● SK bioscience Trivalent Flu Vaccine ‘SKYCellflu’ Acquired WHO PQ Certification

- Splendid achievement on world’s first PQ certification as a cell culture flu vaccine
- Actively participating in international bidding market… plan for tetravalent flu vaccine certification in a year


SK’s trivalent flu vaccine ‘SKYCellflu’ acquired certification for PQ (Pre-qualification) from the WHO (World Health Organization) as the world’s first cell culture flu vaccine.

SK bioscience (CEO Mr. Jae-Yong An) announced on the 10th, that the self-developed trivalent flu vaccine SKYCellflu participated in the PQ certification process of the WHO in September 2017, passed the rigorous eighteen-month screening process, and obtained final certification.

The WHO’s PQ system evaluates the manufacturing process, quality, clinical trial results of the vaccine according to strict standards and certifies its safety and efficacy. Companies obtaining PQ certification are eligible to participate in international bidding organized by UN agencies such as UNICEF (UNICEF) and PAHO (Pan American Health Organization) and are considered for important permits in a number of developing countries.

To obtain PQ certification, strict processes such as △ examination of technical documents with clinical and quality data △ sample quality △ demanding test procedures such as GMP factory equipment and management level need to be passed. In particular, the examinations for SKYCellflu were even more rigorous since there was no precedent PQ certification for flu vaccine produced from cultured animal cells rather than fertilized eggs. SK bioscience achieved approval within a relatively short period under the active support of the WHO-PQ Certification Support Council of Korea’s Ministry of Food and Drug Safety.

SK bioscience will actively participate in international bidding to provide flu vaccine based on the WHO-PQ certification in the future.

SK bioscience＇s SKYCellflu does not require antibiotics or preservatives, since it did not use fertilized eggs and the vaccine was produced using a state-of-the-art sterile incubator. SKYCellflu is safer to administer to those who have egg allergy, and there is no concern about hypersensitivity to antibiotics. In addition, the production period is half that required for vaccine production using fertilized eggs, so rapid production is possible in the event of a flu pandemic.

Through these advantages, SKYCellflu has had sales of 1.8 million doses (1 dose is administered to 1 person) in the 4 years since its launch.

SK bioscience CEO Mr. Jae-Yong An said, "With the success of the world‘s first tetravalent cell culture flu vaccine, we are expecting to acquire PQ certification for SKYVaricella, Korea’s second varicella vaccine. We will continue our growth as a global group that contributes to human health through revolutionary vaccine technology.

SK bioscience was spun off from SK chemicals last July as a company specializing in vaccines such as Korea’s first trivalent cell culture flu vaccine SKYCellflu, the world’s first tetravalent cell culture flu vaccine SKYCellflu Quadrivalent, the world＇s second shingles vaccine SKYZoster, and Korea’s second varicella vaccine SKYVaricella.


※ Description: WHO (World Health Organization) PQ (pre-qualification evaluation) Certified SKYCellflu