TORONTO, July 25,
2024 /CNW/ - The Ontario Ministry of Health has
announced a universal public program with Beyfortus®
(nirsevimab) for all newborns and infants born in 2024 and
through the 2024-2025 RSV season. This also includes some high-risk
children up to 24 months old. This is the first publicly funded
broad infant program in Ontario
offering protection to all newborns and infants entering their
first RSV season. RSV is one of the most common respiratory viruses
in babies that can lead to lung infections such as bronchiolitis
and pneumonia.i
In May, the National Advisory Committee on Immunization (NACI)
recommended working towards a universal RSV immunization program
with Beyfortus® to prevent severe RSV disease in
infants, due to the significant burden of disease in all infants
from RSV and the impacts of RSV on the Canadian health
system.ii According to NACI, RSV infects "almost all
children by the age of 2 years old."iii Offering broad
infant protection is needed as most 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.iv
Delphine
Lansac
General Manager, Vaccines, Sanofi
Canada
"Today's announcement by the Government of Ontario is a significant milestone. Providing
universal access to Beyfortus® to help
protect all infants in Ontario means that parents can focus on the
joys of a new baby and worry less about experiencing a severe RSV
infection. This new program builds on our 110-year heritage as a
committed partner supporting public health in Canada. Our objective continues to be
protecting the health of Canadians with innovative solutions and
introducing Beyfortus® is a step forward to
protect babies and make a positive difference for families and the
healthcare system.
The Honourable Sylvia Jones
Ontario Deputy Premier and Minister of
Health
"Our government is taking steps to ensure Ontarians of all
ages have the tools they need to be prepared and keep their loved
ones safe and healthy ahead of respiratory virus season. Our
government is working with our partners to significantly expand
Ontario's RSV program, to make it
easier for families to connect to the care they need, improving
health outcomes and reducing the number of hospitalizations and ICU
admissions resulting from RSV."
Dr. Eddy
Lau
Pediatrician, St.
Joseph's Health Centre, Unity Health,
Assistant Professor of Pediatrics, University
of Toronto
"RSV infection is one of the highest burdens on pediatric
healthcare during the fall and winter seasons. Two winters ago, it
was the first time in decades where our inpatient hospital capacity
was strained to the point where infants needed ICU level care in
community hospitals in Ontario.
Since that time, RSV has continued to be one of the most
significant infections putting infants and children in hospital.
The availability of a single dose RSV prevention strategy will
result in a significant decrease in infant illness and
hospitalization."
Health Canada issued a Notice
of Compliance for Beyfortus® in April 2023. Additionally, it was approved by the
FDA in the United States in
July 2023 and the European Union
in October 2022.
About Beyfortus®
Beyfortus® is a single-dose, long-acting
antibody designed to help prevent RSV lower respiratory tract
disease (LRTD) for newborns and 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 newborns 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
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.
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
i Public Health Agency of Canada.
Accessed 21 February 2024. Respiratory syncytial virus (RSV):
Canadian Immunization Guide - Canada.ca
|
ii 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)
|
iii 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)
|
iv Pisesky et al. PloS one 11.3
(2016): e0150416
|
SOURCE SANOFI