influenza virus vaccine trivalent (Rx)

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

>10%

Soreness at injection site (10-70%)

Frequency Not Defined

Fever

Malaise

Myalgia

Headache

Allergic reactions

Presyncope

Contraindications

Hypersensitivity to eggs, sulfites (persons with hives-only allergy to eggs, can receive the inactivated influenza vaccine)

Cautions

Use split or purified surface antigen in children

Defer vaccine with febrile illnesses until illness is resolved; may administer vaccine with minor illnesses without fever (eg, URIs)

Expected immune response may not be obtained in immunocompromised individuals, including those receiving immunosuppressive therapy

Syncope (fainting) can occur in association with administration of injectable vaccines; can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements; procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position

Vaccination may not protect all vaccine recipients against influenza disease

Pregnancy

Manufacturers are maintaining prospective pregnancy exposure registries to collect data on pregnancy outcomes following vaccination

Animal data

• No adverse effects observed on preweaning or vaccine-related fetal malformations when administered to female rabbits before pregnancy or during pregnancy

Clinical considerations

• Pregnant women are at increased risk of complication associated with influenza infection compared with nonpregnant women
• The CDC recommends pregnant women be immunized with influenza vaccine by injection and not the live attenuated influenza vaccine (LAIV; intranasal influenza vaccine)
• Vaccination has been shown to reduce the risk of flu-associated acute respiratory infection in pregnant women by up to 50%; immunization also confers some immunity to infants for the first several months after their birth, when they are too young to be vaccinated

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

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

Inactivated influenza virus types A & B subunits

Convey active immunity via stimulation of production of endogenously produced antibodies

Pharmacokinetics

Onset: ~2 weeks

Duration: Several months

Effectiveness: Varies seasonally, depending on viral strain and mutations; lower antibody response in patients aged >65 yr or immunosuppressed individuals

Instructions

Administer at beginning of influenza season

Should not be mixed with any other vaccine in the same syringe or vial

Shake well before administration

Adults and children >8 years

• IM: Administer IM in deltoid muscle of upper arm
• ID (18-64 yr): Administer ID in deltoid region of upper arm

• Afluria

  • For IM injection only, by either needle and syringe (age ≥6 months) or by the PharmaJet Stratis Needle-Free Injection System (aged 18 through 64 years)
  • PharmaJet Stratis is a needleless injection device that delivers an IM injection

Children aged 6 months through 8 years

• IM (aged 6-35 months): Administer IM in anterolateral thigh; do not inject in the gluteal area or areas where there may be a major nerve trunk
• IM (aged 3-8 years): Administer IM in deltoid muscle of upper arm
• 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