influenza virus vaccine quadrivalent, intranasal (Rx)

>10%

Adults

• Runny nose (41-45%)
• Headache (41-45%)
• Sore throat (26-30%)
• Weakness (26-30%)
• Myalgia (16-20%)
• Cough (11-15%)

Children

• Runny nose/nasal congestion (46-50%)
• Cough (36-40%)
• Irritability (16-20%)
• Headache (16-20%)

1-10%

Adults

• Chills (6-10%)
• Nasal congestion (6-10%)
• Sinusitis (2-5%)

Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

Contraindications

Hypersensitivity to eggs, sulfites

IV/IM administration

Children/adolescents receiving aspirin

Asthma, reactive airway disease

Diabetes, renal dysfunction

Hemoglobinopathies

Immunodeficiency diseases

Patients on immunosuppressants

Any chronic pulmonary/cardivascular disorder

Cautions

Do not administer within 2 wk of inactivated vaccine or 4 week of live virus vaccine

Treatment for anaphylactoid and/or hypersensitivity reactions must be present during vaccine use

Use caution in patients with history of Guillain-Barre

Nasal congestion may impair delivery of vaccine (avoid use)

Not recommended in patients with neurologic or neuromuscular disorders

Avoid use in children aged 2 through 4 years who had wheezing in the past 12 months, or those who have any other underlying medical conditions that predispose them to influenza complications

Caution in patients aged ≥5 yr who have asthma

Pregnancy

Not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug

Clinical considerations

• Pregnant women infected with seasonal influenza are at increased risk of severe illness associated with influenza infection compared with nonpregnant women
• Pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery

Lactation

Not absorbed systemically by the mother following intranasal administration and breastfeeding is not expected to result in exposure of the breastfed child

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; vaccines convey active immunity via stimulation of production of endogenously produced antibodies

Pharmacokinetics

Onset: Three weeks after vaccination

Duration: 6 months or more

Distribution: Nasal cavity, stomach, brain, and lungs

Intranasal Administration

Administer at beginning of influenza season

Each sprayer contains a single dose (0.2 mL); administer one-half of the contents of the single-dose intranasal sprayer into each nostril

With the patient in upright position, place tip of syringe applicator just inside the nostril and depress plunger as rapidly as possible

Children aged 2 years through 8 years

• If child requires 2 doses, administer at least 4 weeks apart (see number of doses)

• Number of doses

  • 2 doses administered a minimum of 4 weeks apart are required during child’s first season of vaccination for optimal protection
  • Children who have previously received ≥2 total doses of trivalent or quadrivalent influenza vaccine at least 4 weeks apart, require only 1 dose for the current flu season
  • The 2 doses of influenza vaccine do not have to have been administered in the same season or consecutive seasons
  • From ACIP recommendations: MMWR 2018 Aug 24 / 67(3);1-20