GC Biopharma's MAV/06 Vaccine Strain Gains WHO Recognition for Varicella Vaccination
GC Biopharma, a biopharmaceutical leader based in Yongin, South Korea, proudly announces that its proprietary varicella vaccine strain, recognized as MAV/06, has been integrated into the World Health Organization (WHO) Position Paper concerning varicella vaccination, published on November 21. This pivotal document serves as the primary authoritative guidance for immunization policies globally a contribution by the Strategic Advisory Group of Experts on Immunization (SAGE).
The listing of the MAV/06 strain signifies that GC Biopharma’s BARYCELA Inj.—the varicella vaccine founded on this strain—now holds equivalent recognition alongside vaccines made from the Oka strain, which is the standard vaccine used around the world. In addition, the WHO's endorsement highlights the interchangeability between the MAV/06 and Oka strains, providing significant flexibility for administering vaccines, especially during two-dose immunization schedules. Thus, BARYCELA Inj. emerges as a validated and competitive alternative in the independent varicella vaccine market.
Immunogenicity and safety markers for the MAV/06 strain were confirmed through an extensive Phase 3 clinical trial conducted for BARYCELA Inj., where results published in peer-reviewed journals showcased robust immune responses and a favorable safety profile. These attributes considerably bolster the vaccine's potential for inclusion in national vaccination mandates.
The WHO’s recognition is expected to foster a resilient global supply chain, facilitating strain substitutions and minimizing risks associated with supply shortages. This enhances continuity in vaccination programs across various regions and markets. GC Biopharma anticipates that the WHO’s endorsement will further reinforce its participation in global procurement networks, particularly within platforms such as the Pan American Health Organization (PAHO) where BARYCELA Inj. has been stably supplied to diverse markets over the years.
Jaewoo Lee, Head of Regulatory Science & Product Development at GC Biopharma, emphasized the importance of this milestone, stating, "The inclusion of MAV/06 in the WHO Position Paper marks a significant achievement in bolstering the global supply of varicella vaccines. We are dedicated to ensuring reliable access to high-quality vaccines that meet international standards."
The MAV/06 strain originates from GC Biopharma’s in-house development in 1993 and has been utilized in products such as Suduvax and BARYCELA Inj. for close to three decades. The company’s extensive experience with the strain includes its delivery through PAHO to various regions, demonstrating its commitment to improving global health.
GC Biopharma is committed to driving innovation in the biopharmaceutical sector, leveraging its core capabilities in protein engineering, mRNA technology, and lipid nanoparticle drug delivery to develop therapeutics targeting rare diseases and immunological issues. Founded on robust research and development, the company aims to serve the evolving needs of the global healthcare landscape.
For additional information about GC Biopharma and its wide range of products, visit their official site at www.gcbiopharma.com. This press release may contain forward-looking statements. Although GC Biopharma’s management believes that the assumptions reflected in such statements are reasonable, there can be no assurance that these beliefs will prove correct. The company undertakes no obligation to update or revise such statements, except as required by law or regulations. Troubles related to future performance may arise from known and unknown risks and uncertainties.
For media inquiries, please reach out to Sohee Kim, Yelin Jun, or Yoonjae Na at their respective emails provided in the source section. GC Biopharma continues to be at the forefront of biopharmaceutical innovation and aims to deliver advanced healthcare solutions whilst ensuring the highest standards in vaccine development and supply.
The listing of the MAV/06 strain signifies that GC Biopharma’s BARYCELA Inj.—the varicella vaccine founded on this strain—now holds equivalent recognition alongside vaccines made from the Oka strain, which is the standard vaccine used around the world. In addition, the WHO's endorsement highlights the interchangeability between the MAV/06 and Oka strains, providing significant flexibility for administering vaccines, especially during two-dose immunization schedules. Thus, BARYCELA Inj. emerges as a validated and competitive alternative in the independent varicella vaccine market.
Immunogenicity and safety markers for the MAV/06 strain were confirmed through an extensive Phase 3 clinical trial conducted for BARYCELA Inj., where results published in peer-reviewed journals showcased robust immune responses and a favorable safety profile. These attributes considerably bolster the vaccine's potential for inclusion in national vaccination mandates.
The WHO’s recognition is expected to foster a resilient global supply chain, facilitating strain substitutions and minimizing risks associated with supply shortages. This enhances continuity in vaccination programs across various regions and markets. GC Biopharma anticipates that the WHO’s endorsement will further reinforce its participation in global procurement networks, particularly within platforms such as the Pan American Health Organization (PAHO) where BARYCELA Inj. has been stably supplied to diverse markets over the years.
Jaewoo Lee, Head of Regulatory Science & Product Development at GC Biopharma, emphasized the importance of this milestone, stating, "The inclusion of MAV/06 in the WHO Position Paper marks a significant achievement in bolstering the global supply of varicella vaccines. We are dedicated to ensuring reliable access to high-quality vaccines that meet international standards."
The MAV/06 strain originates from GC Biopharma’s in-house development in 1993 and has been utilized in products such as Suduvax and BARYCELA Inj. for close to three decades. The company’s extensive experience with the strain includes its delivery through PAHO to various regions, demonstrating its commitment to improving global health.
GC Biopharma is committed to driving innovation in the biopharmaceutical sector, leveraging its core capabilities in protein engineering, mRNA technology, and lipid nanoparticle drug delivery to develop therapeutics targeting rare diseases and immunological issues. Founded on robust research and development, the company aims to serve the evolving needs of the global healthcare landscape.
For additional information about GC Biopharma and its wide range of products, visit their official site at www.gcbiopharma.com. This press release may contain forward-looking statements. Although GC Biopharma’s management believes that the assumptions reflected in such statements are reasonable, there can be no assurance that these beliefs will prove correct. The company undertakes no obligation to update or revise such statements, except as required by law or regulations. Troubles related to future performance may arise from known and unknown risks and uncertainties.
For media inquiries, please reach out to Sohee Kim, Yelin Jun, or Yoonjae Na at their respective emails provided in the source section. GC Biopharma continues to be at the forefront of biopharmaceutical innovation and aims to deliver advanced healthcare solutions whilst ensuring the highest standards in vaccine development and supply.
Topics Health）
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