GC Biopharma said on the 8th that the anthrax vaccine "Beritrax inj." jointly developed with the Korea Disease Control and Prevention Agency has been shipped in Korea for the first time. It comes eight months after it was approved in April as the 39th domestically developed new drug. The initial batch will be supplied as stockpiled vaccine for the agency.
Beritrax inj. is the world's first "recombinant protein anthrax vaccine" and a counterterrorism emergency-response drug prepared for bioterrorism situations. Anthrax is a category 1 legally notifiable infectious disease caused by anthrax bacteria, and the risk is high, with a fatality rate reaching 97% if treatment is delayed.
Because of the lethality of anthrax bacteria, it is impossible to conduct clinical trials that infect people and then administer a vaccine. Instead, efficacy is evaluated only through animal testing, and for bioterrorism response vaccines, approval is determined based on safety evaluation in phase 2 clinical trials.
Existing anthrax vaccines use an attenuated live vaccine method that cultures nonpathogenic anthrax bacteria and removes toxins, and only a few countries, including the United States and the United Kingdom, can produce them on their own. Most countries, including Korea, have relied entirely on imports, and the high price has made it difficult to increase stockpiles. The launch of a domestically produced vaccine is significant in that it can reduce this burden.
Beritrax inj. was designed using two protein antigens among the main components of anthrax toxin. GC Biopharma produced the vaccine using recombinant technology that inserts the genes that make those proteins into microorganisms for cultivation and purification. This method is considered safer than existing live vaccines and easier to control for quality. Clinical trials also confirmed excellent safety and a strong immune response.
The vaccine is produced at GC Biopharma's Hwasun plant in South Jeolla, with an annual manufacturing capacity of up to 10 million doses. This amounts to about 2.5 million people based on four doses per person, and rapid mass production is possible if needed.
Heo Eun-cheol, CEO of GC Biopharma, said, "We find great meaning in the first shipment of the domestically developed anthrax vaccine co-developed with the agency," adding, "We will continue to contribute to strengthening national quarantine capacity and achieving vaccine self-sufficiency."