- Results from a randomized, real-world study published in the New England Journal of Medicine demonstrate Sanofi’s Flublok Quadrivalent (Influenza Vaccine) met its primary endpoint, reducing the incidence of PCR-confirmed influenza in adults ages 50-64 years old by 15.3% (95% CI: 5.9-23.8).1
- This large, real-world influenza vaccine effectiveness study leveraged Kaiser Permanente Northern California (KPNC) databases with 1.6 million adults over two flu seasons.1
- Flublok Quadrivalent is approved for adults aged 18 and older. It has been proven to prevent more influenza infections than standard-dose vaccines in a randomized clinical trial.2
Bridgewater, N.J., December 13, 2023. Results from a large-scale, cluster-randomized, observational study published in the New England Journal of Medicine on December 14, 2023 demonstrate that higher-dose Sanofi Flublok® Quadrivalent (Influenza Vaccine) reduced the incidence of PCR-confirmed influenza in adults ages 50-64 years old compared to standard dose inactivated influenza vaccines.1
The study by Kaiser Permanente Northern California (KPNC), one of America’s leading health care providers and not-for-profit health plans, evaluated the relative vaccine effectiveness (rVE) of Flublok Quadrivalent versus standard dose influenza vaccines in 1.6 million adults ages 18-64 years old during two influenza seasons (2018-2019 and 2019-2020).1
This cluster-randomized, observational study compared Flublok Quadrivalent (n=279,400) and standard dose influenza vaccines (n=395,852) in adults ages 50-64 years old. The results demonstrated Flublok Quadrivalent reduced the incidence of PCR-confirmed influenza by 15.3% (95% CI: 5.9 to 23.8) compared to standard dose influenza vaccines in this age group, the primary endpoint of the study.1
Study limitations include some compliance challenges with weekly vaccine schedules due to logistical constraints in a real-world setting, data being limited to two influenza seasons due to the impact of the COVID-19 pandemic on the circulation of influenza, and limited power to detect a clinically meaningful benefit of Flublok Quadrivalent versus standard dose influenza vaccines with respect to less frequent outcomes, such as hospitalized PCR-confirmed influenza. The study was also limited to the KPNC facilities and may not be fully representative of all other populations.
Results were published in the December 14, 2023 edition of the New England Journal of Medicine: DOI: 10.1056/NEJMoa2302099.
Michael Greenberg, MD
North America Medical Head of Vaccines at Sanofi
“This study helps further our understanding of the real-world benefits of higher-dose recombinant influenza vaccine compared to standard-dose vaccines. At Sanofi, we remain committed to advancing the research and development of our industry-leading portfolio of flu vaccines to help improve protection from the flu, including people who are at an increased risk of influenza and its complications.”
In a randomized controlled efficacy trial, Flublok Quadrivalent provided 30% (95% CI: 10-47) better protection in adults 50+ against influenza due to any PCR-confirmed circulating strains versus a standard-dose quadrivalent inactivated influenza vaccine.2 The most common injection-site reactions were tenderness and pain; the most common solicited systemic adverse reactions were headache and fatigue.2
Indication for Flublok® Quadrivalent (Influenza Vaccine)
Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses.2 Flublok Quadrivalent is approved for use in persons 18 years of age and older.2
Important Safety Information for Flublok® Quadrivalent (Influenza Vaccine)
Flublok Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine.
Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.
If Flublok 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 Flublok Quadrivalent may not protect all people who receive the vaccine.
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.
Other side effects may occur.
Please see the Prescribing Information for Flublok Quadrivalent.
About Flublok® Quadrivalent (Influenza Vaccine)
Flublok Quadrivalent is the first and only higher-dose recombinant influenza vaccine for adults ages 18 years and older that was proven to be more effective than a standard-dose vaccine at preventing flu infection in a study including about 9,000 adults ages 50 and older.2 Sanofi's Flublok® Quadrivalent (Influenza Vaccine) is one of the three flu vaccines preferentially recommended by the CDC ACIP for adults 65+.3
About Recombinant Technology
Recombinant technology is a unique method to produce influenza vaccines.4 Production of recombinant flu vaccines does not involve egg-based manufacturing or use of a candidate vaccine virus. Instead, recombinant vaccines are created synthetically by using the virus’ genetic instructions, allowing an exact match.4
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.
To learn more, please visit SanofiFluShots.com. Follow Instagram, Facebook, Twitter and LinkedIn for more information.
Media Relations
Evan Berland | + 1 215 432 0234 | evan.berland@sanofi.com
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Investor Relations
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Corentine Driancourt | + 33 6 40 56 92 21 | corentine.driancourt@sanofi.com
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Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Sanofi Disclaimers or 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. 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, 2022. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
References
1 Hsiao A, et al. N Engl J Med. 2023;389:2245-55. DOI: 10.1056/NEJMoa2302099
2 Flublok Quadrivalent [Prescribing Information]. Swiftwater, PA: Sanofi. Accessed December 2023.
3 Centers 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 December 2023.
4 Center for Disease Control and Prevention. How Influenza (Flu) Vaccines Are Made. Available at: https://www.cdc.gov/flu/prevent/how-fluvaccine-made.htm. Accessed December 2023.