Dosing & Uses
Dosage Forms & Strengths
injection kit, lyophilized antigen component and sterile water diluent
- After reconstitution, each 0.5-mL dose contains 120 mcg of RSV stabilized prefusion F proteins (60mcg RSV PreF A and 60mcg RSV PreF B)
Prevention of Respiratory Syncytial Infection
Aged ≥60 years
- Indicated for active immunization for prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) infection in adults aged ≥60 years
- 0.5 mL IM as a single dose
Maternal vaccination
- Indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age 0.5 mL IM as a single dose
- 32-36 weeks gestation: 0.5 mL IM as a single dose
Dosing Considerations
Limitation of effectiveness: May not protect all vaccine recipients
Ongoing clinical trial
- Clinical trial participants will remain in the study through several RSV seasons to assess duration of effectiveness, as well as 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
See adult dosing for vaccination during pregnancy to prevent respiratory syncytial virus (RSV) in infants from birth through age 6 months
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%
Fatigue, any (15.5%)
Headache, any (12.8%)
Injection site pain, any (10.5%)
Muscle pain, any (10.1%)
1-10%
Injection site pain, mild (9.4%)
Fatigue, mild (9.3%)
Headache, mild (9%)
Joint pain, any (7.5%)
Muscle pain, mild (6.5%)
Fatigue, moderate (5.9%)
Diarrhea, any (5.9%)
Joint pain, mild (4.5%)
Diarrhea, mild (4.4%)
Headache, moderate (3.7%)
Muscle pain, moderate (3.5%)
Nausea, any (3.4%)
Joint pain, moderate (2.9%)
Redness, any (2.7%)
Nausea, mild (2.5%)
Swelling, any (2.4%)
Swelling, mild (1.5%)
Redness, mild (1.5%)
Fever, ≥38ºC (1.4%)
Diarrhea, moderate (1.3%)
Redness, moderate (1.1%)
Injection site pain, moderate (1.1%)
<1%
Swelling, moderate (0.9%)
Nausea, moderate (0.9%)
Nausea, any (0.9%)
Fever >38.4-38.9ºC (0.8%)
Nausea, mild (0.7%)
Fever 38-38.4ºC (0.6%)
Fatigue, severe (0.3%)
Muscle pain, severe (0.2%)
Nausea, moderate (0.2%)
Swelling, severe (0.1%)
Redness, severe (0.1%)
Headache, severe (0.1%)
Diarrhea, severe (0.1%)
Injection site pain, severe (<0.1%)
Joint pain, severe (<0.1%)
Fever >38.9-40ºC (<0.1%)
Warnings
Contraindications
History of severe allergic reaction (eg, anaphylaxis) to any of the vaccine components
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
Preterm births
- A numerical imbalance in preterm births in RSV vaccine recipients was observed compared to placebo recipients in 2 clinical studies
- Available data are insufficient to establish or exclude a causal relationship between preterm birth and the vaccine
- To avoid potential risk of preterm birth (ie, before 32 weeks gestation), administer vaccine at 32 through 36 weeks gestational age
- Pregnant individuals who were at increased risk of preterm birth were generally excluded from clinical studies
Pregnancy & Lactation
Pregnancy
Not approved for use in persons aged <60 yr
Human data
- Data from a clinical trial (NCT04424316) that enrolled pregnant individuals who were randomly assigned 1:1 to receive RSV vaccine or placebo (0.5 mL dose, containing the same buffer ingredients in the same quantities as in a single dose of Abrysvo at 24-36 weeks’ gestation revealed no evidence for vaccine-associated increase in the risk of congenital anomalies or fetal deaths
- In this study, there was a numerical imbalance in preterm births, with more preterm infants born to individuals in the RSV vaccine group compared than to individuals in the placebo group
Animal data
- A developmental and reproductive toxicity study was performed in female rabbits administered a vaccine formulation containing 2 times the antigen content of a single human dose before and during gestation
- Results showed no evidence of fetal harm or of adverse effects on postnatal survival, growth, or development
Lactation
Not approved for use in persons aged <60 yr
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 composed of equal amounts of recombinant RSV prefusion F from subgroups A and B
Induces an immune response against RSV pre F that protects against lower respiratory tract disease caused by RSV
Administration
IM Preparation
Prepare by reconstituting lyophilized antigen component (sterile white powder) with the accompanying prefilled syringe containing sterile water diluent component and a vial adapter
See prescribing information for diagrams
Step 1 - Removal of cap
- Remove plastic flip off cap from vial and cleanse rubber stopper
- Without removing vial adapter from its packaging, peel off top cover
Step 2 - Attachment of vial adapter
- Hold base of vial on flat surface
- Keep vial adapter in packaging and orient it vertically over center of vial so that adapter spike aligns with center of vial’s rubber stopper
- Connect vial adapter to vial with a straight downward push; vial adapter will lock into place
- Do not push vial adapter in at an angle as this may result in leaking during use
- Remove vial adapter packaging
Step 3 - Removal of syringe cap
- For all syringe assembly steps, hold syringe only by Luer lock adapter located at tip of the syringe; this will prevent Luer lock adapter from detaching during use
- Remove syringe cap by slowly turning cap counter-clockwise while holding Luer lock adapter
Step 4 - Connection of syringe to vial adapter
- Hold the syringe’s Luer lock adapter and connect it to vial adapter by turning clockwise
- Stop turning when you feel resistance, overtightening syringe may result in leaking during use
- When syringe is securely attached to vial adapter, there will be a small space between top of vial adapter and the Luer lock adapter of syringe
Step 5 - Reconstitution of lyoophilized antigen component
- Inject entire contents of syringe containing sterile water diluent into vial
- Do not remove empty syringe
- While holding plunger rod down, gently swirl vial in circular motion until powder is completely dissolved (<1 min)
- Do not shake
Step 6 - Withdrawal of reconstituted vaccine
- Invert vial completely with vial adapter and syringe still attached
- Slowly withdraw entire contents into syringe to ensure ~0.5 mL dose of vaccine for administration
- Do not pull plunger rod out
Step 7 - Disconnection of syringe
- Hold Luer lock adapter of syringe and disconnect syringe from vial adapter by turning counter-clockwise
Step 8 - Attachement of new needle
- Attach sterile needle suitable for IM injection to syringe containing vaccine
Step 9 - Visual inspection
- Solution should appear clear and colorless
- Inspect visually for particulate matter and discoloration
- Discard if either condition is present
- Store at room temperature and use within 4 hr after reconstitution
IM Administration
For IM injection only
Storage
Lyophilized antigen and diluent
- Refrigerated at 2-8ºC (36-46ºF) in original carton
- Do not freeze; discard if frozen
Reconstituted solution
- If not administered immediately, store at room temperature up to 15-30ºC (59-86ºF) and use within 4 hr
- Do not store reconstituted vaccine in refrigerator
- Do not freeze reconstituted vaccine
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