Last update 20 Jun 2024

Influenza vaccine(Seqirus GmbH)

Last update 20 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine

Synonyms

influenza vaccine (surface antigen, inactivated, prepared in cell cultures), influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type), influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09-like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2)-like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013-like strain(B/Utah/9/2014, wild type)

+ [1]

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza A virus infectionInfluenza B virus infection

Inactive Indication-

Originator Organization

Seqirus GmbH

Active Organization

Seqirus GmbH

Inactive Organization

Novartis Vaccines & Diagnostics SLNovartis Pharma AG

Drug Highest PhaseApproved

First Approval Date

US (24 Nov 2015),

Influenza A virus infectionInfluenza B virus infection

Regulation-

Clinical Trials associated with Influenza vaccine(Seqirus GmbH)

NCT05291676 / RecruitingPhase 2IIT

Systems Investigation of Vaccine Responses in Aging and Frailty

This study will compare the immune response signatures (including immunologic, transcriptomic and metabolomic) of the two influenza vaccines approved for use in adults age 65 and over (Fluad and Fluzone High-Dose).

Start Date06 Nov 2023

Sponsor / Collaborator

Yale University

[+1]

NCT06029933 / RecruitingNot Applicable

Relative Vaccine Effectiveness of Adjuvanted Quadrivalent Inactivated Influenza Vaccine vs High-Dose Quadrivalent Inactivated Influenza Vaccine Among Adults ≥65 Years for the 2023-24 and 2024-25 Seasons

This study will evaluate the relative vaccine effectiveness of quadrivalent adjuvanted inactivated influenza vaccine (aIIV4) versus quadrivalent high-dose inactivated influenza vaccine (HD-IIV4) in preventing polymerase chain reaction (PCR)-confirmed influenza and influenza-related outcomes in adults ≥65 years of age during the 2023/24 and 2024/25 influenza seasons. The study is an observational study conducted at Kaiser Permanente Northern California (KPNC), an integrated health care system in the United States.

Start Date17 Aug 2023

Sponsor / Collaborator

Kaiser Permanente, Inc.

[+1]

NCT05518500 / RecruitingPhase 4IIT

A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults

This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally follow a cohort of 66 older adults (65 years and older) who will receive three different influenza vaccines over three annual influenza seasons. Blood samples will be collected from the participants at each of the sixteen study visits over three years. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.

Start Date31 Aug 2022

Sponsor / Collaborator

The Jackson Laboratory

[+5]

100 Clinical Results associated with Influenza vaccine(Seqirus GmbH)

100 Translational Medicine associated with Influenza vaccine(Seqirus GmbH)

100 Patents (Medical) associated with Influenza vaccine(Seqirus GmbH)

Literatures (Medical) associated with Influenza vaccine(Seqirus GmbH)

21 Aug 2023·Vaccines

Advances in Adjuvanted Influenza Vaccines.

Review

Author: Shichinohe, Shintaro ; Watanabe, Tokiko

The numerous influenza infections that occur every year present a major public health problem. Influenza vaccines are important for the prevention of the disease; however, their effectiveness against infection can be suboptimal. Particularly in the elderly, immune induction can be insufficient, and the vaccine efficacy against infection is usually lower than that in young adults. Vaccine efficacy can be improved by the addition of adjuvants, and an influenza vaccine with an oil-in-water adjuvant MF59, FLUAD, has been recently licensed in the United States and other countries for persons aged 65 years and older. Although the adverse effects of adjuvanted vaccines have been a concern, many adverse effects of currently approved adjuvanted influenza vaccines are mild and acceptable, given the overriding benefits of the vaccine. Since sufficient immunity can be induced with a small amount of vaccine antigen in the presence of an adjuvant, adjuvanted vaccines promote dose sparing and the prompt preparation of vaccines for pandemic influenza. Adjuvants not only enhance the immune response to antigens but can also be effective against antigenically different viruses. In this narrative review, we provide an overview of influenza vaccines, both past and present, before presenting a discussion of adjuvanted influenza vaccines and their future.

01 Aug 2022·International journal of pharmaceutics

Formulation of dry powders of vaccines containing MF59 or AddaVax by Thin-Film Freeze-Drying: Towards a dry powder universal flu vaccine

Article

Author: Ross, Ted M ; Xu, Haiyue ; Cui, Zhengrong ; Uno, Naoko ; Williams Iii, Robert O ; Cano, Chris ; AboulFotouh, Khaled ; Davenport, Gregory J ; Christensen, Dale J ; Sahakijpijarn, Sawittree ; Moon, Chaeho

MF59® is an oil-in-water (O/W) nanoemulsion-based vaccine adjuvant that is often used in seasonal and pandemic influenza vaccines. We explored the feasibility of developing dry powders of vaccines adjuvanted with MF59 or AddaVax™, a preclinical grade equivalent of MF59 with the same composition and droplet size as MF59, by thin-film freeze-drying (TFFD). Liquid AddaVax alone was successfully converted to a dry powder by TFFD using trehalose as a stabilizing agent while maintaining the droplet size distribution of AddaVax after it was reconstituted. TFFD was then applied to convert liquid AddaVax-adjuvanted vaccines containing either a model antigen (e.g., ovalbumin) or mono-, bi-, and tri-valent recombinant hemagglutinin (rHA) protein-based H1 and/or H3 (universal) influenza vaccine candidates, as well as the MF59-containing Fluad® Quadrivalent influenza vaccine to dry powders. Both antigens and stabilizing agents affected the physical properties of the vaccines (e.g., mean particle size and particle size distribution) after the vaccines were subjected to TFFD. Importantly, the integrity and hemagglutination activity of the rHA antigens did not significantly change and the immunogenicity of reconstituted influenza vaccine candidates was maintained when evaluated in a mouse model. The vaccine dry powder was not sensitive to repeated freezing-and-thawing, in contrast to its liquid counterpart. It is concluded that TFFD can be applied to convert liquid vaccines containing MF59 or AddaVax to dry powders while maintaining the immunogenicity of the vaccines. Ultimately, TFFD technology may be used to prepare dry powders of multivalent universal influenza vaccines.

01 Feb 2022·The Lancet. Respiratory medicineQ1 · MEDICINE

Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Q1 · MEDICINE

Article

BACKGROUND:

The safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines have not yet been reported. We therefore aimed to report the results of a substudy within a phase 3 UK trial, by evaluating the safety, immunogenicity, and efficacy of NVX-CoV2373 when co-administered with licensed seasonal influenza vaccines.

METHODS:

We did a planned exploratory substudy as part of the randomised, observer-blinded, placebo-controlled, phase 3 trial of the safety and efficacy of the COVID-19 vaccine (NVX-CoV2373) by co-administrating the influenza vaccine at four study hospitals in the UK. Approximately, the first 400 participants meeting the main study entry criteria-with no contraindications to influenza vaccination-were invited to join the substudy. Participants of the main study were randomly assigned (1:1) to receive two intramuscular injections of either NVX-CoV2373 (5 μg) or placebo (normal saline) 21 days apart; participants enrolled into the substudy were co-vaccinated with a single (0·5 mL) intramuscular, age-appropriate (quadrivalent influenza cell-based vaccine [Flucelvax Quadrivalent; Seqirus UK, Maidenhead] for those aged 18-64 years and adjuvanted trivalent influenza vaccine [Fluad; Seqirus UK, Maidenhead] for those ≥65 years), licensed, influenza vaccine on the opposite deltoid to that of the first study vaccine dose or placebo. The influenza vaccine was administered in an open-label manner and at the same time as the first study injection. Reactogenicity was evaluated via an electronic diary for 7 days after vaccination in addition to monitoring for unsolicited adverse events, medically attended adverse events, and serious adverse events. Immunogenicity was assessed with influenza haemagglutination inhibition and SARS-CoV-2 anti-spike protein IgG assays. Vaccine efficacy against PCR-confirmed, symptomatic COVID-19 was assessed in participants who were seronegative at baseline, received both doses of study vaccine or placebo, had no major protocol deviations affecting the primary endpoint, and had no confirmed cases of symptomatic COVID-19 from the first dose until 6 days after the second dose (per-protocol efficacy population). Immunogenicity was assessed in participants who received scheduled two doses of study vaccine, had a baseline sample and at least one post-vaccination sample, and had no major protocol violations before unmasking (per-protocol immunogenicity population). Reactogenicity was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo and had data collected for reactogenicity events. Safety was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo. Comparisons were made between participants of the substudy and the main study (who were not co-vaccinated for influenza). This study is registered with ClinicalTrials.gov, number NCT04583995.

FINDINGS:

Between Sept 28, 2020, and Nov 28, 2020, a total of 15 187 participants were randomised into the main phase 3 trial, of whom 15 139 received treatment (7569 received dose one of NVX-CoV2373 and 7570 received dose one of placebo). 431 participants were co-vaccinated with a seasonal influenza vaccine in the substudy (217 received NVX-CoV2373 plus the influenza vaccine and 214 received placebo plus the influenza vaccine). In general, the substudy participants were younger, more racially diverse, and had fewer comorbid conditions than those in the main study. Reactogenicity events were more common in the co-administration group than in the NVX-CoV2373 alone group: tenderness (113 [64·9%] of 174 vs 592 [53·3%] of 1111) or pain (69 [39·7%] vs 325 [29·3%]) at injection site, fatigue (48 [27·7%] vs 215 [19·4%]), and muscle pain (49 [28·3%] vs 237 [21·4%]). Incidences of unsolicited adverse events, treatment-related medically attended adverse events, and serious adverse events were low and balanced between the co-administration group and the NVX-CoV2373 alone group. No episodes of anaphylaxis or deaths were reported within the substudy. Co-administration resulted in no change to influenza vaccine immune response although a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. NVX-CoV2373 vaccine efficacy in the substudy (ie, participants aged 18 to <65 years) was 87·5% (95% CI -0·2 to 98·4) and in the main study was 89·8% (95% CI 79·7-95·5).

INTERPRETATION:

To our knowledge, this substudy is the first to show the safety, immunogenicity, and efficacy profile of a COVID-19 vaccine when co-administered with seasonal influenza vaccines. Our results suggest concomitant vaccination might be a viable immunisation strategy.

FUNDING:

Novavax.

News (Medical) associated with Influenza vaccine(Seqirus GmbH)

13 Feb 2024

·www.prnewswire.com

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

Strong CSL Behring portfolio growth especially Ig FINANCIAL HIGHLIGHTS 4 Revenue $8.05 billion, up 11% at CC3 NPAT $1.90 billion1, up 17% NPAT $1.94 billion1 at CC3, up 20% NPATA $2.02 billion1,2 , up 11% NPATA $2.06 billion1,2 at CC3, up 13% NPATA1,2 earnings per share $4.182, up 11% NPATA1,2 earnings per share $4.26 at CC3 up 13% Interim dividend 5 of US$1.19 per share Converted to Australian currency, the interim dividend is approximately A$1.81 per share, up 12% Guidance reaffirmed – FY24 NPATA2,4 anticipated to be in the range of approximately $2.9 billion to $3.0 billion2 at CC3 MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3. Dr. Paul McKenzie, CSL's Chief Executive Officer and Managing Director said, "Our strong first-half result for the 2024 financial year was driven by CSL Behring's exceptional performance across its portfolio, especially immunoglobulins. The plasma initiatives we have implemented are starting to drive gross margin recovery. "CSL Seqirus achieved solid growth in a challenging season. Its portfolio of differentiated products outperformed the market. "For CSL Vifor we are well prepared for the transitioning iron market." PERFORMANCE CSL Behring Total revenue was $5,238 million, up 14%3 when compared to the prior comparable period. Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand. PRIVIGEN® / INTRAGRAM® (Immune Globulin Intravenous (Human), 10% Liquid) sales grew 27%3 as the momentum from the prior year continued in improving product availability and patient diagnosis rates. HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by patient diagnosis rates. HIZENTRA® continues to be the clear market leader for subcutaneous immunoglobulin. Underlying demand for Ig continues to be strong due to significant patient needs in core indications – namely Primary Immune Deficiency, Secondary Immune Deficiency and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Albumin sales of $613 million, were up 8%3. Sales were strong in emerging markets with solid growth in the US and Europe. Growth in China was modest, tempered by competitive pressure. Haemophilia product sales of $662 million increased 8%3. IDELVION®, CSL Behring's novel long-acting recombinant factor IX product achieved growth of 7%3 and continues to be the market leader in key markets. HEMGENIX®, the first and only gene therapy for haemophilia B was successfully launched in the US in FY23 and patient referrals have been accelerating. The haemophilia A market continued to be competitive resulting in a modest decline in sales for AFSTYLA®, a novel recombinant factor VIII product. Plasma-derived haemophilia products, however, achieved growth of 8% driven by HUMATE® / HAEMATE®, therapies for the treatment of patients with von Willebrand disease. Specialty products sales of $976 million, were up 6%3 led predominately by demand for KCENTRA® and HAEGARDA®. KCENTRA® (4 factor prothrombin complex concentrate) recorded sales growth of 12%3, as it continues to further penetrate the warfarin reversal market in the US. HAEGARDA®, our therapy for patients with Hereditary Angioedema, increased 9%, driven by the continued shift from on-demand to prophylaxis treatment and a strong performance in the UK and Europe. Garadacimab (Anti-FXIIa) for HAE, was filed for regulatory approval in the US and EU. Plasma Collections Plasma collections remain strong. The cost of collections, which includes donor compensation and labour, continued to trend down. A new roll out plan for the RIKA plasmapheresis devices was developed. Deployment across the US fleet is expected over the next 18 months. In addition, results from an individualised nomogram trial conducted by our supplier have been submitted for regulatory approval. CSL Seqirus Total revenue of $1,804 million, was up 2%3 driven by the adjuvanted influenza vaccine FLUAD®, which increased by 14%3. This growth was achieved against a backdrop of reduced rates of immunisation and highlights the strength of CSL Seqirus' differentiated product portfolio. During the period: Self-amplifying mRNA vaccine for COVID was approved by Japan's Ministry of Health, Labour and Welfare aQIVc, a next generation influenza vaccine combining adjuvant technology with cell-based manufacturing, enrolled its last patient in the Phase III clinical study in January 2024. CSL Vifor Total revenue was $1,011 million. The prior comparable period included only 5 months revenue following the acquisition of Vifor Pharma in August 2022. During the period: Preparations were made for the transitioning iron market There was strong performance from the long-acting erythropoiesis-stimulating agent, MIRCERA® TAVNEOS® was successfully launched in multiple European countries While the strategic potential of the business remains strong, we have dampened our near-term growth aspirations for CSL Vifor. Expense Performance Research and development (R&D) expenses were $669 million8 , up 11%3 when compared to the prior comparable period. The increase in expenses reflects higher costs associated with the progression of the R&D portfolio and investment in R&D infrastructure. Selling and marketing expenses (S&M) were $707 million8, up 2%3 in comparison to the prior comparable period. An additional month of CSL Vifor and an increase in labour costs accounts for the increase in S&M expenses while other S&M expenses were held in line with the prior comparable period. General and administrative (G&A) expenses were $323 million8, down 7%3 due to favourable foreign exchange differences and efficiencies generated from the centralisation of the group's Enabling Functions. Depreciation and amortisation (D&A) expense (excluding acquired intellectual property) was $297 million, up 1%3. Net finance costs were $234 million9, up 32%3. The increase in net finance costs was due to the debt associated with the acquisition of Vifor Pharma and higher interest rates. Financial position Cashflow from operations was $1,069 million, up 9%. The increase was driven by higher profitability and overall growth in sales. This was partly offset by higher payments for income tax and interest. Cash outflow from investing was $702 million, down significantly when compared to the prior comparable period as payment for the acquisition of Vifor Pharma was made in the prior period. CSL's balance sheet remains in a strong position with net assets of $19,162 million. Current assets increased by 10% to $10,146 million. The main driver was an increase in receivables due to the increase in sales and the seasonality of CSL Seqirus. Non-current assets increased by 1% to $27,158 million in comparison to the previous year. Current liabilities increased by 2% to $4,718 million. The increase in interest-bearing liabilities and borrowings (bank debt) was offset by the decrease in trade and other payables and current tax liabilities. Non-current liabilities decreased by 3% to $13,424 million. The decrease was due to the reclassification of certain bank borrowings as current, coupled with repayment across the Group's debt portfolio including the private placement senior notes. Outlook (at FY23 exchange rates) Commenting on CSL's outlook, Dr. McKenzie said, "For FY24, I am pleased to reaffirm our previous guidance. CSL's underlying profit, NPATA is expected be in the range of approximately $2.9 billion to $3.0 billion at constant currency3, representing growth over FY23 of approximately 13-17%[6]" "CSL is in a strong position to deliver annualised double-digit earnings growth over the medium term. "The strong growth in our immunoglobulins franchise is expected to continue as patient demand remains strong. "We have a number of initiatives underway in plasma collections that are improving efficiencies and processing times, supporting continued expansion in CSL Behring's gross margin. "Our transformational gene therapy product for haemophilia B patients, HEMGENIX®, is attracting significant interest from patients and health care professionals and patient referrals have accelerated. We expect more patients dosed in the second half of this financial year. "CSL Seqirus has performed well in a challenging season. However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year. "For CSL Vifor, we are operating within an evolving iron market. While there are challenges for near-term growth, we are well positioned for iron competition in the EU and further geographic expansion. Our focus remains on unlocking value by leveraging capabilities across the CSL group", Dr. McKenzie concluded. In compiling the company's financial forecasts for FY24, a number of key variables that may have a significant impact on guidance have been identified and these have been included in the endnote[7]. FURTHER INFORMATION Additional details about CSL's results are included in the company's 4D statement, investor presentation slides and webcast, all of which can be found on CSL's website A glossary of medical terms can also be found on the website. 1 Attributable to CSL shareholders 2 Statutory net profit after tax (NPAT) before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and the unwind of the inventory fair value uplift. 3 Constant currency (CC) removes the impact of exchange rate movements, facilitating the comparability of operational performance. For further detail refer to CSL's Financial Statements for the Half Year ended December 2023 (Directors Report). 4 All figures are expressed in US dollars unless otherwise stated. 5 For shareholders with an Australian registered address, the interim dividend of US$1.19 per share (approximately A$1.81) is expected to be paid on 3 April 2024. For shareholders with a New Zealand registered address the interim dividend of US$1.19 per share (approximately NZ$1.94) is expected to be paid on 3 April 2024. The exchange rates will be fixed at the record date of 12 March 2024. All other shareholders will be paid in US$. CSL also offers shareholders the opportunity to receive dividend payments in US$ by direct credit to a US bank account. 6 % growth rates excludes the one-off gain from the sale of property in FY23 (NPATA $44m). 7 Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; ability to collect plasma; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and CSL's ability to protect its patents and other intellectual property. 8 Underlying results are adjusted to exclude amortisation of acquired intellectual property ($132 million), business acquisition and integrations costs and the unwind of the inventory fair value uplift. 9 At reported currency For further information, please contact: Investors: Bernard Ronchi Director, Investor Relations CSL Limited P: +61 3 9389 3470 E: [email protected] Stephen McKeon Director, Investor Relations CSL Limited P: +61 402 231 696 E: [email protected] Media: Jimmy Baker Communications CSL Limited P: +61 450 909 211 E: [email protected] SOURCE CSL Limited

Phase 3Drug ApprovalVaccineFinancial StatementClinical Result

21 Dec 2023

·www.biospace.com

CSL Seqirus Commends the National Advisory Committee on Immunization for Preferential Recommendation of Enhanced Influenza Vaccines for Adults 65 and Older

FLUAD® is now preferentially recommended by the National Advisory Committee on Immunization for adults 65 years of age and older. MONTREAL, Dec. 21, 2023 /CNW/ - CSL Seqirus commends the National Advisory Committee on Immunization's (NACI's) recent recommendation for adults 65 years of age and older to preferentially receive an enhanced influenza vaccine, which includes adjuvanted, high-dose and recombinant vaccines. This recommendation is based on data from studies that show that all approved enhanced influenza vaccines are effective in reducing the risk of influenza-related hospitalization and medical encounters. NACI summarizes that each enhanced influenza vaccine has increased vaccine efficacy and effectiveness compared to standard-dose vaccines, and all enhanced influenza vaccines are considered equally effective and safe. NACI's recent statement adds to a growing number of international recommendations regarding the effectiveness of enhanced influenza vaccines for adults 65 years of age and older. In July 2022, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) also recommended adults 65 years of age and older to preferentially receive an enhanced influenza vaccine, including adjuvanted and high dose vaccines.i NACI's recommendations to include FLUAD® was made for both individual- and public health program- level decision making. "Provinces should be using every enhanced vaccine in their arsenal to ensure that adults 65 years of age and older are protected against influenza," said Gregg Sylvester, MD, Chief Health Officer, CSL Seqirus. "We are proud to offer provincial immunization programs a safe and effective enhanced influenza vaccine to help protect older Canadians."ii,iii FLUAD® produced a robust immune response against 3 strains of influenza in randomized clinical trials and has a demonstrated safety profile. To complement this data, real-world data for FLUAD® showed effectiveness at reducing influenza-related hospitalizations for people aged 65 and over, versus FLUZONE HD. Influenza causes an average of 12,200 hospitalizations and approximately 3,500 deaths each year in Canada, with the majority occurring in adults over 65 years of age.iv Canadians over 65 years of age accounted for 76% of the reported influenza-associated deaths during the 2022/23 flu season.vii Older adults are at greater risk due to immunosenescence, the age-associated decline of the immune system, and may result in a reduced immune response to antigens in the vaccine.v,vi Influenza A has been associated with the most severe disease in seniors. During the 2021/2022 and 2022/2023 seasons, Influenza A caused 98 to 100% of disease in the 65 years and older adults. "The 2022/23 influenza season was especially challenging for Canadians and added to the already significant strain being experienced by our healthcare systems," said Bertrand Roy, Ph.D., Country Head Medical Affairs Canada at CSL Seqirus. "We are pleased that NACI's thorough review and recommendation will help immunizers optimize the delivery of annual influenza immunizations to help mitigate other potentially difficult flu seasons." NACI is a national advisory committee of experts in the fields of pediatrics, infectious diseases, immunology, pharmacy, nursing, epidemiology, pharmacoeconomics, social science and public health. NACI makes recommendations for the use of vaccines currently or newly approved for use in humans in Canada, including the identification of groups at risk for vaccine-preventable diseases for whom vaccination should be targeted. About CSL Seqirus CSL Seqirus is part of CSL Limited (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. About CSL CSL (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. 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 30,000 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 . For more information about CSL, visit . CSL SEQIRUS and FLUAD® are trademarks of CSL Seqirus. Intended Audience This press release is issued from CSL Seqirus in Montreal, Quebec, Canada 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. References __________________________ SOURCE CSL Seqirus Company Codes: Australia:CSL, OTC-PINK:CSLLY

Vaccine

17 Jul 2023

·www.prnewswire.com

CSL Seqirus Begins Shipping Portfolio of Innovative Influenza Vaccines for the 2023/24 U.S. Season

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

VaccineClinical ResultDrug Approval

100 Deals associated with Influenza vaccine(Seqirus GmbH)

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Indication	Country/Location	Organization	Date
Influenza A virus infection	US	Seqirus GmbH	24 Nov 2015
Influenza B virus infection	US	Seqirus GmbH	24 Nov 2015

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	US	Novartis Vaccines & Diagnostics SL	01 Oct 2007
Influenza, Human	Phase 3	FI	Novartis Vaccines & Diagnostics SL	01 Oct 2007
Influenza, Human	Phase 3	PL	Novartis Vaccines & Diagnostics SL	01 Oct 2007

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05007041 (CTgov)	Phase 4	Herpes Zoster \| Drug-Related Side Effects and Adverse Reactions \| Influenza, Human ... View more	267	Zoster Vaccine Recombinant (RZV) (Zoster Vaccine Recombinant (RZV) and Quadrivalent Adjuvanted Influenza Vaccine)	jmbzxdukeq(mptbjbbivh): Difference in proportions = -0.96 (95.0% CI, -8.94 to 7.1), P-Value = 0.0037 View more	-	01 May 2024
				Zoster Vaccine Recombinant (RZV) (Zoster Vaccine Recombinant (RZV) and High-dose Quadrivalent Influenza Vaccine)
NCT03694808 (CTgov)	Phase 4	Influenza, Human	478	Fluad Vaccine (Fluad Vaccine)	kdiemgfcmr(cmavxnthrk) = rvlnbnrgvw submanmvru (nolvtrnrxt, mjttehwrvb - dllecucgbm) View more	-	30 Apr 2024
				Fluzone HD Vaccine (Fluzone Vaccine)	kdiemgfcmr(cmavxnthrk) = oyvonrbhyf submanmvru (nolvtrnrxt, qnqjfghoxf - zcaqvezvwh) View more
NCT03603509 (CTgov)	Phase 4	Influenza, Human	241	Fluad Vaccine (Fluad Vaccine)	alidbpzbqe(vehexzadtl) = wqqrdhpacy ejqwhwvuli (xfsrwfrkst, ctfzqovhrs - obfpnpwfum) View more	-	16 May 2023
				Fluzone High-Dose (Fluzone Vaccine)	alidbpzbqe(vehexzadtl) = jjrjyfekqd ejqwhwvuli (xfsrwfrkst, kvvjofqrhy - tvsdlgbyka) View more
NCT04077424 (single cell, CTgov)	Phase 4	Influenza, Human	10	Fluzone-High Dose Quadrivalent (Fluzone-High Dose)	iaqbdtihow(bykolbitnh) = pjlnllcqle elukqgroco (jolmybhrgx, dtxhssxsge - zmzkziyoqo) View more	-	12 Jul 2022
				Fluad (Fluad)	iaqbdtihow(bykolbitnh) = saacbajlwn elukqgroco (jolmybhrgx, nmdhgitbcq - pnfrvtlwat) View more
NCT03183908 (CTgov)	Phase 4	Influenza, Human \| Drug-Related Side Effects and Adverse Reactions \| Injection Site Reaction ... View more	757	FLUAD® (Adjuvanted Influenza Vaccine (FLUAD®))	jwvpzcgcoc(bdpmdhbxml): Difference in proportions = -2.7 (95% CI, -5.8 to 0.4) View more	-	30 Mar 2021
				Fluzone® High-Dose (High-dose Influenza Vaccine (Fluzone® HD))

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Influenza vaccine(Seqirus GmbH)

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