Beyfortus real-world evidence published in The Lancet shows 82%
reduction in infant RSV hospitalizations
- New real-world evidence shows
Beyfortus (nirsevimab) substantially reduced RSV lower respiratory
tract disease and hospitalizations in infants during the 2023-2024
RSV season, versus no intervention1-6
- Results add to the consistent high
efficacy of Beyfortus against medically attended RSV lower
respiratory tract disease, shown in the pivotal clinical studies
and the outcomes from HARMONIE, a phase 3b clinical study conducted
in close to real-life conditions7-10
Paris, May 2, 2024. Beyfortus reduced
respiratory syncytial virus (RSV) hospitalizations by 82% (95% CI:
65.6 to 90.2) in infants under 6 months of age, compared to infants
who received no RSV intervention, according to the interim results
of an ongoing study published in The Lancet. These results, from
the first RSV season after Beyfortus’ introduction, are part of the
three-year NIRSE-GAL study conducted in Galicia, Spain under a
collaborative framework with the Galician Directorate of Public
Health of the Xunta de Galicia (Galician government) and
Sanofi.1
The results echo real-world evidence (RWE) reported from several
broad infant immunization programs across the US, Spain and France
during the 2023-2024 RSV season, which add to the consistent and
high efficacy seen in pivotal clinical studies with Beyfortus.
Real-world evidence demonstrates if a treatment or immunization is
effective in day-to-day practice, as opposed to “efficacy”
determined in carefully controlled clinical trials. A favorable
safety profile was observed following Beyfortus use, consistent
with clinical study results.1-10
Federico Martinon TorresHead of
Pediatrics, Hospital Clínico Universitario Santiago, Spain and
principal investigator of NIRSE-GAL study“Galicia provides the
first population-based real-world evidence of the impact of
nirsevimab to prevent RSV disease in infants, showing a reduction
by almost 90% in the number of hospitalizations due to this virus
when compared with several previous RSV seasons. This achievement
is the result of the exemplary pragmatic collaboration among
scientists, industry, healthcare providers and policy makers
aligned with a carefully planned roll-out of the immunization
campaign, and the outstanding response of the Galician parents to
this prophylaxis campaign.”
Thomas TriompheExecutive Vice
President, Vaccines, Sanofi“The scale and speed of impact seen
after Beyfortus’ introduction demonstrates the strength of
all-infant immunization strategies against RSV in babies. In
Galicia, we saw an effectiveness of 82% in reducing RSV
hospitalizations following the launch of Beyfortus, with more than
90% of eligible infants immunized. A growing body of evidence from
these programs support policymakers, healthcare providers and
parents who share our collective ambition to safeguard babies from
RSV disease.”
NIRSE-GAL is a large, population-based, three-year follow-up
study to evaluate the effectiveness of Beyfortus following its
inclusion in the Galician immunization schedule. The study aims to
measure the impact of Beyfortus on hospitalizations due to RSV,
all-cause lower respiratory tract disease, severe lower respiratory
tract disease caused by RSV, all-cause lower respiratory tract
disease hospitalizations, and all-cause hospitalizations among
infants born during the RSV season, infants under 6 months of age
at the start of the season, and children aged 6-24 months who are
vulnerable to severe RSV disease at the start of the season. The
2023-2024 immunization campaign ran from September 25, 2023 to
March 31, 2024.1
RWE from countries with Beyfortus all-infant immunization
programs in 2023-24
In addition to this new effectiveness study, evidence of the
high impact following Beyfortus’ introduction has been consistently
shown in several other real-world studies.
- An interim analysis of 2023-24 surveillance data published in
the US Centers for Disease Control and Prevention’s (CDC) Morbidity
and Mortality Weekly Report (MMWR) shows a single dose of Beyfortus
was 90% effective in preventing hospitalizations due to RSV in
babies who were immunized below 8 months of age.2
- A recent draft recommendation from Haute Autorité de Santé in
France reported, across six hospitals, an effectiveness of 83%
against RSV-associated hospitalization in infants who received
Beyfortus compared to those with no intervention.3
- In Catalonia, Spain, a study pre-printed in The Lancet showed
reductions of 87.6% and 90.1% in hospital and ICU admissions for
RSV, respectively, among babies born before the start of the RSV
season, who were eligible to receive Beyfortus, compared to those
with no intervention.4
- A pooled analysis of data from three Spanish regions, including
Valencia, Murcia, and Valladolid, showed an 84.4% effectiveness in
preventing hospitalizations due to RSV in infants under 9 months of
age versus infants who received no intervention. The results were
published in Eurosurveillance.5
- A study from Navarra, Spain published in Vaccines found an
effectiveness of 88.7% in preventing hospitalizations among infants
immunized at birth with Beyfortus, compared to no
intervention.6
The expansion of the Beyfortus manufacturing network is
progressing well and according to plan. This expansion will
allow Sanofi and AstraZeneca to more than triple manufacturing
capacity. Based on this, and assuming regulatory validations are
delivered in due time by regulatory agencies, Sanofi and
AstraZeneca are confident to meet global commitments and build
inventory that can be used in future RSV seasons. In addition, the
companies are producing Beyfortus well in advance of the RSV
season, with the vast majority of doses planned to be available by
October.
About RSVRSV is a highly contagious virus that can lead to
serious respiratory illness for infants.11 Two out of three infants
are infected with RSV during their first year of life and almost
all children are infected by their second birthday.11,12 RSV
is the most common cause of lower respiratory tract disease,
including bronchiolitis and pneumonia, in infants.13 It is also a
leading cause of hospitalization in infants worldwide, with most
hospitalizations for RSV occurring in healthy infants born at
term.14-17 Globally, in 2019, there were approximately 33 million
cases of acute lower respiratory infections leading to more than 3
million hospitalizations, and it was estimated that there were
26,300 in-hospital deaths of children younger than 5 years.18
RSV-related direct medical costs, globally — including hospital,
outpatient and follow-up care — were estimated at €4.82 billion in
2017.19
About BeyfortusBeyfortus (nirsevimab) is the first immunization
designed for all infants for protection against RSV through their
first RSV season, including for those born healthy at term or
preterm, or with specific health conditions that make them
vulnerable to RSV disease. Beyfortus is also designed to protect
children up to 24 months of age who remain vulnerable to severe RSV
disease through their second RSV season.
As a long-acting antibody provided directly to newborns and
infants as a single dose, Beyfortus offers rapid protection to help
prevent lower respiratory tract disease caused by RSV without
requiring activation of the immune system. Beyfortus administration
can be timed to coincide with the RSV season.
In March 2017, Sanofi and AstraZeneca announced an
agreement to develop and commercialize Beyfortus. Under the
terms of the agreement, AstraZeneca leads development and
manufacturing activities and Sanofi leads commercialization
activities and records revenues. Under the terms of the global
agreement, Sanofi made an upfront payment of €120m, has paid
development and regulatory milestones of €120m and will pay up to a
further €375m upon achievement of certain regulatory and
sales-related milestones. The two companies share costs and profits
in all territories except in the US where Sanofi consolidates 100%
of the economic benefits in its Business Operating Income.
Beyfortus has been approved for use in the European Union, the
US, China, Japan, and many other countries around the world.
Special designations to facilitate expedited development of
Beyfortus were granted by several regulatory agencies, including
Breakthrough Therapy Designation and Priority Review designation by
The China Center for Drug Evaluation under the National Medical
Products Administration; Breakthrough
Therapy Designation and Fast Track Designation from the
US Food and Drug Administration; access granted to the European
Medicines Agency (EMA) PRIority MEdicines (PRIME)
scheme and EMA accelerated assessment; Promising Innovative
Medicine designation by the UK Medicines and Healthcare products
Regulatory Agency; and Beyfortus has been named “a medicine for
prioritized development” under the Project for Drug Selection to
Promote New Drug Development in Pediatrics by the Japan Agency for
Medical Research and Development.
About SanofiWe 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 RelationsSandrine Guendoul | + 33 6 25 09
14 25 | sandrine.guendoul@sanofi.comSally Bain | +
1 617 834 6026 | sally.bain@sanofi.comEvan Berland
| + 1 215 432 0234 |
evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21 27 55
| nicolas.obrist@sanofi.com
Investor RelationsThomas Kudsk Larsen |+ 44
7545 513 693 | thomas.larsen@sanofi.comAlizé
Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comTarik Elgoutni| + 1 617
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Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
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References:
- Ares-Gómez S, et al. Effectiveness and
impact of universal prophylaxis with nirsevimab in infants against
hospitalisation for respiratory syncytial virus in Galicia, Spain:
initial results of a population-based longitudinal study. Lancet.
2024. DOI: https://doi.org/10.1016/S1473-3099(24)00215-9.
- U.S. Centers for Disease Control and
Prevention. Early Estimate of Nirsevimab Effectiveness for
Prevention of Respiratory Syncytial Virus–Associated
Hospitalization Among Infants Entering Their First Respiratory
Syncytial Virus Season — New Vaccine Surveillance Network, October
2023–February 2024. Morbidity and Mortality Weekly Report (MMWR).
2024; 73(9);209–214.
- Haute Autorité de santé.
Recommandation vaccinale contre les infections à VRS chez les
femmes enceintes.
https://www.has-sante.fr/upload/docs/application/pdf/2024-03/recommandation_vaccinale_contre_les_infections_a_vrs_chez_les_femmes_enceintes_-_version_provisoire.pdf.
April 25, 2024.
- Coma E, et al. Effectiveness of
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Virus-Related Outcomes in Hospital and Primary Care Settings: A
Retrospective Cohort Study in Infants in Catalonia (Spain).
Preprints with The Lancet. March 7, 2024.
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4749763.
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