WNAM REPORT: Two men, clad head to toe in protective gear, examine a monitor as they converse. On the screen is a fermentor holding 400 liters of a genetically transformed strain, engineered to express the antigen that triggers immunity against anthrax.
Welcome to GC Biopharma Corp’s Hwasun plant, home to the world’s first facility dedicated to producing Barythrax — the first anthrax vaccine developed using recombinant protein technology. Created in collaboration with the Korea Disease Control and Prevention Agency (KDCA), the vaccine is the culmination of 28 years of relentless research and development.
Approved by the Ministry of Food and Drug Safety in April, Barythrax significantly reduces toxin-related side effects compared to earlier versions.
Anthrax, most notably used in the 2001 bioterror attacks — when spores were sent through mail in the United States, leading to five deaths — is regarded as one of the most dangerous potential biological weapons due to its lethal properties.
Its spores can survive for decades, even in harsh environments. While lethality varies depending on the mode of exposure, inhaling anthrax spores can be nearly 100 percent fatal if untreated. However, vaccination dramatically reduces both the risk of infection and the chances of death.
Only three countries produce anthrax vaccines using domestic technology: South Korea, the United States and the United Kingdom. Of these, South Korea is the only one — and the first globally — to use recombinant protein technology.
Using this method, Barythrax expresses only specific antigens through genetic recombination, significantly reducing the risk of toxin-related side effects. In contrast, traditional anthrax vaccines, made from the bacteria itself, contain toxic components that can lead to adverse reactions.
“There were no precedents for making an anthrax vaccine this way, so there were no domestic or international guidelines to follow,” said Chung Yoon-seok, director of the KDCA. “We had to create entirely new evaluation standards and set our own benchmarks.”
From the outset in 1997, the team identified recombinant protein technology as the key to overcoming the limitations of existing anthrax vaccines — specifically, the side effects caused by residual toxins left after injection.
Emergent BioSolutions, the U.S. manufacturer of anthrax vaccines, also developed a recombinant protein version to enhance safety, but it has yet to receive regulatory approval.
At a press conference held at the plant, Kim Gab-jung, director general of the KDCA, emphasized the need to strengthen national preparedness for infectious diseases.
“As we saw during the COVID-19 pandemic, outbreaks can spread rapidly and cause widespread damage in a short time,” Kim said.
Kim added that with Barythrax’s approval, South Korea can now produce anthrax vaccines domestically, ending its complete reliance on imports. This shift will help reduce vaccine import costs and ensure a stable supply in the event of national emergencies, such as bioterror attacks.
However, the shift did not happen overnight.
The KDCA launched vaccine development efforts in 1997 to bolster South Korea’s biosecurity and reduce dependence on foreign suppliers. Over the past 28 years, the agency and GC Biopharma conducted extensive development and clinical trials, with the KDCA investing 10 billion won ($7.32 million) and GC Biopharma contributing 20 billion won.
While preparing for the threat of bioterrorism is a global priority, it holds particular significance for South Korea, which shares a border with one of the world’s most dangerous regimes in terms of biological warfare: North Korea.
To offset its relatively weak conventional military capabilities compared to Seoul and Washington, the regime has focused on developing asymmetric weapons, including biological agents such as anthrax.
Concerns over North Korea’s potential use of biological weapons intensified last year after the regime sent about 5,500 trash-filled balloons into South Korea on 22 separate occasions between May and September. While most balloons contained household waste, experts warned that similar methods could be used to deliver anthrax or other biological agents.
With the successful development of the world’s first anthrax vaccine using recombinant protein technology, South Korea aims to not only strengthen its protection against potential biological threats but also contribute to global public health and expand its vaccine development initiatives.
“Every country wants to prepare for public health threats, but not many have the capacity to develop vaccines on their own,” said Kim, the KDCA director general. “I hope vaccines developed with Korean technology can be widely introduced abroad and help strengthen global health security.”
Lee Jae-woo, chief development officer at GC Biopharma, said the experience of developing Barythrax will be invaluable in creating vaccines for other diseases.
“The gap between Barythrax and traditional anthrax vaccines is night and day,” Lee said. “This project not only advanced our technical expertise, but also gave us intangible assets that money can’t buy. That’s why, despite the significant investments made by both the KDCA and our company, the returns go far beyond cost.”
