Influenza Virus Vaccine(Seqirus)

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 SUMMIT, N.J., July 17, 2023 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX:CSL), today announced it has begun to ship its portfolio of innovative cell-based, adjuvanted and egg-based influenza vaccines across the U.S. in preparation for the 2023/24 influenza season. The company is positioned to supply over 55 million doses of influenza vaccines to healthcare providers across the U.S. "Last season underscored the devastating impact flu can have, with over 300,000 flu-related hospitalizations and 19,000 flu-related deaths reported based on preliminary data through April 2023," said Dr. Gregg Sylvester, Chief Health Officer, CSL Seqirus.2 "This year in the Southern Hemisphere, we're already seeing high levels of influenza activity, especially in children, which has historically been a strong predictor of what's to come in the Northern Hemisphere.4,5 As we commence shipment to healthcare providers across the U.S., it's critical that we raise immunization rates this season to help protect as many people as possible from influenza and its potentially life-threatening complications." CSL Seqirus is the only manufacturer to offer differentiated influenza vaccine options approved for use in individuals six months of age and older. This year's 2023/24 U.S. influenza season portfolio includes: FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine indicated for use in people six months and older.6 By avoiding egg adaptation, cell-based flu vaccines provide an exact antigenic match to the World Health Organization--selected influenza virus strains.7,8,9 There were two real world evidence (RWE) studies conducted by the Marshfield Clinic Research Institute during the 2022/23 Northern Hemisphere season, in which a large majority (84%) of vaccinated participants received FLUCELVAX QUADRIVALENT. Influenza vaccine effectiveness was found to be 54% effective at preventing medical care cases in children and adults six months to 64 years of age, and 71% effective at preventing symptomatic flu among children ages 1 to 17 years of age.10 Limitations of these studies include small sample sizes from a single geographic area and the potential for confounding and bias. FLUCELVAX QUADRIVALENT immunogenicity, efficacy and safety are supported by randomized clinical trials.6 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), the first and only adjuvanted quadrivalent seasonal influenza vaccine for adults 65 years and older, is preferentially recommended by the CDC's Advisory Committee on Immunization Practices (ACIP) over standard-dose influenza vaccines.11,12 FLUAD QUADRIVALENT contains an MF59® adjuvant that, when added to a flu vaccine, is designed to strengthen, broaden, and lengthen the immune response.11,13,14 This is important for adults 65 years and older whose immune systems may have a decreased capacity to respond to flu illness or vaccines. AFLURIA® QUADRIVALENT (Influenza Vaccine), an egg-based, quadrivalent influenza vaccine approved for use in eligible people six months of age and older.15 The CDC recommends annual influenza vaccination for all eligible individuals, ages six months and older, as a critical tool to prevent and lessen the severity of disease.3 Annual influenza vaccination is especially important for people at a higher risk of developing serious influenza-related complications, including older adults, pregnant people and children younger than 5 years old.3,16 According to the CDC, most people who need only one dose of influenza vaccine for the season, should receive their vaccine in September or October.3 For children six months through 8 years of age, who require two vaccine doses, the CDC recommends they receive the first dose as soon as the vaccine is available, as early as July and August.3 For children of any age who need only one dose of flu vaccine or pregnant people in their third trimester, vaccination as early as July and August can also be considered. 3 "It's unfortunate that in a year when we saw an early onset and significant increase in influenza cases from the previous year, especially in children, vaccination rates in the U.S. and globally were so low," said Dave Ross, Vice President, North America Commercial Operations, CSL Seqirus. "Influenza vaccination is critical in reducing flu-related hospitalizations and overall burden of disease.17 At CSL Seqirus, we're committed to working with our public health partners to do what we can to help drive vaccination rates at least back up to pre-pandemic levels." For additional information on influenza vaccine options for the upcoming flu season, visit flu360.com. About Seasonal Influenza Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.17 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.17 Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.17 Preliminary estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2022/23 influenza season, there were an estimated 300,000-650,000 influenza-related hospitalizations in the U.S.2 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.3 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.3 The CDC recommends that for most people who need only 1 dose of flu vaccine, vaccination should ideally happen in September or October.3 About CSL Seqirus CSL Seqirus is part of CSL (ASX:CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit CSLSeqirus.com. About CSL CSL (ASX:CSL) (USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information about CSL, visit . Intended Audience This press release is issued from CSL Seqirus in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products. Forward-Looking Statements This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. USA-CRP-23-0005 MEDIA CONTACT Tiffany Cody +1 (908) 370-1863 [email protected] FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), FLUCELVAX® QUADRIVALENT (Influenza Vaccine), and AFLURIA® QUADRIVALENT (Influenza Vaccine) INDICATION AND IMPORTANT SAFETY INFORMATION What are FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), FLUCELVAX® QUADRIVALENT (Influenza Vaccine), and AFLURIA® QUADRIVALENT (Influenza Vaccine)? FLUAD QUADRIVALENT is a vaccine that helps protect people aged 65 years and older from the flu. FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 6 months and older from the flu. AFLURIA QUADRIVALENT is a vaccine that helps protect people aged 6 months and older from the flu. Vaccination with any of these may not protect all people who receive the vaccine. Who should not get FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT? You should not get FLUAD QUADRIVALENT nor AFLURIA QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine in the past, including egg protein, or a severe allergic reaction to a previous influenza vaccine. You should not get FLUCELVAX QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine. Before receiving FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you: have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu vaccine. The decision to give any flu vaccine should be made by your healthcare provider, based on careful consideration of the potential benefits and risks. have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine have ever fainted when receiving a vaccine What are common side effects possible with FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, and AFLURIA QUADRIVALENT? pain, tenderness, redness, itching, bruising, swelling, and/or a raised hardened area where the vaccine was given headache overtiredness with low energy muscle aches feeling unwell (malaise) Additional side effects in children include: sleepiness irritability diarrhea changes in eating habits These are not all the possible side effects of FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, and AFLURIA QUADRIVALENT. You can ask your healthcare provider for more information. What do I do if I have side effects? Ask your healthcare provider for advice about any side effects that concern you. To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and . You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1–800–FDA–1088. Before receiving this vaccine, please see the full US Prescribing Information for FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT. The information provided here does not include all that is known about FLUAD QUADRIVALENT, FLUCELVAX QUADRIVALENT, or AFLURIA QUADRIVALENT. To learn more, talk with your healthcare provider. FLUAD® QUADRIVALENT, FLUCELVAX® QUADRIVALENT, and AFLURIA® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates. MF59® is a registered trademark of Seqirus UK Limited or its affiliates. REFERENCES 1 Centers for Disease Control and Prevention (CDC). Weekly Flu Vaccination Dashboard. Retrieved from: , Accessed June 2023. 2 CDC. 2022-2023 Preliminary In-Season Burden Estimate. Retrieved from: . Accessed June 2023. 3 CDC. Who Needs a Flu Vaccine and When. Retrieved from: . Accessed June 2023. 4 Zhang, Y., Yakob, L., Bonsall, M.B. et al. Predicting seasonal influenza epidemics using cross-hemisphere influenza surveillance data and local internet query data. Sci Rep 9, 3262 (2019). . 5 Australian Government Department of Health and Aged Care. AISR fortnightly report No. 5 – 29 May to 11 June 2023. Retrieved from: . Accessed June 2023. 6 FLUCELVAX® QUADRIVALENT (Influenza Vaccine) [package insert]. Holly Springs, NC: CSL Seqirus Inc, 2023. 7 Rajaram S, Boikos C, Gelone DK, Gandhi A. Influenza vaccines: the potential benefits of cell-culture isolation and manufacturing. Ther Adv Vaccines Immunother. 2020;8:2515135520908121. doi: 10.1177/2515135520908121. 8 CDC. Cell-based flu vaccines. Retrieved from . Accessed June 2023. 9 Rockman S, Laurie K, Ong C, Rajaram S, McGovern I, Tran V, Youhanna J. Cell-Based Manufacturing Technology Increases Antigenic Match of Influenza Vaccine and Results in Improved Effectiveness. Vaccines. 2023; 11(1):52. . 10 McLean HQ, Petrie JG, Hanson KE, et al. Interim Estimates of 2022–23 Seasonal Influenza Vaccine Effectiveness — Wisconsin, October 2022–February 2023. MMWR Morb Mortal Wkly Rep 2023;72:201–205. 11 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: CSL Seqirus Inc, 2023. National 12 Grohskopf LA, Blanton LH, Ferdinands JM, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022–23 Influenza Season. MMWR Recomm Rep 2022;71(No. RR-1):1–28. . 13 Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034. 14 O'Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines: 2013;12(1): 13-3. 15 AFLURIA® QUADRIVALENT [package insert]. Parkville, AU: CSL Seqirus Inc, 2023. 16 CDC. People at Higher Risk of Flu Complications. . Accessed June 2023. 17 CDC. Key Facts about Influenza. Retrieved from . Accessed June 2023. SOURCE CSL Seqirus

This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID Preliminary topline immune responses for all three vaccine candidates were robust versus authorized comparators For the stand-alone influenza vaccine candidate, HAI responses were 31 to 56% higher for all four influenza strains compared to Fluad®, and were 44 to 89% higher for A strains compared to Fluzone HD® For the COVID-Influenza Combination vaccine candidate, anti-S IgG and neutralization responses achieved levels seen in Phase 3 trial with Novavax's prototype vaccine, with HAI responses generally consistent with Fluad® and Fluzone HD® All three vaccine candidates were well-tolerated and demonstrated a reassuring preliminary safety profile, with reactogenicity comparable to authorized comparators These Phase 2 results support continued development for all three vaccine candidates GAITHERSBURG, Md., May 9, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that its COVID-Influenza Combination (CIC), stand-alone influenza and high-dose COVID vaccine candidates all showed a reassuring preliminary safety pro well as comparable reactogenicity to individual Novavax influenza and COVID vaccine candidates or authorized influenza vaccine comparators. Additionally, all three vaccines demonstrated preliminary robust immune responses. The primary endpoint evaluated the safety of different formulations of the CIC vaccine candidate and the quadrivalent influenza vaccine candidate compared to Fluad®* and Fluzone High-Dose Quadrivalent®** (Fluzone HD), as well as a high-dose COVID vaccine candidate in adults aged 50 through 80. All three vaccine candidates contained Novavax's patented Matrix-M adjuvant and showed reassuring preliminary safety profiles and reactogenicity that was comparable to Fluad and Fluzone HD. The reactogenicity pro consistent as the adjuvant or antigen dose was increased. In all groups there were no adverse events (AE) of special interest, no potentially immune mediated medical conditions and no treatment-related serious AEs. Unsolicited AEs occurred in 25% or fewer of any group and were consistent with diagnoses in the older adult population. Local and systemic symptoms were mostly mild and moderate and occurred at rates comparable to Fluad and Fluzone HD. "The reactogenicity results support our previous observations that this technology is well suited for combination vaccines because large amounts of antigen can be incorporated without impacting tolerability," said Filip Dubovsky President, Research and Development, Novavax. "The immune responses we observed were robust, and the data we have shared today significantly increase the probability of Phase 3 success." The CIC vaccine candidate achieved both immunoglobulin G (IgG) and neutralizing levels comparable to Novavax's prototype COVID vaccine (NVX-CoV2373). In addition, several of the combination formulations achieved responses to both SARS-CoV-2 and to the four homologous influenza strains that were comparable to the reference comparators, supporting their prioritization for advanced development. The stand-alone influenza vaccine candidate achieved statistically significant hemagglutination inhibition (HAI) antibody responses 31 to 56% higher for all four strains compared to Fluad. Titers were 44 (H1N1) to 89% (H3N2) higher for A strains and statistically non-inferior for B-strains compared to Fluzone HD. The highest dose stand-alone COVID vaccine candidate achieved statistically significant anti-S IgG and neutralization responses approximately 30% higher than Novavax's prototype COVID vaccine while maintaining comparable safety and reactogenicity to currently authorized dose level of Nuvaxovid. "Today's positive data are encouraging and further validate the value of our technology platform and its potential to improve global public health," said John C. Jacobs, President and Chief Executive Officer, Novavax. "This is an important milestone in our journey to create additional value and diversify our portfolio of vaccines." About the Phase 2 Trial for CIC, Stand-alone Influenza and High-Dose COVID Vaccine Candidates The Phase 2 Trial is a dose-confirming, randomized, observer-blinded trial evaluating the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates, and higher doses of Novavax's COVID vaccine in adults aged 50 through 80. The trial is assessing a CIC vaccine candidate comprised of Novavax's recombinant protein-based COVID vaccine, quadrivalent influenza vaccine candidate and patented saponin-based Matrix-M adjuvant. Primary and secondary objectives of the study are to assess the safety, tolerability and immune responses to various formulations of the CIC, influenza and high-dose COVID vaccine candidates. The Phase 2 dose-confirmation trial is being conducted in two parts. About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels. About Matrix-M™ Adjuvant When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes. About Novavax Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID, influenza, and COVID and influenza combined. Please visit novavax.com and LinkedIn for more information. Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, the CIC, the high-dose COVID vaccine candidates, the quadrivalent influenza investigational vaccine candidate, the potential impact and reach of Novavax and NVX-CoV2373 in improving public health, the efficacy, safety intended utilization, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; challenges in implementing our global restructuring and cost reduction plan; challenges in obtaining commercial adoption of NVX-CoV2373 or a COVID-19 variant strain-containing formulation; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and , for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. *Fluad® is a registered trademark of Seqirus UK Limited **Fluzone High-Dose Quadrivalent®* is a registered trademark of Sanofi Pasteur Inc. Contacts: Investors Erika Schultz 240-268-2022 ir@novavax.com Media Ali Chartan 240-720-7804 media@novavax.com View original content to download multimedia: SOURCE Novavax, Inc. Company Codes: NASDAQ-NMS:NVAX