Respiratory Syncytial Virus Vaccine, Adjuvanted (Systemic)

Usage of Respiratory Syncytial Virus Vaccine, Adjuvanted (Systemic)

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.

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How to use Respiratory Syncytial Virus Vaccine, Adjuvanted (Systemic)

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.

Warnings

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.

What other drugs will affect Respiratory Syncytial Virus Vaccine, Adjuvanted (Systemic)

Specific Drugs

Drug

Interaction

Comments

Influenza vaccine

Parenteral inactivated quadrivalent influenza vaccine: No evidence of interference in immune response when administered concurrently or separated by 1 month

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