SEPTEMBER 28, 2021
New research from Sanofi Pasteur on respiratory syncytial virus (RSV), meningococcal disease, and influenza will be featured at IDWeek 2021, from September 29 to October 3, 2021, underscoring the company’s pledge to develop meaningful solutions for patients.
“As one of the leading global vaccines companies, we continue to bring options which help protect people’s health around the world,” said Michael Greenberg, MD, MPH, Medical Head, Sanofi Pasteur North America. “We look forward to sharing developments from our leading vaccines pipeline which underscore our ongoing commitment to uncovering insights that will help prevent severe infectious diseases at every stage of life, especially in diseases with an unmet need such as respiratory syncytial virus.”
Underscoring the need for all infant protection in RSV
RSV is a highly contagious virus that causes respiratory illness in infants, including lung infections such as bronchiolitis and pneumonia.1 Illness coded as RSV specific bronchiolitis was found to be the leading cause of hospitalization in infants under 12 months, according to a study of pediatric hospitalizations between 1997 and 2000.2 A study conducted from 2014 to 2015 showed 72% of infants hospitalized for RSV were previously healthy with no underlying conditions.3
Nirsevimab is being developed by Sanofi and AstraZeneca and is being evaluated as the first investigational long-acting antibody designed to help prevent lower respiratory tract infection (LRTI) caused by RSV in all infants from birth up to 12 months of age during their first RSV season.
The following data reinforce the need for a preventative option that could help to protect all infants with one dose for the entire RSV season:
* AstraZeneca leads all development activity through initial approvals.
Evaluating the impact of vaccination for meningococcal disease
Meningococcal disease, which includes meningococcal meningitis, is a rare but potentially deadly bacterial infection.4,5 Anyone can get meningococcal disease, but teens and young adults are among those who are at the highest risk for the infection.6,7 Although rare, meningococcal disease develops rapidly and can claim the life of an otherwise healthy individual in as little as one day after the first symptoms appear.4,5 The CDC recommends a first dose of the MenACWY vaccine at 11-12 years old and a second dose at 16 years old. Despite these recommendations, approximately half of U.S. teens have missed the crucial second dose.8
MenQuadfi® [Meningococcal (Groups A, C, Y, W) Conjugate Vaccine] is a vaccine given to people 2 years of age and older to help prevent invasive meningococcal disease (including meningitis) caused by serogroups A, C, W, and Y of meningococcal bacteria.7 MenQuadfi does not prevent serogroup B disease.9 The following new research evaluates the long-term impact of MenQuadfi across various age groups:
Examining the relationship between influenza and antibiotic resistance patterns
New analyses will examine the link between antibiotic resistance patterns and seasonal influenza, which may help inform targeted antimicrobial stewardship initiatives during influenza season.
These abstracts are currently available for meeting attendees viewing, and the full presentations (including audio and/or poster PDFs) will become available at the beginning of the data presentation session.
MenQuadfi is a vaccine given to people 2 years of age and older to help prevent invasive meningococcal disease (including meningitis) caused by serogroups A, C, W, and Y of meningococcal bacteria. MenQuadfi does not prevent serogroup B disease.
Important Safety Information for MenQuadfi in the U.S.
MenQuadfi should not be given to people who have had a severe allergic reaction after a previous dose of MenQuadfi, any of its ingredients, or another vaccine that contains tetanus toxoid.
If MenQuadfi is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected. People with certain complement deficiencies and people taking certain complement inhibitors (for example, eculizumab) may still be at risk for meningococcal disease even if they receive a meningococcal vaccine, including MenQuadfi.
Fainting can occur shortly before or after injecting vaccines, including MenQuadfi.
Tell your health care provider if you ever had Guillain-Barré syndrome (severe muscle weakness) after a previous meningococcal vaccination.
Vaccination with MenQuadfi may not protect all people who receive the vaccine.
The most common side effects after a first dose of MenQuadfi for people 2 years and older include pain where the shot is given; muscle aches, headache, and tiredness. In children 2 through 9 years of age, other common side effects include redness and swelling where the shot is given. In adolescents and adults receiving a booster dose of MenQuadfi, the most common side effects include those occurring after a first dose. Other side effects may occur.
Please see the full Prescribing Information.
Nirsevimab is an investigational long-acting antibody designed to help protect all infants for the RSV season. Due to its extended half-life technology, nirsevimab is being investigated as a single dose for all infants experiencing their first RSV season and infants with congenital heart disease or chronic lung disease entering their first and second RSV season.
Nirsevimab is an immunization designed to provide prophylactic RSV protection to all infants via an antibody given directly to an infant to help prevent LRTI caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer rapid and direct protection against disease.
In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities, and Sanofi will lead commercialization activities and record revenues. Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid a development milestone of €30m and will pay up to a further €465m upon achievement of certain development and sales-related milestones. The two companies share all costs and profits. Revenue from the agreement is reported as Collaboration Revenue in the Company’s financial statements.
Nirsevimab has been granted breakthrough designation by four major regulatory agencies around the world. These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; access granted to the European Medicines Agency PRIority Medicines scheme; and Promising Innovation Medicine designation by the Medicines and Healthcare Products Regulatory Agency. Nirsevimab is currently under clinical investigation and its safety and efficacy have not been reviewed by any regulatory authority.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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