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.
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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.
