Beyfortus® immunization to protect infants against RSV has begun

Classified in: Health
Subject : New products and services
  • Au Canadasix out of 10 newborns will have access to the protective Beyfortus antibody® for the first time this season.
  • Newborns in remote communities, most affected by respiratory syncytial virus (RSV), will have access to Beyfortus®in the three Canadian territories and in northern Quebec andOntario.
  • Beyfortus® statistically demonstrated a 74.5% reduction in risk of lower respiratory tract infection due to RSV in infants going through their first RSV seasoni.

TORONTO, the 28 oct. 2024 /CNW/ – Sanofi is pleased to announce that Beyfortus® (nirsevimab) will be widely available this fall for infants born in Ontarioin Quebec, in Nunavutau Yukon and in the Northwest Territories. The first injections have started. Beyfortus® is the first long-lasting protective antibody developed to protect infants and newborns against RSVii. RSV circulates seasonally from November to April, and causes a large number of cases of bronchiolitis, pneumonia and hospitalizations in infants. Immunization aims to protect the most vulnerable populations during this critical period. Given the current challenges posed by RSV, Sanofi is committed to increasing access to this immunization Canada.

“We understand the concerns of parents during this RSV season, and we are determined to provide a solution to protect all babies, noted Delphine LansacGeneral Manager Vaccines at Sanofi. The arrival of Beyfortus® is an important step in our mission to protect the health of infants and ease the burden on the health care system during respiratory illness season. »

In Quebec, in Ontarioau Nunavutin the Northwest Territories and YukonBeyfortus® will be provided in hospital to eligible infants born during the RSV season; infants born before the start of the RSV season will have access to Beyfortus® through primary care physicians or public health. Beyfortus® is reimbursed by public plans and offered free of charge in these territories. Healthcare professionals can contact their local health authority for more information about Beyfortus®.

The National Advisory Committee on Immunization (NACI) and the National Institute of Excellence in Health and Social Services (INESSS) of Quebec recommended Beyfortus® to protect infants and newborns against RSViii,iv. Health Canada issued a notice of compliance for Beyfortus® in April 2023.

About RSV

RSV, which is highly contagious, can cause respiratory illnesses in babies, including lung infections like bronchiolitis and pneumonia.v. About 2 in 3 infants are infected with RSV before their first birthday, and almost all infants are infected before age 2vi. Infants under 1 year old are on average almost 16 times more likely to be hospitalized for RSV than for the fluvii. The majority of hospitalizations for RSV occur in children without any risk factors. A recent study showed that, of infants hospitalized with RSV, 80% were previously healthy and born at termviii. According to NACI, each year, between 10% and 20% of RSV cases in healthy infants require medical care, including a doctor’s office, emergency care, emergency room visits and hospitalizations.ix Until now, only a small fraction of infants born in Canada has access to protection against RSV.

About Beyfortus®

Beyfortus® is a long-acting antibody administered in a single dose that helps prevent lower respiratory tract infection with RSV in infants during their first RSV season. Beyfortus® is also indicated in children younger than 24 months who remain vulnerable to serious RSV infection during their second season of RSV exposure. Beyfortus® provides rapid protection against RSV lower respiratory tract infection for at least 5 months, coinciding with the RSV season.

Beyfortus® is administered directly to newborns and infants in a single dose and provides rapid protection with an antibody to help prevent lower respiratory tract infection with RSV, without requiring activation of the immune system. Beyfortus’s administration® can be scheduled at the start of the RSV season.

Beyfortus® statistically demonstrated its effectiveness in reducing the relative risk of lower respiratory tract infection, and associated hospitalizations, by 74.5% compared to placebo in children born at term or near term (35 weeks of gestation or more) and entering their first season of VRSx (95% CI: 49.6-87.1; p<0.0001).

About Sanofi

We are an innovative, global healthcare company with one purpose: we harness the miracles of science to improve people’s lives. Around the world, our team strives to transform the practice of medicine by seeking to make the impossible possible. We deliver life-changing treatments and life-saving vaccines to millions of people around the world, while placing the concepts of sustainability and responsibility at the center of our ambitions.

Au Canadawe employ more than 2,000 people and invest 20% of our annual revenues in biopharmaceutical research (representing 1.2 billion Canadian dollars in R&D over the last decade) to stimulate job creation, trade and business opportunities across the country. We are also on track to make investments of more than C$2 billion in new infrastructure by 2028, including two new vaccine manufacturing plants on our Toronto campus.

In 2024, we celebrate 110 years of creating innovative health solutions for Canadians.? What began as a small laboratory in May 1914 grew to become the largest biopharmaceutical manufacturing facility in the world. Canada in addition to being recognized for having advanced some of the greatest contributions to public health, both Canada than in the world.

Sanofi is listed on (EURONEXT: SAN) and (NASDAQ: SNY)

__________________________________________________________________________

i BEYFORTUS monograph®Sanofi Pasteur Limited, June 14, 2024.

ii BEYFORTUS monograph®Sanofi Pasteur Limited, June 14, 2024.

iii An Advisory Committee Statement (ACC), National Advisory Committee on Immunization (NACI), Statement on the Prevention of Respiratory Syncytial Virus (RSV) Illness in Infants, April 2024.

iv National Institute of Excellence in Health and Social Services: BEYFORTUSMC: Prevention of serious respiratory syncytial virus infections in children.

v Public Health Agency of Canada. Accessed February 21, 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 Opinion 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 An Advisory Committee Statement (ACC), National Advisory Committee on Immunization (NACI), Statement on Prevention of Respiratory Syncytial Virus (RSV) Illness in Infants, April 2024.

x BEYFORTUS monograph®Sanofi Pasteur Limited, June 14, 2024.

SOURCE SANOFI

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