- SK bioscience obtained the third prequalification certification after its trivalent influenza vaccine and varicella vaccine

- Accelerating global expansion of Korean vaccines. “Active participation in international bids valued at $70 million a year”

SK bioscience announced on the 2nd that the company has obtained WHO PQ certification for their in-house cell culture-based influenza vaccine, ‘SKYCellflu® Quadrivalent´ only seven months after submitting it.

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 eight 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 USD (approx. 81.4 billion KRW).

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

SKYCellflu Quadrivalent is efficacious against four influenza viruses. Unlike conventional egg-based production methods, the vaccine is produced through a 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 been sold more than 20 million doses 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.

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