FluMist® Quadrivalent Influenza Vaccine 2024
AstraZeneca's FluMist® (Fluenz® Tetra) Quadrivalent (Influenza Vaccine Live, Intranasal) contains four weakened live viruses. FluMist Quadrivalent triggers an immune response in the nose, where people usually catch the flu, says the U.S. Centers for Disease Control and Prevention (CDC). FluMist nasal vaccine works in three ways in your nose, cells, and bloodstream to help provide flu protection within 14 days. It then triggers people's immune systems to build defenses (called antibodies) for people 2-49 years of age. Estimates show that as many as 2 in 3 children and 1 in 4 adults have strong fears around needles.
FluMist Quadrivalent is the only Canadian and U.S. Food and Drug Administration (FDA)-approved flu vaccine to use a needle-free nasal spray administrative technique; FluMist was initially approved by the FDA in 2003. ATC code: J07BB03; CAS Number: 1704512-59-3; and the FDA issued BL 125020/2852 on July 27, 2022, and is approved for the 2023–2024 Influenza Season in the U.S. However, the U.S. CDC says people with certain medical conditions should not receive the nasal spray flu vaccine. On October 24, 2023, AstraZeneca announced a Supplemental Biologics License Application (sBLA) for approving a self- or caregiver-administered option for FluMist Quadrivalent has been accepted for review by the FDA. If approved, FluMist Quadrivalent will be the first flu vaccine available to be self-administered by eligible patients or administered by caregivers, adding an option to be vaccinated against influenza. The FDA's Prescription Drug User Fee Act date for FluMist Quadrivalent is expected during the first quarter of 2024.
"As we enter another flu season, AstraZeneca remains steadfast in our commitment to protecting people and communities from influenza. More than 20 years ago, the FDA approved FLUMIST QUADRIVALENT, making it the first and only needle-free flu vaccination in the U.S.," commented Liz Bodin, Vice President, U.S. Respiratory & Immunology at AstraZeneca, on September 5, 2023.
Delaware-based AstraZeneca (AZN) is a global, science-led biopharmaceutical company focusing on discovering, developing, and commercializing prescription medicines. Click here to find a FluMist Quadrivalent location in the USA.
FluMist Quadrivalent Indication
About 8% of the U.S. population gets sick from flu each season. The LAIV vaccine is not recommended for people with some chronic health conditions because this vaccine's safety and effectiveness in people with those conditions have not been established. In addition, children under two years old have an increased risk of wheezing (difficulty with breathing) after getting FluMist Quadrivalent. You should not get FLUMIST QUADRIVALENT if you have a severe allergy to eggs or to any inactive ingredient in the vaccine, have ever had a life-threatening reaction to influenza vaccinations, or are 2 through 17 years old and take aspirin or medicines containing aspirin – children or adolescents should not be given aspirin for four weeks after getting FLUMIST QUADRIVALENT unless your healthcare provider tells you otherwise. Children under two years old have an increased risk of wheezing (difficulty with breathing) after getting FLUMIST QUADRIVALENT. Tell your healthcare provider if you or your child are currently wheezing; have a history of wheezing if under five years old; have had Guillain-Barré syndrome; have a weakened immune system or live with someone who has a severely weakened immune system; have problems with your heart, kidneys, or lungs; have diabetes; are pregnant or nursing; or are taking a medication used to treat influenza.
FluMist Quadrivalent Side Effects
The most common side effects are runny or stuffy nose, sore throat, and fever over 100°F. FluMist Quadrivalent is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, or after a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy. In clinical trials, the risks of hospitalization and wheezing were increased in children <24 months of age who received trivalent FluMist. In a study published by the AAP journal Pediatrics on March 25, 2022, LAIV4 was not associated with an increased frequency of asthma exacerbations, an increase in asthma-related symptoms, or a decrease in peak expiratory flow rate compared with IIV4 among children aged 5 to 17 years with asthma.
FluMist Quadrivalent and COVID-19 Vaccines
The US CDC previously issued interim clinical considerations stating that 'COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing.
FluMist Quadrivalent Vaccine Dosage
FluMist Quadrivalent is a vaccine sprayed into the nose by a healthcare professional. One spray of FluMist in each nostril can help protect eligible children and adults ages 2-49. People 9 years and older need one dose of FluMist Quadrivalent each year. Children 2 through 8 years old may need two doses of FluMist Quadrivalent, depending on their history of previous influenza vaccination. Your healthcare provider will decide if your child needs to come back for a second dose.
FluMist Quadrivalent Vaccine Effectiveness
Since the 2018 flu season, the FLUMIST QUADRIVALENT vaccine has demonstrated moderate effectiveness, similar to other FDA-approved flu shots.
Fluenz® Tetra Influenza Vaccine
The LAIV) has been used in the U.K. since 2013 to protect children against influenza infection. In the United Kingdom (U.K.), over 3 million students in secondary school years 7 to 11 will be offered the nasal spray vaccine through their school's vaccination program from September 2023. The following groups will be eligible for a free flu vaccination - those aged 65 years and over, aged six months to under 65 years in clinical risk groups (as defined by the Green Book, chapter 19, pregnant women, and those in long-stay residential care homes. The nasal spray flu vaccine is approved for healthy, non-pregnant individuals, two through 49 years old. The vaccine is the preferred product for children with flu who are 'at-risk' and is part of the routine children's program in schools and general practices. The U.K. says if it's their first time being vaccinated against the flu, children under nine years old with long-term health conditions will usually be offered a 2nd dose of the flu vaccine four weeks after the 1st dose. On December 16, 2022, the U.K. Health Security Agency confirmed Fluenz Tetra offers protections for scarlet fever and group A strep infections in children.
FluMist Quadrivalent News
October 24, 2023 - AstraZeneca confirmed Supplemental Biologics License Application for the approval of a self- or caregiver-administered option for FLUMIST® QUADRIVALENT.
September 5, 2023 - AstraZeneca announced FLUMIST® QUADRIVALENT (Influenza Vaccine Live, Intranasal) doses were available in the U.S. for the 2023-2024 flu season.
February 28, 2023 - Japan health ministry panel endorses nasal flu vaccine for children.
November 10, 2022 - AstraZeneca confirmed Flumist vaccine revenues reached about 59 million year-to-date.
September 23, 2022 - AstraZeneca announces FLUMIST® QUADRIVALENT doses are available in the U.S. for the 2022-2023 influenza season. "Educating communities about flu safety measures and encouraging yearly flu vaccination remains an important part of reducing serious and contagious health threats," said Liz Bodin, Vice President, U.S. Respiratory & Immunology, AstraZeneca.
March 25, 2022 - The results from a limited (151 children) clinical trial published by the AAP suggest within 42 days of vaccination, 10.8% of children who received the intranasal LAIV4 experienced an asthma exacerbation compared with 14.7% of those who received the intramuscular IIV4; risk difference -0.0390, 90% CI -0.1453 to 0.0674).
August 31, 2021 - AstraZeneca announced that FLUMIST® QUADRIVALENT vaccine doses are available in the U.S. for the 2021-2022 influenza season. FLUMIST QUADRIVALENT is the only U.S. FDA-Approved nasal-spray flu vaccine.
August 26, 2021 - The U.S. FDA confirmed that (3) FluMist Quadrivalent lots from MedImmune, LLC, were released.
June 1, 2021 - Global Nasal Spray Vaccine Market 2020 Development Analysis – AstraZeneca FluMist, Cipla, BCHT
February 11, 2021 - AstraZeneca plc published financial results, which stated Flumist Total Revenue, entirely comprising Product Sales, increased by 161% in the year (153% at CER) to $295 m, reflecting the greater use of influenza vaccines as health authorities in northern-hemisphere countries expanded seasonal-vaccination programs beyond typical levels during the ongoing COVID-19 pandemic. In the U.S., sales increased by 254% in the year to $70m and, in Europe, by 135% (126% at CER) to $219m.
November 25, 2020 - Israel ordered AstraZeneca's FluMist vaccines for its citizens.
August 13, 2020 - AstraZeneca Ships FLUMIST® QUADRIVALENT Vaccine in the U.S. for the 2020-2021 Flu Season. AstraZeneca has increased production of FluMist QUADRIVALENT doses in the U.S. by over 25% more than planned, most of which are expected to be available by the end of September.
FluMist Quadrivalent Clinical Trials
Astra Zeneca's FluMist has been studied in several clinical trials.
