SK Bioscience said that the World Health Organization (WHO) has granted prequalification (PQ) certification for its Skycellflu, the first cell-cultured quadrivalent vaccine covering four strains of influenza viruses in the world.

SK Bioscience's quadrivalent vaccine Skycellflu

The company had been trying to receive approval since May last year.

Skycellflu does not require any antibiotics or preservatives as the company manufactures the vaccine using a state-of-the-art sterile incubator. As it does not use a fertilized egg to produce the vaccine, the treatment is safe for those who are allergic to eggs or sensitive to antibiotics, according to SK Bioscience.

“This is the first cell-cultured quadrivalent vaccine that received PQ certification,” the company said. “Even in the case of fertilized egg-cultured vaccines, there are only three quadrivalent flu vaccines with PQ certification, except for Skycellflu.”

Through its PQ process, the WHO certifies the safety and efficacy of a vaccine, as well as its manufacturing process, quality 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.

“Given that it usually takes about a year and six months to finalize the certification, the company has managed to shorten the approval process by about 10 months,” the company said. “Companies that have obtained PQ certification are eligible to participate in international bids organized by various U.N. agencies, including UNICEF, as well as the Pan American Health Organization (PAHO).”

According to SK Bioscience, the amount of chickenpox vaccine bid for PAHO was estimated at around $70 million in 2019.

With the approval, the company plans to participate actively in the global procurement market.

“The company has confirmed the possibility of globalizing local vaccines by securing three PQ certifications in a single year, including trivalent flu vaccine and chickenpox vaccine,” SK Bioscience CEO Ahn Jae-yong said. “As the global paradigm of flu vaccines is shifting to quadrivalent, our company will be able to enter overseas markets more aggressively.”

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