- 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 and NASDAQ: SNY.
Contacts
Sandrine Guendoul | + 33 6
25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215
432 0234 | evan.berland@sanofi.com
Timothy Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Investor Relations
Thomas Kudsk Larsen |
+44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11
| alize.kaisserian@sanofi.com
Arnaud Delépine | + 33 6 73 69 36 93
| arnaud.delepine@sanofi.com
Felix Lauscher | + 1 908 612 7239
| felix.lauscher@sanofi.com
Keita Browne | + 1 781
249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17
| nathalie.pham@sanofi.com
Tarik Elgoutni| + 1 617 710 3587
| tarik.elgoutni@sanofi.com
Thibaud Châtelet | + 33 6 80 80 89 90 |
thibaud.chatelet@sanofi.com
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.
All trademarks mentioned in this press release are the property
of the Sanofi group.
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.
https://doi.org/10.1016/j.xagr.2024.100395.
2 Centers for Disease Control and Prevention. Flu
Vaccine Safety and Pregnancy. Available at:
https://www.cdc.gov/flu/vaccine-safety/vaccine-pregnant.html.
Accessed October 2024.
3 The American College of Obstetricians and
Gynecologists. Influenza in Pregnancy: Prevention and Treatment.
Available at:
https://www.acog.org/clinical/clinical-guidance/committee-statement/articles/2024/02/influenza-in-pregnancy-prevention-and-treatment#.
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: https://www.cdc.gov/mmwr/volumes/73/rr/rr7305a1.htm.
Accessed October 2024.
5 Flublok [Prescribing Information]. Swiftwater, PA: Sanofi.
View original
content:https://www.prnewswire.com/news-releases/flublok-influenza-vaccine-us-label-updated-with-one-of-sanofis-largest-flu-vaccine-safety-studies-in-pregnant-individuals-302278204.html
SOURCE Sanofi
