GC Biopharma scores third WHO PQ for chickenpox vaccine

GC Biopharma said on Monday that its chickenpox vaccine, Barycela, has obtained prequalification (PQ) certification from the World Health Organization (WHO), following the same certification for its H1N1 pandemic and seasonal influenza vaccines.

The system evaluates the quality, effectiveness, and safety of vaccines and grants qualifications to participate in bidding in the international procurement market. 

Consequently, the PQ decision means that Barycela is eligible for procurement by the United Nations agencies, including the Pan American Health Organization (PAHO), for use in national immunization programs.

Barycela is a live attenuated varicella virus vaccine, containing MAV/06 strain. While containing a higher amount of virus, this new vaccine, compared to its previous product, shows a higher level of product stability, GC Biopharma said.

In global clinical trials,  Barycela proved non-inferiority in immunogenicity with an equivalent level of safety to Varivax, an existing prequalified vaccine in the market.

The company said Barycela is being produced in a state-of-the-art aseptic condition from cell culture and virus infection to purification.

“It is the only varicella vaccine produced without antibiotics,” said a company official. “With the WHO PQ 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.”

The company credited this certification to the improvement of the status of domestic licensing authorities. In November last year, the Ministry of Food and Drug Safety (MFDS) achieved maturity level 4 (ML4), the highest level in WHO’s classification of regulatory authorities for the regulation of medicines and vaccines.

GC Biopharma plans to subsequently target global markets with  Barycela by utilizing the global supply network for Suduvax, its existing varicella vaccine.

"We hope that  Barycela will contribute to reducing the social burden and cost of chickenpox outbreaks around the world," GC Biopharma CEO Heo Eun-chul said.