Respiratory Syncytial Virus Vaccine (mRNA) (Monograph)

Drug class: Vaccines

Medically reviewed by Drugs.com on Sep 10, 2024. Written by ASHP.

Introduction

Nucleoside modified mRNA vaccine that stimuates active immunity to respiratory syncytial virus (RSV) infection.

Uses for Respiratory Syncytial Virus Vaccine (mRNA)

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

Used for active immunization for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals ≥60 years of age.

A single dose of RSV vaccine has demonstrated 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 all adults ≥75 years of age receive a single dose of RSV vaccine. ACIP also recommends that adults 60–74 years of age who are at increased risk of severe RSV disease receive a single dose of RSV vaccine.

Respiratory Syncytial Virus Vaccine (mRNA) 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

Supplied as a white to off-white suspension in a prefilled syringe containing a frozen suspension that must be thawed prior to administration.

Thaw each syringe before use, either in refrigerator or at room temperature. Do not refreeze after thawing. Do not shake.

A carton containing a single prefilled syringe may be thawed in refrigerator (2-8°C) for 60 minutes, then allowed to stand at room temperature for 10–20 minutes before administration. May also thaw at room temperature (15-25°C) for 45 minutes and can be administered at that time.

Cartons containing 10 prefilled syringes may be thawed in refrigerator (2-8°C) for 155 minutes, then allowed to stand at room temperature for 10–20 minutes before administration. May also thaw at room temperature (15-25°C) for 140 minutes and can be administered at that time.

Dosage

Adults

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

IM

Single 0.5-mL dose

Cautions for Respiratory Syncytial Virus Vaccine (mRNA)

Contraindications

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

Warnings/Precautions

Preventing and Managing Allergic Vaccine Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions.

Syncope

Syncope (fainting) may occur. Ensure that procedures are in place to avoid injury from fainting.

Individuals with Altered Immunocompetence

Consider possibility that immune response to vaccine may be diminished or suboptimal in these individuals.

Specific Populations

Pregnancy

Not approved for use in individuals <60 years of age.

No human data available to establish whether there is a vaccine-associated risk with use in pregnancy.

Lactation

Not approved for use in individuals <60 years of age.

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

Pediatric Use

Safety and effectiveness in individuals <18 years of age not established.

Geriatric Use

Approved for use in individuals ≥60 years of age and older. Efficacy against RSV-related lower respiratory tract disease was 58.8% among participants 60 to 69 years of age and 78% among participants 70 to 79 years of age; insufficient cases were available to determine efficacy in patients ≥80 years of age.

Common Adverse Effects

Most common adverse reactions (≥10%): injection-site pain, fatigue, headache, myalgia, arthralgia, axillary (underarm) swelling or tenderness, chills.

Stability

Storage

Parenteral

Injection

Minimize exposure to room light, and avoid exposure to direct sunlight and UV light.

Frozen Storage: Store between -40°C to -15°C.

Storage after Thawing (refrigerated): Store refrigerated between 2-8°C for up to 30 days prior to use.

Storage after Thawing (room temperature): May be stored between 8-25°C for a total of 24 hours after removal from refrigerated conditions; do not exceed 24 hours. Discard pre-filled syringe if not used within this time. Do not return to refrigerator after the drug is thawed at room temperature. Do not refreeze once thawed.

Transportation of Thawed Pre-filled Plastic Syringes: Can be transported at 2-8°C. Once thawed and transported at this temperature, do not refreeze and store at 2-8°C until use.

Actions

• Vaccine containing nucleoside modified mRNA encoding the RSV F glycoprotein stabilized in the prefusion conformation (preF protein); encapsulated in lipid nanoparticles (LNPs).

• Mechanism of action is based on delivery of mRNA-LNPs into host cells to allow expression of the RSV preF protein.

• Stimulates an immune response to the preF protein antigen, which protects against lower respiratory tract disease caused by RSV.

Advice to Patients

• Advise patients of the potential benefits and risks of RSV vaccine (mRNA).

• Clinicians or individuals can report any adverse reactions that occur following vaccination to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].

• Advise patients 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 patients 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.

Reload page with references included

Frequently asked questions

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

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