Respiratory Syncytial Virus Vaccine (Monograph)

Drug class: Vaccines

Introduction

Bivalent respiratory syncytial virus (RSV) stablized prefusion F protein-based (RSVpreF) vaccine that stimulates active and passive immunity to RSV infection; the antigen component contains recombinant RSV preF A and RSV preF B proteins.

Uses for Respiratory Syncytial Virus Vaccine

Prevention of Lower Respiratory Tract Disease Caused by RSV in Infants

Used for active immunization of pregnant individuals at 32 through 36 weeks gestational age for prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age.

Prevention of Lower Respiratory Tract Disease Caused by RSV in Older Adults

Used for active immunization for prevention of LRTD caused by RSV in individuals ≥60 years of age.

A single dose of RSV vaccine has demonstrated moderate to high efficacy in preventing symptomatic RSV-associated LRTD in this age group.

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommends that adults ≥60 years of age may receive a single dose of RSV vaccine, using shared clinical decision-making. Vaccination in older adults should be targeted to those at highest risk for severe RSV disease and therefore most likely to benefit.

Respiratory Syncytial Virus Vaccine Dosage and Administration

General

Dispensing and Administration Precautions

• Appropriate medications and supplies for managing allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following vaccine administration.

• Syncope may occur following administration of injectable vaccines. Procedures should be in place to avoid injury from fainting; if syncope develops, patients should be observed until the symptoms resolve.

Administration

Administer only by IM injection.

IM Administration

Administer preferably into the deltoid muscle.

Supplied in a kit that includes a vial of lyophilized antigen component (a sterile white powder), a prefilled syringe containing sterile water diluent component, and a vial adapter.

Reconstitute lyophilized antigen component with accompanying sterile water diluent syringe using the vial adapter as described in manufacturer's prescribing information.

Slowly withdraw entire contents into the syringe to ensure an approximately 0.5 mL dose.

Attach a sterile needle suitable for IM injection to syringe containing vaccine. Visually inspect solution; vaccine should be clear and colorless. Discard if discoloration or particulate matter is observed.

Dosage

Adults

Prevention of Lower Respiratory Tract Disease Caused by RSV

Immunization in Pregnant Individuals at 32 through 36 Weeks Gestational Age

IM

Single 0.5-mL dose.

Manufacturer states safety and effectiveness of vaccine in infants born to individuals vaccinated at <10 years of age not established.

Immunization in Individuals ≥60 Years of Age

IM

Single 0.5-mL dose.

Cautions for Respiratory Syncytial Virus Vaccine

Contraindications

• History of severe allergic reaction (e.g., anaphylaxis) to any component of RSV vaccine.

Warnings/Precautions

Potential Risk of Preterm Birth

Increased preterm births observed in pregnant individuals who received RSV vaccine compared to placebo.

To avoid potential risk of preterm birth before 32 weeks of gestation, administer the vaccine as indicated in pregnant individuals at 32 through 36 weeks gestational age.

Preventing and Managing Allergic Vaccine Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of RSV vaccine.

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, including RSV vaccine, and procedures should be in place to prevent injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to RSV vaccine.

Limitations of Vaccine Effectiveness

Vaccination with RSV vaccine may not protect all recipients.

Specific Populations

Pregnancy

A pregnancy exposure registry has been established. Individuals who receive the vaccine during pregnancy are encouraged to contact, or have their healthcare provider contact 1-800- 616-3791 to enroll or obtain information about the registry.

Increased preterm births observed in pregnant individuals who received the vaccine compared with placebo; however, available data insufficient to establish or exclude causal relationship to the drug. No evidence of a vaccine-associated increase in risk of congenital anomalies or fetal deaths.

To avoid potential risk of preterm birth with use of RSV vaccine before 32 weeks of gestation, administer as indicated in pregnant individuals at 32 through 36 weeks gestational age. Not studied in pregnant individuals <24 weeks gestational age and those at increased risk for preterm birth.

Results of a developmental toxicity study in animals showed no evidence of fetal harm or adverse effects on postnatal survival, growth, or development.

Lactation

Not known whether RSV vaccine is excreted in human milk; effects of vaccine on the breastfed infant or on milk production also not known.

Consider developmental and health benefits of breastfeeding along with the mother's clinical need for RSV vaccine and any potential adverse effects on the breastfed child from the vaccine or underlying maternal condition. For preventative vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

Pediatric Use

Safety and effectiveness in infants born to individuals vaccinated at <10 years of age not established.

Safety and effectiveness in non-pregnant individuals <18 years of age via active immunization not established.

Geriatric Use

Approved for use in individuals ≥60 years of age.

Common Adverse Effects

Most common local and systemic adverse reactions in pregnant individuals (≥10%): pain at injection site, headache, muscle pain, nausea.

Most common local and systemic adverse reactions in individuals ≥60 years of age (≥10%): fatigue, headache, pain at injection site, muscle pain.

Drug Interactions

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

No safety concerns identified when non-pregnant women received RSV vaccine and Tdap (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) concomitantly. Immune responses to RSV A, RSV B, diphtheria, and tetanus were non-inferior to those after separate administration; however, geometric mean antibody concentrations (GMCs) to the acellular pertussis antigens were lower when RSV vaccine was administered concomitantly with Tdap compared to when Tdap was administered alone.

Stability

Storage

Injectable solution

Prior to reconstitution, store refrigerated at 2-8°C in the original carton. Do not freeze.

After reconstitution, administer immediately or store at room temperature (15-30ºC) and use within 4 hours. Do not store reconstituted vaccine under refrigerated conditions. Do not freeze.

Actions

• A bivalent RSV stablized prefusion F protein-based (RSVpreF) vaccine that stimulates active and passive immunity to RSV infection; the antigen component contains recombinant RSV preF A and RSV preF B proteins.

• Induces an immune response against RSV preF that protects against lower respiratory tract disease caused by RSV.

• RSV F glycoprotein (prefusion and postfusion) mediates viral fusion and host-cell entry, elicits neutralizing antibodies, and is highly conserved across the 2 RSV subtypes (A and B).

Advice to Patients

• Advise vaccine recipient of the potential benefits and risks of vaccination with respiratory syncytial virus (RSV) vaccine.

• Advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967or [Web].

• Advise patient to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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Frequently asked questions

• What is the difference between Arexvy and Abrysvo?
• What are the symptoms of respiratory syncytial virus (RSV)?

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