Influenza A Virus Vaccine (H5N1)

The GlaxoSmithKline product is an adjuvanted monovalent split virus (inactivated) preparation of the type A, subtype H5N1 avian strain of influenza virus (A/Indonesia/05/2005)

The Sanofi Pasteur product is a monovalent, split virus (inactivated) preparation of the type A, subtype H5N1 avian strain of influenza virus (A/Vietnam/1203/2004)

Both promote active immunity to influenza A H5N1 (avian).

Influenza A (H5N1) prevention:

GlaxoSmithKline product (adjuvanted): For active immunization of persons ≥6 months of age at increased risk of exposure to the influenza A (H5N1) virus subtype contained in the vaccine

Sanofi Pasteur product: For active immunization of persons 18-64 years of age at increased risk of exposure to the influenza A (H5N1) virus subtype contained in the vaccine

Primary immunization: GlaxoSmithKline product (adjuvanted): Children ≥6 months and Adolescents: IM: 0.25 mL, followed by a second 0.25 mL dose administered 21 days later.

There are no dosage adjustments provided in the manufacturer’s labeling.

GlaxoSmithKline product (adjuvanted): Prior to mixing, bring one vial of H5N1 antigen and one vial of AS03 adjuvant to room temperature (minimum of 15 minutes). Invert each vial to mix; do not use if particulate matter or discoloration are present. Withdraw contents of adjuvant vial and add to the H5N1 antigen vial. Mix thoroughly by inversion and label with the time and date of mixing on vial. Use within 24 hours of mixing.

Sanofi Pasteur product: Store in a refrigerator at 2°C to 8°C (35°F to 46°F). Do not freeze. Discard if frozen. Protect from light.

GlaxoSmithKline product (adjuvanted): Prior to mixing, the H5N1 antigen and AS03 adjuvant vials should be stored in a refrigerator between 2°C and 8°C (36°F and 46°F). Do not freeze. Discard if frozen. Protect from light. After mixing, the vaccine may be stored under refrigeration between 2°C and 8°C (36°F and 46°F) or at room temperature up to 30°C (86°F) for up to 24 hours. Do not freeze. Discard if frozen. Protect from light.

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index.

>10%:

Central nervous system: Headache (3% to 35%), fatigue (34%), shivering (17%)

Dermatologic: Diaphoresis (11%)

Local: Pain at injection site (74% to 83%), tenderness at injection site (70%), erythema at injection site (9% to 20%), swelling at injection site (10% to 15%)

Neuromuscular & skeletal: Myalgia (45%), arthralgia (25%)

1% to 10%:

Gastrointestinal: Nausea (10%), diarrhea (6%)

Local: Itching at injection site (2%), burning sensation at injection site (1%)

Respiratory: Nasal congestion (1%)

Miscellaneous: Fever (5%)

<1% (Limited to important or life-threatening): Celiac disease, cerebrovascular accident, convulsions, cranial nerve palsy (IV), Crohn’s disease, erythema nodosum, facial paralysis, giant-cell arteritis, hepatitis, malignant neoplasm of thyroid, organ transplant rejection (corneal), polymyalgia rheumatica, psoriasis, pulmonary embolism, radiculopathy, rheumatoid arthritis, rheumatoid lung