Type: Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine
Form: Lyophilized Powder for Solution, 120 mcg RSV stabilized prefusion F protein per 0.5 mL
Manufacturer: Pfizer Canada ULC
Indications and Clinical Use
Indication:
Pregnant Individuals: Active immunization from 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age.
Individuals 60 Years and Older: Prevention of LRTD caused by RSV by active immunization.
Pediatrics: Safety and efficacy in individuals younger than 18 years (except in pregnancy) not established.
Geriatrics: Clinical studies include participants 65 years and older.
Dosage and Administration
Recommended Dose:
Pregnant Individuals: Single dose of 0.5 mL intramuscularly in the third trimester (32-36 weeks gestation).
Individuals 60 Years and Older: Single dose of 0.5 mL intramuscularly.
Reconstitution:
Reconstitute the lyophilized vaccine with the provided sterile water diluent.
Inject the entire contents of the syringe into the vial, swirl gently until dissolved.
Withdraw the entire reconstituted solution for administration.
Administration: Administer intramuscularly into the deltoid muscle. Do not mix with other vaccines or medicinal products.
Contraindications
Hypersensitivity to the active substance or any component of the vaccine.
Warnings and Precautions
General: Medical treatment and supervision should be available for anaphylactic events. Syncope may occur.
Concurrent Illness: Postpone vaccination in individuals with acute severe febrile illness.
Special Populations:
Pregnant Women: Studied in pregnant individuals from 24 through 36 weeks gestation.
Breastfeeding: No data on excretion in human or animal milk.
Immunocompromised Individuals: May have a diminished immune response.
Adverse Reactions
Very Common: Injection site pain, headache, myalgia.
Common: Injection site redness and swelling.
Uncommon: Hypersensitivity reactions.
Rare: Severe allergic reactions.
Drug Interactions
Concurrent Vaccination: Immune response data available for concomitant administration with Tdap vaccine. No data for concomitant administration with influenza vaccines.
Administration: Do not mix with other vaccines in the same syringe.
Storage and Stability
Unreconstituted Vaccine: Store at 2°C to 8°C. Protect from light. Do not freeze.
Reconstituted Vaccine: Use immediately (within 4 hours). Store at 15°C to 30°C. Do not refrigerate or freeze.
Clinical Trials and Efficacy
Pregnant Individuals (Study C3671008):
Demonstrated efficacy in preventing RSV-associated medically attended lower respiratory tract illness and severe LRTD in infants up to 6 months of age.
Efficacy: 81.8% at 90 days, 69.4% at 180 days for severe LRTD.
Older Adults (Study C3671013):
Demonstrated efficacy in preventing RSV-associated lower respiratory tract illness with ≥2 symptoms.
Efficacy: 66.7% for ≥2 symptoms, 85.7% for ≥3 symptoms.
