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Fluzone Influenza Vaccine

Fluzone® Influenza Vaccine Clinical Trials, Dosage, Efficacy, Side Effects

Sanofi Pasteur's Fluzone® Quadrivalent influenza vaccine contains influenza A and B strains identified for the current flu season. The Fluzone vaccine is given to people six months of age and older. The Fluzone High-Dose vaccine contains four killed flu virus strains for people 65 and older. In addition, Fluzone High-Dose has four times the antigen (the part of the vaccine that helps your body build up protection against flu viruses) of standard-dose inactivated influenza vaccines. Sanofi says the higher dose of antigen in the vaccine is intended to give older people a better immune response and better protection against the flu.

Sanofi Pasteur produces influenza vaccines each year across five international sites: Swiftwater (Pennsylvania, United States), Pearl River (New York, United States), Val-de-Reuil, Ocoyoacac (Mexico), and Shenzhen (China). As the largest manufacturer of influenza vaccines globally, Sanofi has continuously invested in expanding manufacturing capabilities and will distribute more than 250 million doses of influenza vaccines globally in 2020.

Fluzone Quadrivalent and Fluzone High-Dose vaccines help prevent influenza disease caused by influenza A and B strains contained in each vaccine. It is approved to help protect eligible people six months and older. Fluzone High-Dose is formulated for people 65 years and older, including four times the standard dose. It's proven 24.2% more effective than the standard-dose Fluzone vaccine in preventing the flu.

As of 2024, the Fluzone High-Dose Quadrivalent vaccine (STN: 103914, updated Nov. 2023) has shown better protection than standard-dose flu shots in older adults. Canada's National Advisory Committee on Immunization's annual Statement on Seasonal Influenza Vaccine for 2024-2025 recommends Fluzone® among the preferential influenza vaccines to protect seniors against influenza.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Fluzone Vaccine Price

Sanofi Pasteur provides a coding and reimbursement guide for healthcare providers. According to CMS.gov 2022-2023 flu season payment allowance, the Fluzone High-Dose price is $69.94. Fluzone Quadrivalent is priced at $21.52.

Fluzona Dose and Schedule

Fluzone High-Dose Quadrivalent should be administered as a single 0.7 mL injection by the intramuscular route in adults 65 and older. The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas with a major nerve trunk. Do not administer this product intravenously.

Fluzone Safety

Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any vaccine component (including eggs or egg products for Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent) or after a previous dose of the vaccine. In addition, Fluzone vaccines should not be given to anyone with a severe allergic reaction after the last dose of any influenza vaccine.

Fluzone and COVID-19 Vaccines

The US Centers for Disease Control and Prevention (CDC) issued interim clinical considerations stating that 'COVID-19 vaccines and other vaccines, including influenza vaccines, can be administered without regard to timing.

Fluzone Vaccine Side Effects

Fluzone vaccines are generally well-tolerated. In adults >65 years of age, the most common (>10%) injection-site reaction was pain (41.3%); the most common solicited systemic adverse reactions were myalgia (22.7%), headache (14.4%) and malaise (13.2%). If you or your loved one has an adverse reaction to the vaccine, that information should be reported to VAERS. VAERS is a U.S. passive reporting system that relies on individuals to send reports of their experiences with a vaccine. However, anyone, including parents and patients, can submit information to VAERS. Furthermore, healthcare providers are required by law to report to VAERS.

Fluzone Immunocompetence

If Fluzone High-Dose Quadrivalent is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be lower than expected.

Fluzone Lactation and Pregnancy

There are limited human data on Fluzone High-Dose and no animal data available on Fluzone High-Dose Quadrivalent to establish whether there is a vaccine-associated risk with the use of Fluzone High-Dose Quadrivalent in pregnancy. No human or animal data are available to assess the effects of Fluzone High-Dose Quadrivalent on the breastfed infant or milk production/excretion.

Fluzone Vaccine News

July 26, 2024 - The National Advisory Committee on Immunization's (NACI) annual Statement on Seasonal Influenza Vaccines for 2024-2025 continues to recommend Fluzone® High-Dose Quadrivalent among the preferential influenza vaccines over standard-dose influenza vaccines to protect adults 65 years of age and older against influenza.

January 3, 2024 - Delphine Lansac, General Manager, Vaccines Canada, Sanofi, stated in a press release, "This long-standing recommendation as a preferential influenza vaccine for adults 65 years of age and older speaks to the science that Fluzone® High-Dose Quadrivalent is built on and demonstrates our continued leadership in vaccines. It's been a groundbreaking year, where over 50% – more than one in two – seniors who received influenza vaccines in Canada were immunized with Fluzone®."

September 13, 2023 - Michael Greenberg, MD, MPH, North America Medical Head of Vaccines at Sanofi, commented in a press release, "The flu can be a serious public health threat and lead to complications such as heart attack, stroke, and pneumonia. These can be especially dangerous for older adults, ethnic and racial minority groups at an increased risk of being hospitalized from the flu, and those living with chronic conditions like asthma, diabetes, and heart disease. Our hope is that, as a part of our annual commitment to educating the public about the flu, this campaign will increase awareness of the importance of flu vaccination and remind older adults and at-risk populations that there are vaccines available to them that may provide better protection for their specific needs, such as Fluzone High-Dose Quadrivalent or Flublok Quadrivalent."

June 17, 2021 - The U.S. Food and Drug Administration Center for Biologics Evaluation and Research has approved Sanofi Pasteur, Sanofi's vaccines global business unit, for an additional influenza manufacturing facility in Swiftwater, PA.

March 8, 2021 - Certain patients have an increased risk of influenza infections and poor serologic response to standard influenza vaccination. A new study found that high-dose influenza vaccination leads to more robust and durable seroprotection in high-risk patients.

October 7, 2020 - High-dose flu vaccine is in short supply. The CDC recommends getting the regular dose if the high-dose vaccine is unavailable.

Fluzone Influenza Clinical Trials

Fluzone has been tested in over 150 clinical trials.

0 min read

Manufacturer:

Sanofi Pasteur, Ltd.

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Vaccine:

Fluzone Influenza Vaccine

VIS:

PDF

Availability:

USA, UK, Canada, Germany, and various countries

Generic:

Influenza Vaccine

Drug Class:

Vaccine

Find Price:

Discounts

Clinical Trial Phase II:

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

Clinical Trial Phase III:

Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

Clinical Trial Phase IV:

Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children

Lab Test:

Influenza A and B Antigen, DFA

Condition:

Influenza

Availability Link:

Flu Vaccine Locator

Last Reviewed:

Friday, July 26, 2024 - 13:10

Brand:

Fluzone

CPT Code:

90688

Accession Number:

DB15703

Status:

Approved

Manufacturer Country ID:

Kosher:

Yes

Halal:

Yes

Side Effects:

Warnings and Precautions

Ingredients:

Countries:

UNII:

Cell Line Production:

Chicken Eggs

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FluMist Influenza Vaccine

FluMist® Influenza Vaccine Clinical Trials, Dosage, Indication, Side Effects

AstraZeneca's FluMist® (Fluenz® Tetra) Influenza Vaccine Live, Intranasal contains weakened live viruses that trigger 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 the nose, cells, and bloodstream to help provide flu protection within 14 days. FluMist then triggers people's immune systems to build defenses (called antibodies) for individuals aged 2-49 years.

FluMist is the only U.S. Food and Drug Administration (FDA)-approved (STN: 125020) flu vaccine with a needle-free nasal spray administration technique. On September 20, 2024, the FDA announced the approval of FluMist for self- or caregiver-administration. A prescription is still required to receive FluMist Home. FluMist was initially approved by the FDA in 2003. The FDA issued STN: BL 125020/2606 on July 9, 2020, and BL 125020/2852 on July 27, 2022, and was approved for the 2024–2025 Influenza Season. On October 24, 2023, AstraZeneca announced that a Supplemental Biologics License Application (sBLA) for approving a self- or caregiver-administered option for FluMist has been accepted for review by the U.S. FDA. On August 6, 2024, the FDA issued STN: BL 125020/3070.

"Today's approval of the first influenza vaccine for self- or caregiver administration provides a new option for receiving a safe and effective seasonal influenza vaccine, potentially with greater convenience, flexibility, and accessibility for individuals and families," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, in a press release. The FDA approved FluMist for MedImmune LLC. ATC code: J07BB03; CAS Number: 1704512-59-3.

On August 15, 2025, Flumist Home became available in the United States.

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 location in the USA.

FluMist Indication

FluMist is FDA-approved for preventing influenza disease caused by influenza virus subtypes A and B in individuals 2 through 49 years of age. It is the first influenza vaccine that does not require administration by a healthcare provider.

Flumist Dosage

There are now two approved options for receiving FluMist. The vaccine may be administered by a healthcare provider in a healthcare setting (including a pharmacy) or by the vaccine recipient or a caregiver who is 18 years or older. FluMist is sprayed into the nose. Vaccine recipients and caregivers who administer FluMist will be sent the vaccine, the Prescribing Information, Information for Patients and their Caregivers, and Instructions for Use. Estimates show that as many as 2 in 3 children and 1 in 4 adults have intense fears around needles.

FluMist Quadrivalent Side Effects

The most common side effects are a runny or stuffy nose, a sore throat, and a 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 risk of hospitalization and wheezing was increased in children aged <24 months 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 Vaccine Effectiveness

Since the 2018 flu season, the FLUMIST vaccine has demonstrated effectiveness comparable to that of other FDA-approved flu shots.

FluMist Home

In 2025, FluMist Home will utilize an online pharmacy. Although a prescription will still be required, the vaccine manufacturer plans to make FluMist accessible through a third-party online pharmacy for the 2025-2026 flu season. Caregivers aged 18 years or older are required to administer the vaccine to children. On April 15, 2025, AZ presented the updated FluMist Home launch plan to the U.S. CDC ACIP. More information is available at www.FluMist.com.

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 starting September 2023. On December 16, 2022, the U.K. The Health Security Agency confirmed that Fluenz Tetra offers protection for scarlet fever and group A strep infections in children.

FluMist Vaccine News

August 15, 2025 - Joris Silon, US Country President and Senior Vice President, AstraZeneca, said: "The launch of FluMist Home is a transformational moment in the evolution of influenza protection, bringing a simple and accessible option directly into the hands of consumers. FluMist Home reflects the growing importance of direct-to-consumer offerings and underscores our commitment to continuous innovation, making it easier for people to get vaccinated and stay protected."

September 20, 2024 - Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, commented, "Getting vaccinated each year is the best way to prevent influenza, which causes illness in a substantial proportion of the U.S. population every year and may result in serious complications, including hospitalization and death. This approval adds another option for vaccination against influenza disease and demonstrates the FDA's commitment to advancing public health."

October 24, 2023 - AstraZeneca confirmed a 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 that 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

AstraZeneca's FluMist has been studied in several clinical trials.

0 min read

Manufacturer:

AstraZeneca

Reviewer:

Robert Carlson, MD

Vaccine:

Flumist Influenza Vaccine

VIS:

PDF

Availability:

USA, UK, Canada, Japan

Generic:

Flu Nasal Vaccine

Drug Class:

Intranasal vaccine

Clinical Trial Phase I:

A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist

Clinical Trial Phase II:

A Phase 2 Study to Evaluate Immune Responses of FluMist®

Clinical Trial Phase III:

Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted

Clinical Trial Phase IV:

Self-Administered Nasal Influenza Feasibility Study (SNIF)

Lab Test:

CDC

Condition:

Influenza

Availability Link:

FluMist

Last Reviewed:

Monday, December 15, 2025 - 09:50

Brand:

FluMist®, Fluenz® Tetra

Abbreviation:

LAIV

CPT Code:

90672

ChemSpider ID:

1704512-59-3

Accession Number:

J07BB03

Status:

Approved

Manufacturer Country ID:

FDA First In Class:

Yes

Kosher:

Yes

Side Effects:

Warnings and Precautions

Ingredients:

Countries:

Cell Line Production:

Chicken Eggs

Rate Vaccine:

CgagJK7r

Location tags:

Fluarix Quadrivalent Influenza Vaccine

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