Flucelvax Quadrivalent Vaccine Description
Flucelvax Quadrivalent (QIVc) is a cell culture-based flu vaccine to help protect against 4 flu virus strains recommended by the World Health Organization the year before 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.”
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.
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. 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.
Flucelvax Quadrivalent Vaccine Indication
Flucelvax Quadrivalent is indicated for active immunization of people 4 years of age and older to prevent disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
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.
Cell-based flu vaccines have been approved for use in many European countries.
Flucelvax Quadrivalent Vaccine Dosage
Flucelvax Quadrivalent is a vaccine for intramuscular injection only and is also preservative and latex-free.
Flucelvax Quadrivalent Vaccine News
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 the peer-reviewed medical journal Vaccine. 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 Clinical Trials
Clinical Trial NCT03165617: Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age
Clinical Trial NCT04074928: Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Clinical Trial NCT03438487: Flucelvax (TIVc or QIVc) Pregnancy Registry
Clinical Trial NCT03932682: Efficacy Study With QIVc in Pediatric Subjects