AdultPediatricDosage Forms & Strengths injection kit, lyophilized antigen component and adjuvant suspension After reconstitution, each 0.5-mL dose contains 120 mcg of recombinant RSVPreF3 antigen and 50 mcg of AS01E adjuvant Prevention of Respiratory Syncytial Infection Indicated for active immunization for prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) infection in adults aged ≥60 years 0.5 mL IM as a single dose Dosing Considerations Ongoing clinical trial Clinical trial participants will remain in the study through 3 RSV seasons to assess duration of effectiveness, and safety and effectiveness of repeat vaccination Data for a single dose from the first RSV season of the study were available for the FDA’s analysis for approval Safety and efficacy not establishedEvidence from an animal model strongly suggests that this vaccine would be unsafe in children aged <2 years because of an increased risk of enhanced respiratory disease VAERS Reporting Instruct vaccine recipients to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System (VAERS) or call 1-800-822-7967 >10% Pain, any grade (60.9%) Fatigue, any grade (33.6%) Myalgia, any grade (28.9%) Headache, any grade (27.2%) Arthralgia, any grade (18.1%) 1-10% Erythema, >20 mm (7.5%) Swelling, >20 mm (5.5%) Fever ≥38ºC/100.4ºF (2%) Fatigue, Grade 3 (1.7%) Myalgia, Grade 3 (1.4%) Headache, Grade 3 (1.3%) Arthralgia, Grade 3 (1.3%) Pain, Grade 3 (1%) <1% Erythema, >100 mm (0.2%) Swelling, >100 mm (0.2%) Fever >39ºC/102.2ºF (0.1%) Contraindications History of severe allergic reaction (eg, anaphylaxis) Cautions Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration Syncope (fainting) may occur in association with administration; ensure procedures are established to avoid injury from fainting Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response Pregnancy Not approved for use in persons aged <60 years An increase in preterm births was observed compared to pregnant individuals who received placebo in clinical study that enrolled pregnant individuals who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen Lactation Not approved for use in persons aged <60 years Unknown if excreted in human milk; no human or animal data are available to assess effects on breastfed infants or on milk production/excretionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with AS01E adjuvant Induces an immune response against RSVpreF3 that protects against lower respiratory tract disease caused by RSV IM Preparation Supplied as a vial of lyophilized recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (RSVPreF3) as the antigen component, which must be reconstituted at the time of use with the accompanying vial of AS01E adjuvant as the adjuvant suspension component Prepare by reconstituting lyophilized antigen component (sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid) Use only supplied adjuvant suspension component for reconstitution Do NOT shake vigorously; gently swirl vial until powder completely dissolved Reconstituted vaccine should be an opalescent, colorless to pale brownish liquid Visually inspect for particulate matter and discoloration before administration; discard if particles or discoloration observed Vial stoppers are not made with natural rubber latex Contains no preservatives IM Administration For IM injection only Storage Lyophilized antigen and adjuvant suspension vials Refrigerated at 2-8ºC (36-46ºF) Store in original package to protect from light Do not freeze; discard if frozen Reconstituted suspension If not administered immediately, store protected from light in refrigerator at 2-8ºC (36-46ºF) or at room temperature up to 25ºC (77ºF) Administer within 4 hr of reconstitution Discard if not used within 4 hr Do not freeze; discard if frozen No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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