SK Bioscience said on Thursday it obtained the Ministry of Food and Drug Safety’s permit to export SKYTyphoid Multi Inj., a typhoid vaccine.

In 2013, SK Bioscience and the International Vaccine Institute (IVI) started jointly developing SKYTyphoid, a conjugate typhoid vaccine.

The Bill & Melinda Gates Foundation has supported research expenses from the early stage of R&D.

SK Bioscience handled R&D, manufacturing, licensing, and IVI global clinical trials.

SKYTyphoid is a polysaccharide-protein conjugate vaccine developed by conjugating the polysaccharide of typhoid bacteria, which acts as the antigen, to the diphtheria toxin protein (diphtheria toxoid), which acts as a carrier.

SKYTyphoid is expected to demonstrate excellent immunogenicity even with a single dose and provide longer-term protection than the existing live oral or polysaccharide vaccines, SK Bioscience said.

Thanks to conjugation technology, the company added that infants aged six months to two years could receive the new typhoid vaccine.

SK Bioscience and IVI confirmed the excellent immunogenicity and safety of SKYTyphoid in a phase 3 trial on 2,160 healthy people aged between six months and 44 in Nepal.

In a comparative study with the existing typhoid conjugate vaccine that obtained WHO Prequalification (PQ) certification, SKYTyphoid showed equivalent immunogenicity and safety in all age groups.

SK Bioscience cited results of the phase 2 study of the vaccine booster shot, published in njp (Nature Partner Journal) Vaccine in January this year, saying two doses of SKYTyphoid in infants aged 6-23 months induced a strong immune response with antibody titer increasing 64 folds, compared to before inoculation.

SK Bioscience said it would seek to get WHO PQ swiftly. Working with IVI, the company aims to obtain WHO PQ certification for SKYTyphoid and supply the vaccine globally as early as next year.

The company’s vaccine plant, L House in Andong, North Gyeongsang Province, will manufacture and supply the vaccine.

Dr. Sushant Sahastrabuddhe, Head of IVI’s Typhoid Program, said IVI could confirm SKYTyphoid’s excellent safety and immunogenicity with the generous support from the Bill & Melinda Gates Foundation and the Korean government.

“SKYTyphoid will play a major role in providing vaccine access in the endemic countries with support from Gavi, the Vaccine Alliance after its prequalification by the WHO.”

IVI Director-General Dr. Jerome Kim said he was pleased that SKYTyphoid got the license.

“This is the culmination of an exemplary global public-private partnership that has brought yet another vaccine against one of the world’s neglected diseases,” Kim said. “IVI is committed to collaborating with SK bioscience and other vaccine developers worldwide to accelerate the discovery, development, and delivery of vaccines for global public health.”

SK Bioscience CEO Ahn Jae-yong said he was pleased that the company’s study for over a decade through global cooperation resulted in an innovative achievement.

“We will contribute to making children in low- and middle-income countries free of suffering from typhoid,” he said.