Press Release: Two combination vaccine candidates for prevention of
influenza and COVID-19 granted Fast Track designation in the US
Two combination vaccine candidates for prevention of
influenza and COVID-19 granted Fast Track designation in the
US
- First non-mRNA combination vaccine candidates that include two
already licensed vaccines to prevent influenza and COVID-19
infections
- Two phase 1/2 clinical studies are
ongoing to evaluate the safety profile and immune response induced
by the combination vaccine candidates
Paris, December 11, 2024. The US Food and Drug
Administration has granted Fast Track designation to two Sanofi
combination vaccine candidates to prevent influenza and COVID-19
infections in individuals 50 years of age and older. Both
candidates combine two already licensed and authorized vaccines
with proven efficacy through randomized controlled studies, and
with favorable tolerability.
The first combination vaccine candidate (NCT06695117) consists
of the influenza protein-based trivalent vaccine Fluzone High-Dose
combined with the adjuvanted recombinant Novavax COVID-19 vaccine.
The second candidate (NCT06695130) combines the influenza
recombinant protein-based trivalent vaccine Flublok with the
Novavax COVID-19 vaccine.
Both Fluzone High-Dose and Flublok have been proven to prevent
more influenza infections in older adults than standard-dose
influenza vaccines in pivotal randomized clinical studies.
Additionally, in real-world evidence studies they have demonstrated
significant and consistent reductions in flu-related
hospitalizations. The Novavax COVID-19 vaccine has been shown to
have a better tolerability profile than currently available mRNA
COVID-19 vaccines when administered as a booster dose. It has also
demonstrated high efficacy against COVID-19 as primary vaccination
in two pivotal phase 3 studies.
Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“Building on our immunology expertise and on 12 years of robust
clinical and real-world data, we aim to continue leading the way in
protection against flu and its severe outcomes. Our goal is to
develop a combined flu and COVID-19 vaccine that offers simpler
scheduling and fewer injections without compromising on the
industry leading levels of efficacy, safety and tolerability of the
standalone vaccines included in our combination
vaccine.”
Fast Track designation was granted based on the potential for
the combination vaccine candidates to address the significant
individual and healthcare system burden of two serious illnesses
that can result in hospitalization and death, particularly among
older adults.
Sanofi has initiated two separate phase 1/2 parallel,
randomized, modified double-blind, multi-arm studies (NCT06695117
and NCT06695130) to evaluate the safety and immune response induced
by the two combination vaccine candidates.
About NCT06695117 and NCT06695130
The two combination vaccine candidates consist of:
- NCT06695117: TIV-HD (FLUZONE
High-Dose) combined with NVXC19 (Novavax COVID-19 vaccine) to
prevent Influenza subtype A, influenza subtype B and coronavirus
(SARS CoV-2) infections in individuals 50 years of age or
older.
- NCT06695130: RIV3 (FLUBLOK) combined
with NVXC19 (Novavax COVID-19 vaccine) to prevent Influenza subtype
A, influenza subtype B and coronavirus (SARS CoV-2) infection in
individuals 50 years of age or older.
One recent systematic review and meta-analysis suggests a
combination booster vaccine could increase the uptake of COVID-19
vaccines among the 50 years and above age group by 56%.
Combination vaccines may also be attractive to healthcare
professionals conducting immunization programs as they may be
easier and quicker to administer with fewer injections to protect
against multiple diseases, less errors and decreased syringe and
vial disposal requirements.
Influenza (flu) is a contagious, acute viral respiratory
disease. Every year, there are an estimated 290,000 to 650,000
influenza-related respiratory deaths globally. In developed
countries most deaths associated with flu occur in people aged 65
years or older.
Adults aged 65 or older account for most hospitalizations from
flu. Among this population there is a higher hospitalization rate
for flu with 2-fold longer average length of hospital stay than
with younger adults. One quarter of patients are readmitted to
hospital within 90-days post-discharge.
Flu can wreak havoc across major organ systems. It can lead to
an 8-fold increased risk of stroke and pneumonia, a 10-fold
increased risk of heart attack and among older adults hospitalized
for flu, 1 in 5 experience a decline in their ability to
independently undertake simple daily tasks, such as bathing, and
dressing themselves.
Coronavirus disease (COVID-19) is an infectious disease caused
by the SARS-CoV-2 virus. Most people infected with the virus will
experience mild to moderate respiratory illness and recover without
requiring special treatment. However, some will become seriously
ill resulting in hospitalization and death.
Many individuals continue to experience long-term sequelae
following COVID-19, also referred to as “long COVID”. Long COVID
symptoms can vary from mild to severe, potentially necessitating
extensive medical attention, and may even lead to disability. A
meta-analysis of 12 studies shows that 30% of COVID-19 patients
have persistent symptoms two years after infection, the most common
of which are fatigue, cognitive problems, and pain.
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
Media Relations
Sandrine Guendoul | + 33 6 25 09 14 25 |
sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 |
evan.berland@sanofi.com
Nicolas Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.com
Léo Le Bourhis | + 33 6 75 06 43 81 |
leo.lebourhis@sanofi.com
Victor Rouault | + 33 6 70 93 71 40 |
victor.rouault@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 |
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Felix Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.com
Keita Browne | + 1 781 249 1766 |
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Nathalie Pham | + 33 7 85 93 30 17 |
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Tarik Elgoutni | + 1 617 710 3587 |
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Thibaud Châtelet | + 33 6 80 80 89 90 |
thibaud.chatelet@sanofi.com
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