Dosing & Uses
Dosage 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 established
Evidence 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
Adverse Effects
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%)
Warnings
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 & Lactation
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/excretion
Pregnancy 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.Pharmacology
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
Administration
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
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Formulary
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