● “SKY Varicella Inj.,” SK bioscience’s Varicella Vaccine Obtains World’s 2nd WHO PQ Certification

- Proved the company’s vaccine competitiveness by obtaining PQ certification following a global pharmaceutical company
- Another achievement after its cell culture flu vaccine. Active participation in international bidding markets


Vaccines developed by SK are continuously being certified by the World Health Organization’s Pre-qualification (WHO PQ) certification, speeding up their advance into the global market.

SK bioscience (CEO Ahn Yong-yong) announced on the 11th that they have obtained WHO PQ certification for their varicella vaccine, SKY Varicella Inj., which was developed using their own bioprocess technology.

SKY Varicella Inj., which obtained marketing approval from the Korea Ministry of Food and Drug Safety in June 2018, participated in the WHO PQ certification in September 2018, and passed the difficult screening and obtained certification in only 16 months, much faster than the usual processing period for a new vaccine.

The only varicella vaccine that received PQ before the recent certification of SKY Varicella Inj. was Varivax Inj., which was manufactured by a global pharmaceutical company. SK bioscience obtained only the second PQ certification for a varicella vaccine, proving the global competitiveness of Korean vaccines and solidifying the foundation for market expansion.

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

The successive PQ certifications of SK’s vaccine reflect the Korea Ministry of Food and Drug Administration’s consulting and support for “WHO PQ Certification Support Council,” and the elevated status of Korean licensing authorities as a WHO certification regulating authority.

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 SKY Varicella Inj. 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 3 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 Inj. as a control to confirm the excellent antibody value and equivalent safety profile, and also secured supply stability by producing the vaccine at its world-class vaccine factory, L House (Andong).

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

SK bioscience is a newly established bio and vaccine company that was spun off from SK chemicals in July 2018, and the company is expanding into the global market with its self-developed vaccines.The company has successfully marketed and is selling cell-cultured influenza vaccine, shingles vaccine and varicella vaccine. In February 2018, the company exported its “cell culture vaccine production technology” to Sanofi Pasteur, a global vaccine leader. They have been co-developing the next-generation pneumococcal vaccine since 2014 and entered phase 1 global clinical trials last December.

The company is also developing a typhoid vaccine with the International Vaccine Institute under the support of the Bill & Melinda Gates Foundation, and is also involved in developing injection-type rotavirus vaccines for developing countries by the global organization PATH (Program for Appropriate Technology in Health).



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