US FLUBLOK label1 updated to incorporate new safety study in pregnant individuals
New safety data involving more than 48,000 pregnant individuals published in American Journal of Obstetrics and Gynecology (AJOG) Global Reports
Recombinant or inactivated flu vaccines are recommended by the U.S. Centers for Disease Control and Protection (CDC), Advisory Committee on Immunization Practices (ACIP) and American College of Obstetricians and Gynecologists (ACOG) for individuals who are or will become pregnant during flu season2,3,4
Sanofi is committed to the ongoing rigorous scientific study of flu vaccines in at-risk populations, including older patients, patients with comorbidities and pregnant individuals
BRIDGEWATER, N.J., Oct. 16, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has updated the label for FLUBLOK (Influenza Vaccine) to include data from a new safety study involving pregnant individuals 18 years and older, in time to inform those hoping to comply with U.S. Centers for Disease Control and Prevention (CDC) recommendations to receive their annual flu vaccine ideally before the end of October.4,5 The results from the study of more than 48,000 pregnant individuals across multiple flu seasons were recently published in American Journal of Obstetricians and Gynecologists (AJOG) Global Reports and demonstrate FLUBLOK safety is consistent with a standard-dose flu vaccine and pregnancy-related outcomes in the general population.1,5
Thomas Grenier
Head of Vaccines, North America, Sanofi
"Today, we're proud to announce an important update to our label for FLUBLOK, from one of Sanofi's largest flu vaccine safety studies ever done in pregnant individuals, an important at-risk population group for influenza. Here at Sanofi, we strive to bring immunizations to populations at various stages of life. This update is an example of our ambition to continue expanding the body of real-world evidence for our flu vaccines portfolio, grounded in robust efficacy data. We do this so that patients and healthcare providers can have the confidence to use our vaccines as an important preventative tool ahead of the influenza season."
This study was a post-licensure, observational, retrospective safety surveillance study of 48,781 pregnant individuals, including those with chronic conditions.1 In the study, patients were immunized with either FLUBLOK Quadrivalent (30.7%; n=14,981) or with a comparator standard-dose quadrivalent inactivated influenza vaccine (67.3%; n=33,800) during the Northern Hemisphere influenza seasons 2018-2019 and 2019-2020.1 Immunization occurred within 28 days prior to pregnancy or during pregnancy.1 The efficacy of FLUBLOK (quadrivalent) is relevant to FLUBLOK (trivalent) because both vaccines are manufactured using the same process and have overlapping compositions.5
Results showed:
FLUBLOK demonstrated no increased risk of pregnancy, birth or neonatal/infant outcomes when compared to a standard-dose flu vaccine and estimated pregnancy outcomes for the general population.1
The most frequently reported pregnancy outcomes in the FLUBLOK Quadrivalent and SD-IIV4 groups respectively were eclampsia/preeclampsia (8.4% in both cohorts), preterm labor (3.6% and 3.5%), spontaneous abortion (3.1% and 3.0%), congenital/fetal anomalies detected during pregnancy (2.4% in both cohorts), placental abruption (0.8% and 0.7%) and stillbirth/fetal death (0.4% and 0.5%).1
The most frequently reported birth and neonatal/infant outcomes in the FLUBLOK Quadrivalent and SD-IIV4 groups were small for gestational age (SGA) (8.8% and 8.7%), major congenital anomalies (7.7% in both cohorts), preterm birth (7.3% and 7.5%), low birth weight (LBW) (5.9% and 5.8%) and failure to thrive (1.0% and 1.1%), respectively.1
Per the CDC, pregnant and postpartum (up to two weeks after the end of pregnancy) individuals are at higher risk for severe illness and complications from flu, particularly during the second and third trimesters.4 The American College of Obstetricians and Gynecologists (ACOG) recommends full vaccination during pregnancy, as this is when the risk of severe illness is highest.3,4 The CDC, Advisory Committee on Immunization Practices (ACIP) and ACOG recommend that individuals who are or will become pregnant during flu season receive an inactivated or recombinant vaccine as soon as it is available, as pregnant persons with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery.2,3,4
With over 125 years of heritage in helping protect global public health, Sanofi is one of the world leaders in vaccines, helping to vaccinate more than 500 million people annually. As one of the largest providers of influenza vaccines to the United States with a wide range of options, Sanofi meets immunization needs across the lifespan, from children as young as six months of age through adults 65 years of age and older.
Indication and Important Safety Information for FLUBLOK (Influenza Vaccine)
What is FLUBLOK (Influenza Vaccine)?
FLUBLOK is a vaccine indicated for immunization for the prevention of disease caused by influenza A and B strains represented by antigens contained in the vaccine. FLUBLOK is given to people 18 years of age and older.
IMPORTANT SAFETY INFORMATION FOR FLUBLOK® (INFLUENZA VACCINE)
FLUBLOK 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 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 may not protect all people who receive the vaccine.
Fainting has occurred following vaccination with FLUBLOK. Procedures should be in place to avoid injury from fainting.
In adults 18 through 64 years of age, the most common side effects were pain where you got the shot, headache, tiredness, and muscle pain. In adults 65 years of age and older, the most common side effects were pain where you got the shot, tiredness and headache. Other side effects may occur.
For more information, talk to your health care professional and refer to the full Prescribing Information for Flublok.
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 the world, 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.
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Sanofi Forward-Looking Statements
This media update 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 pandemics or other global crises may 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, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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1 HSIAO, A., YEE, A., IZIKSON, R., FIREMAN, B., HANSEN, J., LEWIS, N., … KLEIN, N. P. (2024). Safety of quadrivalent recombinant influenza vaccine in pregnant persons and their infants. AJOG Global Reports, 100395. .
2 Centers for Disease Control and Prevention. Flu Vaccine Safety and Pregnancy. Available at: . Accessed October 2024.
3 The American College of Obstetricians and Gynecologists. Influenza in Pregnancy: Prevention and Treatment. Available at: . Accessed October 2024.
4 Centers for Disease Control and Prevention. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices – United States, 2024-25 Influenza Season. Available at: . Accessed October 2024.
5 Flublok [Prescribing Information]. Swiftwater, PA: Sanofi.
SOURCE Sanofi
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