SK Bioscience said its Sky Varicella has become the world's second chickenpox vaccine to receive a pre-qualification (PQ) certification from the World Health Organization (WHO).
|SK Bioscience's chickenpox vaccine Sky Varicella|
The company submitted a PQ application for the vaccine in September last year after passing a rigorous screening at home in June.
"MSD's Varivax had been the only chickenpox vaccine to obtain PQ before the Sky Varicella received its certification," the company said. "Therefore, the certification has proved the global competitiveness of Korea’s vaccines, solidifying the foundation for expanding overseas markets."
Through PQ, the WHO certifies the safety and efficacy of a vaccine, as well as the manufacturing process, quality of the vaccine and clinical results. To receive PQ certification, companies must pass rigorous procedures such as the review of technical documents with clinical and quality data, sample quality testing, factory good manufacturing practice installation, and management-level inspection.
Companies that have obtained PQ certification are eligible to participate in international bids organized by U.N. agencies, such as UNICEF and Pan American Health Organization (PAHO).
According to SK Bioscience, the amount of chickenpox vaccine bid for PAHO was estimated at around $30 million in 2018.
Also, as many developing countries give benefits related to licensing or bidding process for products that have received WHO PQ certification, the company expects that it will be able to increase market shares in those countries.
"It is rather astonishing that a vaccine developed in Korea is getting PQ certification ahead of the world's leading companies," SK Bioscience CEO Ahn Jae-yong said. "We will try hard to secure vaccine sovereignty and contribute to the public's right to health."
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