Respiratory Syncytial Virus Vaccine, Adjuvanted (Monograph)

Drug class: Vaccines

Introduction

Adjuvanted recombinant stabilized pre-fusion F protein (RSVpreF3) that stimulates active immunity to respiratory syncytial virus (RSV) infection.

Uses for Respiratory Syncytial Virus Vaccine, Adjuvanted

Prevention of Lower Respiratory Tract Disease Caused by RSV

RSV vaccine, adjuvanted is used for active immunization for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals ≥60 years of age.

Vaccination with 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, Adjuvanted 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

IM Administration

Administer only by IM injection.

Administer preferably into the deltoid muscle.

Supplied as a single-dose vial of lyophilized antigen component to be reconstituted with the accompanying vial of adjuvant suspension component.

Reconstitute lyophilized antigen component (sterile white powder) with the adjuvant suspension component (opalescent, colorless to pale brownish sterile liquid).

Only use the supplied adjuvant suspension component for reconstitution.

Using aseptic technique, withdraw all of the adjuvant suspension component (liquid) with a sterile needle and syringe.

Slowly transfer entire syringe contents into the lyophilized antigen component vial. Gently swirl vial until powder is completely dissolved; do notshake vigorously.

Reconstituted vaccine should be an opalescent, colorless to pale brownish liquid; do not use if discolored or contains particulates.

Administer vaccine immediately after reconstitution, or store between 2°-25°C protected from light, and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

To administer the dose, withdraw 0.5 mL of the reconstituted vaccine and administer by IM injection.

Dosage

Adults

Prevention of Lower Respiratory Tract Disease Caused by RSV

IM

For active immunization for prevention of lower respiratory tract disease caused by RSV in patients ≥60 years of age: administer single 0.5-mL dose.

Cautions for Respiratory Syncytial Virus Vaccine, Adjuvanted

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.

Increased preterm births observed in pregnant individuals who received an investigational unadjuvanted RSVPreF3 antigen vaccine.

Lactation

Not approved for use in individuals <60 years of age. Not known whether respiratory syncytial virus IRSV) vaccine, adjuvanted is distributed in human milk. No data available to assess effects on the breastfed infant or on milk production.

Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for vaccination and any potential adverse effects on the breastfed child from the vaccine or underlying maternal condition (susceptibility to disease prevented by the vaccine).

Pediatric Use

Not approved for use in individuals <60 years of age. Evidence from animal models strongly suggests administration is unsafe in children <2 years of age because of an increased risk of enhanced respiratory disease. Safety and efficacy not established in children 2–17 years of age.

Geriatric Use

Approved for use in individuals ≥60 years of age. All individuals enrolled in principal efficacy study were ≥60 years of age.

Common Adverse Effects

Common local adverse reactions (≥10%): injection site pain.

Common systemic adverse reaction (≥10%): fatigue, myalgia, headache, arthralgia.

Drug Interactions

Specific Drugs

Stability

Storage

Parenteral

Injection, for IM use

Adjuvant suspension component: 2–8°C; do not freeze. Protect from light.

Lyophilized antigen component: 2–8°C; do not freeze. Protect from light.

Actions

• A recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) with AS01 adjuvant.

• The AS01-based adjuvant is composed of 3‑O‑desacyl‑4’‑monophosphoryl lipid A (MPL) from Salmonella minnesota and QS-21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation.

• Stimulates an immune response against RSVPreF3 to protect 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 patient of the potential benefits and risks of respiratory syncytial virus (RSV) vaccine, adjuvanted vaccination.

• Advise patients about the potential for adverse reactions that have been observed following vaccine administration.

• Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website ([Web]).

• 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 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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