NEWS

• 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