- The National Advisory Committee on Immunization (NACI) strongly
recommends working towards a universal Respiratory Syncytial Virus
(RSV) immunization program using BEYFORTUS®
(nirsevimab).i
- BEYFORTUS® is the first long-acting antibody
approved in Canada for the
prevention of RSV lower respiratory tract disease in neonates and
infants through their first RSV season.ii
- BEYFORTUS® is also approved for children up to 24
months of age who remain vulnerable to severe RSV disease through
their second RSV season.iii
TORONTO, May 21, 2024
/CNW/ - The National Advisory Committee on Immunization issued a
recommendation for BEYFORTUS® (nirsevimab) to be
used for the prevention of RSV. The committee has presented two
strong recommendations for the delivery of
BEYFORTUS® to all Canadian infants that could be
implemented through established systems and programs.
NACI recommends a universal RSV immunization program using
BEYFORTUS® for all infant protection due to the
significant burden of disease in infants from RSV and impacts of
RSV on the healthcare system, parents and caregivers. This
preferential recommendation for BEYFORTUS® is due to its
protective efficacy, potential duration of effect and
once-per-season dosing compared to other treatment
options.iv
NACI also recommends RSV immunization programs using
BEYFORTUS® to prevent severe RSV disease. In this
approach, NACI has two priority groups. The first group includes
infants born before or during their first RSV season, or entering
their second RSV season who are at increased risk of severe
disease, or whose access to treatment may be complex. The second
priority group includes all infants under 8 months of age entering
their first RSV season.v
Delphine
Lansac
General Manager, Vaccines Canada,
Sanofi
"I am pleased that NACI recognizes the benefits of
BEYFORTUS® to protect all infants from RSV.
This dangerous illness affects the most vulnerable among us with
devastating impacts each year and parents and physicians have long
been seeking this preventative option. No baby should be left at
risk and no parent should have to realize the fear of their baby
experiencing a severe RSV infection."
Dr. Christine
Palmay
MD, CCFP, FCP
"NACI's most recent statement regarding prevention of
RSV in infants marks a pivotal step towards enhancing the best form
of medicine: prevention. As a society, we have a duty to
protect those most at risk. Arguably, infants and children are at
the top of this list. As a health care provider, I have seen
firsthand the devastating effects of RSV, including hospitalization
requiring severe interventions, long term health complications and
most tragically, death. In the community, RSV infections have
plagued countless families who endlessly need to seek medical
attention and feel the strain associated with constantly caregiving
for their sick children. The option to have a preventative
immunization is a game changer and offers a tool to protect our
precious babies and children from RSV. As we rebuild a medical
system post pandemic, proactive care in the form of prevention is
the only way to move forward."
BEYFORTUS® received Notice of Compliance from Health
Canada in April 2023. Additionally,
it was approved by the FDA in the United
States in July 2023, the
European Union in October 2022 and in
Great Britain in November 2022. Regulatory applications are also
currently under review in several other countries.
Sanofi is working with provincial authorities to make
BEYFORTUS® available to a broad cohort of infants for
the 2024-25 RSV season.
About RSV
RSV, a highly contagious virus, can lead to respiratory illness
in babies, including lung infections such as bronchiolitis and
pneumonia.vi Approximately 2 out of 3 infants are
infected by RSV by their first birthday and almost all infants are
infected by the age of 2.vii Infants under 1 year are on
average almost 16 times more likely to be hospitalized for RSV than
for influenza.viii The majority of RSV hospitalizations
occur in infants without risk factors. A recent study showed among
infants hospitalized for RSV, 80% were previously healthy and born
at term.ix As highlighted by NACI, each year, between
10% and 20% of RSV cases among healthy infants require medical care
including physician office, urgent care, emergency room visits and
hospitalizations.x Currently, only a small fraction
of infants born in Canada have
access to RSV protection.
About
BEYFORTUS®
BEYFORTUS® is a single-dose, long-acting antibody designed
to help prevent RSV lower respiratory tract disease (LRTD) for
infants during their first RSV season.
BEYFORTUS® is also indicated for children up to 24 months of age
who remain vulnerable to severe RSV disease through their second
RSV season. BEYFORTUS® offers timely protection against RSV lower
respiratory tract disease lasting at least 5 months, to coincide
with the RSV season.
BEYFORTUS® is
administered directly to neonates and infants as a
single dose and offers rapid protection via an
antibody to help prevent LRTD caused by RSV, without requiring
activation of the immune system. BEYFORTUS®
administration can be timed to the start of 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 €25m in
sales-related milestones. Sanofi will pay up to a further
€350m upon achievement of additional regulatory and
sales-related milestones. The two companies share costs and profits
in all territories except in the U.S. where
Sanofi consolidates 100% of the economic benefits in its
Business Operating Income.
About Sanofi
Sanofi is 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.
In Canada, we employ over 2,000 people. We invest 20% of our
revenue annually in biopharma research (representing $1.2 billion CAD in R&D investment over the
last decade) creating jobs, business, and opportunities throughout
the country. We are also on track to deliver over $2 billion CAD in new infrastructure investments
by 2028, including two new vaccine manufacturing facilities at our
Toronto Campus.
In 2024, we are celebrating 110 years of heritage dedicated to
developing innovative health solutions for Canadians. What started
as a small laboratory in May of 1914, recognized for having
advanced some of the greatest contributions to public health, both
nationally and globally, has evolved to become the largest
biomanufacturing facility in Canada.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
_____________________________
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i An
Advisory Statement, National Advisory Committee on Immunization
(NACI), Statement on the prevention of
Respiratory Syncytial Virus (RSV) disease in infants, 17
May, 2024. naci-statement-2024-05-17.pdf
(canada.ca)
|
ii
BEYFORTUS™ Product Monograph. Sanofi Pasteur
Limited. March 14, 2024.
|
iii BEYFORTUS™ Product
Monograph. Sanofi Pasteur Limited. March 14,
2024.
|
iv An
Advisory Statement, National Advisory Committee on Immunization
(NACI), Statement on the prevention of
Respiratory Syncytial Virus (RSV) disease in infants, 17
May, 2024. naci-statement-2024-05-17.pdf
(canada.ca)
|
v An
Advisory Statement, National Advisory Committee on Immunization
(NACI), Statement on the prevention of
Respiratory Syncytial Virus (RSV) disease in infants, 17
May, 2024. naci-statement-2024-05-17.pdf
(canada.ca)
|
vi Public Health Agency of Canada.
Accessed 21 February
2024. Respiratory syncytial virus (RSV): Canadian
Immunization Guide - Canada.ca
|
vii
Simoes EAF. Lancet 1999;
354:847-852
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viii
Demont C et al. BMC Infect Dis 2021;
21(1) :
730, Sanchez-Luna M et al. Curr Med Res Opin 2016;
32(4) : 693-698, Kobayashi Y et.
Al. J Infect Dis 2022;
226 :386-395, Yu J et al. Emerg Infect
Dis 2019; 25(6) :
1127-1135, Thwaites R et al. Eur J Pediatr 2020;
179(5):
791-799, Arriola C et al. J Pediatric
Infect Dis Soc 2020; 8(12): 2048.
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ix
Pisesky et al. PloS one 11.3 (2016):
e0150416
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x Abrams
EM, Doyon-Plourde P, Davis P, Brousseau N,
Irwin A, Siu W, et al. Burden of disease of
respiratory syncytial virus in infants, young children
and pregnant women and people. Canada Communicable Disease Report.
2024 Feb;50(1/2):1-15.
https://doi.org/10.14745/ccdr.v50i12a01.
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For more information and media inquiries, please contact:
Alana Vineberg, +1
416-529-1654, alana.vineberg@sanofi.com
SOURCE Sanofi Canada