SK bioscience obtained the world’s first WHO PQ certification of a cell culture-based influenza vaccine
SK bioscience plans to participate in international bidding market

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

SK bioscience announced on the 10th, that the company’s self-developed trivalent influenza vaccine ‘SKYCellflu®´ received the prequalification(PQ) certification from the WHO.

The WHO’s PQ system evaluates the manufacturing process, quality, clinical trial results of vaccines and pharmaceuticals based on 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).

SKYCellflu® is the world first cell culture-based influenza vaccine, received the certification, SK bioscience achieved the 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(KMFDS).

SK bioscience further plans to participate in the international bidding market to supply the influenza vaccine based on acquisition of the WHO PQ certification.

SK bioscience´s SKYCellflu® does not require antibiotics or preservatives, since the product is not produced by fertilized eggs and the vaccine is manufactured in sterile incubators. SKYCellflu® is safer to administer to those who have egg allergy. In addition, the production period is half of that of conventionally manufactured vaccines with fertilized eggs, so rapid response to emergent even such as pandemics.

Through these advantages, SKYCellflu® has been sold domestically more than 1.8 million doses in four years since its launch.

Jaeyong Ahn, CEO of SK bioscience said, “With the success of the world’s first tetravalent cell culture-based influenza vaccine, we will also plan to obtain the WHO PQ certification for SKYVaricella®, Korea’s second varicella vaccine. We will continue to grow ourselves a global innovative partner that can contribute to human health with our technology.”