CSL LTD SP/ADR - CSLLY STOCK NEWS

The FDA has granted approval for a multi-dose vial presentation of AUDENZ™, the first adjuvanted, cell-based influenza vaccine aimed at protecting against influenza A(H5N1) for individuals six months and older. Originally approved in February 2020, this new format will enhance pandemic preparedness, allowing Seqirus to deliver 150 million doses to the U.S. government within six months. AUDENZ utilizes proprietary MF59® adjuvant technology, which improves immune response and reduces the antigen needed per dose, thus expediting vaccine availability.

CSL Plasma has opened its 300th U.S. plasma donation center in Greenacres, Florida. As a significant player in the plasma collection industry, CSL Plasma emphasizes the critical need for plasma to produce therapies for serious diseases. Each center employs about 60 staff members and contributes approximately $4 million annually to local economies. The company aims to enhance community engagement through its Adopt-a-Patient Program, which raises awareness about plasma-derived therapies. CSL Plasma is part of CSL Behring, which serves patients in over 100 countries.

Seqirus, part of CSL Limited, announced new real-world evidence detailing the effectiveness of its cell-based and adjuvanted seasonal influenza vaccines at the ISIRV-WHO Virtual Conference (Oct 19-21, 2021). Analyses reveal the cell-based quadrivalent vaccine (QIVc) outperformed egg-based vaccines (QIVe) in preventing influenza-related medical encounters in both children and adults during the 2019/20 season. Data from older populations showed the adjuvanted trivalent vaccine (aTIV) was comparable to high-dose alternatives in reducing hospitalizations. These findings emphasize the importance of annual vaccine assessments.

CSL Limited (ASX:CSL; USOTC:CSLLY) reported significant advancements during its R&D investment briefing on Oct. 18, 2021. The company announced a phase 3 study for a 4-Factor Prothrombin Complex Concentrate to address traumatic injury, and successfully enrolled patients ahead of schedule in its VANGUARD Phase 3 trial for Garadacimab. Over $1 billion was invested in R&D, marking a milestone in company history. The Seqirus division is progressing mRNA and adjuvanted influenza vaccines, while a new partnership with the Walter and Eliza Hall Institute aims to enhance biologic therapies development.

Seqirus has received FDA approval for FLUCELVAX QUADRIVALENT, allowing its use for children as young as six months. This is the first cell-based influenza vaccine in the U.S. and now eligible for all age groups. The approval is based on a Phase 3 clinical study demonstrating safety comparable to standard vaccines in young children. FLUCELVAX QUADRIVALENT can offer better effectiveness due to its manufacturing process, which avoids egg-adapted changes. Seqirus aims to enhance vaccine accessibility and effectiveness, addressing potential risks in upcoming flu seasons.

Seqirus, part of CSL Limited, announced the publication of efficacy data for its cell-based quadrivalent influenza vaccine (QIVc) in The New England Journal of Medicine. The randomized controlled trial demonstrated an efficacy of 54.6% in children aged 2 to < 18 years across three seasons and eight countries. This study marks the first absolute efficacy assessment for a cell-based influenza vaccine in young children. The FDA has approved QIVc for children ≥2 years and is reviewing its use for those aged six months. This vaccine manufacturing process aims to enhance effectiveness and expedite production during pandemics.

Seqirus has been awarded a $34.95 million contract by BARDA to develop two influenza A(H2Nx) virus vaccine candidates. The agreement aims to evaluate the safety and immunogenicity of these candidates in a Phase 1 clinical study, with the objective of enhancing pandemic preparedness. Seqirus will utilize its advanced cell-based and self-amplifying mRNA technologies. This contract strengthens Seqirus' longstanding partnership with BARDA and supports its role as a leader in pandemic influenza preparedness, addressing the potential threat of influenza viruses that have no current human strains.

Seqirus announced promising data on the effectiveness of its cell-based and adjuvanted seasonal influenza vaccines during the 2019/20 season. Presented at IDWeek 2021, research revealed that the cell-based quadrivalent vaccine (QIVc) outperformed the egg-based version in preventing hospitalizations among the general population and high-risk groups. Additionally, the adjuvanted standard dose trivalent vaccine (aTIV) was as effective as the non-adjuvanted high-dose variant. These studies emphasize the public health significance of innovative vaccine technologies.

CSL's Global Chief Human Resources Officer, Elizabeth Walker, has joined the Board of Directors for the Urban League of Philadelphia. Walker emphasizes CSL's commitment to equitable community support while addressing public health concerns. The partnership aims to enhance public health, leadership development, and workforce diversity. With CSL's U.S. headquarters in Philadelphia and operations in over 100 countries, this collaboration will strengthen community outreach and plasma donation awareness.