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About RSV


Hospitalization, seasonality and pathophysiology

Respiratory syncytial virus (RSV) poses a significant threat to infants in the United States;1 all infants are susceptible to developing lower respiratory tract infections caused by this virus. Although most of the time RSV will cause mild cold-like symptoms, we cannot predict which infants will develop RSV lower respiratory tract disease.

RSV infections are particularly concerning due to their potential to cause severe respiratory illness and high hospitalization rates.2

Despite this universal risk, there remains a critical need for increased awareness of the burden of RSV on infants, as well as their parents and caregivers. We cannot predict which infants will develop RSV lower respiratory tract disease; therefore, proactive preventative measures such as infection control, monoclonal antibody prophylaxis, and caregiver education are essential.3

Learn About Beyfortus (nirsevimab-alip)

Recognizing RSV and its characteristics

RSV is a common and highly contagious respiratory virus that can lead to lower respiratory tract infections, and serious lung conditions such as pneumonia and bronchiolitis in neonates and infants.4,5 The pathogen belongs to the Pneumoviridae (genus orthopneumovirus), a family of negative-strand RNA viruses.3

Transmission occurs through the nasopharyngeal or conjunctival mucosa with respiratory secretions from infected individuals (i.e. other children, older siblings/family members).6

RSV shares similar characteristics to that of other respiratory viruses including:7,8

  • Runny nose
  • Coughing
  • Sneezing
  • Fever
  • Decreased appetite
  • Wheezing

However in very young infants, symptoms may include irritability, decreased activity, and breathing difficulties.7
RSV therefore remains an unpredictable threat.5

RSV incidence and hospitalization rates in infants

RSV is a prominent contributor to acute respiratory tract infections among young children.5

A recent meta-analysis found that US infants under 1 year old had an annual hospitalization rate of 19.4 per 1000 due to RSV.10* Extrapolating this to the 2020 US birth cohort suggests around 80,000 RSV-associated infant hospitalizations may occur annually, aligning with CDC data.10

The virus is also a significant contributor to pneumonia admissions, accounting for up to 50% among infants.11

2 out of 3 infants will be infected with RSV by age 1.12

Infants younger than 1 year are on average 16x more likely to be hospitalized due to RSV than for influenza.13
 

Young infants under 6 months face an elevated risk of severe RSV, especially if born prematurely or with underlying conditions.14 Examples of such conditions include: chronic lung or congenital heart disease, and neurological issues or immunodeficiency.14

However, pre-existing risk factors are recognized in only 22-32% of total hospital admissions.3

As mentioned above, infants under 1 year of age are much more likely to be hospitalized due to RSV than influenza.13 However, for children aged 5 and older, influenza is more likelu to lead to hospitalizations than RSV, highlighting the significant impact each virus has across different stages of life.13

These statistics on RSV hospitalization rates and incidence emphasize that RSV presents a risk to all infants, not just those born prematurely, or with underlying medical conditions.13

RSV is the primary cause of hospitalization in infants.15 It leads to hospitalizations by causing bronchiolitis and pneumonia.10,15 Acute bronchiolitis due to RSV accounted for ~10% of total infant hospitalizations.10,15

Bronchiolitis manifests with:14

  • Respiratory distress
  • Coughing
  • Differing levels of hypoxia caused by airway blockage in older children, and may instead present as apnea in infants

RSV seasonality

RSV is seasonal, with infections peaking at certain times throughout the year. 16 A typical RSV season runs roughly from Fall through Spring, with some exceptions, such as in Florida and Hawaii, where the RSV season may start earlier.16,17

Shortly after the COVID-19 pandemic, the detection of RSV infections became more unpredictable in some regions, with many off-season resurgences of cases.14 Epidemiology monitoring can identify when local RSV seasons begin, and this will remain an important process as RSV seasonality shifts back to normal.18

Based on a 2019 UK study of the number of hospitalized infants born in-season (Oct-Mar: 48%) and born before the season (Apr-Sept: 50%), infants born before the RSV season are equally at risk as those born during it.19 As a result, the number of RSV-hospitalized infants born in season vs before the season is roughly equal.19

RSV pathophysiology

See how RSV symptoms progress

RSV symptoms can progress from an asymptomatic stage to severe. Below is a timeline of the typical RSV symptoms over the duration of the disease:

RSV at days 1 and 2

Droplets containing RSV from infected contact enter the infant's nasopharynx. There is usually no manifestation of symptoms at this point.20

RSV at days 3 through 5

Nasopharyngeal cells are sloughed and may be aspirated, carrying RSV to lower respiratory tract cells.20

 

Symptoms can include:

  • Congestion
  • Runny nose
  • Fever
  • Irritability
  • Poor feeding

RSV at days 6 through 8

RSV-infected epithelial cells can travel deeper into the infant's lungs, infecting the bronchioles and alveoli, causing bronchiolitis and/or pneumonia.

Symptoms can include:

  • Cough
  • Excess phlegm
  • Rapid breathing (tachypnea)
  • Wheezing and/or grunting noises
  • Nasal flaring
  • Abnormal chest movement when breathing20

RSV O₂ (oxygen) therapy in cases of severe RSV

2 to 3 out of every 100 infants with RSV infection may need to be hospitalized; those hospitalized may require O₂, IV fluids, intubation, and/or mechanical ventilation.5

O₂ therapy in cases of severe RSV requires O₂ levels given at a higher rate through a nasal cannula, known as ‘high flow’. 21

Respiratory rate as an indicator of RSV severity

Parents should be informed that respiratory rate is a key indicator when deciding to seek medical attention.

A respiratory rate over than 60 BPM (breaths per minute) for those under 2 months, a respiratory rate over 50 BPM for those 2 to 12 months and over 40 BPM for those between 1 and 5 years old could indicate lower respiratory complications.22

Take a deeper dive into RSV

ARTICLE

Quality of life burden on United States infants and caregivers due to lower respiratory tract infection and adjusting for selective testing

A pilot prospective observational study estimating the quality of life (QoL) for otherwise healthy term US infants with RSV-LRTI and their caregivers.

ARTICLE

Infants admitted to US intensive care units for RSV infection during the 2022 seasonal peak

A surveillance study of 600 infants across 39 hospitals requiring intensive care for RSV infection found that most were delivered full-term and previously healthy.

ARTICLE

Optimal site of care for administration of extended half-life respiratory syncytial virus (RSV) antibodies to infants in the United States (US)

A study to assess the time from birth hospitalization discharge to the first outpatient visit among US infants in order to determine optimal site of administration for the extended half-life antibody.

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Power to Help Prevent RSV Disease

Learn how Beyfortus® (nirsevimab-alip) is the first and only long-acting antibody indicated for the prevention of RSV lower respiratory tract disease in term and preterm infants.14

Discover more about Beyfortus®

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Demonstrated Safety and Efficacy Profile14

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BPM, breaths per minute; HCP, healthcare professional; RSV, respiratory syncytial virus.

*An analysis published in 2022 including studies between 2000-2020. Annual hospitalization rates ranged from 8.4 to 40.8 per 1000, with a pooled rate of 19.4.
†Study provides the estimated community-onset RSV–associated hospitalizations among children aged <2 years in the USA, during the 2014–15 season.
‡This is one example of progression, which can vary in each individual infant.

Important Safety Information

Contraindication
Beyfortus is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients.

Warnings and Precautions
  • Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions have been reported following Beyfortus administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.

  • Use in Individuals with Clinically Significant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.

Most common adverse reactions with Beyfortus were rash (0.9%) and injection site reactions (0.3%).

Indication

Beyfortus is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in:

  • Neonates and infants born during or entering their first RSV season.
  • Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Important Safety Information

Indication

References: 1. Arriola, C. S. et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus–Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014–15. J Pediatric Infect Dis Soc 9, 587–595 (2019). 2. Reichert, H. et al. Mortality Associated With Respiratory Syncytial Virus, Bronchiolitis, and Influenza Among Infants in the United States: A Birth Cohort Study From 1999 to 2018. J. Infect. Dis. 226, S246–S254 (2022). 3. Baraldi, E. et al. RSV disease in infants and young children: Can we see a brighter future? Hum. Vaccin. Immunother. 18, 2079322 (2022). 4. Yamin, D. et al. Vaccination strategies against respiratory syncytial virus. Proc. Natl. Acad. Sci. U. S. A. 113, 13239–13244 (2016). 5. CDC. Respiratory Syncytial Virus Infection (RSV) - RSV in Infants and Young Children. Centers for Disease Control and Prevention https://www.cdc.gov/rsv/high-risk/infants-young-children.html. 6. Piedimonte, G. & Perez, M. K. Respiratory syncytial virus infection and bronchiolitis. Pediatr. Rev. 35, 519–530 (2014).7. CDC Symptoms and Care of RSV (Respiratory Syncytial Virus). Centers for Disease Control and Prevention https://www.cdc.gov/rsv/about/symptoms.html (2023). 8. NFID. How to Tell the Difference between Flu, RSV, COVID-19, and the Common Cold. National Foundation for Infectious Diseases https://www.nfid.org/resource/how-to-tell-the-difference-betweenflu-rsv-covid-19-and-the-common-cold/ (2022).9.  Rainisch, G. et al. Estimating the impact of multiple immunization products on medically attended respiratory syncytial virus (RSV) infections in infants. Vaccine. 38, 251-257 (2020). 10. McLaughlin, J. et al. Respiratory syncytial virus–associated hospitalization rates among US infants: A systematic review and meta-analysis. J. Infect. Dis. 225, 1100–1111 (2020). 11. Walsh, E. E. & Hall, C. B. 160 - Respiratory Syncytial Virus (RSV). in Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases (Eighth Edition) (eds. Bennett, J. E., Dolin, R. & Blaser, M. J.) 1948–1960.e3 (W.B. Saunders, Philadelphia, 2015). 12. Glezen, W. P., Taber, L. H., Frank, A. L. & Kasel, J. A. Risk of primary infection and reinfection with respiratory syncytial virus. Am. J. Dis. Child. 140, 543–546 (1986). 13. Zhou, H. et al. Hospitalizations Associated With Influenza and Respiratory Syncytial Virus in the United States, 1993–2008. Clin. Infect. Dis. 54, 1427–1436 (2012). 14. Abu-Raya, B., Viñeta Paramo, M., Reicherz, F. & Lavoie, P. M. Why has the epidemiology of RSV changed during the COVID-19 pandemic? eClinicalMedicine 61, (2023). 15. Suh, M. et al. Respiratory Syncytial Virus Is the Leading Cause of United States Infant Hospitalizations, 2009–2019: A Study of the National (Nationwide) Inpatient Sample. J. Infect. Dis. 226, S154–S163 (2022). 16. CDC. RSV Surveillance & Research. Centers for Disease Control and Prevention https://www.cdc.gov/rsv/research/index.html (2023). 17. Rose, E. B., Wheatley, A., Langley, G., Gerber, S. & Haynes, A. Respiratory Syncytial Virus Seasonality - United States, 2014-2017. MMWR Morb. Mortal. Wkly. Rep. 67, 71–76 (2018). 18. Obando-Pacheco, P. et al. Respiratory Syncytial Virus Seasonality: A Global Overview. J. Infect. Dis. 217, 1356–1364 (2018). 19. Reeves, R. M. et al. Burden of hospital admissions caused by respiratory syncytial virus (RSV) in infants in England: A data linkage modelling study. J. Infect. 78, 468–475 (2019). 20. Meissner, H. C. Viral Bronchiolitis in Children. N. Engl. J. Med. 374, 62–72 (2016). 21. Piedra, P. A. & Stark, A. R. Patient education: Bronchiolitis and RSV in infants and children (Beyond the Basics). UpToDate. (2021). 22. Clinical care of severe acute respiratory infections – Tool kit. World Health Organization; 2022 [cited 2024 Jul 9]. Available from: https://www.who.int/publications/i/item/clinical-care-of-severe-acute-respiratory-infections-tool-kit

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