influenza A (H5N1) vaccine (Rx)

>10% (Audenz)

Adults aged 18-64 yr

• Injection site pain (64%)
• Fatigue (25%)
• Headache (25%)
• Malaise (22%)
• Myalgia (14%)

Adults aged 65 yr or older

• Injection site pain (36%)
• Fatigue (20%)
• Malaise (16%)
• Headache (16%)

Children aged 6-17 yr

• Injection site pain (68%)
• Myalgia (30%)
• Fatigue (27%)
• Malaise (25%)
• Headache (22%)
• Loss of appetite (14%)
• Nausea (13%)
• Arthralgia (13%)

Infants and children aged 6 mo through 5 yr

• Injection site tenderness (56%)
• Irritability (30%)
• Sleepiness (25%)
• Change in eating habits (18%)
• Fever ≥100.4ºF (16%)

1-10% (Audenz)

Adults aged 18-64 yr

• Arthralgia (10%)
• Nausea (10%)

Adults aged 65 yr or older

• Arthralgia (10%)

Children aged 6-17 yr

• Fever ≥100.4ºF (4%)
• Injection site induration (2%)
• Injection site pain, severe (1%)
• Injection site erythema (1%)
• Fatigue, severe (1%)
• Malaise, severe (1%)
• Loss of appetite, severe (1%)
• Nausea, severe (1%)
• Fever ≥102.1ºF (1%)

Infants and children aged 6 mo through 5 yr

• Injection site erythema (3%)
• Fever ≥102.1ºF (2%)
• Injection site tenderness (1%)
• Injection site induration (1%)
• Severe irritability (1%)

Postmarketing Reports (Audenz)

Blood and lymphatic system disorders: Lymphadenopathy

Immune system disorders: Hypersensitivity reactions including angioedema and anaphylaxis

Nervous system disorders: Bell Palsy, convulsions, including febrile convulsion, demyelination, encephalitis, Guillain-Barre Syndrome, neuritis, paresthesia, syncope

Skin and subcutaneous tissue disorders: Urticaria, pruritus, nonspecific rash

Musculoskeletal and connective tissue disorders: Muscular weakness

Contraindications

History of a severe allergic reaction (eg, anaphylaxis) to any vaccine component or after previous dose of an influenza vaccine

Cautions

Hypersensitivity reactions reported; appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions after vaccine administration

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give influenza A (H5N1) vaccine should be based on careful consideration of potential benefits and risks

Vaccination may not protect all recipients; immunocompromised individuals may have a diminished immune response

Drug interaction overview

• No data are available to evaluate concomitant administration with other vaccines
• Immunosuppressive or corticosteroid therapies may reduce immune response to vaccine

Pregnancy

Data are insufficient to inform of vaccine-associated risks during pregnancy

Animal data

• Female rabbits were administered MF59 adjuvant vaccine 1 and 3 weeks before mating, and on gestation days 7 and 20
• No vaccine-related fetal malformations or variations and no adverse effects on preweaning development were observed

Clinical considerations

• Limited information on risk of influenza A (H5N1) infection in pregnant women
• However, pregnant women infected with pandemic H1N1 or with seasonal influenza are at increased risk of severe illness associated with influenza infection compared to non-pregnant women
• Pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery

Lactation

Unknown if excreted in human milk; data are not 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

Influenza vaccines induce antibodies against the viral HA in the vaccine, which then blocks viral attachment to human respiratory cells

IM Preparation

AS03 adjuvant vaccine

• Supplied as 2 separate vials that must be combined before administration: a vial of H5N1 antigen and a vial of AS03 adjuvant
• Place 1 vial of H5N1 antigen and 1 vial of AS03 adjuvant at room temperature for minimum of 15 minutes
• Mix each vial by inversion and inspect visually for particulate matter and discoloration
• Cleanse both vial stoppers and withdraw the entire contents of the AS03 adjuvant vial using a sterile syringe with a 23-gauge sterile needle and add it to the H5N1 antigen vial to formulate the vaccine (may substitute 22-gauge or 21-gauge needle if 23-gauge needle not available)
• Mix vaccine thoroughly by inversion; after mixing, label the H5N1 antigen vial (now containing the vaccine) with the date and time mixed in the designated area on the vial label
• Withdraw 0.5 mL for an adult dose or 0.25 mL for a pediatric dose
• If stored in refrigerator after mixing, place vaccine at room temperature for minimum of 15 minutes before administration
• Mix the vaccine thoroughly by inversion before each administration

Prefilled syringe (Audenz)

• Gently shake syringe emulsion

IM Administration

Aged ≥12 months: Administer preferably in lateral aspect of deltoid muscle of upper arm

Aged 6-11 months: Administer in the anterolateral thigh; do not inject gluteal region or areas where a major nerve trunk might be present

Storage

Unopened AS03 adjuvant vials and MF59 adjuvant (Audenz) prefilled syringes

• Refrigerate at 2-8ºC (35-46ºF)
• Do not freeze (discard if frozen)
• Protect from light

AS03 adjuvant storage after mixing

• Administered within 24 hr of combining
• Once combined, may refrigerate at 2-8ºC (36-46ºF) or at room temperature up to 30ºC (86ºF) for up to 24 hr
• Do not freeze (discard if frozen)
• Protect from light