respiratory syncytial virus (RSV) vaccine (Rx)

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%)

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

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.

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

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