- There is currently no preferred flu vaccine for older adults
- The ACIP evaluation comes at a critical time, when the US is preparing for the next flu season, when infections could rebound after two years of low flu cases
- Fluzone® High-Dose (Influenza Vaccine) is the first and only influenza vaccine with superior flu protection and 10 years of evidence in preventing flu-related hospitalizations in adults aged 65+1,2*
CAMBRIDGE, MA – February 22, 2022. The CDC’s Advisory Committee on Immunization Practices (ACIP) is currently evaluating data to provide guidance for influenza (flu) vaccines for adults 65+ years. With a broad-base of experience and scientific evidence with Fluzone High-Dose Quadrivalent (Influenza Vaccine), Sanofi is urging ACIP to adopt a recommendation for Fluzone High-Dose Quadrivalent as the preferred vaccine for adults 65+ years.
Recommendations for influenza vaccines for those 65 years and older have not changed since 2010.3 Recent estimates showed that 70-85% of flu-related deaths and 50-70% flu-related hospitalizations occurred in adults 65 years and older.4 Now is the time for ACIP to take action to ensure its recommendation for our 65+ population takes into account the full breadth of evidence regarding the prevention of flu and its related complications.
Thomas Triomphe
Executive Vice President of Vaccines at Sanofi
“Sanofi is committed to public health and collaborates with policy makers and the healthcare professional community to implement evidence-based policies to ensure that vulnerable populations have better access to vaccines that provide superior protection from the flu. We believe more can be done to protect the most vulnerable from influenza and its related complications. By making clinically-driven recommendations for the use of tailored influenza vaccines for older persons, as already done by other health authorities outside the U.S., the burden caused by seasonal influenza on the healthcare system can be relieved.”
Influenza disproportionately impacts people over 65, people of color, and people with co-morbidities such as diabetes, asthma, chronic obstructive pulmonary disease, and heart disease.5 These populations require clear recommendations rooted in science than what ACIP guidelines currently provide. Additionally influenza can lead to potentially life-threatening complications, including pneumonia or serious heart conditions, especially in older adults.6,7 Fluzone High-Dose Quadrivalent has the potential to help lower the burden of disease in this population with the greater risk for severe-flu related complications, hospitalizations and death.
With protection against four flu strains, Fluzone High-Dose is the only influenza vaccine licensed for use in adults 65 years of age and older to have demonstrated superior efficacy in a randomized controlled trial versus a standard dose influenza vaccine for the prevention of laboratory-confirmed influenza illness and the only influenza vaccine with 10 years of data demonstrating protection from flu and its related complications.1,2* In a real-world analysis of approximately 34 million people, those who received Fluzone High-Dose experienced an 18% reduction in cardiorespiratory hospitalizations and over a 27% decrease in pneumonia hospitalizations, both of which are reductions above what the standard dose vaccines provided.2
Michael Greenberg, MD
North America Medical Head of Vaccines at Sanofi
“Flu vaccination is one of the most important tools we have for protecting the public’s health, especially for adults 65 years and older who may suffer the greatest burden and these populations require clear recommendations rooted in science than what ACIP guidelines currently provide.4 Available scientific data clearly support Fluzone High-Dose (Influenza Vaccine) as being more effective at preventing influenza infection and hospitalization in this population than a standard dose vaccine.1,2
A decision to designate Fluzone High-Dose as the preferred flu vaccine for older adults could help avoid unnecessarily compromising the health of those who are already at higher risk for severe flu-related complications. We look forward to working with ACIP, as these discussions are vital to the health of older adults across the country.”
*Proven superiority in a clinical trial between Fluzone High-Dose (Influenza Vaccine) (trivalent formulation) and a standard-dose influenza vaccine1
*Includes 10 years of evidence (2009-2019) with Fluzone High-Dose (trivalent formulation)2
About Fluzone High-Dose Quadrivalent
Fluzone High-Dose Quadrivalent is a vaccine indicated for prevention of influenza disease caused by influenza A and B strains contained in the vaccine. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older.1
Fluzone High-Dose is the only vaccine approved by the U.S. FDA for superior flu protection in adults 65 years of age and older, compared to a standard-dose flu vaccine.1 With 4-strain protection, Fluzone High-Dose Quadrivalent builds on the legacy of the trivalent formulation, which was clinically proven to be 24.2% more effective at preventing flu than standard-dose Fluzone (Influenza Vaccine) in adults 65+.8 Based on data from Fluzone High-Dose (Influenza Vaccine), side effects were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.1
In addition, Fluzone High-Dose has demonstrated protection against influenza and its related complications including cardiorespiratory events, pneumonia and hospitalization.2
The efficacy of trivalent formulation is relevant to Fluzone High-Dose Quadrivalent since both products are manufactured according to the same process and have overlapping compositions.1
Outside of the U.S., Sanofi's High-Dose influenza vaccine has also earned recommendations for use over standard-dose influenza vaccine in individual adults 65 years and older by the National Advisory Committee on Immunization (NACI) in Canada, along with a recommendation for priority use in older adults by Germany's Standing Committee on Vaccination (STIKO).9,10
Important Safety Information
Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine, including eggs or egg products, or after previous dose of any influenza vaccine.
Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.
If Fluzone High-Dose Quadrivalent is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.
Vaccination with Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine.
For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle ache, headache, and general discomfort. Other side effects may occur.
Please see the Prescribing Information, including Patient Information Sheet.
About Sanofi
We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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Investor Relations
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Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2020. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
[1] Fluzone High-Dose Quadrivalent [Prescribing Information]. Swiftwater, PA: Sanofi
2 Lee JKH, Lam GKL, Shin T, et al.(2021) Efficacy and effectiveness of high-dose influenza vaccine in older adults by circulating strain and antigenic match: An updated systematic review and meta-analysis. Vaccine 2021; 39: A24-A35. https://doi.org/10.1016/j.vaccine.2020.09.004.
3Centers for Disease Control and Prevention. Influenza ACIP Vaccine Recommendations. Available at: https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/flu.html.
4Centers for Disease Control and Prevention. Flu & People 65 Years and Older. Available at: https://www.cdc.gov/flu/highrisk/65over.htm.
5Centers for Disease Control and Prevention. People at Higher Risk for Flu Complications. Available at: https://www.cdc.gov/flu/highrisk/index.htm.
6 Warren-Gash C., et al. (2018). Laboratory-confirmed respiratory infections as triggers for acute myocardial infarction and stroke: a self-controlled case series analysis of national linked datasets from Scotland. Eur Respir J. 2018 Mar 29;51(3):1701794. doi: 10.1183/13993003.01794-2017.
7Ohland J, Warren-Gash C, Blackburn R, et al. Acute myocardial infarctions and stroke triggered by laboratory-confirmed respiratory infections in Denmark, 2010 to 2016. Euro Surveill. 2020;25(17):1900199. doi:10.2807/1560-7917.ES.2020.25.17.1900199.
8DiazGranados CA, et al. N Engl J Med. 2014;371(7):635-645 https://www.nejm.org/doi/full/10.1056/nejmoa1315727
9Public Health Agency of Canada (2020. An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI) Canadian Immunization Guide Chapter on Influenza and Statement on Seasonal Influenza Vaccine for 2021–2022
10Epidemiological Bulletin 1/2021. Decision and scientific justification of the STIKO for the update of the influenza vaccination recommendation for people aged ≥60 years. Available at: https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2021/01/Tabelle.html;jsessionid=24A230AD6414D945791E39A4474D7164.internet071?nn=2371176https://www.rki.de/DE/Content/Infekt/EpidBull/Archiv/2021/01/Tabelle.html;jsessionid=24A230AD6414D945791E39A4474D7164.internet071?nn=2371176