Exploring the importance of vaccines that help protect from flu and its related complications

Why should we worry about flu? Covid-19 has reframed our collective understanding of the threat viral infections pose to major organ systems and the risk for long-term complications that significantly impact people’s lives.¹ Now, for viral diseases like the flu, there is an increasing importance for vaccines to help people avoid serious flu-related illness and hospitalization and thereby reduce the burden on health systems.²

Flu infection for some can lead to severe complications.³ Indeed, there is a study that found flu can wreak havoc on the human body and is associated with a ten times increased risk of heart attack and eight times increased risk of stroke within three days of infection.⁴ At Sanofi, we recognize the potentially devastating, unpredictable effects flu^3,5 can cause and have been working to set a new standard for evaluating vaccine success that incorporates both protection from initial infection and protection from flu-related complications.

“Sanofi is a part of the global endeavor to improve the flu vaccine. We are always looking at improving protection and raising the bar, both in terms of providing broader protection against flu strains but also protection from the devastating complications it can cause,” said Bogdana Coudsy, Sanofi Head of Medical, Vaccines.

How do vaccines demonstrate protection from flu-related complications?

Vaccines that help prevent the flu and its severe complications may ultimately keep patients out of hospitals, benefiting individuals, families and health systems.² High-quality and consistent data in relation to how vaccines perform is key to demonstrating this benefit and is why we’ve invested in innovative randomized controlled clinical trials with real-world evidence studies.^6,7 Using the gold standard of randomized controlled clinical trials along with real world studies helps to measure the real impact influenza can have over respiratory seasons.

Fluzone® High-Dose Quadrivalent (Influenza Vaccine) is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses. It is approved for use in adults ages 65 years of age and older. Fluzone High-Dose is the only influenza vaccine with 10 years of real-world data evaluating flu-related outcomes. This is based on a group analysis of 15 published studies in ~34 million adults aged 65 and older conducted during 10 flu seasons from 2009-2010 through 2018-2019. Study funding was provided by Sanofi and the authors were employees of Sanofi. In this meta-analysis, those who received Fluzone High-Dose experienced an 18% reduction in cardiorespiratory hospitalizations and 27% decrease in pneumonia hospitalizations, both of which are reductions above what the standard dose vaccines provided. Other data endpoints include 13% fewer hospitalizations due to combined flu and pneumonia, 40% fewer deaths due to combined flu and pneumonia, 28% fewer deaths due to cardiorespiratory causes, 12% fewer hospitalizations due to flu, and 22% fewer deaths due to flu. Please note, percentages are approximate and results may have been influenced by other variables. Results shown are pooled analysis from multiple studies. Select endpoints are presented here. Influenza-like illness, all-cause hospitalizations, and all-cause mortality were also evaluated. Individual results may vary.⁸

Fluzone High-Dose has been proven to provide better flu protection than standard-dose flu shots in adults aged 65 and older.¹³ It’s even been shown to better protect against flu-related complications.⁸

What do flu vaccines of the future look like?

When looking to the future, it’s easy to be hypnotized by the promise of technology. But for us, flu vaccine innovation is more than a technology story: it is about preventing serious outcomes in the most vulnerable patients, regardless of the manufacturing platform utilized. That’s why we continue to add to and improve the tools in our vaccine portfolio.

Through our mRNA Center of Excellence, we’re investing in new mRNA technologies for vaccines.⁹ Data from the first generation of these vaccines show promise, yet improvements still need to be made. Our ambition is to match our Fluzone High-Dose vaccine standard to help provide better protection from flu and its related complications with our next-generation mRNA flu vaccines, and we are confident we are well-positioned to achieve this.
 

“The opportunity for mRNA vaccines is enormous, but there is a long way to go. In the short term, we must overcome three major challenges: improving immunogenicity - in particular enhancing the B strain immune response, improving reactogenicity to make mRNA vaccines more tolerable and ensuring easy administration and thermostability,” said Saranya Sridhar, Sanofi Head of Global Translational Medicine, Vaccines.

As we pioneered the transition to the quadrivalent flu vaccines – designed to protect against four different flu virus strains – we continue to innovate to provide broader protection, including upgrading antigen design with the addition of the neuraminidase protein, so as to improve vaccine effectiveness. We’re also applying innovative machine learning with the aim of optimizing strain selection and predicting which antigens might provide broader protection against the unpredictable flu virus in order to use this data to guide our development pipeline.¹⁰

Continuing to raise the bar in flu vaccines

At Sanofi, in all of our work in flu, today and tomorrow, we seek to ensure people have access to vaccines that not only help prevent flu but reduce the risks of its severe complications, supported by evidence. We’re already delivering on that with our Fluzone High-Dose vaccine.⁸ And we’ll strive to continue to lead the flu market through our pursuit of the next chapter of prevention with mRNA technology, machine learning, and better antigen design, and work to ensure that new vaccines offer broad protection from initial infection and protection from flu and its complications.¹⁰

<sup>INDICATIONS 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 are vaccines indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Fluzone Quadrivalent is approved for use in persons 6 months of age and older. Flublok Quadrivalent is approved for use in persons 18 years of age and older. Fluzone High-Dose Quadrivalent is approved for use in persons 65 years of age and older.11,12,13

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 administered to anyone who has had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine (including egg protein for Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent). In addition, Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent should not be administered to anyone who has had a severe allergic reaction after previous dose of any influenza vaccine. 11,12,13</sup>

<sup>Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.11,12,13

If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent should be based on careful consideration of the potential benefits and risks. 11,12,13

If Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent are administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be lower than expected. 11,12,13

Vaccination with Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent may not protect all recipients.11,12,13

Syncope (fainting) has been reported following vaccination with Fluzone Quadrivalent. Procedures should be in place to avoid injury from fainting.11

For Fluzone Quadrivalent, in children 6 month through 35 months of age, the most common injection site reactions were pain or tenderness, erythema, and swelling; the most common solicited systemic adverse reactions were irritability, abnormal crying, malaise, drowsiness, appetite loss, myalgia, vomiting, and fever. In children 3 years through 8 years of age, the most common injection-site reactions were pain, erythema, and swelling; the most common solicited systemic adverse reactions were myalgia, malaise, and headache. In adults 18 years and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, headache, and malaise.11

For Flublok Quadrivalent, in adults 18 through 49 years of age, the most common injection-site reactions were tenderness and pain; the most common solicited systemic adverse reactions were headache, fatigue, myalgia, and arthralgia. In adults 50 years of age and older, the most common injection-site reactions were tenderness and pain; the most common solicited systemic adverse reactions were headache and fatigue.12

For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common injection-site reaction was pain; the most common solicited systemic adverse reactions were myalgia, headache, and malaise.13

For Fluzone Quadrivalent, Flublok Quadrivalent, and Fluzone High-Dose Quadrivalent, other adverse reactions may occur. 11,12,13

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

References</sup>

<sup>1. Jain U. Effect of COVID-19 on the Organs. Cureus. 2020;12(8):e9540. Published 2020 Aug 3. doi:10.7759/cureus.9540. Accessed September 2023.
2. Centers for Disease Control and Prevention. Key Facts About Seasonal Flu Vaccination. Available at: https://www.cdc.gov/flu/prevent/keyfacts.htm. Accessed September 2023.
3. Centers for Disease Control and Prevention. Key Facts About Influenza (Flu). Available at: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed September 2023.
4. Warren-Gash C, et al. 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. Accessed September 2023.
5. Centers for Disease Control and Prevention. Guidance for School Administrators to Help Reduce the Spread of Seasonal Influenza in K-12 Schools. Available at: https://www.cdc.gov/flu/school/guidance.htm. Accessed September 2023.
6. Hariton E, Locascio JJ. Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG. 2018;125(13):1716. doi:10.1111/1471-0528.15199. Accessed September 2023.
7. Eichler, H.-G., Pignatti, F., Schwarzer-Daum, B., Hidalgo-Simon, A., Eichler, I., Arlett, P., Humphreys, A., Vamvakas, S., Brun, N. and Rasi, G. (2021), Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth. Clin. Pharmacol. Ther., 109: 1212-1218. https://doi.org/10.1002/cpt.2083. Accessed September 2023.
8. Lee JKH, Lam GKL, Shin T, et al. 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. Accessed September 2023.
9. Sanofi. Sanofi launches dedicated vaccines mRNA Center of Excellence. Sanofi. June 29, 2021. Accessed September 8, 2023. https://www.sanofi.com/en/media-room/press-releases/2021/2021-06-29-08-00-40-2254458. Accessed September 2023.
10. Vaccines Investor Event. Sanofi. June 29, 2023. Available at: https://www.sanofi.com/en/investors/financial-results-and-events/investor-presentations/vaccines-investor-event. Accessed September 2023.
11. Fluzone Quadrivalent [Prescribing Information]. Accessed September 2023.
12. Flublok Quadrivalent [Prescribing Information]. Accessed September 2023.
13. Fluzone High-Dose Quadrivalent [Prescribing Information]. Accessed September 2023.</sup>

Sponsored by