Made in Korea: World's first recombinant anthrax vaccines ready for production

Back here on the local front.

South Korean drug regulators have approved the world's first recombinant anthrax vaccine developed by researchers here.

Park Kun-woo has more.

Made in Korea.

That's a term describing the world's first recombinant anthrax vaccine, which is set to be manufactured in a plant in Hwasun-gun County, in the southwest of South Korea, after decades of joint research between the public and private sectors.

The Barythrax vaccine uses recombinant protein technology, minimizing the toxic side effects of other conventional vaccines.

"For years, Korea had to rely on expensive imports for anthrax vaccines. But now, that's starting to change. This homegrown vaccine isn't just set to be made in Korea, but will be the result of nearly three decades of accumulated research and technology."

The vaccine was approved by the Ministry of Food and Drug Safety in April and is expected to be produced later this year.

The Hwasun facility alone can produce up to 10 million doses annually, helping ensure a stable supply.

However, there were challenges to developing a first-of-its-kind product.

"Because this was the first recombinant anthrax vaccine, there were no established guidelines. We had to create and verify the evaluation standards step by step."

She stressed the importance of this immunization tool in national preparedness, especially to respond to global health crises, including bioterrorism.

She added that those working in high-risk sectors, including lab researchers, military personnel, police, and firefighters, are being considered as priority groups for vaccination.

While the product didn't go through a Phase 3 clinical trial due to ethical constraints, there have been concerns regarding its safety.

"We couldn't go through a full Phase 3 clinical trial, but we confirmed safety through non-clinical tests with rabbits."

He added that rabbits are sensitive to anthrax and require high levels of neutralizing antibodies, which adds weight to the test results.

Lee also said the shot is expected to be competitively priced and rising global demand is widely opening possibilities for exports.

From a country once reliant on foreign supply, Korea is now positioning itself as an exporter.

And with this step toward vaccine self-reliance, expectations are rising for the future of "K-vaccines."

Park Kun-woo, Arirang News, Hwasun.