EuBiologics said on Tuesday that its Euvichol-S, a simplified formulation of the oral cholera vaccine co-developed with the International Vaccine Institute (IVI), has obtained prequalification (PQ) certification from the World Health Organization (WHO).

Euvichol-S is a new oral cholera vaccine that has improved production capacity by about 40 percent by improving the manufacturing method of the original solution compared to the existing Euvichol-Plus. As part of the WHO-PQ certification support project of the Ministry of Food and Drug Safety (MFDS), the company applied for PQ certification to the WHO in May 2023, on the condition that the WHO recognizes the results of the on-site GMP inspection by the MFDS. 

In December last year, Euvichol-S received the export license from the MFDS. 

The WHO’s PQ certification allows EuBiologics to produce and supply three oral cholera vaccines, including Euvichol (in glass vials) and the existing Euvichol-Plus. 

Recently, cholera has been spreading in Africa and there is a global shortage of vaccines to prevent cholera. The supply of Euvichol-S to U.N. agencies will help alleviate this situation, EuBiologics said.

Euvichol-S was developed in technical collaboration with Dr. Julia Lynch, Director of IVI’s Cholera Program. It demonstrated its efficacy in a phase 3 comparative clinical trial in Nepal last year. The vaccine development was funded by the Bill & Melinda Gates Foundation and will be produced and distributed by EuBiologics. 

Euvichol-S will be mass-produced in GMP facilities at Plant 1 and Plant 2 in Chuncheon, Gangwon Province, in the second half of the year after the scale-up process.

"The WHO’s PQ certification for Euvichol-S is the result of our ongoing international collaboration with the IVI and will contribute significantly to global health initiatives,” an official at EuBiologics said.

Also, the company expects to receive WHO approval for the addition of cholera vaccine concentrate and finished vaccine production facilities at Plant 2, which will contribute to solving the global cholera vaccine shortage and increase the company's revenue, the official added.