Fluarix Quadrivalent Vaccine 2023
GSK plc's Fluarix Quadrivalent is prepared from influenza viruses propagated in embryonated chicken eggs. Each of the influenza viruses is produced and purified separately. After harvesting the virus-containing fluids, each influenza virus is concentrated and purified by zonal centrifugation using a linear sucrose density gradient solution containing detergent to disrupt the viruses. Following dilution, the GSK flu vaccine is further purified by diafiltration. Each influenza virus solution is inactivated by the consecutive effects of sodium deoxycholate and formaldehyde, producing a "split virus." Each split-inactivated virus is then suspended. Fluarix Quadrivalent is thimerosal-free.
GSK announced in July 2023 that it has started shipping about 40 million doses of its quadrivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2023-24 flu season. This immediately follows a licensing and lot-release approval from the U.S. Food and Drug Administration (FDA). The FDA) announced on March 7, 2023, their recommendation for the 2023-2024 vaccine compositions. CPT code: 90686; STN: BL 125127
Please see full Prescribing Information for FLUARIX QUADRIVALENT and for FLULAVAL QUADRIVALENT.
GSK is a Philadelphia-based, global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.
Fluarix Quadrivalent Indication
Fluarix Quadrivalent is a vaccine indicated for active immunization to prevent disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Do not administer FLUARIX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any vaccine component, including egg protein, or following a previous dose of any influenza vaccine.
Fluarix Quadrivalent Dosage
The preferred sites for intramuscular injection are the anterolateral thigh for children aged 6 through 11 months and the deltoid muscle of the upper arm for persons aged 12 months and older if muscle mass is adequate. 6 months through 8 years: Not previously vaccinated with influenza vaccine: Two doses (0.5-mL each) at least four weeks apart. Six months through 8 years: Vaccinated with influenza vaccine in a previous season: One or two doses (0.5-mL each) and nine years and older: One 0.5-mL dose.
Fluarix Quadrivalent 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.
Fluarix Quadrivalent Side Effects
Fluarix Quadrivalent is generally well-tolerated; however, if you or your loved one has an adverse reaction to the vaccine, that information should be reported to VAERS, a U.S. passive reporting system, meaning it relies on individuals to send in reports of their experiences to a vaccine. Anyone can submit information to VAERS.
Fluarix Quadrivalent News
July 13, 2023 - GSK shipped influenza vaccine doses for the US's 2023-24 flu season.
March 17, 2023 - The CDC reported 134 pediatric influenza-related deaths for the 2022-2023 influenza season.
May 4, 2022 - The WHO reported for week 16 that influenza activity remained low globally, but activity has increased since February 2022 after an initial decrease in January 2022. Detections were mainly influenza A(H3N2) viruses and B/Victoria lineage viruses.
April 8, 2022 - The CDC flu report FluView stated that influenza activity increased nationally this week. The majority of flu viruses detected are A(H3N2).
February 9, 2022 - GSK reported Fluarix/FluLaval sales decreased in 2021 by 7% AER, 2% CER, to £679 million as a result of unfavorable prior period RAR movements in the US, partially offset by higher volume in the US and strong southern hemisphere demand in International.
November 11, 2021 - The WHO reported that influenza detections remain low globally, but among the positive cases, influenza B viruses predominated.
October 16, 2021 - During week 41, the CDC reported that 1.8% of patient visits reported through ILINet were due to ILI. Two jurisdictions experienced moderate activity, while none reported high or very high.
October 7, 2021 - The UK weekly National Influenza reported eight influenza-positive case samples.
September 11, 2021 - The CDC reported that nationwide influenza-like illness continues to be below baselines.
September 4, 2021 - According to the US CDC, influenza virus circulation remains low; therefore, increases in ILI activity are likely due to increased circulation of other respiratory viruses.
August 13, 2021 - Nationwide, during week 31, 2.0% of patient visits reported through ILINet were due to ILI. However, 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 areas 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 28, 2021 - GSK announced its financial results. Fluarix/FluLaval sales grew by over 100% AER and CER to £33 million, driven by strong international southern hemisphere demand.
July 23, 2021 - GSK announced it started shipping its quadrivalent influenza vaccines to US healthcare providers and pharmacies for the 2021-22 flu season. "GSK's focus continues to be increasing vaccination rates during the COVID-19 pandemic, and flu vaccination is an integral part of that public health effort," said Judy Stewart, Senior Vice President and Head of US Vaccines at GSK.
July 2, 2021 - The U.S. FDA confirmed, 'We have approved your request submitted and received March 5, 2021, to supplement your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (42 U.S.C. 262) for Influenza Vaccine (Fluarix), manufactured at your Dresden, Germany facility, to include the 2021-2022 United States formulation and associated labeling revisions.'
July 28, 2020 - GSK expects to supply more than 50 million doses of its influenza vaccines for the US market in the 2020-21 season
Fluarix Quadrivalent Clinical Trials
Fluarix Quadrivalent Vaccine has been involved in over 220 clinical studies.
