fluad quadrivalent seqirus

Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Because transmission 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. As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Polina.Miklush@seqirus.com. Fluad Quadrivalent also contains MF59C.1 adjuvant (MF59®), a squalene based oil-in-water emulsion. For the full list of excipients, see section 6.1. In some human studies, HI antibody titers of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects. Influenza control in the 21st century: Optimizing protection of older adults. FLUAD QUADRIVELENT includes an additional. General disorders and administration site conditions: Extensive swelling of injected limb lasting more than one week, injection site cellulitis-like reactions (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week), Allergic reactions including anaphylactic shock, anaphylaxis, and angioedema. Success criteria required the lower bound of the 2-sided 95% CI for the proportion of subjects with an HI titer ≥1:40 to be ≥60% and for the lower bound of the 2-sided 95% CI for the proportion of subjects with seroconversion to be ≥30%. The vaccine is specifically developed to protect adults 65 years and older against four strains of seasonal influenza. Today, CSL — including our two businesses, CSL Behring and Seqirus - provides life-saving products to more than 60 countries and employs more than 22,000 people. Accessed February 2020. The racial distribution of subjects consisted of 89% Caucasian, 11% Asian and <1% American Indian or Alaska Native. As part of our leading role on the front line of influenza prevention, we are pleased to offer FLUAD QUADRIVALENT as another seasonal vaccine option for healthcare providers and their patients in the fight against influenza.”. In the U.S., influenza impacts adults 65 years and older with higher hospitalization and death rates compared to young, healthy adults. Ensure procedures are in place to avoid injury from falling associated with syncope. Each 0.5 mL dose contains 15 mcg of hemagglutinin (HA) from each of the four recommended influenza strains and MF59C.1 adjuvant (9.75 mg squalene, 1.175 mg of polysorbate 80, 1.175 mg of sorbitan trioleate, 0.66 mg of sodium citrate dihydrate and 0.04 mg of citric acid monohydrate) at pH 6.9-7.7. Safety advisory - risk to patients with latex allergy. (2019). A developmental toxicity study has been performed in female rabbits administered FLUAD (trivalent formulation) prior to mating and during gestation. [6] CDC. Retrieved from: CDC. N Engl J Med 1998; 339(25): 1797-1802. Fluad Quadrivalent does not contain a preservative. FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Retrieved from: http://www.cdc.gov/flu/about/disease/65over.htm. Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention of influenza globally, with extensive research and production expertise and manufacturing plants in the U.S., U.K. and Australia. Retrieved from: https://www.fda.gov/vaccines-blood-biologics/vaccines/fluad. 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. This press release is issued from Seqirus U.S. Inc. in Summit New Jersey, USA and is intended to provide information about our global business. Unsolicited adverse events (AEs) were collected for all subjects for 21 days after vaccination. Accessed February 2020. Fluad Tetra must not be used in people allergic to the active substances or any of the other ingredients or to the following substances which may be present in the vaccine in trace amounts: ovalbumin (egg protein), the antibiotics kanamycin and neomycin, formaldehyde, … Why … The majority of solicited reactions resolved within 3 days. Seqirus Afluria® IIV4 33332-0419-10 5.0 mL MDV 6 months+ 158 influenza, injectable, quadrivalent Seqirus IIV4Afluria® 33332-0319-01 . Fluad Quadrivalent is standardized according to United States Public Health Service requirements and each 0.5 mL dose is formulated to contain 15 mcg of hemagglutinin (HA) from each of the following four influenza strains recommended for the 2020-2021 influenza season: A/Victoria/2454/2019 IVR-207 (an A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like virus), A/Hong Kong/2671/2019 IVR-208 (an A/Hong Kong/2671/2019 (H3N2)-like virus), B/Victoria/705/2018 BVR-11 (a B/Washington/02/2019-like virus), B/Phuket/3073/2013 BVR-1B (a B/Phuket/3073/2013-like virus). The immune response to Fluad Quadrivalent in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. Influenza vaccine effectiveness also tends to be lower in this population due to age-related immune decline, which reduces the body’s ability to produce a sufficient, protective immune response to the vaccine. Qualitative and quantitative composition. Fluad Quadrivalent is supplied in the product presentation listed below: Store Fluad Quadrivalent refrigerated at 2°C to 8°C (36°F to 46°F). Instruct vaccine recipients to report adverse reactions to their healthcare provider and/or to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 and www.vaers.hhs.gov. Accessed February 2020. Retrieved from: https://www.cdc.gov/ncird/index.html. To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1- 855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov. The syringe, syringe plunger stopper and tip cap are not made with natural rubber latex. Revised: 10/2020. Do not mix Fluad Quadrivalent with any other vaccine in the same syringe. Discard if the vaccine has been frozen. Accessed February 2020. Sanofi Pasteur Fluzone High-Dose (2019/2020) $56.006 : 08/01/2019 – 07/31/2020 90672 . Onset usually occurred within the first 2 days after vaccination. The surface antigens, hemagglutinin and neuraminidase, are obtained from the influenza virus particle by further centrifugation in the presence of cetyltrimethylammonium bromide (CTAB). Flu season: Preliminary burden estimates. (2018). Holly Springs, NC: Seqirus Inc; 2020. Print. There are insufficient human data to establish whether there is a vaccine-associated risk with use of Fluad Quadrivalent in pregnancy. [1] FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. (2009). O’Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. All rights reserved. Fluad is approved for use in persons 65 years of age and older. Table of Contents. For more information about CSL Limited, visit www.csl.com. No human or animal data are available to assess the effects of Fluad Quadrivalent on the breastfed infant or on milk production/excretion. Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. Vaccine group: Adults aged ≥65 years only. When you join Seqirus, you join a team dedicated to protecting people and communities from influenza. designed to create a strong, broad and durable immune response. Dosage Form: injection, suspension. It's a feeling of purpose and possibility that inspires us every day. It has received the go-ahead from the U.S. Food and Drug Administration to produce and sell its Fluad Quadrivalent vaccine. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. A quadrivalent influenza (flu) vaccine is designed to protect against four different flu viruses, including two influenza A viruses and two influenza B viruses. Accessed February 2020. Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Fluad Quad, a quadrivalent influenza vaccine, adjuvanted; Fluad Quadrivalent, a quadrivalent influenza vaccine, ... (Seqirus). [6] Influenza vaccine effectiveness also tends to be lower in this population due to age-related immune decline, which reduces the body’s ability to produce a sufficient, protective immune response to the vaccine. CDC. Please note that if you do not accept the cookies, your user experience may be significantly less positive. [see Concurrent Use With Immunosuppressive Therapies (, Proportion of subjects with HI titer ≥1:40, influenza vaccine, adjuvanted injection, suspension, We comply with the HONcode standard for trustworthy health information -, 0.5 mL dose in a pre-filled syringe (needle not supplied), package of 10 syringes per carton [NDC 70461-120-04], INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/HONG KONG/2671/2019 IVR-208 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/VICTORIA/705/2018 BVR-11 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 BVR-1B ANTIGEN (FORMALDEHYDE INACTIVATED), Gently shake each syringe. FLUAD® QUADRIVALENT is the first-and-only adjuvanted quadrivalent seasonal influenza vaccine approved for adults Reimbursed by Medicare Part B CPT code 90694 114+ million FLUAD doses across 29 countries over the past 20 years10 Fluad Quadrivalent is a sterile injectable emulsion supplied in 0.5 mL single-dose pre-filled syringes. Both Fluad Quadrivalent and Fluad (trivalent) will be available this season. All inuenza vaccines available in the UK for the 2020 to 2021 season Seqirus USA Inc #70461012003 FLUAD™ 2020 - 2021 Flu Vaccine, Adjuvanted 45 mcg / 0.5 mL Indicated For People 65 Years of Age and Above Prefilled Syringe 0.5 mL Log in for pricing and availability Injected quadrivalent inactivated influenza vaccines, available from the 2014/2015 season in some EU/EEA countries, are expected to replace the trivalent vaccines over time. Ad-Free Version. The US Food and Drug Administration has approved the first adjuvanted quadrivalent influenza vaccine, Fluad Quadrivalent (influenza vaccine, adjuvanted), to help protect adults 65 years and older against seasonal influenza from Seqirus. For Fluad Quadrivalent, injection site bruising (1.0%) was the only unsolicited adverse reaction reported in ≥ 1% of subjects. Lasky T, Terracciano GJ, Magder L, et al. Study 1 (NCT02587221) was a multi-center, randomized, observer-blind, non-influenza comparator-controlled efficacy and safety study conducted in 12 countries during the 2016-2017 Northern Hemisphere and 2017 Southern Hemisphere seasons. Sanofi Pasteur. Proper Name: Influenza Vaccine, Adjuvanted. Holly Springs, NC: Seqirus Inc; 2018. The company broke ground this month for a $140 million expansion of its vaccine-production plant in Holly Springs. FLUAD and FLUAD Quadrivalent is a standard-dose, inactivated influenza (flu) vaccine, manufactured by Seqirus that contains an adjuvant. CSL (ASX:CSL) is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Please consult your local regulatory authority on the approval status of Seqirus products. SAEs were reported by 238 (7.0%) Fluad Quadrivalent recipients and 234 (6.9%) comparator recipients. There were no SAEs, AESIs or deaths in this study that were related to the study vaccine. Fluarix Quadrivalent (2019/2020) (Pres free) Flulaval Quadrivalent (2019/2020) (Pres Free) Fluzone Quadrivalent (2019/2020) (Pres Free) Afluria Quadrivalent (2019/2020) (Pres Free) $19.032: 08/01/2019 - 07/31/2020: 90687: Sanofi Pasteur. (2013). Protect from light. Influenza illness and its complications follow infection with influenza viruses. Key facts about seasonal flu vaccine. Seqirus. The syringe, syringe plunger stopper and tip caps are not made with natural rubber latex. Expert Rev Vaccines. Animals were administered FLUAD (trivalent formulation) by intramuscular injection twice prior to gestation, during the period of organogenesis (gestation day 7) and later in pregnancy (gestation day 20), 0.5 mL (45 mcg)/rabbit/occasion. FLUAD vs. Fluzone High-Dose Study The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Key facts about influenza (flu). According to the Centers for Disease Control and Prevention (CDC), everyone who is six months and older should receive an annual flu shot, but it is particularly important for those 65 years and older who are at risk of developing serious complications from influenza. See 17 for PATIENT COUNSELING INFORMATION. Fluad Quadrivalent is approved for use in persons 65 years of age and older. Antibody responses for all 4 strains are presented in Table 2. This Product Information was approved at the time this AusPAR was published. (2008). (2014). The vaccine should be administered by intramuscular injection, preferably in the region of the deltoid muscle of the upper arm. Educate vaccine recipients regarding the potential side effects. Inform vaccine recipients that annual vaccination is recommended. Therapeutic Indications Vaccination is the most effective way to prevent influenza . The mean age of subjects at enrollment was 72 years, 62% were female, 48% White, 34% Asian, 16% Other, 2% American Indian/Alaska Native, and 18% of Hispanic/Latino ethnicity. First Adjuvanted Quadrivalent Influenza Vaccine by Seqirus Receives EU Approval PR Newswire MAIDENHEAD, England, June 8, 2020 MAIDENHEAD, England, June 8, 2020 /PRNewswire/ -- … -- FLUCELVAX QUADRIVALENT is the second FDA approval for Seqirus since the formation of the company in July of 2015, and will be available during the 2016-2017 flu season. Thrombocytopenia (some cases were severe with platelet counts less than 5,000 per mm3), lymphadenopathy. During the 2020-2021 influenza season, both trivalent FLUAD and FLUAD Quadrivalent will be available. studies were myalgia (15%), headache (13%), and fatigue (13%). “As part of our leading role on the front line of influenza prevention, we are pleased to offer FLUAD QUADRIVALENT as another seasonal vaccine option for healthcare providers and their patients in the fight against influenza.”, In the U.S., influenza impacts adults 65 years and older with higher hospitalization and death rates compared to young, healthy adults. FLUAD™ 2020 - 2021 Flu Vaccine, Adjuvanted 45 mcg / 0.5 mL Indicated For People 65 Years of Age and Above Prefilled Syringe 0.5 mL Seqirus USA Inc 70461012003 For a comprehensive list of local and systemic adverse reactions, please see full prescribing information. to FLUAD, which has an extensive clinical legacy, with 114+ million doses distributed and licensure in 29 countries since it was first approved in 1997. remains an important public health concern,” said, Gregg Sylvester, MD, Chief Medical Officer at Seqirus, “At Seqirus, we’re committed to developing advanced technologies and vaccines designed to address unmet needs, especially in vulnerable populations, such as adults 65 years and older.”. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Fluad Quadrivalent is approved for use in persons 65 years of age and older. Anjana Narain, executive vice president and general manager at Seqirus, said the company is pleased to offer Fluad Quadrivalent as another seasonal vaccine option for influenza. Estimated influenza illnesses, medical visits, hospitalizations, and deaths in the United States – 2017 – 2018 influenza season. [7], FLUAD QUADRIVELENT (aQIV) utilizes the same MF59® adjuvant technology as FLUAD® (aTIV),[8] designed to create a strong, broad and durable immune response.1,2,3,4 FLUAD QUADRIVELENT includes an additional strain to FLUAD, which has an extensive clinical legacy, with 114+ million doses distributed and licensure in 29 countries since it was first approved in 1997. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine. FLUAD and FLUAD Quadrivalent is a standard-dose, inactivated influenza (flu) vaccine, manufactured by Seqirus that contains an adjuvant. Vaccine. This website uses cookies to ensure the best possible user experience. [5] During the 2017/18 influenza season, 70 percent of influenza-related hospitalizations and 90 percent of influenza-related deaths occurred in this age group. Fluad Quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. Fluad Quadrivalent is not approved for use in persons < 65 years of age. Solicited local and systemic adverse reactions were collected for 7 days after vaccination in a subset of 665 subjects who received Fluad Quadrivalent and 667 subjects who received the comparator vaccine. For more information visit www.seqirus.com and www.csl.com. Fluad, Suspension for injection in pre-filled syringe. Quotes. Tradename: FLUAD QUADRIVALENT. Retrieved from: CDC. [11] CDC. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). Retrieved from: https://www.cdc.gov/flu/about/burden/2017-2018.htm, http://www.cdc.gov/flu/about/disease/65over.htm, https://www.fda.gov/vaccines-blood-biologics/vaccines/fluad, https://www.cdc.gov/flu/about/keyfacts.htm, https://www.cdc.gov/flu/prevent/keyfacts.htm, https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. In the immunogenicity set, the mean age across both vaccination groups was 72 years and females represented 59% of subjects. The most common (≥10%) local (injection site) adverse reactions observed in, The most common (≥10%) systemic adverse reactions observed in clinical, To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1- 855-358-8966 or VAERS at 1-800-822-7967 and, Before administration, please see the full. For vaccine ordering and supply enquiries, email: vaccinesupply@phe.gov.uk. The antigen preparation is further purified. As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. (2008). Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine. (2018). (2020/2021 SEASON) 2. Fluad has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. [12] Food and Drug Administration (FDA). Do not use after expiration date. Before administration, please see the full Prescribing Information for FLUAD or FLUAD QUADRIVALENT. Seqirus Receives FDA Approval for FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) for Adults 65 Years and Older. The most common (≥ 10%) local and systemic reactions in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%). c Severe reactions of each type were reported in 1.1% or fewer subjects receiving Fluad Quadrivalent; severe reactions of each type were also reported in the comparator group at similar percentages. (2018). Seqirus president Gordon Naylor has pegged a switch to quadrivalent flu vaccines as one growth driver for the budding CSL unit. Severe definitions: Erythema, Induration and Ecchymosis = >100 mm diameter; Injection site pain, = prevents daily activity. Afluria Quadrivalent official prescribing information for healthcare professionals. Fluad Quadrivalent is a registered trademark of Seqirus UK Limited or its affiliates. Vaccine. Retrieved from: https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm. Accelerated approval – Department of Health and Human Services. US Package Insert BRIEF-Seqirus Receives FDA Approval For FLUAD® QUADRIVALENT. Seqirus is on the front line of battling influenza, working hard to suppress costly and life-threatening epidemics and pandemics. Fluad Quad, inactivated, quadrivalent influenza vaccine (surface antigen), adjuvanted, suspension for injection, 0.5 mL pre-filled syringe, with attached needle (AUST R 316323) is a 0.5 mL suspension for injection in a pre-filled syringe (type I glass) with attached needle. Do not inject the vaccine in the gluteal region or areas where there may be a major nerve trunk. FLUAD QUADRIVALENT is a sterile injectable emulsion supplied in 0.5 mL single-dose pre- filled syringes. +1 (908) 608-7170 Serious AEs and AESIs were collected up to 181 days after vaccination. © 2021 Seqirus. 19 April 2018. Syncope (fainting) may occur in association with administration of injectable vaccines including Fluad Quadrivalent. The first adjuvanted quadrivalent flu vaccine for older adults was approved by the FDA on Monday, vaccine manufacturer Seqirus announced. [9],[10], “The burden of seasonal influenza among adults 65 and older, remains an important public health concern,” said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. ... of Queensland COVID-19 vaccine candidate is an Adjuvanted SARS-CoV-2 Sclamp Protein Subunit Vaccine combined with Seqirus MF59 to improve immune response, reduce the amount of antigen needed for each vaccine, and … Accelerated approval – Department of Health and Human Services. Fluad trivalent influenza vaccine. a All solicited systemic adverse events reported within 7 days of vaccination are included. Generic Name: influenza vaccine, adjuvanted This indication is approved under accelerated approval based on the immune response elicited by FLUAD and FLUAD QUADRIVALENT. Fluad did not affect female fertility in a rabbit developmental toxicity study [see Pregnancy ]. (ASX: CSL). (2019). 2008;2(6):243-249. Subscribe now to follow markets, faster and distraction-free. It doesn't matter whether you are a scientist or an administrator, a marketer or an operator - as long as you are inspired by the chance to create something that will help others, you can find your role at Seqirus. 08/01/2019 – 07/31/2020 90674 : Seqirus Inc . [5] Centers for Disease Control and Prevention (CDC). * SEQIRUS RECEIVES FDA APPROVAL FOR FLUAD® QUADRIVALENT (INFLUENZA VACCINE, ADJUVANTED) FOR ADULTS 65 YEARS AND OLDER Source text for Eikon: Further company coverage: All … Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year's influenza vaccine. Fluad Tetra is a vaccine used to protect people aged from 65 years against influenza (flu). Polina Miklush Seqirus Receives FDA Approval for FLUAD® Quadrivalent for Adults 65 Years and Older, Quadrivalent formulation of the first-and-only adjuvanted seasonal influenza vaccine for older adults (65+ years) receives FDA approval, Designed with MF59® adjuvant to help strengthen, broaden and lengthen the body’s immune response against the influenza strains contained in the vaccine, Seqirus announced today that the U.S. Food and Drug Administration (FDA) has approved the first adjuvanted quadrivalent influenza vaccine, FLUAD® QUADRIVALENT. Key facts about seasonal flu vaccine. Therefore, inactivated quadrivalent influenza vaccines are standardized to contain the hemagglutinin of influenza virus strains (two subtypes A and two types B), representing the influenza viruses likely to be circulating in the United States in the upcoming influenza season. 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. Retrieved from: CDC. There were no SAEs, AESIs or deaths in this study that were related to Fluad Quadrivalent. No vaccine-related fetal malformations or variations and no adverse effects on pre-weaning development were observed in the study. Retrieved from: Food and Drug Administration (FDA). [15] Since it takes about two weeks after vaccination for antibodies to develop in the body that protect against influenza virus infection, it is best that people get vaccinated to help protect them before influenza begins spreading in their community.14. [15] CDC. Fluad Quadrivalent has a milky-white appearance. If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Fluad Quadrivalent should be based on careful consideration of the potential benefits and risks. The role of serum hemagglutinin-inhibiting antibody in protection against challenge infection with influenza A2 and B viruses.