Preventing RSV

(modified October 30, 2023)

-- Please see the October 23, 2023 CDC Health Alert Network (HAN) Health Advisory for US recommendations to manage the limited supply of nirsevimab at https://emergency.cdc.gov/han/2023/han00499.asp. --

RSV is a common virus that infects most children before the age of two years.1,2 Infection does not confer long-term immunity, which leads to continual reinfection throughout a patient’s lifetime.1 This FAQ answers common questions about who’s at risk of severe RSV infection and the products used to prevent it.

Question

Answer/Pertinent Information

What is RSV?

Respiratory syncytial virus (RSV) typically causes mild, self-limiting (one to two weeks) cold-like symptoms.3

Serious RSV infections can cause respiratory distress, bronchiolitis, pneumonia, hospitalization, and death.2,4

The typical season for RSV is from fall through late winter (i.e., October/November to March/April).2,5

Who is at risk of severe RSV disease?

Those at risk of severe RSV disease include:

  • Infants and children less than two years.
    • Up to 40% of first RSV infections in children under one year result in bronchiolitis.4
    • RSV is a leading cause of hospitalization of infants in the US and Canada.5,21,22
  • Children with lung disease (e.g., congenital airway anomalies, chronic lung disease of prematurity, cystic fibrosis), congenital heart disease, neuromuscular disorders, Down syndrome, immunosuppressive disorders, and some infants in remote communities (e.g., northern Inuit, American Indian, and Alaska Native children).2,4,6-8
  • Older adults and patients with chronic lung disease, heart disease, or immunosuppressive disorders.2

How can RSV be prevented?

RSV is transmitted via respiratory droplets (inhaled and from contact with contaminated surfaces).5,9

  • Prevent transmission of RSV (and other respiratory illnesses) by:9
    • coughing or sneezing into a tissue or your shirt sleeve/elbow (not your hands).
    • washing hands with soap and water for at least 20 seconds.
    • avoiding close contact with people (i.e., stay at home) when you feel ill (i.e., cold-like symptoms).
    • cleaning frequently touched surfaces (e.g., doorknobs, mobile devices).

Monoclonal antibody formulations are available to prevent RSV in infants and young children (see below for details).

  • Provide passive immunization.
  • Protection wanes over time.
  • Must be administered in a clinic or hospital.

RSV vaccines are available for pregnant patients (US only) and adults over 60 years (see below for more details).

Infants can be protected with either maternal immunization (US) OR monoclonal antibodies. Most infants do not need both.21

Who should get the monoclonal antibody, nirsevimab (Beyfortus)?

Nirsevimab is FDA- and Health Canada-indicated for the prevention of RSV infection in:6,11

  • all infants born during or entering their first RSV season.
  • children up to 24 months of age who are at risk of severe RSV disease during their second RSV season.

US recommendations: ACIP recommends nirsevimab for infants <8 months born during or entering their first RSV season and children aged 8 to 19 months who are at increased risk of severe RSV disease entering their second RSV season.5,20

  • If RSV prevention has been initiated with palivizumab and less than five doses of palivizumab have been administered, the infant should receive one dose of nirsevimab. No further palivizumab should be administered.20
  • Nirsevimab should be administered during season two (as indicated) regardless of which monoclonal antibody was administered during season one.

In Canada, NACI recommendations on the use of nirsevimab are pending as of the publication of this chart. The Public Health Agency of Canada (PHAC)’s requested CADTH report recommends: nirsevimab for infants entering their first RSV season, prioritized by risk of severe RSV disease:19

  • Tier 1 (highest risk): infants with limited access to healthcare (e.g., rural or remote settings who would require air transport for hospitalization) AND <33 weeks gestational age OR one or more of these risk factors: chronic lung disease of prematurity or other severe chronic lung disease, hemodynamically significant heart disease, or moderately to severely immunocompromised.
  • Tier 2 (high risk): <37 weeks gestational age who have limited access to healthcare, <33 weeks gestational age, OR one or more risk factors.
  • Tier 3: limited access to healthcare.

Who should get the monoclonal antibody, palivizumab (Synagis)?

Palivizumab is indicated for the prevention of RSV infection in high-risk infants and toddlers with:9,10,12

In the US, palivizumab is recommended (per the high-risk indications below) if nirsevimab is not available or not feasible to administer.20

The American Academy of Pediatrics recommends palivizumab for patients:12,23

  • born before 29 weeks gestation and younger than 12 months at the beginning of RSV season.
  • with chronic lung disease of prematurity during the first year of life. During the second year of life, palivizumab can be considered if these children continue to require medical support during the six months prior to RSV season.
  • palivizumab can also be considered for patients:12,23
    • younger than 24 months who are profoundly immunocompromised during RSV season.
    • with a pulmonary or neurological abnormality that impairs clearance of upper airway secretions and who are younger than 12 months.
    • who have hemodynamically significant congenital heart disease and who are 12 months or younger.
 

How do the available RSV monoclonal antibodies compare?

Palivizumab (Synagis)9,10

Nirsevimab (Beyfortus)6,11

How Supplied

Single-dose vials:

50 mg/0.5 mL, 100 mg/1 mL

Single-dose prefilled syringes:

50 mg/0.5 mL, 100 mg/1 mL

Storage

Refrigerate (2°C to 8°C).

Opened vials may be kept (refrigerated) for up to 6 hours.7

Store in original packaging.

Do not shake.

Refrigerate (2°C to 8°C).

May be kept at room temperature for up to 8 hours.

Store in original packaging to protect from light.

Do not shake.

Dosing

15 mg/kg IM monthly throughout the RSV season.

Give an additional dose to children following cardiopulmonary bypass surgery (even if less than one month since last dose).7,9

It is recommended to stop monthly palivizumab if a child has an RSV hospitalization.7,12

Usual duration is four to five months.7,9

First RSV season:

  • Less than 5 kg: 50 mg IM x one dose
  • 5 kg or more: 100 mg IM x one dose

Second RSV season:

  • 200 mg IM x one dose
  • Give an additional dose to children following cardiopulmonary bypass surgery. See footnote “b” for dosing.

Adverse Effects

Rash, fever, severe hypersensitivity reactions

Rash, injection site reactions.

Potential for serious hypersensitivity reactions.

Usual Admin Site

Anterolateral thigh preferred.

Avoid the gluteal muscle.

Anterolateral thigh preferred.

Avoid the gluteal muscle.

Cost (US)a

$1,800/dose

$495/dose

Can monoclonal antibodies be given with vaccines?

Nirsevimab can be given at the same time as routine childhood vaccines.20 Give in separate syringes and at different injection sites.

Who should get an RSV vaccine?

Recommendations for Abrysvo (US only):

  • ACIP (US) recommends shared decision making to determine which patients 60 years and older are vaccinated.
  • ACIP (US) recommends the seasonal use (usually September through January) of Abrysvo in pregnant patients who are 32 weeks through 36 weeks gestation to prevent RSV disease in newborns.21

Recommendations for Arexvy:

  • ACIP (US) recommends shared clinical decision making to determine which patients (over 60 years) are vaccinated.14
  • NACI (Canada) recommendations for the use of Arexvy are pending as of the publication date of this chart.7

How do the available RSV vaccines compare?

Abrysvo (US only)13

Arexvy17,18

Vaccine type

non-adjuvanted

adjuvanted (with AS01E to boost immunity).

Approved indications

for the prevention of RSV in:

  • pregnant women, 32 to 36 weeks gestation (to prevent RSV in newborns via placental transfer of antibodies).
  • patients 60 years and older.

for the prevention of RSV in patients 60 years and older.

Dosing

0.5 mL IM x one dose

0.5 mL IM x one dose

Use in pregnant patients

There is a potential risk of preterm birth with Abrysvo. To avoid this risk, do not administer Abrysvo prior to 32 weeks gestation. Patients at risk of preterm birth were generally excluded from the studies.

There are no data on the administration of Arexvy in pregnant patients.

Storage

Refrigerate (2°C to 8°C) in the original packaging.

36 to 46 °F (2 to 8°C) in the original packaging to protect from light.

Reconstitution and stability

Reconstitute with the diluent provided. Use immediately or keep at room temperature (15°C to 30°C) and use within four hours.

Reconstitute with the diluent provided. Use immediately or refrigerate (36°F to 46°F [2°C to 8°C]) and use within four hours.
Efficacy

Data show moderate to high efficacy of one dose of Abrysvo in older adults for the prevention of RSV-associated symptomatic LRTD and medically attended LRTD over two RSV seasons [Evidence Level A-1].14

 Data on the prevention of hospitalization, severe illness, and death are lacking.14

Infants born to pregnant patients who were given Abrysvo, had a significantly reduced risk of severe LRTD at both 90 days and 180 days after birth [Evidence Level A-1].15 

Data show moderate to high efficacy of one dose of Arexvy in older adults for the prevention of RSV-associated symptomatic LRTD and medically attended LRTD over two RSV seasons [Evidence Level A-1].14

Data on the prevention of hospitalization, severe illness, and death are lacking.14 

Cost (US)

   $295/dose $280/dose 

Abbreviations: ACIP = Advisory Committee on Immunization Practices; admin = administration; CADTH = Canada’s Drug and Health Technology Agency; IM = intramuscular; LRTD = lower respiratory tract disease; NACI = National Advisory Committee on Immunization; RSV = respiratory syncytial virus.

  1. Pricing based on wholesale acquisition cost (WAC). US medication pricing by Elsevier, accessed September 2023.
  2. Once infants are stable following cardiopulmonary bypass surgery, administer an additional dose of nirsevimab to ensure adequate serum levels. If it is the child’s first RSV season and within 90 days of the initial nirsevimab dose, give a weight-based dose (<5 kg: 50 mg; ≥5 kg: 100 mg). If it has been more than 90 days since the initial nirsevimab dose, give a 50 mg dose. If it is the child’s second RSV season and within 90 days of the initial nirsevimab dose, give a 200 mg dose. If it has been more than 90 days since the initial nirsevimab dose, give a 100 mg dose.6,11
  3. In the US, nirsevimab is recommended for children between the ages of 8 and 19 months, entering their second RSV season, with increased risk of severe RSV disease:5 
  • chronic lung disease of prematurity, requiring medical support during the six months prior to RSV season.
  • severe immunocompromise.
  • cystic fibrosis with manifestations of severe lung disease OR abnormalities on chest imaging that persist when stable OR weight-for-length rate is less than the 10th percentile.
  • American Indian or Alaska Native children.

Levels of Evidence

In accordance with our goal of providing Evidence-Based information, we are citing the LEVEL OF EVIDENCE for the clinical recommendations we publish.

Level

Definition

Study Quality

A

Good-quality patient-oriented evidence.*
  1. High-quality randomized controlled trial (RCT)
  2. Systematic review (SR)/Meta-analysis of RCTs with consistent findings
  3. All-or-none study

B

Inconsistent or limited-quality patient-oriented evidence.*
  1. Lower-quality RCT
  2. SR/Meta-analysis with low-quality clinical trials or of studies with inconsistent findings
  3. Cohort study
  4. Case control study

C

Consensus; usual practice; expert opinion; disease-oriented evidence (e.g., physiologic or surrogate endpoints); case series for studies of diagnosis, treatment, prevention, or screening.

*Outcomes that matter to patients (e.g., morbidity, mortality, symptom improvement, quality of life).

[Adapted from Ebell MH, Siwek J, Weiss BD, et al. Strength of Recommendation Taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician 2004;69:548-56. https://www.aafp.org/pubs/afp/issues/2004/0201/p548.html.]

References

  1. Jain H, Schweitzer JW, Justice NA. Respiratory Syncytial Virus Infection. [Updated 2023 Jun 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-.Available from: https://www.ncbi.nlm.nih.gov/books/NBK459215/.
  2. Government of Canada. Respiratory syncytial virus (RSV): for health professionals. April 14, 2023. https://www.canada.ca/en/public-health/services/diseases/respiratory-syncytial-virus-rsv/health-professionals.html. (Accessed April 14, 2023).
  3. CDC. Respiratory syncytial virus (RSV). August 4, 2023. https://www.cdc.gov/rsv/index.html. (Accessed September 14, 2023).
  4. American Academy of Pediatrics. Updated guidance: use of palivizumab prophylaxis to prevent hospitalization from severe respiratory syncytial virus infection during the 2022=2023 RSV season. November 17, 2022. https://www.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/clinical-guidance/interim-guidance-for-use-of-palivizumab-prophylaxis-to-prevent-hospitalization/. (Accessed September 15, 2023).
  5. Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72(34):920-925.
  6. Product monograph for Beyfortus. AstraZeneca Canada. Mississauga, ON L4Y 1M4. April 2023.
  7. Government of Canada. Respiratory syncytial virus (RSV): Canadian Immunization Guide. Last modified September 8, 2023. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html. (Accessed September 19, 2023).
  8. Atwell JE, Hartman RM, Parker D, et al. RSV Among American Indian and Alaska Native Children: 2019 to 2020. Pediatrics. 2023 Aug 1;152(2):e2022060435.
  9. Product information for Synagis. Sobi. Waltham, MA 02451. November 2020.
  10. Product monograph for Synagis. AstraZeneca Canada. Mississauga, ON L4Y 1M4. July 2021.
  11. Product information for Beyfortus. Sanofi Pasteur. Swiftwater, PA 18370. July 2023.
  12. American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014 Aug;134(2):415-20. Erratum in: Pediatrics. 2014 Dec;134(6):1221.
  13. Product information for Abrysvo. Pfizer. New York, NY 10001. October 2023.
  14. Melgar M, Britton A, Roper LE, et al. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023 Jul 21;72(29):793-801.
  15. Kampmann B, Madhi SA, Munjal I, et al. Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants. N Engl J Med. 2023 Apr 20;388(16):1451-1464.
  16. CDC. Respiratory syncytial virus (RSV) for healthcare providers. August 4, 2023. https://www.cdc.gov/rsv/clinical/index.html. (Accessed September 20, 2023).
  17. Product information for Arexvy. GlaxoSmithKline. Durham, NC 27701. April 2023.
  18. Product monograph for Arexvy. GlaxoSmithKline. Mississauga, ON L5R 4H1. August 2023.
  19. Canada’s Drug and Health Technology Agency (CADTH). CADTH health technology review, nirsevimab (Beyfortus). July 26, 2023. https://www.cadth.ca/sites/default/files/hta-he/HC0059%20Nirsevimab%20for%20RSV%20prophylaxis-secured.pdf. (Accessed September 21, 2023).
  20. American Academy of Pediatrics. ACIP and AAP recommendations for nirsevimab. August 15, 2023. https://publications.aap.org/redbook/resources/25379. (Accessed September 21, 2023).

  21. CDC. Healthcare providers:  RSV vaccination for pregnant people. September 29, 2023. https://www.cdc.gov/vaccines/vpd/rsv/hcp/pregnant-people.html. (Accessed October 6, 2023).

  22. Buchan SA, Chung H, To T, et al. Estimating the Incidence of First RSV Hospitalization in Children Born in Ontario, Canada. J Pediatric Infect Dis Soc. 2023 Jul 31;12(7):421-430.

  23. Caserta MT, O'Leary ST, Munoz FM, et al. Palivizumab Prophylaxis in Infants and Young Children at Increased Risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics. 2023 Jul 1;152(1):e2023061803.

Cite this document as follows: Clinical Resource, Preventing RSV. Pharmacist’s Letter/Pharmacy Technician’s Letter/Prescriber Insights. October 2023. [391002]


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