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Home Drug Development FDA Approvals

WHO grants prequalification GC Biopharma’s varicella vaccine, Barycela

Content Team by Content Team
21st February 2023
in FDA Approvals, News
Gavi, the Vaccine Alliance, Collaborates with Salesforce to Help Equitably Distribute Two Billion COVID-19 Vaccines by the End of 2021

GC Biopharma, a leading provider of biopharmaceutical products in South Korea, announced that the World Health Organization (WHO) has granted prequalification for the company’s varicella vaccine, Barycela.

WHO prequalification decision has made Barycela now eligible for procurement by the United Nations agencies, including the Pan American Health Organization (PAHO), to be used in national immunization programmes. Barycela is now one of the three PQ vaccines that GC Biopharma has obtained so far along with H1N1 pandemic and seasonal influenza vaccines.

Barycela is a live attenuated varicella virus vaccine, containing MAV/06 strain, a virus exclusively attenuated by GC Biopharma. While containing higher amount of virus, this new vaccine, compared to its previous product, shows higher level of product stability. Barycela has also proved non-inferior in immunogenicity with an equivalent level of safety to “Varivax”, an existing prequalified vaccine in the market.

In addition, Barycela is being produced in a state-of-the-art aseptic condition from cell culture and virus infection to purification to make it the world’s single only varicella vaccine produced without antibiotics.

With the WHO’s prequalification decision, MAV/06 strain has moved a step closer to being registered in the WHO Technical Report Series (TRS) along with the previously listed OKA strain.

GC Biopharma’s next plan is to target global markets with Barycela. The strategy is to utilize the global supply network for Suduvax, its existing varicella vaccine.

“We hope Barycela will continue our contribution to reducing the world’s social and economic cost incurred by varicella outbreaks.” said EC Huh, Ph.D., president of GC Biopharma.

Developed in 1993, GC Biopharma’s Suduvax is Korea’s first and the world’s second varicella vaccine. Over 28million doses of the vaccine have been sold worldwide over the past 3 decades through PAHO and others, proving its high level of safety.

GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is one of the leading plasma protein and vaccine product manufacturers globally and has been dedicated to quality healthcare solutions for more than half a century.

 

 

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