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SK bioscience receives WHO prequalification for typhoid conjugate vaccine
SK bioscience's SKY Typhoid by / Courtesy of SK bioscience
By Ko Dong-hwan
SK bioscience obtained prequalification (PQ) certification from the World Health Organization (WHO) for a typhoid conjugate vaccine called SKY Typhoid, according to the global vaccine and biotech company, Friday.
This is the fourth time the SK Group subsidiary obtained WHO PQ following successful qualifications for two influenza vaccines and a varicella vaccine.
The WHO PQ system rigorously assesses the manufacturing process, quality standards, and clinical trial outcomes of a vaccine, adhering to stringent criteria to ensure the safety and efficacy of the new drug. The tested vaccine passed the organization's evaluation criteria, which includes examinations of technical documents, testing of sample quality, as well as inspections of manufacturing facilities to ensure adherence to good manufacturing practices (GMP), and quality control standards.
SKY Typhoid was jointly developed by the International Vaccine Institute (IVI) and is supported by the Bill and Melinda Gates Foundation. The vaccine's unique conjugate technology allows it to be safely administered to infants and children aged six months to two years old.
The company anticipates the new vaccine, with a single dose, will offer immunogenicity and long-term protection in a way more efficacious than the existing oral live or polysaccharide typhoid vaccines.
SKY Typhoid received an export license from the Ministry of Food and Drug Safety in 2022 based on the results of a global clinical study. Phase III study, with tests on 2,160 participants from 6-month-old toddlers to individuals aged 45 years in Nepal, demonstrated positive immunogenicity and safety profile of SKY Typhoid. The findings were published in the Lancet Infectious Disease, a sister journal of the international medical journal Lancet.
With WHO PQ, the company plans to target global markets with SKY Typhoid, focusing on public procurement markets including major typhoid-endemic countries with high demands. Typhoid fever cases worldwide number between 11 million to 20 million each year and result in approximately 120,000 to 160,000 deaths, according to the WHO.
"We're pleased that our global collaboration to address the global vaccine supply imbalance and improve public health has been recognized by the WHO PQ certification," the company CEO Ahn Jae-yong said. "We'll spare no effort in supplying SKY Typhoid by obtaining approvals in multiple countries.”