NEWS

CSL Seqirus is the only manufacturer to offer a differentiated influenza vaccine portfolio for all eligible age groups in the U.S.
According to the U.S. Centers for Disease Control and Prevention (CDC), it is recommended that all eligible people aged six months and older receive an annual influenza vaccine, especially people at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.[1,2]
CDC data indicate a significant decline in influenza vaccination rates since the 2020/21 season, with the 2024/25 season being called the worst influenza season in 15 years.[1,3,4,5]

• Results of the first season of a randomized study showed adjuvanted and high-dose influenza vaccines did not differ in effectiveness against PCR-confirmed influenza.
• This is the first randomized study to evaluate the relative vaccine effectiveness of adjuvanted influenza vaccines compared to high-dose influenza vaccines for prevention of lab-confirmed influenza.

• Analysis from a dynamic model showed the need to increase influenza vaccination rates in the U.S. to at least 45% to avoid saturation of hospital system resources, particularly in intensive care units (ICUs). [1]
• Results from multiple real-world evidence (RWE) studies over different seasons showed improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing outpatient test-confirmed influenza across different age groups, including as young as 6 months. [2,3]
• A model based on RWE from the 2022-23 flu season study estimated that the use of a cell-based influenza vaccine would have averted a significant burden of influenza-related illnesses compared to an egg-based influenza vaccine. [4]

• CSL Seqirus has received a Biomedical Advanced Research and Development Authority (BARDA) award to complete the fill and finish process for additional pre-pandemic vaccines to further support the U.S. government’s outbreak and preparedness response.
• BARDA has requested adjuvanted H5N1 pre-pandemic vaccines and additional H5N8 antigen as part of its decision to expand its portfolio of pre-pandemic vaccines.
• This $34 million investment is the sixth avian influenza pandemic preparedness award made to CSL Seqirus by BARDA.

• Results from real-world evidence (RWE) studies to be presented at OPTIONS XII show the effectiveness of cell-based and MF59® adjuvanted influenza vaccines.
• Results from different studies suggested improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing test-confirmed influenza across different age groups, including children as young as six months.[1,2]
• Results from a real-world study covering the 2023/24 season showed that cell-based vaccine was effective against medically attended, laboratory-confirmed influenza, with vaccine effectiveness (VE) highest in children six months to three years of age at 88%, compared with unvaccinated participants.[3]
• RWE studies can play a key role in assessing influenza vaccine effectiveness each season. RWE complements randomized controlled trials (RCT), assessing influenza vaccine effectiveness on an ongoing basis and contributing to an ever-growing data set on real-world outcomes.

· Biomedical Advanced Research and Development Authority (BARDA) and CSL Seqirus will expand their reserves of MF59® adjuvant to the equivalent of 40 million doses as part of the National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS).
· The multi-year $121.4 million award from BARDA is the fifth avian influenza pandemic preparedness award for CSL Seqirus.

• CSL Seqirus is the only manufacturer to offer a differentiated influenza vaccine for all eligible people aged six months and older in the United States.
• Centers for Disease Control and Prevention (CDC) trend findings indicate a significant decline in influenza vaccination rates, which poses a serious risk to public health infrastructure and underscores the importance of receiving an annual influenza vaccination. 1,2
• According to the CDC, it is recommended that all eligible people aged six months and older receive their annual influenza vaccine, especially people at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old. 2,3

· CSL Seqirus to complete the fill and finish process for pre-pandemic vaccine to support the U.S. government’s outbreak and preparedness response.
· Outbreaks of highly pathogenic avian influenza (HPAI) viruses in birds and livestock have been reported in the U.S.
· Fourth avian influenza pandemic preparedness award to CSL Seqirus under a multi-year agreement with Biomedical Advanced Research and Development Authority (BARDA).

• A real-world evidence (RWE) study recently published in Open Forum Infectious Diseases (OFID) examined three consecutive U.S. flu seasons in the United States. The study suggests that cell-based quadrivalent influenza vaccine (QIVc) may have the potential to be more effective than egg-based vaccines (QIVe) in preventing test-confirmed influenza.1
• The study results reveal that the relative vaccine effectiveness of QIVc versus QIVe in prevention of test-confirmed influenza was at least 10% higher across three consecutive flu seasons, 2017–2020.

• Data evaluating the impact of cell-based quadrivalent influenza vaccines suggests an additional 31%–39% of influenza cases may have been prevented among persons 0–64 years of age during the 2017-2020 U.S. flu seasons.1
• Vaccination of children 6 months to 17 years of age with cell-based quadrivalent influenza vaccines would be cost-effective in >95% of simulations, compared to traditional egg-based vaccines based on modeling data from 2011/12 and 2017/18 U.S. flu seasons.2
• Influenza vaccination with an adjuvanted quadrivalent influenza vaccine or standard-dose egg-based quadrivalent vaccine significantly reduced cardiovascular, respiratory, and other complications of influenza among U.S. adults 65 years of age and older over the 2018/19 and 2019/20 influenza seasons.3

• Results from a retrospective cohort study from 2015 to 2020 demonstrated a notable rise with increasing age in pneumonia-related medical encounters following an influenza encounter.1
• Results from a retrospective cohort study during the 2019/20 season demonstrated the benefit of an adjuvanted influenza vaccine in prevention of influenza-related medical encounters among adults 65 years and older.2
• Results from a study across three consecutive influenza seasons showed that vaccination with cell-based influenza vaccines resulted in lower rates of test-confirmed influenza compared with traditional egg-based vaccines.3

• CSL Seqirus will deliver further H5N8 A/Astrakhan antigen to support the U.S. government's pandemic preparedness activities
• This is the third influenza pandemic preparedness award to CSL Seqirus in the last two years, building on a longstanding partnership with BARDA

• CSL Seqirus is the only influenza vaccine manufacturer that offers differentiated vaccine options for individuals six months of age and older.
• Since the COVID-19 pandemic, there has been a significant drop in influenza immunization rates and high levels of influenza-related illness, underscoring that flu is an ongoing threat.1,2
• The Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for all eligible people aged six months and older, as a critical tool to help prevent flu and lessen the severity of influenza-related illness and potentially life-threatening associated complications.3

CSL to access late-stage next-generation mRNA platform technology, enabling development of vaccines for COVID-19, influenza, multi-pathogen pandemic preparedness and other respiratory pathogens

• CSL Seqirus will manufacture and clinically assess a cell-based, adjuvanted pre-pandemic influenza vaccine candidate to support the U.S. government’s pandemic preparedness activities
• Third influenza pandemic preparedness award to CSL Seqirus under a multi-year agreement with Biomedical Advanced Research and Development Authority (BARDA)

Data published in Molecular Therapy – Methods and Clinical Development confirm the potential preclinical benefit of the sa-mRNA technology platform, the next generation of mRNA vaccine technology