Respiratory Syncytial Virus Vaccine, Adjuvanted (Monograph)

Drug class: Vaccines

Introduction

Protein subunit vaccine that stimulates active immunity to respiratory syncytial virus (RSV) infection; an adjuvanted recombinant stabilized pre-fusion F protein (RSVpreF3).

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 and in individuals 50–59 years of age who are at increased risk for LRTD caused by RSV.

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. ACIP is continuing to evaluate recommendations for the use of RSV vaccines in adults <60 years of age pending additional data in this population.

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.

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 in Older Adults

IM

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

Guillain-Barré Syndrome

Results of a postmarketing observational study suggest that risk of Guillain-Barré syndrome (GBS) may be increased during the 42 days following vaccination Based on the totality of evidence, FDA states that the current evidence suggests an increased risk of GBS with the RSV vaccine, but is insufficient to establish a causal relationship.

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 <50 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 <50 years of age. Not known whether RSV 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 <50 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 ≥50 years of age. Efficacy against RSV-related lower respiratory tract disease was 81% among participants 60 to 69 years of age and 93.8% among participants 70 to 79 years of age; insufficient cases were available to determine efficacy in patients ≥80 years of age.

Common Adverse Effects

Common adverse reactions (≥10%) in patients ≥60 years of age: injection site pain, fatigue, myalgia, headache, arthralgia.

Common adverse reactions (≥10%) in patients 50–59 years of age: injection site pain, fatigue, myalgia, headache, arthralgia, erythema, swelling.

Drug Interactions

Specific Drugs

Stability

Storage

Parenteral

Injectable Solution

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

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

Administer vaccine immediately after reconstitution, or store under refrigeration (2-8°C) or at room temperature (up to 25°C); protect from light and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.

Actions

• A recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) with AS01_E adjuvant.

• The AS01_E-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 patients of the potential benefits and risks of vaccination with RSV vaccine, adjuvanted.

• 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 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.

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