 infectious disease, poses considerable risks due to its ability to survive in extreme conditions and its potential for airborne transmission. The vaccine's effectiveness lies in its use of protective antigen (PA) proteins, produced through genetic recombination. This innovative approach enables the vaccine to stimulate an immune response capable of neutralizing anthrax toxins, thereby offering an advanced form of protection compared to traditional methods.

Traditional anthrax vaccines involve the use of attenuated bacteria or non-pathogenic strains, which may pose residual risks. In contrast, BARYTHRAX eliminates these concerns by employing a safer recombinant protein model. This method also enhances the stability of the vaccine, addressing a common pitfall of recombinant protein vaccines, which typically experience diminished immunogenicity over time.

In the Phase II clinical trials, healthy adult participants demonstrated robust antibody responses against anthrax toxins, with no reports of severe adverse effects. Notably, because of the lethal nature of Bacillus anthracis, carrying out Phase III human clinical trials is considered unethical. Therefore, the approval came under the