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. In addition, Seqirus announced on October 15, 2021, that the U.S. FDA had Approved FLUCELVAX® QUADRIVALENT for an expanded age indication for children as young as six months old.
With this FDA Approval, FLUCELVAX QUADRIVALENT, the first and only cell-based influenza vaccine in the U.S. and is now indicated for everyone eligible to receive an influenza vaccine in the U.S., says the Company.
Seqirus Flucelvax is the first FDA-Approved flu vaccine to use cells instead of chicken eggs and represented the first significant 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 four flu strains for 2020-2021, and is well-tolerated.
'Cell-based' refers to how an influenza vaccine is made, says the U.S. CDC. Most inactivated flu vaccines are produced by growing flu viruses in eggs. However, the flu viruses used in the cell-based vaccines are grown in cultured cells of mammalian origin instead of in hens' eggs.
In the United Kingdom and European Union, QIVc is marketed as FLUCELVAX® TETRA and is licensed for use in people nine 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.
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.
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.
The U.S. FDA updated 'For active immunization to prevent influenza disease caused by influenza virus subtypes A and type B viruses contained in the vaccine.' And on July 2, 2021, issued a letter 'approving the request submitted April 2, 2021, received April 2, 2021, to supplement your Biologics License Application under section 351(a) of the Public Health Service Act for Influenza Vaccine (Flucelvax) manufactured at your Holly Springs, NC facility. STN: BL 125408.
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 two 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 addition, Flucelvax Quadrivalent Vaccine (QIVc) is currently under review with the U.S. Food and Drug Administration (FDA) for an expanded age indication for children as young as six months of age.
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.
The U.S. FDA recommends cell vaccines to contain the following for the 2021-2022 flu season: A/Wisconsin/588/2019 (H1N1)pdm09-like virus; A/Cambodia/e0826360/2020 (H3N2)-like a virus; B/Washington/02/2019 (B/Victoria lineage)-like virus; B/Phuket/3073/2013-like (B/Yamagata)-like virus.
October 20, 2021, Lisa Grohskopf, M.D., MPH, Influenza Division, NCIRD, CDC Advisory Committee on Immunization Practices, presented: Change in Age Indication for Flucelvax Quadrivalent.
Flucelvax Quadrivalent Vaccine (QIVc) and COVID-19 Vaccines
The US Centers for Disease Control and Prevention (CDC) previously issued interim clinical considerations stating that 'COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing. And the annual influenza vaccination is recommended for all persons aged six months and older who do not have contraindications. 'Providers should be aware of the potential for increased reactogenicity with coadministration and should consult the CDC for updated guidance as more information becomes available. If coadministered, COVID-19 vaccines and vaccines that might be more likely to cause a local reaction (e.g., aIIV4 or HD-IIV4) should be administered in different limbs, if possible.'
'No data are currently available concerning coadministration of currently Authorized COVID-19 vaccines and influenza vaccines,' stated Lisa Grohskopf, M.D., MPH, CDC's ACIP vaccine committee presentation (slide #14) on June 24, 2021.
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 Quadrivalent Vaccine (QIVc) and Pregnant Women
Seqirus presented original safety data at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) annual meeting from a new prospective observational cohort study evaluating pregnancy outcomes and fetal events of interest following vaccination with the Company's cell-based Flucelvax Quadrivalent seasonal influenza vaccine (QIVc). The study found no unexpected adverse pregnancy outcomes in pregnant women in the U.S. who were vaccinated with QIVc.
On July 30, 2021, Seqirus announced a 'prospective observational cohort study that evaluated pregnancy outcomes and events of interest in the fetus or infant following vaccination with QIVc during any trimester. "Pregnant people (women) and people (women) who have recently given birth can be particularly vulnerable to infectious diseases like influenza," commented Christopher Robinson, M.D., MSCR, Charleston Maternal-Fetal Medicine and study author, in a press release. "These data provide further reassurance on the safe use of seasonal influenza vaccines in pregnant people (women)."
Flucelvax Quadrivalent Vaccine (QIVc) Side Effects
Seqirus published a FluCelVax vaccine side effect disclosure in 2016, followed by Australia, and the EMA updated Flucelvax Tetra in 2020. The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%), headache (18.7%), fatigue (17.8%) and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%), according to the U.S. FDA.
VAERS is a U.S. passive reporting system, meaning it relies on individuals to send in reports of their experiences to a vaccine. However, anyone can submit a report to VAERS, including parents and patients. Furthermore, healthcare providers are required by law to report to VAERS. People are also encouraged to report adverse side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1–800–FDA–1088.
Flucelvax Vaccine Coding and Billing (QIVc) Information
Access information about coding and billing for Seqirus flu vaccines.
Flucelvax Quadrivalent Vaccine (QIVc) News
November 18, 2021 - The Lancet published results of a UK phase 4 study in which adults received concomitant administration of either an age-appropriate influenza vaccine or placebo alongside their second dose of COVID-19 vaccine. 3 weeks later the group who received a placebo received the influenza vaccine and vice versa. Concomitant vaccination with ChAdOx1 or BNT162b2 plus an age-appropriate influenza vaccine raised no safety concerns and preserved antibody responses to both vaccines.
November 11, 2021 - The WHO reported globally influenza activity continues to remain at lower levels than expected.
October 20, 2021 - For week 41, the CDC reported nationwide, 1.8% of patient visits reported through ILINet were due to ILI. This percentage is below the national baseline of 2.5%.
October 19, 2021 - Seqirus presented new real-world evidence (RWE) at the global International Society for Influenza and other Respiratory Virus Diseases (ISIRV). Most notably, Seqirus' cell-based quadrivalent seasonal influenza vaccine (QIVc) was more effective than standard, egg-based quadrivalent influenza vaccines (QIVe) in reducing influenza-related medical encounters (IRME) in children (aged ≥4 to ≤17) and adults (aged ≥18) during the U.S. 2019/20 U.S. influenza season.
October 15, 2021 - New Jersey-based Seqirus announced that the U.S. FDA had Approved FLUCELVAX® QUADRIVALENT for an expanded age indication for children as young as six months old.
October 14, 2021 - The New England Journal of Medicine reported the results of a clinical trial of the Efficacy of a Cell-Culture–Derived Quadrivalent Influenza Vaccine in Children. The study showed between 2017 and 2019, a total of 4514 participants were randomly assigned to receive IIV4c or the meningococcal ACWY vaccine. Laboratory-confirmed influenza occurred in 175 of 2257 participants (7.8%) in the IIV4c group and 364 of 2252 participants (16.2%) in the comparator group, and the efficacy of IIV4c was 54.6% (95% confidence interval [CI], 45.7 to 62.1). Efficacy was 80.7% (95% CI, 69.2 to 87.9) against influenza A/H1N1, 42.1% (95% CI, 20.3 to 57.9) against influenza A/H3N2, and 47.6% (95% CI, 31.4 to 60.0) against influenza B. IIV4c showed consistent vaccine efficacy in subgroups according to age, sex, race, and previous influenza vaccination. The incidences of adverse events were similar in the IIV4c group and the comparator group.
October 7, 2021 - 8 influenza-positive cases were reported in week 40 by the UK respiratory Datamart.
September 29, 2021 - Seqirus (ASX: CSL) announced at the IDWeek 2021 conference data from two real-world studies conducted during the 2019-2020 flu season. "In our analyses, QIVc and aTIV demonstrated effectiveness in preventing hospitalizations related to influenza, during both the broader influenza season and the high activity period," said study co-author Joaquin Mould-Quevedo, Ph.D., Head of Global Health Economics, Seqirus. "These data further underscore the public health benefits of innovative technologies, including cell-based and adjuvanted technologies, in producing seasonal influenza vaccines."
September 18, 2021 - The CDC FluView reports only one region; Region 3 reports above their baseline for week 37. This is down from 3 regions reporting above the baseline last week.
September 11, 2021 - ILINet reports that patient visits are below the national baseline of 2.6%.
September 4, 2021 - The U.S. CDC reported that as of week 35, influenza virus circulation remains low.
August 20, 2021 - The U.S. CDC published the 2020-2021 Influenza Season for Week #32 report, with data ending August 14, 2021. One influenza-associated pediatric death occurring during the 2020-2021 season has been reported to CDC.
August 19, 2021 - Seqirus announced plans to accelerate the development of its next generation of messenger RNA (mRNA) vaccine technology, self-amplifying messenger RNA (sa-mRNA), with the creation of a dedicated sa-mRNA program. Seqirus is currently developing several sa-mRNA-based influenza vaccine candidates, with pre-clinical results demonstrating promise compared to more traditional influenza vaccine technologies. The Company targets clinical trials for seasonal and pandemic influenza vaccine candidates in the second half of 2022.
August 18, 2021 - The U.S. FDA confirmed the number of flu vaccine lots released and available for distribution by the manufacturers in the USA. There were (23) lots for Flucelvax Quadrivalent.
August 16, 2021 - The WHO published Influenza Update N° 400 based on data up to August 1, 2021. Globally, despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year. The WHO GISRS laboratories tested more than 186,515 specimens during that time period. Eight hundred ninety-four were positive for influenza viruses, of which 383 (42.8%) were typed as influenza A and 511 (57.2%) as influenza B. Of the sub-typed influenza A viruses, 51 (14.2%) were influenza A(H1N1)pdm09, and 307 (85.8%) were influenza A(H3N2). Of the characterized B viruses, 456 (99.6%) belonged to the B-Victoria lineage and 2 (0.4%) to the B-Yamagata lineage.
August 13, 2021 - Nationwide, during week #31, 2.0% of patient visits reported through ILINet were due to ILI. Although increasing, the percentage of patient visits for ILI remains below the baseline of 2.6% nationally. One region (Region 7) is at its region-specific baseline while the remaining regions are below their baselines. Influenza virus circulation remains low; therefore, increases in ILI activity are likely due to increased circulation of other respiratory viruses.
July 30, 2021 - Flucelvax Quadrivalent Vaccine (QIVc) was found safe for pregnant women. "These data provide additional safety information with regards to unexpected pregnancy complications and/or fetal outcomes to healthcare providers considering vaccination to protect their pregnant patients from the flu," said Josephine van Boxmeer, lead Clinical Scientist for the study at Seqirus and an author. "We are committed to helping to protect as many people as possible against influenza, including those who are pregnant."
July 6, 2021 - The U.S. FDA issued an update for Flucelvax Quadrivalent; Manufacturer: Seqirus; Indication: For active immunization to prevent influenza disease caused by influenza virus subtypes A and type B viruses contained in the Vaccine.
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 two years and older.
June 14, 2021 - Novavax, Inc. announced data from the first coadministration 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 in clinical trials.