New research presented at IDWeek 2021 reinforces Sanofi’s robust vaccines pipeline and commitment to advancing public health protection
- Presentations focused on respiratory syncytial virus, meningococcal disease, and influenza
SEPTEMBER 27, 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:
- Medically Attended Illness Due to Respiratory Syncytial Virus Infection Among Infants in the United States During the 2016-17, 2017-18, 2018-19, and 2019-20 Seasons: The Need for all Infants Protection. Poster presentation number 1137.
- The Efficacy and Impact in Heathy Infants of Nirsevimab on Medically Attended RSV Lower Respiratory Tract Infection. Oral presentation number 1106281.*
* 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
In the U.S., MenQuadfi® Meningococcal (Groups A, C, Y, W) Conjugate Vaccine is 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:
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered as a Booster to Adults > 59 Years of Age (PNM-43489). Poster presentation number 1046.
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered as a Booster Dose in Adults and Adolescents Vaccinated Against Meningococcal Disease 3-6 Years Earlier (PNM-51872). Poster presentation number 3.
- Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered in Meningococcal Vaccine Naïve Participants Across a Broad Age Range (2-55 years) in Japan (PNM-51878). Poster presentation number 4.
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.
- Antibiotic Resistance Patterns, Seasonality, and Correlation with the Influenza Season in the United States: A Multicenter Evaluation. Oral presentation number 35.
- A Multicenter Analysis of Inpatient Antibiotic Use During the 2015-2019 Influenza Season in the US: Untapped Opportunities for Antimicrobial Stewardship. Poster presentation number 171.
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.
In the U.S., MenQuadfi vaccine is 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.
MenQuadfi® is approved by The European Commission (EC) for the prevention of Invasive Meningococcal Disease in individuals 12 months of age and older and is currently under review by several health authorities across the world to help meet local immunization efforts.
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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- Ralston SL et al. American Academy of Pediatrics. 2014;134(5):e1474-e1502.
- Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003; Nov; 143(5 Suppl):S127-S132. doi:10.1067/s0022-3476(03)00510-9. PMID: 14615711.
- Arriola CS, Kim L, Langley G, Anderson EJ, Openo K, Martin AM, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. Journal of the Pediatric Infectious Diseases Society. 2020;9(5):587-95.
- "Disease and Prevention Information." National Meningitis Association, https://www.nmaus.org/disease-prevention-information/.
- "Meningococcal Disease." World Health Organization, World Health Organization, 24 June 2016, www.who.int/csr/disease/meningococcal/test/en/.
- "Meningococcal Vaccination for Preteens and Teens: Information for Parents." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 26 July 2019, www.cdc.gov/vaccines/vpd/mening/public/adolescent-vaccine.html.
- "Meningococcal – Clinical Information." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 31 May 2019, www.cdc.gov/meningococcal/clinical-info.html.
- "National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2019." Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 22 Aug. 2019, https://www.cdc.gov/mmwr/volumes/69/wr/mm6933a1.htm.
- MenQuadfi Prescribing Information. Swiftwater, PA: Sanofi Pasteur Inc.