- SK bioscience proved the vaccine competitiveness by obtaining the WHO PQ certification

SK bioscience announced on the 11th that the company has obtained the WHO PQ certification for its varicella vaccine, ‘SKYVaricella®.´

SKYVaricella, which obtained marketing approval from the Korea Ministry of Food and Drug Safety(KMFDS) in June 2018, was applied to the WHO PQ certification in September 2018, and passed the difficult screening and obtained certification in only 16 months.

SK bioscience obtained the second PQ certification for a varicella vaccine, proving the global competitiveness of Korean vaccines and strengthening the market expansion.

Earlier in April, SK bioscience’s SKYCellflu®(Trivalent) obtained the world’s first PQ certification for a cell culture flu vaccine.

The WHO’s PQ system evaluates the manufacturing process, quality, and clinical trial results of a vaccine according to strict criteria that certify its safety and efficacy, and it must pass 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.

Companies that have obtained PQ certification are eligible to participate in international bids organized by U.N. agencies such as UNICEF and the Pan-American Health Organization (PAHO). The estimated market for PAHO bids for varicella vaccine is about $30 million (about 35.6 billion KRW) as of 2018.

Many developing countries are providing benefits to products that have earned WHO PQ certification in their approval or bidding process, and the company is expected to gain further momentum in entering these markets.

With the WHO PQ certification, SK bioscience will actively participate in international bids for varicella vaccines and expand into developing countries

SK bioscience´s SKYVaricella is a live varicella virus vaccine that is produced through cell culture, virus infection, and purification in the latest aseptic production system.

In 19 domestic and overseas clinical institutions, the global phase III clinical trials were conducted for children over 12 months to under 12 years of age to confirm immunogenicity and efficacy. In particular, the company used the WHO PQ certified Varivax as a control vaccine to confirm the excellent antibody value and equivalent safety profile, and also secured supply stability by producing the vaccine at its certified vaccine plant, L HOUSE.

Jaeyong Ahn, CEO of SK bioscience, said, “It is a remarkable achievement that domestically developed vaccines have obtained the PQ certification ahead of other world-leading companies. Going forward, we will continue to secure vaccine sovereignty to contribute to the national health and accelerate our entry into the global market”.