Recombinant Influenza vaccine quadrivalent(Protein Sciences Corp.)

This recommendation may help reduce the risk of the flu and flu-related complications in this high-risk population Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and Flublok® Quadrivalent (Influenza Vaccine) are both proven to help prevent more cases of flu in older adults compared to a standard-dose vaccine as assessed in randomized controlled trials1,2 In real-world evidence, they also demonstrated a reduction in flu-related complications.3,4 BRIDGEWATER, N.J., Aug. 26, 2022 /PRNewswire/ -- The Centers for Disease Control and Prevention (CDC) has published the updated Advisory Committee on Immunization Practices (ACIP) guidance granting preferential recommendation for specific flu vaccines in people age 65+ in its Morbidity and Mortality Weekly Report (MMWR), a journal highlighting the latest in public health news and communicating recommendations derived from science-based research.5 Sanofi's Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and Flublok® Quadrivalent (Influenza Vaccine) were among the flu vaccines preferentially recommended by the CDC ACIP for adults 65+. The recommendation included the use of specific flu vaccines for adults 65+ including higher dose vaccines. If none of these are available at the time of administration, people in this age group should get any other age-appropriate influenza vaccine instead.6 Influenza disproportionately impacts the 65+ population, underrepresented communities, and people with co-morbidities such as diabetes, asthma, chronic obstructive pulmonary disease, and heart disease.7 Since 2010, the CDC estimates 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.8 The ACIP flu vaccination guidance will ensure the high-risk population of adults 65+ are immunized with the vaccine best suited for their needs. Michael Greenberg, MD, MPH North America Medical Head of Vaccines at Sanofi "We remain committed to ensuring adults 65 and older have access to flu vaccines, demonstrated to protect them from what really matters, such as flu-related hospitalizations due to cardiovascular events and pneumonia. While the ACIP's guidance is a good first step, as a leader in flu vaccines, we believe more can be done to provide healthcare providers with additional guidance." About Fluzone® High-Dose Quadrivalent (Influenza Vaccine) and Flublok® Quadrivalent (Influenza Vaccine) Flublok Quadrivalent and Fluzone High-Dose Quadrivalent are indicated for immunization against disease caused by influenza A and B strains contained in the vaccine. 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.1,2 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 approximately 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+.9 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.10 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 Flublok Quadrivalent is the first and only recombinant influenza vaccine for adults 18+ proven in a clinical study to be 30% more effective than a standard dose vaccine (Fluarix Quadrivalent [Influenza 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, The effectiveness of Flublok Quadrivalent was also judged by data from general day-to-day medical practice amongst more than 12 million adults 65 years and older, vaccination with Flublok Quadrivalent was compared to standard dose vaccines: this analysis of data captured during day-to-day medical practice of Medicare fee-for-service claims collected from during the 2019-2020 influenza season. A 5-vaccine relative effectiveness analysis showed Flublok Quadrivalent had 13.3% fewer flu-related hospitalizations and emergency room visits versus an egg-based standard dose quadrivalent flu vaccine. The other influenza vaccines evaluated within the study (Fluad, Fluzone High-Dose and Flucelvax Quadrivalent), also showed fewer flu-related hospitalizations and emergency room visits (8.2%, 6.8% and 2.8%, respectively) versus an egg-based standard dose quadrivalent flu vaccine. These data are based on one of three primary analyses. Two additional primary analyses were also conducted: two vaccine analyses comparing cell-derived inactivated quadrivalent influenza vaccine with an egg-based quadrivalent inactivated influenza vaccine (IIV4) and a quadrivalent recombinant influenza vaccine (RIV4) with IIV4. Specific characteristics of 2019-2020 season, such as varied strain circulation, may have impacted results. Study limitations include lack of access to information to confirm specific viral cases may have reduced the impact of comparisons made in the study and distortion caused by unlimited variables could have affected results. In addition, the study period was cut off at the end of February 2020 to avoid potential bias from the overlap between influenza season and the escalation of the COVID-19 pandemic in the US. This study was conducted by the FDA and Centers for Medicare and Medicaid Services. 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 Flublok® Quadrivalent (Influenza Vaccine) and Fluzone® High-Dose Quadrivalent (Influenza Vaccine) 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 High-Dose Quadrivalent). In addition, 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 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 Flublok Quadrivalent and Fluzone High-Dose 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.  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 Flublok Quadrivalent and Fluzone High-Dose Quadrivalent, other side effects may occur.   Please see the Prescribing Information for Flublok Quadrivalent. Please see the Prescribing Information and Patient Information for 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 andNASDAQ: SNY Media Relations Evan Berland | + 1 215 432 0234 | [email protected] Sally Bain | + 1 781 264 1091 | [email protected] Kate Conway | + 1 617 981 2738 | [email protected] Investor Relations Eva Schaefer-Jansen | + 33 7 86 80 56 39 | [email protected] Felix Lauscher | + 1 908 612 7239 | [email protected] Priya Nanduri | +1 908 981 5560 | [email protected] Nathalie Pham | + 33 7 85 93 30 17 | [email protected] 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 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]. Meriden, CT: Protein Sciences Corporation 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. . 4Izurieta HS, Lu M, Kelman J, et al. Comparative Effectiveness of Influenza Vaccines Among US Medicare Beneficiaries Ages 65 Years and Older During the 2019-2020 Season. Clin Infect Dis. 2021;73(11):e4251-e4259. 5Centers for Disease Control and Prevention. Morbidity and Mortality Weekly Report, DATE. Available at . Accessed August 2022. 6Centers for Disease Control and Prevention. ACIP Flu Meeting Update: Flu Vaccines Worked Better than Reported & ACIP Recommends Specific Vaccines for Seniors. Available at . Accessed June 2022. 7Centers for Disease Control and Prevention. People at Higher Risk for Flu Complications. Available at: . Accessed June 2022. 8Centers for Disease Control and Prevention. Flu & People 65 Years and Older. Available at: . Accessed June 2022. 9DiazGranados CA, et al. N Engl J Med. 2014;371(7):635-645 10Falsey 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 SOURCE Sanofi

The site location is in Swiftwater, Pennsylvania. The U.S. Department of Health and Human Services (HHS) awarded Sanofi Pasteur $226 million to increase its domestic pandemic flu vaccine capabilities. The site location is in Swiftwater, Pennsylvania. The contract is supported by monies from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response at HHS. It will support clinical development and manufacture of an adjuvanted recombinant pandemic vaccine with the goal of improving U.S. and global preparedness for a flu pandemic. An adjuvant is an ingredient used in vaccines to cause a stronger immune response. The investigational vaccine will leverage the same recombinant technology Sanofi used for its Flublok Quadrivalent flu vaccine. It will also expand the site’s operations as a center of excellence for pandemic preparedness. It will do so by adding recombinant and adjuvant manufacturing to its current egg-based manufacturing. Most flu vaccines are grown in eggs. However, Sanofi’s Flublok Quadrivalent is engineered from recombinant DNA grown in cells. “We are pleased to be taking this critical next step in our longstanding relationship with BARDA, which will enable us to significantly enhance flu vaccine supply under pandemic influenza scenarios,” said David Loew, executive vice president, Vaccines at Sanofi. “We are deeply committed to advancing influenza vaccine technology and manufacturing, and our public and private partnerships are an important part of these ongoing efforts to help protect people from influenza.” hbspt.cta.load(4413123, '4e87abe9-779b-4c65-98dd-ea451779faa9', {}); The contract has options for Sanofi to retrofit a second facility to manufacture adjuvant, develop an adjuvanted, pandemic flu vaccine, and grant HHS access to production for up to 25 years. As a part of the deal, HHS stated, “Sanofi Pasteur could provide nearly 100 million doses of recombinant influenza vaccine for use during a pandemic.” Sanofi Pasteur has been working for years on building up its recombinant, cell-based vaccine manufacturing. In 2017, it acquired Protein Sciences for $750 million. The contract is a response to a September 2019 executive order by President Trump, which described the U.S. vaccine sector’s utilization of egg-based vaccine manufacturing as a “critical shortcoming,” noting, “Most influenza vaccines are made in chicken eggs, using a 70-year-old process that requires months-long production timelines, limiting their utility for pandemic control.” The executive order also directed HHS and the U.S. Food and Drug Administration (FDA) to encourage research in this area, to support “applied scientific research regarding developing cell lines and expression systems that markedly increase the yield of cell-based and recombinant influenza vaccine manufacturing processes.” Rick Bright, director of BARDA, stated, “The question is not if, but when the next influenza pandemic will occur, carrying potentially devastating consequences for public health and the U.S. economy. As the recent presidential executive order on pandemic preparedness emphasized, technology to produce effective vaccines quickly and safely in the United States can improve access, protect more people sooner and, ultimately, strengthen national and global health security.” In September 2019, shortly after the executive order, Novavax noted it was working hard to get into this area as well. At the time, its nanoparticle seasonal flu vaccine, NanoFlu, was entering a Phase III trial in November, with topline data expected in the first quarter of 2020. The recombinant protein nanoparticle is adjuvanted with Novavax’s Matrix-M adjuvant. John Trizzino, the company’s chief financial officer, said at the time, “This provides for greater and broader immune responses and is addressing the concerns related to the vaccines in the marketplace today.”