Exclusive: South Korea nears approval of first domestic anthrax vaccine

Anthrax vaccine approval gains urgency amid North Korean balloon threat

As concerns grow over the potential bio-terror threat posed by North Korea’s recent “waste balloon” launches, South Korea is on the verge of approving its first domestically developed anthrax vaccine. The vaccine, a critical defense against biological weapons, has reached the final stages of review by the Ministry of Food and Drug Safety (MFDS), according to sources.

Developed jointly by the Korea Disease Control and Prevention Agency (KDCA) and GC Biopharma, the vaccine is expected to receive approval soon. A medical expert advising the health authorities said, “GC Biopharma submitted the final documents for approval to the MFDS earlier this month. Approval is imminent and could come as early as this month, or by the end of the year.”

GC Biopharma declined to provide specific details but confirmed that “after approval, the vaccine will be added to the national stockpile,” underscoring its importance for enhancing public health security and achieving vaccine sovereignty.

A North Korean balloon carrying trash floats over Seoul on the morning of Oct. 7, 2024./Yonhap News

The development of this vaccine, known as GC1109, began in 2002 as part of a KDCA research initiative. On Oct. 31, 2023, the KDCA announced that it had formally applied for MFDS approval, aiming to commercialize the world’s first recombinant protein anthrax vaccine for bio-terror crisis response. Anthrax is classified as a highly lethal infectious disease, with a 97% mortality rate if not treated early. Due to the high risk, human clinical trials are not feasible, and efficacy is tested on animals. For bio-terror vaccines, only Phase 2 clinical trials are required to assess safety before approval.

Currently, only a few countries, including the United States and the United Kingdom, produce their own anthrax vaccines. These vaccines are made using live attenuated anthrax bacteria. South Korea, like many other nations, has relied on expensive imports to stockpile anthrax vaccines. The approval of a domestic vaccine would reduce costs and strengthen preparedness.

The urgency for anthrax vaccine production has intensified amid concerns over North Korea’s potential bio-terror capabilities. A health expert explained, “North Korea’s waste balloons use timed detonation devices to spread their contents. If these were used for bio-terror, the resulting spread of infectious diseases could be catastrophic.”

An anonymous industry source pointed out that even with vaccine approval, production will depend on government purchases. “No company will produce the vaccine unless the government is committed to buying it. If the government is serious about preparing for bio-terror threats, it needs to increase the vaccine stockpiling budget.”

During a National Assembly Health and Welfare Committee audit on Oct. 7, Jee Young-mee, head of the KDCA, addressed the risks associated with North Korea’s waste balloons. “We are aware of the potential bio-terror threat and recognize the need to stockpile vaccines for diseases like smallpox and anthrax,” Jee said. “We plan to start stockpiling in earnest next year.”