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Last update 17 Sep 2026

Inactivated influenza vaccine(Seqirus Pty Ltd)

Last update 17 Sep 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Inactivated vaccine, Prophylactic vaccine, Multivalent vaccine

Synonyms

3 influenza strains: A/Victoria/4897/2022 IVR-238 (an A/Victoria/4897/2022 (H1N1)pdm09-like virus); A/Croatia/10136RV/2023 X-425A (an A/Croatia/10136RV/2023 (H3N2)-like virus); and B/Austria/1359417/2021 BVR-26 (a B/Austria/1359417/2021-like virus), Afluria, Afluria Quadrivalent

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication

Influenza, Human

Inactive Indication

Influenza A virus infectionInfluenza B virus infection

Originator Organization

Seqirus Pty Ltd.

Active Organization

Scandinavian Regulatory Services ABSeqirus Pty Ltd.

Inactive Organization

Seqirus GmbH

License Organization-

Drug Highest PhaseApproved

First Approval Date

Denmark (30 Dec 1997),

Influenza, Human

RegulationPriority Review (Australia)

Clinical Trials associated with Inactivated influenza vaccine(Seqirus Pty Ltd)

NCT05734040

/ CompletedPhase 2

Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years.

The present study OVX836-006 aims principally to:
* Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms;
* Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ;
* Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response;
* Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response;
* Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies;
* Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

Start Date10 May 2023

Sponsor / Collaborator

Osivax SAS

[+2]

NCT05330975

/ CompletedPhase 3

A Phase 3 Randomized, Observer-Blind, Study to Evaluate Safety, Tolerability, and Immunogenicity of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), When Given Alone or Coadministered With a Seasonal Influenza Vaccine or SARS-CoV-2 Vaccine and When Given as an Open-label Boost at 1 Year Following a Primary Dose in Adults ≥ 50 Years of Age

The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza.
The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.

Start Date01 Apr 2022

Sponsor / Collaborator

ModernaTX, Inc.

NCT07386509

/ TerminatedEarly Phase 1IIT

WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza

Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.

Start Date17 Mar 2020

Sponsor / Collaborator

Washington University School of Medicine

[+1]

100 Clinical Results associated with Inactivated influenza vaccine(Seqirus Pty Ltd)

100 Translational Medicine associated with Inactivated influenza vaccine(Seqirus Pty Ltd)

100 Patents (Medical) associated with Inactivated influenza vaccine(Seqirus Pty Ltd)

Literatures (Medical) associated with Inactivated influenza vaccine(Seqirus Pty Ltd)

08 Oct 2025·mBio

An NLRP3-stimulatory adjuvant improves the immunogenicity of influenza virus vaccines in mice and non-human primates

Article

Author: Chow, Jonathan ; Matissek, Stephan ; Finn, Kelsey ; Iheanyichukwu, Victory ; Komoroski, Veronica ; Lamberti, Nicolina ; Arinze, Chisom ; Kagan, Jonathan C. ; Elloul, Sivan ; Alkekhia, Dahlia ; Coblentz, Philip D. ; Kelly, Colin ; MacFarlane, Carolyn ; Zhivaki, Dania ; Chokshi, Milap ; Sengupta, Debrup ; Gosselin, Emily ; Nikiforov, Anastasia ; Cornforth, Andrew ; Concepcion, Holly

ABSTRACT:

Dendritic cells (DCs) are the primary inducers of immunity induced by infection or vaccination. To stimulate durable T cell-mediated immunity, multiple DC activities are required. DCs must present antigen, express costimulatory molecules, and secrete inflammatory cytokines to direct T cell activation. These activities must be coordinated with DC migration to the lymph node and production of memory T cell-inducing cytokines, such as IL-1β. Common vaccination approaches use adjuvants that stimulate a subset of these activities, leading to diminished T cell activities and poor immune durability. We describe herein a lipid-based adjuvant, called a hyperactivator, which elicits all five of the aforementioned DC activities. Other adjuvants examined, including those used clinically, were defective for one or more of the key activities needed for robust T cell activation. Vaccines in mice and nonhuman primates targeting influenza virus antigens, including the quadrivalent commercial product Afluria, displayed enhanced adaptive immune responses when administered using hyperactivators as adjuvants. These data highlight the impact of hyperactivator adjuvants as a means to enhance antigen-specific immunity, with potential applications towards a universal influenza vaccine.

IMPORTANCE:

The generation of vaccines that stimulate T cell activities is an unmet need for the scientific community, as T cells are the primary mediators of immune memory. In this study, we report a new vaccine adjuvant called a hyperactivator. This hyperactivator adjuvant diversifies the T cell and antibody responses to virus antigens, such that in nonhuman primates, all influenza strains in the clinical vaccine Afluria are targeted. Hyperactivator adjuvants may represent a means to achieve the long-sought-after goal of a universal influenza vaccine.

04 Feb 2025·JOURNAL OF INFECTIOUS DISEASES

Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial

Article

Author: Lee, Ivan T ; Henry, Carole ; Nachbagauer, Raffael ; McGrath, Shannon ; Choi, Angela ; Kuo, Hsiao-Hsuan ; Chen, Ren ; Paris, Robert ; Huang, Wenmei ; Stadlbauer, Daniel ; Ensz, David ; Avanesov, Andrei ; Pucci, Alicia ; Schaefers, Kristi ; Ananworanich, Jintanat ; Carmona, Lizbeth

Abstract:

Background:

Seasonal influenza remains a global public health concern. A messenger RNA (mRNA)–based quadrivalent seasonal influenza vaccine, mRNA-1010, was investigated in a first-in-human, phase 1/2 clinical trial conducted in 3 parts.

Methods:

In parts 1 to 3 of this stratified observer-blind study, adults aged ≥18 years were randomly assigned to receive a single dose (6.25–200 µg) of mRNA-1010 or placebo (part 1) or an active comparator (Afluria; parts 2 and 3). Primary study objectives were assessment of safety, reactogenicity, and humoral immunogenicity of mRNA-1010, placebo (part 1), or active comparator (parts 2 and 3). Exploratory end points included assessment of cellular immunogenicity (part 1) and antigenic breadth against vaccine heterologous strains (A/H3N2; parts 1 and 2).

Results:

In all study parts, solicited adverse reactions were reported more frequently for mRNA-1010 than placebo or Afluria, and most were grade 1 or 2 in severity. No vaccine-related serious adverse events or deaths were reported. In parts 1 and 2, a single dose of mRNA-1010 (25–200 µg) elicited robust day 29 hemagglutination inhibition titers that persisted through 6 months. In part 3, lower doses of mRNA-1010 (6.25–25 µg) elicited day 29 hemagglutination inhibition titers that were higher or comparable to those of Afluria for influenza A strains. When compared with Afluria, mRNA-1010 (50 µg) elicited broader A/H3N2 antibody responses (part 2). mRNA-1010 induced greater T-cell responses than placebo at day 8 that were sustained or stronger at day 29 (part 1).

Conclusions:

Data support the continued development of mRNA-1010 as a seasonal influenza vaccine.

Clinical Trials Registration:

NCT04956575 (https://clinicaltrials.gov/study/NCT04956575).

15 Oct 2020·AMERICAN FAMILY PHYSICIAN

Influenza Vaccination: Updated 2020-2021 Recommendations from ACIP.

Article

Author: Carrie Armstrong ; Armstrong, Carrie

Updates this year include the antigenic composition of seasonal influenza vaccines available in the United States, the addition of two new influenza vaccines for use in people 65 years and older, and new contraindications and precautions for the use of live attenuated influenza vaccine (LAIV) Because the 2020–2021 influenza season will coincide with the coronavirus disease 2019 (COVID-19) pandemic, vaccination of people six months and older is of particular importance to reduce symptoms that could be confused with those of COVID-19 and to alleviate stress on the health care system Influenza Vaccines—United States, 2020–2021 Influenza Season Trade name Formulation Age indication Hemagglutinin or virus count per vaccine virus (per dose) Route of administration Mercury from thimerosal (mcg per 0 5 mL) IIV4, standard dose, egg based* Afluria Quadrivalent 0 25-mL prefilled syringe† 6 to 35 months 7 5 mcg per 0 25 mL IM‡ — 0 5-mL prefilled syringe† ≥ 3 years 15 mcg per 0 5 mL IM‡ — 5 0-mL multidose vial† ≥ 6 months (needle/syringe) 7 5 mcg per 0 25 mL/15 mcg per 0 5 mL IM‡ 24 5 18 to 64 years (jet injector) Fluarix Quadrivalent 0 5-mL prefilled syringe ≥ 6 months 15 mcg per 0 5 mL IM‡ — Flulaval Quadrivalent 0 5-mL prefilled syringe ≥ 6 months 15 mcg per 0 5 mL IM‡ — Fluzone Quadrivalent 0 5-mL prefilled syringe§ ≥ 6 months 15 mcg per 0 5 mL IM‡ — 0 5-mL single-dose vial ≥ 6 months 15 mcg per 0 5 mL IM‡ — 5 0-mL multidose vial ≥ 6 months 15 mcg per 0 5 mL IM‡ 25 IIV4, standard dose, cell culture based Flucelvax 0 5-mL prefilled syringe ≥ 4 years 15 mcg per 0 5 mL IM‡ — Quadrivalent 5 0-mL multidose vial ≥ 4 years 15 mcg per 0 5 mL IM‡ 25 IIV4, high dose, egg based* Fluzone High-Dose Quadrivalent 0 7-mL prefilled syringe ≥ 65 years 60 mcg per 0 7 mL IM‡ — IIV4, standard dose, egg based* with MF59 adjuvant Fluad Quadrivalent 0 5-mL prefilled syringe ≥ 65 years 15 mcg per 0 5 mL IM‡ — IIV3, standard dose, egg based* with MF59 adjuvant Fluad 0 5-mL prefilled syringe ≥ 65 years 15 mcg per 0 5 mL IM‡ — Recombinant influenza vaccine Flublok Quadrivalent 0 5-mL prefilled syringe ≥ 18 years 45 mcg per 0 5 mL IM‡ — Live attenuated influenza vaccine, egg based* Flumist Quadrivalent 0 2-mL prefilled single-use intranasal sprayer 2 to 49 years 106 5–7 5 fluorescent focus units per 0 2 mL Intranasal — Note: Vaccination providers should consult prescribing information for 2020–2021 influenza vaccines for the most complete and updated information Higher-risk people: ○ Adults 50 years and older ○ American Indians/Alaska Natives ○ Children six to 59 months of age ○ Children up to 18 years of age who are receiving aspirin- or salicylate-containing medications (risk of Reye syndrome after influenza virus infection) ○ Immunocompromised people ○ People with a body mass index of 40 kg per m2 or greater ○ People with chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic, or metabolic disorders other than uncomplicated hypertension ○ Pregnant women ○ Residents of long-term care facilities Household contacts and caregivers of higher-risk people Health care professionals, including students and staff who could be exposed to infectious agents Guideline source:

News (Medical) associated with Inactivated influenza vaccine(Seqirus Pty Ltd)

23 Jul 2025

·www.fiercepharma.com

RFK Jr. rubber-stamps ACIP recommendation to remove thimerosal from all vaccines in US

Department of Health and Human Services Secretary Robert F. Kennedy Jr. has endorsed a Centers for Disease Control and Prevention advisory committee recommendation banning the use of thimerosal in all vaccines in the U.S. RFK Jr. and other anti-vaccine activists have said that the preservative, which contains mercury, can cause autism, while studies have shown no link. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has signed off on a Centers for Disease Control and Prevention (CDC) advisory committee recommendation to remove the preservative thimerosal from all flu shots distributed in the U.S.Thimerosal, which contains mercury, has been used in vaccines for nearly a century to prevent fungal or bacterial contamination after one dose has been drawn from a multidose vial.In 1999, the HHS, the American Academy of Pediatrics and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure. Two years later, the U.S. recommended that children age 6 and younger not receive vaccines that contain thimerosal.Anti-vaccine activists have claimed that the preservative can cause autism, though multiple studies, including one by the CDC in 2010, have shown that there is no link.Last month, RFK Jr.’s revamped Advisory Committee on Immunization Practices (ACIP) recommended against the use of thimerosal in flu shots. In three separate rounds of voting, the ACIP advised that children, pregnant women and adults should not receive vaccines that contain thimerosal. Each of the votes were 5-1 in favor of removing thimerosal from vaccines, with one committee member abstaining.“After more than two decades of delay, this action fulfills a long-overdue promise to protect our most vulnerable populations from unnecessary mercury exposure,” RFK Jr. said in a release. “Injecting any amount of mercury into children when safe, mercury-free alternatives exist defies common sense and public health responsibility. Today, we put safety first.”Most companies have already removed the preservative from their vaccines. The exceptions are Sanofi, which produces multidose vials of Fluzone in addition to single-dose syringes, and CSL Seqirus, which includes thimerosal in its multidose vials of Afluria and Flucelvax. Each of these flu shots include a 0.01% concentration of thimerosal.“We acknowledge the recommendation of the new (ACIP),” a Sanofi spokesperson said in a brief statement. “We will have sufficient supply of Sanofi flu vaccine to support customer preference for this season.”Meanwhile, a spokesperson from CSL Seqirus said that “delivery of our thimerosal-free flu vaccines for the upcoming season is already underway and we don't expect the ACIP recommendation to have any impact on our vaccine supply or shipment timings." Both companies have said that they provide many more flu shots in single-dose syringes, which don’t contain thimerosal, than they do in multidose vials.Last month, during the ACIP meeting, Tracy Beth Hoeg, M.D., Ph.D., of the FDA, told the committee that fewer than 5% of the flu vaccines administered in the 2024-25 season contained thimerosal.While the decision does not have a major impact on the industry, it does raise concern about the influence of RFK Jr. and his hand-picked panel of ACIP experts, many of whom have expressed anti-vaccine views. Early last month, RFK Jr. dismissed all 17 previous members of the committee. In placing the lone dissenting vote in the ACIP meeting, Cody Meissner, M.D., of Dartmouth’s Geisel School of Medicine, said the "risk from influenza is so much greater than the nonexistent—as far as we know—risk from thimerosal."“I would hate for a person not to receive the influenza vaccine because the only available preparation contains thimerosal. I find that very hard to justify,” Meissner added.Meanwhile, with his decision, RFK Jr. urged "global health authorities to follow this prudent example for the protection of children worldwide."

Vaccine

09 Jul 2024

·www.prnewswire.com

CSL Seqirus Begins Shipping Its Portfolio of Influenza Vaccines for the 2024/25 Flu Season

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 SUMMIT, N.J., July 9, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced that it has commenced shipping its differentiated portfolio of influenza vaccines. This year, the company's influenza vaccines are being produced as trivalent influenza vaccine (TIV) formulations, in compliance with the U.S. Food and Drug Administration's (FDA) directive to remove the B/Yamagata strain.4 "We are proud to support healthcare providers in their efforts to vaccinate their patients and communities to help turn around concerning declines in seasonal influenza vaccination rates," said Stefan Merlo, Vice President of Commercial Operations, North America, CSL Seqirus. "We are a committed partner in public health and are doing our part to educate, inform, and meet the evolving needs of the public, ensure customers are prepared for the upcoming flu season, and help reverse this downward trend to restore vaccination rates." This season, the 2024/25 influenza vaccine portfolio for CSL Seqirus, the only manufacturer to offer a differentiated influenza vaccine option approved for use in people aged six months and older, includes: FLUCELVAX® (Influenza Vaccine), the first and only cell-based influenza vaccine indicated for use in people six months and older.5 FLUAD® (Influenza Vaccine, Adjuvanted), the first and only adjuvanted seasonal influenza vaccine for adults 65 and older, which is preferentially recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) over standard-dose influenza vaccines.6,7 FLUAD contains an MF59® adjuvant that is designed to strengthen, broaden, and lengthen the immune response when added to an influenza vaccine.6,8,9 AFLURIA® (Influenza Vaccine), an egg-based, influenza vaccine approved for use in eligible people six months of age and older.10 The impact of declining vaccination rates poses a serious risk to public health infrastructure, with preliminary estimates from the CDC reporting an increase in influenza-related hospitalizations and deaths last season, in comparison to seasons prior, as well as an overburdened healthcare system.11,12 Across all age cohorts, vaccination rates experienced double-digit percentage declines over the past three flu seasons according to internal calculations based on influenza tracking data.13 This includes a notable 22% drop among children aged 6 months to 18 years and a 14% decrease in adults over 65, a group that typically maintains stable immunization rates.13 Additionally, the public health burden of influenza outpaces other respiratory illness.11,14,15 During the 2023/24 flu season, influenza accounted for nearly half of hospitalizations attributed to infectious diseases including influenza, COVID and respiratory syncytial virus (RSV) combined and over half of total deaths.11,14,15 This data underscores the importance of the CDC's recommendation that all eligible people aged six months and older receive an annual influenza vaccination as an essential measure to help prevent influenza and its complications.2 This is especially important for those at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.3 "Influenza continues to pose a significant threat, as evidenced by recent flu seasons," said Dr. Gregg Sylvester, Chief Health Officer, CSL Seqirus. "As we begin distributing influenza vaccines to healthcare providers throughout the U.S., it is imperative that we work to maintain high vaccination rates this season to help reduce the burden of influenza-related illnesses and the risk of severe outcomes." For additional information on our influenza vaccines for the upcoming flu season as well as resources about vaccination campaigns and CDC guidance, 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.16 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.16 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.16 Preliminary estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2023/24 influenza season, there were an estimated 390,000-810,000 influenza-related hospitalizations in the U.S.11 The CDC recommends annual vaccination for people aged six months and older, who do not have any contraindications.2 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.2 The CDC recommends that for most people who need only 1 dose of flu vaccine, vaccination should ideally happen in September or October.2 About CSL Seqirus CSL Seqirus is part of CSL (ASX: CSL). As a global leader in the protection of public health and one of the largest influenza vaccine providers in the world, CSL Seqirus is committed to preventing infectious diseases, like influenza and COVID-19, and is 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 offers a broad portfolio of innovative, differentiated vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit . 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-24-0016 MEDIA CONTACT Tiffany Cody +1 (908) 370-1863 [email protected] FLUAD ® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine) IMPORTANT SAFETY INFORMATION What are FLUAD® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine)? FLUAD is a vaccine that helps protect people aged 65 years and older from the flu. FLUCELVAX and AFLURIA are vaccines 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 receive FLUAD, FLUCELVAX, or AFLURIA? You should not receive FLUAD nor AFLURIA if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. You should not receive FLUCELVAX if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine. Before receiving FLUAD, FLUCELVAX, or AFLURIA, 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 the most common side effects of FLUAD, FLUCELVAX, and AFLURIA? pain, tenderness, redness, itching, bruising, and/or swelling where the vaccine was given headache extreme tiredness muscle aches feeling unwell (malaise) Additional side effects seen in children include: raised hardened area where the vaccine was given changes in eating habits/loss of appetite sleepiness irritability diarrhea These are not all the possible side effects of FLUAD, FLUCELVAX, and AFLURIA. You can ask your healthcare provider for more information and for advice about any side effects that concern you. What do I do if I have side effects? Report any severe or unusual side effects to your healthcare provider . To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or . Before receiving any of these vaccines, please see the full US Prescribing Information for FLUAD, FLUCELVAX, or AFLURIA. You can ask your healthcare provider or pharmacist for information about FLUAD, FLUCELVAX, or AFLURIA that is written for healthcare professionals. REFERENCES 1 Centers for Disease Control and Prevention (CDC). Flu Vaccination Coverage Update. Retrieved from: . Accessed June 2024. 2 CDC. Who Needs a Flu Vaccine and When. Retrieved from: . Accessed June 2024. 3 CDC. People at Higher Risk of Flu Complications. . Accessed June 2024. 4 Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. 184th Vaccines and Related Biological Products Advisory Committee. March 2024. Retrieved from: . Accessed June 2024. 5 FLUCLEVAX. Package Insert. CSL Seqirus Inc. 6 FLUAD. Package Insert. CSL Seqirus Inc. 7 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, 2023–24 Influenza Season. MMWR Recomm Rep 2023;72(No. RR-2):1–25. DOI: . 8 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. 9 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. 10 AFLURIA. Package Insert. CSL Seqirus Inc. 11 CDC. 2023-2024 Preliminary In-Season Burden Estimate. Retrieved from: . Accessed June 2024. 12 CDC. Disease Burden of Flu. Retrieved from: . Accessed June 2024. 13 IQVIA PharMetrics Plus Administrative Claims Database. 14 CDC. RSV Surveillance & Research. Retrieved from: . Accessed June 2024. 15 CDC. COVID Data Tracker. . Accessed June 2024. 16 CDC. Key Facts about Influenza. Retrieved from . Accessed June 2024. SOURCE CSL Seqirus

VaccineDrug Approval

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 Inactivated influenza vaccine(Seqirus Pty Ltd)

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KEGG	Wiki	ATC	Drug Bank
-	-	J07BB01	-

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Influenza A virus infection	United States	Seqirus Pty Ltd.	28 Sep 2007
Influenza B virus infection	United States	Seqirus Pty Ltd.	28 Sep 2007
Influenza, Human	Denmark	Scandinavian Regulatory Services AB	30 Dec 1997
Influenza, Human	Finland	Scandinavian Regulatory Services AB	30 Dec 1997
Influenza, Human	Netherlands	Scandinavian Regulatory Services AB	30 Dec 1997
Influenza, Human	Sweden	Scandinavian Regulatory Services AB	30 Dec 1997

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02255409 (CTgov)	Phase 3	Influenza, Human	607	Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)	hngsvqyiyf = rsuphajkpg iwelclrbth (ajatqywrmh, mzkljbathd - uxgjquaroi) View more	-	15 Mar 2023
NCT02914275 (CTgov)	Phase 3	Influenza, Human	2,250	Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV Cohort A)	wyuwgtkzcs(veiushgwnb) = dzqpdojtvp udqioalcnl (yfaragyysw, cwbvtbhhie - xffppynjxn) View more	-	23 Jan 2019
				Seqirus Quadrivalent Inactivated Influenza Vaccine (Seqirus QIV Cohort B)	wyuwgtkzcs(veiushgwnb) = rtyfpbaqnj udqioalcnl (yfaragyysw, bbqxrnrlie - dbsngyweto) View more
NCT01688921 (JIFI, CTgov)	Phase 4	Influenza, Human	1,250	Needle-Syringe+AFLURIA vaccine (2012-2013 formulation)	bsmyzngimg(hlpyjrwhba) = mpeyxeehpk wcknhgbxvw (kejteooyfg, 1.352) View more	-	22 Oct 2014
NCT01857297 (CTgov)	Phase 4	Influenza, Human	120	CSL Influenza Vaccine (Adults (18 to 59 Years))	awyogkhqti = nzazdgjfyf ppizipbzzr (lbkjpjyyax, ysjphldzgr - qtkizmaqdw) View more	-	15 Jan 2014
				CSL Influenza Vaccine (Older Adults (60 Years or Older))	awyogkhqti = zkwdfzanrj ppizipbzzr (lbkjpjyyax, liflclvkky - tobvaosslv) View more
NCT01863433 (CTgov)	Phase 4	Influenza, Human	120	Trivalent Influenza Vaccine	fozxpeanjz = xdmlrqbonk gnnpqbqbdy (uoxewepzyi, wrizfmidjg - vufsxtmnrk) View more	-	15 Jan 2014
NCT01591837 (CTgov)	Phase 4	Influenza, Human	120	CSL Influenza Vaccine (Adults)	zxtritdvcq = lvoomakgcr qdoiryulur (xlvocgpfso, lumaebjtmx - ubbxdwdhcm) View more	-	18 Nov 2013
				CSL Influenza Vaccine (Older Adults)	zxtritdvcq = tigjtfxycf qdoiryulur (xlvocgpfso, oqucabmojs - yemyhfvnmi) View more
NCT01113580 (CTgov)	Phase 4	Influenza, Human	120	Enzira® Vaccine (Adults)	tscctzpcbc = ruibebpoga xrvxtcxygk (nvqsnxortw, vbtbxtlaxg - owgblfbqnl) View more	-	18 Jul 2012
				Enzira® Vaccine (Older Adults)	tscctzpcbc = gukddgpsht xrvxtcxygk (nvqsnxortw, ggfbtxjggm - gvgijaqqip) View more
NCT00735475 (CTgov)	Phase 4	Influenza, Human	1,268	Afluria (Afluria® Group)	thviszwghe(zgekbtnrpf) = dgtluvitwo kanlstrqfe (sqilckenzk, fconrgkzxo - uimqxrqhgs) View more	-	01 Sep 2011
				Fluzone (Fluzone® Group)	thviszwghe(zgekbtnrpf) = jxwjonaccd kanlstrqfe (sqilckenzk, dizbkqragu - ffzzqexaoj) View more
NCT00959049 (CTgov)	Phase 3	Influenza, Human	1,474	CSL's Influenza Virus Vaccine (Afluria) (Afluria Cohort A)	affmlswyda(wlctajcene) = auaeiqfsaa xvluhcrcdv (vknijlxzqo, ufdphagkqr - vpfywjlweq) View more	-	29 Jul 2011
				Influenza Virus Vaccine (Fluzone) (Fluzone Cohort A)	affmlswyda(wlctajcene) = scnmrpgxzv xvluhcrcdv (vknijlxzqo, idxityutwx - hgsaszqgkx) View more

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