● “SKYCellflu Quadrivalent” of SK bioscience receives world’s first WHO PQ certification for quadrivalent cell culture flu vaccine

- The third PQ certification after its trivalent flu vaccine and varicella vaccine
- Accelerating global expansion of Korean vaccines. “Active participation in international bids valued at $70 million a year”


SK vaccine once again proved its global competitiveness by securing WHO PQ (World Health Organization Pre-qualification) certification.

SK bioscience (CEO Ahn Jae-yong) made an announcement on the 2nd that they participated in WHO PQ certification process last May for their in-house cell culture flu vaccine SKYCellflu Quadrivalent, which passed the rigorous screening process and obtained certification in just seven months.

It was the first time in the world that a quadrivalent flu vaccine produced by cell culture has obtained WHO PQ certification. Even after including egg-based vaccines, there are only three other quadrivalent flu vaccines that have obtained PQ certification.

The WHO PQ system evaluates the manufacturing process, quality, and clinical trial results of a vaccine according to strict criteria to certify its safety and efficacy. The tested vaccine must be in compliance with rigorous procedures such as △examination of technical documents including clinical and quality data, △testing of sample quality, △testing of plant GMP facilities and quality control levels.

Final certification routinely requires 18 months, but SKYCellflu Quadrivalent accomplished it in only 8 months. In addition to the excellent quality of SK vaccines and its world-class management level, Korea’s Ministry of Food and Drug Safety＇s active advice and business support through the “WHO PQ Certification Support Council” provided valuable guidance. The status of the Korean health authorities, which were upgraded to the WHO-accredited regulators, was also the basis of this achievement.

Companies that have obtained PQ certification are eligible to participate in future international bids organized by U.N. agencies such as UNICEF and the Pan-American Health Organization (PAHO). It is estimated that the market for the PAHO bid for flu vaccine as of 2019 is about $70 million (approx. 81.4 billion won).

SK bioscience is planning to actively participate in international bidding for flu vaccine based on WHO PQ certification.

SKYCellflu Quadrivalent vaccine is efficacious against four influenza viruses. Unlike conventional egg-based production methods, SK’s vaccine is produced through a state-of-the-art sterile incubator, requiring no administration of antibiotics or preservatives. Patients with egg allergy can now be safely inoculated without concerns about hypersensitivity to antibiotics. The production period is nearly half that of conventional methods, so quantities can be ramped up in case of a pandemic.

Based on these advantages, SKYCellflu has sold more than 20 million doses (one dose is one inoculation amount) in Korea in just four years. Recently, the company has been speeding up its global presence with successive market approvals in Malaysia, Thailand, Singapore, and Mongolia.

Ahn Jae-yong, CEO of SK bioscience, said, “We confirmed the possibility of globalization of Korean vaccines by securing three PQ certifications in a year, which include trivalent flu vaccine and varicella vaccine.” He also said, “As the global paradigm for flu vaccine is shifting to quadrivalent, we will be more active in entering the overseas market.”

SK bioscience is a new vaccine company that was spun off from SK chemicals in July 2018. The company has internally developed vaccines, such as SKYCellflu, the first cell-cultured trivalent flu vaccine in Korea, SKYCellflu Quadrivalent, the world＇s first cell-cultured quadrivalent flu vaccine, SKY Zoster, the world＇s second herpes zoster vaccine, and SKY Varicella, the second varicella vaccine developed in Korea.


* Photo description: SKYCellflu Quadrivalent certified by WHO (World Health Organization) PQ (Pre-qualification) certification