Flucelvax Quadrivalent Vaccine (QIVc) Description
Flucelvax Quadrivalent (QIVc) is a cell culture-based flu vaccine to protect against four flu virus strains recommended by the World Health Organization for the current influenza season.
Seqirus' Flucelvax is the first FDA-approved flu vaccine to use cells instead of chicken eggs and represented the first major advance in flu vaccine manufacturing technology since flu vaccine production began in the 1930s. This modern manufacturing process allows the flu shot to be antibiotic-free, helps protect against the identified 4 flu strains for 2020-2021, and is well-tolerated.
In the United Kingdom and European Union, QIVc is marketed as FLUCELVAX® TETRA and is currently licensed for use in people 9 years of age and older.
On December 9, 2020, a poster presentation demonstrated that QIVc prevented significantly more influenza-related medical encounters among individuals age ≥4 years (n=2,113,216) with at least one health condition than QIVe in the 2018 - 2019 U.S. influenza season.
“These studies underscore the important role of a cell-based influenza vaccine in reducing medical encounters during the 2018/19 US influenza season, which further supports our commitment to advancing our cell-based manufacturing technology,” stated Gregg Sylvester, M.D., Chief Medical Officer at Seqirus. “Particularly amidst the COVID-19 pandemic, we are grounded in our mission to have as many people as possible receive a flu vaccine to not only protect against influenza but also to reduce the impact on our healthcare systems.”
The U.S. CDC says Cell-based influenza vaccine technology may offer advantages over the standard influenza manufacturing process, including being more scalable and offering faster production in the event of an influenza pandemic.
U.S. Cell vaccines are recommended to contain the following for the 2021-2022 flu season: A/Wisconsin/588/2019 (H1N1)pdm09-like virus; A/Cambodia/e0826360/2020 (H3N2)-like virus; B/Washington/02/2019 (B/Victoria lineage)-like virus; B/Phuket/3073/2013-like (B/Yamagata)-like virus.
Cell-based flu vaccine production does not use flu viruses grown in eggs and is not dependent on eggs' supply. Also, cell-based flu vaccines that use cell-based candidate vaccine viruses (CVVs) can offer better protection than traditional, egg-based flu vaccines. This is because the viruses used to make cell-based vaccines may be more similar to circulating “wild” flu viruses than the viruses used to make egg-based vaccines, says the US CDC.
In the U.S., Seqirus operates a state-of-the-art cell-based manufacturing facility in Holly Springs, NC, purpose-built in partnership with the Biomedical Advanced Research and Development Authority (BARDA) to increase cell-based vaccine manufacturing capacity and combat pandemic influenza threats. Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 20,000 people with operations in more than 60 countries.
Flucelvax Quadrivalent Vaccine (QIVc) Indication
Flucelvax Quadrivalent is indicated for active immunization of people 2 years of age and older to prevent disease caused by influenza A subtype viruses and type B viruses in the vaccine. The company announced the U.S. FDA approval on March 5, 2021.
In one study published in the Journal of Infectious Diseases in February 2020, among Medicare beneficiaries 65 years and older, the cell-based vaccine provided greater protection against flu-related hospitalizations than standard-dose, egg-based vaccines.
On June 24, 2021, Gregg C. Sylvester, M.D., MPH Chief Medical Officer Seqirus, Inc., presented FLUCELVAX QUADRIVALENT (ccIIV4), a Phase III Randomized Controlled Trial Immunogenicity & Safety Results in Young Children (6 through 47 months of age), to the U.S. CDC ACIP committee.
Flucelvax Quadrivalent Vaccine (QIVc) Dosage
Flucelvax Quadrivalent is a vaccine for intramuscular injection only and is also preservative and latex-free. Flucelvax is available as a 0.5ml intramuscular vaccine per dose for the 2021-2022 U.S. influenza season.
Flucelvax Coding and Billing (QIVc) Information
Access information about coding and billing for Seqirus flu vaccines.
Flucelvax Quadrivalent Vaccine (QIVc) News
June 24, 2021 - The U.S. CDC vaccine committee reviewed this presentation: Immunogenicity & Safety Results in Young Children (6 through 47 months of age). This flu vaccine is currently approved for ages 2 years and older.
June 14, 2021 - Novavax, Inc. announced data from the first co-administration study of a SARS-CoV-2 vaccine candidate [Novavax, NVX-CoV2373] and an approved influenza vaccine [Seqirus, adjuvanted, trivalent seasonal influenza vaccine (aTIV) or a cell-based, quadrivalent seasonal influenza vaccine (QIVc)]. The findings suggest simultaneous vaccination may be a viable immunization strategy.
May 3, 2021 - Seqirus-US presented new Phase 3 clinical data demonstrating that the company’s cell-based quadrivalent seasonal influenza vaccine (QIVc) was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine (QIV) in children six months through <4 years of age during the U.S. 2019/20 influenza season.
March 25, 2021 - Seqirus announced the publication of a new real-world evidence analysis indicating that their cell-based influenza vaccine "provides significantly higher effectiveness, compared with standard-dose egg-based quadrivalent influenza vaccine, in preventing all-cause hospitalizations and hospitalizations/ER visits related to any respiratory events, including pneumonia and asthma/COPD/bronchial events. Also evident is the potential costs saving from QIVc resulting from its greater comparative effectiveness, " said Stephen I Pelton, MD, Professor of Pediatrics at Boston University School of Medicine and Public Health & Boston Medical Center, and study author.
March 18, 2021 - Seqirus announced that Health Canada had approved FLUCELVAX® QUADRIVALENT, its cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age and older. Flucelvax was previously approved for use in persons nine years of age and older.
March 4, 2021 - Seqirus announced that the U.S. Food and Drug Administration had approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the company’s cell-based quadrivalent influenza vaccine (QIVc), for an expanded age indication for people two years of age and older. FLUCELVAX QUADRIVALENT was previously FDA-approved for use in persons four years of age and older. The expanded age indication is based on absolute efficacy data indicating that FLUCELVAX QUADRIVALENT was effective and produced a sufficient immune response against influenza in children and adolescents between ≥2 to <18 years of age over three influenza seasons in the Southern (2017) and Northern (2017/18 and 2018/19) Hemispheres, compared to a non-influenza comparator. This represents the first absolute efficacy study of a cell-based influenza vaccine in this population.
December 9, 2020 - Seqirus presented new real-world evidence at the European Scientific Working Group on Influenza 2020 showing the clinical benefits of a cell-based, quadrivalent seasonal influenza vaccine (QIVc) in preventing influenza-related medical encounters compared to an egg-based quadrivalent influenza vaccine (QIVe) during the 2018 - 2019 United States influenza season. Cell-based influenza vaccine technology is an alternative to egg-based influenza vaccine manufacturing. It may offer advantages over the standard influenza manufacturing process, including being more scalable and faster production, both critically important in an influenza pandemic.
October 29, 2020 - Seqirus presented absolute efficacy data on the company's cell-based quadrivalent influenza vaccine (QIVc) from a randomized controlled trial, which met its primary endpoint in children and adolescents between ≥2 to <18 years of age over three influenza seasons.
September 16, 2020 - Seqirus announced real-world evidence on its cell-based quadrivalent influenza vaccine (QIVc) in Vaccine's peer-reviewed medical journal. Study results indicate that QIVc was more effective than the standard, egg-based quadrivalent vaccine (QIVe-SD) in preventing influenza-related hospitalizations/ER visits, all-cause hospitalizations, and hospitalizations/ER visits related to serious respiratory events.
July 30, 2020 - Seqirus announced it has begun shipping its portfolio of seasonal influenza vaccines to customers in the U.S. for the 2020/21 influenza season. Seqirus is one of the world's largest influenza vaccine companies, well-positioned to supply up to 60 million doses to the U.S. market this year, depending on demand.
Flucelvax Quadrivalent Vaccine (QIVc) Clinical Trials
Seqirus continues to Evaluate the Efficacy, Safety, and Immunogenicity of QIVc.