SK Bioscience said Wednesday that it has received the prequalification (PQ) certification from the World Health Organization regarding SKY Cellflu Injection, its trivalent influenza vaccine.
|SK Bioscience's influenza vaccine SKY Cellflu|
SK Bioscience's SKY Cellflu does not use fertilized eggs and produces vaccines through state-of-the-art aseptic incubators, which eliminates the need for antibiotics and preservatives. Therefore, patients with egg allergy can receive the vaccine.
The company has also shortened the production period than that of the existing methods, which allows it to mass produce the vaccine in case of influenza epidemics.
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, and the company is eligible to participate in international biddings hosted by WHO’s units and to supply products.
To receive PQ certification, companies must pass rigorous procedures such as review of technical documents with clinical and quality data, sample quality testing, factory good manufacturing practice installation and management level inspection.
”In particular, the examination was more rigorous as it was the first time a flu vaccine produced by culturing animal cells received a PQ certification,” the company said.
The company stressed that it had received the PQ approval in a relatively short period under the active support from the Ministry of Food and Drug Safety.
With the certification, SK Bioscience plans to participate in international bids for influenza vaccines actively.
“The company expects to win PQ certifications for Sky Cellflu4, the world's first quadrivalent flu vaccine, and Sky Varicella, a vaccine for chicken pox, within the year,” SK Bioscience CEO Ahn Jae-yong said. “Through innovative vaccine technology, we will become a global company that contributes to human health.”
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