S. Korea develops world's 1st recombinant anthrax vaccine

Korea Herald

07-07-2025

South Korea has developed the world's first recombinant protein-based anthrax vaccine, a major step toward self-sufficiency that could also open export markets for the new vaccine with fewer side effects, the government said.
The Korea Disease Control and Prevention Agency partnered with private firm GC Biopharma Corp. to develop the vaccine that, unlike conventional versions, eliminates the risk of exposure to toxins produced by Bacillus anthracis, a high-risk pathogen considered a potential bioterrorism agent.
The new vaccine, Barythrax inj., received regulatory approval from the Ministry of Food and Drug Safety in April. The approval allows South Korea to produce its own supply for the first time, ending its reliance on imports, the KDCA said at a press conference held last week.
"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.
Kim said the achievement would help reduce vaccine import costs and enable faster, more stable responses in the event of national emergencies such as bioterrorism.
"Beyond infectious disease preparedness, the vaccine's development represents a major contribution to strengthening the country's overall public health security," the official said.
When asked whether tensions with North Korea factored into the vaccine's development, she said it was not specifically aimed at a potential attack from the North, but rather designed for national public health crisis preparedness.
"But one thing is clear: more thorough preparedness is required, as South Korea faces a different geopolitical situation compared to many other countries," she said.
Until now, South Korea had relied on imports of Biothrax, the US-made anthrax vaccine produced by Emergent BioSolutions Inc.
Regarding future stockpiles, the official said, "All newly secured doses will come from domestic vaccines, although specific plans cannot be disclosed at this stage."
On top of domestic stockpiling, the KDCA and GC Biopharma expect some overseas demand for Barythrax from countries without the capability to produce their own anthrax vaccines. Demand is expected to rise globally, as anthrax remains a public health concern -- particularly in regions experiencing recent outbreaks.
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.
"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.
He added that the anthrax vaccine is part of GC Biopharma's social contribution efforts, noting that the company has earned significant profits from its varicella and influenza vaccines, its major revenue drivers.
The KDCA began basic research on anthrax vaccines in 1997, and GC Biopharma, formerly Green Cross, joined the development effort in 2002. Together, they invested a combined 30 billion won ($22 million) in the project.
Unlike traditional anthrax vaccines, Barythrax uses a non-toxin-producing strain of Bacillus brevis to produce only the protective antigen, the key to immunity. This method significantly reduces exposure to toxins and side effects, making the vaccine safer and more cost-effective than existing options.
No anthrax cases have been reported in South Korea since it was designated a notifiable disease in 2000.
GC Biopharma primarily exports varicella and influenza vaccines, as well as specialty drugs, such as Aliglo for treating immunodeficiency and Hunterase for treating hemophilia.
The company's sales rose 3.3 percent on-year to 1.68 trillion won last year, with exports accounting for 380 billion won, or 23 percent of the annual revenue. (Yonhap)