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Sanofi flu vaccines licensed and approved for 2022-2023 influenza season, including CDC preferred higher-dose vaccines for adults 65+

SNY | July 1, 2022

* Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and Flublok® Quadrivalent (Influenza Vaccine) are the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators as assessed in randomized controlled trials, the gold standard in evaluating clinical evidence for vaccine licensure1,2
* 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+2,3,a,b
* As the leaders in flu, Sanofi is committed to protecting patients most at-risk for the flu and its related complications, including hospitalizations due to pneumonia & cardiovascular events4

BRIDGEWATER, N.J., July 1, 2022 /PRNewswire/ -- Today the US Food and Drug Administration (FDA) approved Sanofi's licensure request for vaccine approval for the upcoming 2022-2023 flu season, including: Fluzone High-Dose Quadrivalent (Influenza Vaccine), Flublok Quadrivalent (Influenza Vaccine) and Fluzone Quadrivalent (Influenza Vaccine).5 This approval comes on the heels of the CDC's Advisory Committee on Immunization Practices (ACIP) preferential recommendation for adults 65+ including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent.6 Following this licensure, Sanofi will begin to ship their vaccines helping to ensure more people, including some of our most vulnerable population of 65 years and older, will be immunized with the vaccine best suited for their needs as recommended by the ACIP.

Influenza disproportionately impacts people over 65, underrepresented communities, and people with co-morbidities such as diabetes, asthma, chronic obstructive pulmonary disease, and heart disease.7 Since 2010, it's estimated by the CDC that between 70% and 85% of seasonal flu-related deaths have occurred in people 65+, and between 50% and 70% of seasonal flu-related hospitalizations have occurred among people in this age group.4 ACIP's June 22nd recommendation will undoubtedly help reduce the risk of influenza cases and severe flu-related complications in this population at highest risk.

Michael Greenberg, MD, MPH
North America Medial Head of Vaccines at Sanofi
"ACIP's recommendation is a first step to help improve protection against flu and its complications for this 65 years and older high-risk population. Not every flu vaccine is created equal and we are pleased with ACIP's acknowledgment that Fluzone High-Dose Quadrivalent & Flublok Quadrivalent have demonstrated improved protection from flu & its related complications through randomized controlled trials and real-world evidence.8 Of note ACIP recognized that Fluzone High-Dose Quadrivalent had the most data available, including evidence favoring its use over standard dose for all the benefit outcomes within the GRADE analysis; influenza illnesses, outpatient/ER visits, hospitalizations, and deaths.8 Nevertheless, we believe even more can be done to provide healthcare providers with clearer guidance. As a leader in flu vaccination, we remain committed to ensure adults 65 years and older have access to flu vaccines, proven to protect them from what really matters, such as flu-related hospitalizations due to cardiovascular events and pneumonia."

About the Composition of Sanofi's 2022-2023 Licensed and Approved Influenza Vaccines

Each year, the FDA, World Health Organization (WHO), Centers for Disease Control and Prevention, and other partners collaborate by collecting and reviewing data on the circulating strains of influenza from around the world to identify those likely to cause the most illness in the upcoming flu season.9 Once strains are selected, flu vaccine manufacturers include the newly selected flu strains in their FDA-approved vaccines, and then submit applications to the FDA to include the new flu strains in their FDA-approved vaccines, including for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent and Fluzone Quadrivalent.9 Today those requests for licensure were approved for the upcoming 2022-2023 flu season.5

About Fluzone® Quadrivalent (Influenza Vaccine), Flublok® Quadrivalent (Influenza Vaccine) and Fluzone® High-Dose Quadrivalent (Influenza Vaccine)

Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are vaccines indicated for immunization against disease caused by influenza A and B strains contained in the vaccine. Fluzone Quadrivalent is given to people 6 months of age and older. Flublok Quadrivalent is given to people 18 years of age and older. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older.

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.2,3,a,b In a meta-analysis of 15 published reports, including approximately 34 million people, those who received Fluzone High-Dose experienced an 18% reduction in cardiorespiratory hospitalizations and 28% decrease in pneumonia hospitalizations, both of which are reductions above what the standard dose vaccines provided.3

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+.10 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.11

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.2

In a clinical study, Flublok Quadrivalent is the first and only recombinant influenza vaccine for adults 18+ that was proven to be 30% more effective than a standard dose vaccine at preventing flu infection in over 9,000 adults 50+.1 In adults 50+, the most common side effects were tenderness, and/or pain at the injection site; headache, and tiredness.1

aProven superiority in a clinical trial between Fluzone High-Dose (Influenza Vaccine) (trivalent formulation) and a standard-dose influenza vaccine2
bIncludes 10 years of evidence (2009-2019) with Fluzone High-Dose (trivalent formulation)3

Important Safety Information for Fluzone® Quadrivalent (Influenza Vaccine), Flublok® Quadrivalent (Influenza Vaccine) and Fluzone® High-Dose Quadrivalent (Influenza Vaccine)

Fluzone Quadrivalent, Flublok Quadrivalent, and 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 for Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent) or after previous dose of the vaccine. In addition, Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction 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 Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are 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 Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine.

For Fluzone Quadrivalent, in children 6 months through 35 months of age, the most common side effects were pain, tenderness, redness, and/or swelling where you got the shot; irritability, abnormal crying, general discomfort, drowsiness, loss of appetite, muscle aches, vomiting, and fever. In children 3 years through 8 years of age, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle aches, general discomfort, and headache. In adults 18 years and older, the most common side effects were pain where you got the shot; muscle aches, headache, and general discomfort.

For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common side effects were tenderness, and/or pain where you got the shot; headache, tiredness, muscle aches, and joint pain. In adults 50 years of age and older the most common side effects were tenderness, and/or pain where you got the shot; headache and tiredness.

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 aches, headache, and general discomfort.

For Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent, other side effects may occur.

Please refer to the full Prescribing Information for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, or Fluzone Quadrivalent. Also please see complete Patient Information for Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent.

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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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 and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. 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, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, 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, 2021. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

References
1Flublok Quadrivalent [Prescribing Information]. Swiftwater, PA: Sanofi
2Fluzone High-Dose Quadrivalent [Prescribing Information]. Swiftwater, PA: Sanofi
3Lee 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.
4Centers for Disease Control and Prevention. Flu & People 65 Years and Older. Available at: https://www.cdc.gov/flu/highrisk/65over.htm. Accessed June 2022.
5FDA Approval of Sanofi Licensure Request for Vaccine Approval for 2022-2023 Influenza Season [Data on File]
6Centers for Disease Control and Prevention. ACIP Flu Meeting Update: Flu Vaccines Worked Better than Reported & ACIP Recommends Specific Vaccines for Seniors. Available at https://www.cdc.gov/flu/spotlights/2021-2022/specific-vaccines-seniors.htm. Accessed June 2022.
7Centers for Disease Control and Prevention. People at Higher Risk for Flu Complications. Available at: https://www.cdc.gov/flu/highrisk/index.htm. Accessed June 2022.
8Grohskoph L. Influenza Vaccines for Persons Aged ≥65 Years: Evidence to Recommendations (EtR) Framework. Available at https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/03-influenza-grohskopf-508.pdf. Accessed on June 22, 2022.
9Centers for Disease Control and Prevention. Selecting Viruses for the Seasonal Influenza Vaccine. Available at https://www.cdc.gov/flu/prevent/vaccine-selection.htm. Accessed June 2022.
10DiazGranados CA, et al. N Engl J Med. 2014;371(7):635-645 https://www.nejm.org/doi/full/10.1056/nejmoa1315727
11Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009;200(2):172-180. doi:10.1086/599790