respiratory syncytial virus (RSV) vaccine, adjuvanted (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%

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/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 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