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Skytypoid Multistate

Skytypoid Multistate

(Seoul = Larose.VIP) Reporter Hyunsoo Kim = SK Bioscience[302440]announced on the 23rd that its typhoid fever conjugate vaccine ‘Skytyphoid Multi-Injection’ has received pre-qualification (WHO-PQ) certification from the World Health Organization (WHO).

WHO-PQ is a system that certifies safety and effectiveness by evaluating the manufacturing process, quality, and clinical results of vaccines. WHO-PQ certification is required to participate in international bidding hosted by UN-affiliated organizations such as UNICEF and the Pan-American Health Organization.

SK Bioscience has already received WHO-PQ certification for two types of flu vaccines and chickenpox vaccines.

Skytyphoid Multi-Injection is a vaccine jointly developed by SK Bioscience and the International Vaccine Institute (IVI) with research funding from the Bill & Melinda Gates Foundation.

SK Bioscience explained that the immunogenicity and safety of Skytypoid multi-injection were confirmed in a phase 3 clinical trial conducted in IVI and Nepal on 2,160 healthy people over 6 months old and under 45 years old.

Based on global clinical results, it received approval for export from the Ministry of Food and Drug Safety in 2022.

SK Bioscience said that it established the clinical design and quality data requirements for the vaccine at an early stage through support from the Ministry of Food and Drug Safety, including prior consultation, and was able to respond to the difficult WHO PQ review process based on the domestic review process.

SK Bioscience plans to expand its global presence, including countries with major typhoid fever outbreaks, through the public procurement market.

According to WHO, 11 to 20 million typhoid fever patients occur every year around the world, and about 120,000 to 160,000 of them die.

Jae-yong Ahn, CEO of SK Bioscience, said, “In addition to WHO-PQ certification, we will obtain additional country-specific permits to ensure that the vaccine can be supplied quickly.”

hyunsu@yna.co.kr

Report to KakaoTalk okjebo 2024/02/23 17:38 Sent

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