- Six out of 10 infants and newborns in Canada will have access to the protective
antibody Beyfortus® for the first time this season
- Access to Beyfortus® includes infants in remote
communities most impacted by respiratory syncytial virus (RSV), in
all three territories and northern Quebec and Ontario
- Beyfortus® demonstrated the ability to reduce the
risk of RSV lower respiratory tract infections by 74.5%, including
hospitalizations in infants entering their first RSV
seasoni
TORONTO, Oct. 28,
2024 /CNW/ - Sanofi is pleased to announce
Beyfortus® (nirsevimab) will be broadly available for
babies born in Ontario,
Quebec, Nunavut, Northwest
Territories, and the Yukon
this fall. The administration of this immunization to infants has
begun. Beyfortus® is the first long-acting antibody
approved in Canada for the
prevention of RSV lower respiratory tract disease in newborns and
infants through their first RSV season.ii As RSV
circulates seasonally between November and April, causing a high
burden of bronchiolitis, pneumonia and hospitalizations in infants
and newborns, this timely availability aims to help safeguard the
most vulnerable populations during this critical period. With
the ongoing challenges posed by RSV, Sanofi is committed to
increasing access to this immunization across Canada.
"We understand the concerns parents face during RSV season,
and we are dedicated to providing new solutions to protect all
babies," said Delphine Lansac,
General Manager of Vaccines at Sanofi. "The availability of
Beyfortus® is a significant step forward in
our mission to protect infant health and to help alleviate the
burden on the healthcare system during respiratory illness
season."
Beyfortus® will be provided in hospital prior to
discharge for babies born during RSV season and is available
through primary care providers or public health in Quebec, Ontario, Nunavut, Northwest
Territories, and the Yukon
for infants born prior to RSV season. Beyfortus® is
publicly funded and available free of charge in these
jurisdictions. Healthcare providers can contact their local health
authority to obtain more information about
Beyfortus®.
The National Advisory Committee on Immunization (NACI) and
Quebec's National Institute of
Excellence in Health and Social Services (INESSS) recommended
Beyfortus® to protect newborns and infants from
RSV.iii,iv Health Canada issued a Notice of
Compliance for Beyfortus® in April 2023.
About RSV
RSV, a highly contagious virus, can lead to respiratory illness
in babies, including lung infections such as bronchiolitis and
pneumonia.v 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.vi Infants under 1 year are on average
almost 16 times more likely to be hospitalized for RSV than for
influenza.vii 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.viii 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.ix Until now, only a
small fraction of infants born in Canada have been eligible to receive RSV
protection.
About Beyfortus®
Beyfortus® is the first immunization designed
for all infants to help prevent RSV lower respiratory tract disease
through 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.
As a long-acting antibody provided directly to newborns and
infants in 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® demonstrated statistically significant
efficacy in reducing the relative risk of respiratory syncytial
virus lower respiratory tract infections, including
hospitalizations, by 74.5% vs. placebo in term and late preterm
infants (gestational age greater than or equal to 35 weeks)
entering their first RSV season (95% CI: 49.6-87.1;
p<0.0001).x
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.
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 BEYFORTUS® Product Monograph,
Sanofi Pasteur Limited, June 14, 2024.
|
ii
BEYFORTUS® Product Monograph, Sanofi Pasteur Limited, June 14,
2024.
|
iii An
Advisory Statement, National Advisory Committee on Immunization
(NACI), Statement on the prevention of Respiratory Syncytial Virus
(RSV) disease in infants, April 2024.
|
iv Institut national d'excellence en
santé et en services sociaux: BEYFORTUSMC: Prévention
des infections graves par le virus respiratoire syncytial chez
l'enfant.
|
v Public Health Agency of Canada.
Accessed 21 February 2024. Respiratory syncytial virus (RSV):
Canadian Immunization Guide - Canada.ca
|
vi Simoes EAF. Lancet 1999;
354:847-852
|
vii 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.
|
viii Pisesky
et al. PloS one 11.3 (2016): e0150416
|
ix 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.
|
x BEYFORTUS® Product Monograph,
Sanofi Pasteur Limited, June 14, 2024.
|
SOURCE SANOFI