EuBiologics’ 2nd plant authorized by WHO to manufacture cholera vaccine

EuBiologics said Friday that it has passed the World Health Organization (WHO) pre-qualification (PQ) test for its cholera vaccine concentrate (drug substance) production facility at its second plant in Chuncheon, Gangwon Province.

EuBiologics has invested in its second plant to expand the production of its oral cholera vaccines, “Euvichol” and "Euvichol Plus."

Until now, cholera vaccine solution manufacturing was only possible at Chuncheon Plant 1, but to expand the supply of cholera vaccine, the company has received about $5 million from the Bill & Melinda Gates Foundation over the past three years to expand manufacturing facilities at Chuncheon Plant 2.

After passing the GMP field inspection of the Ministry of Food and Drug Safety late last year for the cholera vaccine concentrate manufacturing facility at Plant 2, the WHO approved the addition of the facility.

EuBiologics said the WHO’s authorization will allow the company to increase the production of cholera vaccine concentrate by about 60 percent compared to the previous year. It will also produce about 50 million vaccine doses this year, which exceeds the UNICEF requirement. The company signed a contract in November last year to outsource the manufacturing of cholera vaccine doses that exceed its capacities to GC Biopharma this year.

"We are fortunate to have received WHO approval for the second manufacturing facility in the first half of the year, thanks to the active support of the Ministry of Food and Drug Safety (MFDS),” a company official said.

The official continued, “We also plan to apply to the MFDS and WHO for permission to expand the production scale of the improved oral cholera vaccine “Euvichol-S” at Plant 1 and approval to manufacture a complete manufacturing facility at Plant 2. These projects are progressing well according to plan, so we will be able to produce and supply more than 90 million doses of cholera vaccine annually starting in 2026. We expect these efforts to help alleviate the global vaccine shortage and increase revenue."