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influenza virus vaccine trivalent (Afluria, Fluzone, Agriflu, Flucelvax, Fluvirin, Fluzone High-Dose, Fluzone Intradermal)

 

Classes: Vaccines, Inactivated, Viral

Dosing and uses of Fluzone, Afluria (influenza virus vaccine trivalent)

 

Adult dosage forms and strengths

IM injection, regular strength

  • 22.5mcg/0.25mL
  • 45mcg/0.5mL
  • Flucelvax: New brand using mammalian culture instead of chicken embyros

IM injection, high-dose

  • 180mcg/0.5mL

ID injection

  • 27mcg/0.1mL

 

Influenza Prophylaxis

CDC's ACIP recommends that everyone 6 months of age and older receive an annual influenza vaccination

For more vaccine information see https://www.cdc.gov/vaccines/schedules/hcp/index.htmL

IM regular strength

  • 0.5 mL IM x1 dose

IntradermaL

  • Fluzone Intradermal (18-64 yr): 0.1 mL ID x1 dose

IM high-dose

  • Fluzone high dose (≥65 yr): 0.5 mL IM x1 dose

 

Dosing Considerations

Contains the following 3 viral strains for 2016-2017 northern hemisphere season:

A/California/7/2009 (H1N1)pdm09-like (same strain as was used for 2009 H1N1 monovalent vaccines)

A/Hong Kong/4801/2014 (H3N2)-like virus (new for 2016-2017)

B/Brisbane/60/2008-like virus (B/Victoria lineage vaccine virus) (new for the trivalent vaccine for 2016-2017)

 

Other Information

Up-to-date vaccination schedules available at https://www.cdc.gov/vaccines/schedules/hcp/index.htmL

 

Pediatric dosage forms and strengths

injection, regular strength

  • 22.5mcg/0.25mL
  • 45mcg/0.5mL

 

Influenza Prophylaxis

CDC's ACIP recommends that everyone 6 months of age and older receive an annual influenza vaccination

See Administration section for information regarding if 1or 2 doses are required for the 2013/2014 vaccine in children aged 6 months through 8 years

Fluzone

  • Approved for children >6 months
  • 6-18 months: 0.25 mL IM (anterolateral thigh) x1-2 doses/season
  • 18-35 months: 0.25 mL IM (deltoid) x1-2 doses/season
  • 3-8 years: 0.5 mL IM (deltoid) x1-2 doses/season
  • ≥9 years: 0.5 mL IM x1 dose/season

Fluvirin

  • <4 years: Safety and efficacy not established
  • 4-8 years: 0.5 mL IM (deltoid) x1-2 doses/season
  • ≥9 years: 0.5 mL IM x1 dose/season

Fluarix

  • Fluarix available only as quadrivalent vaccine for 2015/2016 flu season
  • <3 years: Safety and efficacy not established
  • 3-8 years: 0.5 mL IM (deltoid) x1-2 doses/season
  • ≥9 years: 0.5 mL IM x1 dose/season

Afluria

  • <5 years: Safety and efficacy not established
  • 5-8 years: 0.5 mL IM (deltoid) x1-2 doses/season
  • 9 years or older: As in adults

Flucelvax

  • <4 years: Safety and efficacy not established
  • 4-8 years: 0.5 mL IM (deltoid) x1-2 doses/season
  • ≥9 years: 0.5 mL IM x1 dose/season

 

Dosing Considerations

Contains the following 3 viral strains for 2016-2017 northern hemisphere season:

A/California/7/2009 (H1N1)pdm09-like (same strain as was used for 2009 H1N1 monovalent vaccines)

A/Hong Kong/4801/2014 (H3N2)-like virus (new for 2016-2017)

B/Brisbane/60/2008-like virus (B/Victoria lineage vaccine virus) (new for the trivalent vaccine for 2016-2017)

 

Geriatric dosage forms and strengths

Fluzone High-Dose: 0.5 mL IM x1 dose for adults 65 yr or older

 

Fluzone, Afluria (influenza virus vaccine trivalent) adverse (side) effects

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

 

Warnings

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 and lactation

Pregnancy category: B/C (manufacturer specific)

CDC recommends Influenza vaccine be administered during pregnancy (all trimesters); vaccination during pregnancy shown to decrease risk of illness in the mother, as well as the risk of influenza and influenza hospitalization in their infants during the first 6 months of life (MMWR August 26, 2011;60[33]:1128-32)

Lactation: excretion in milk unknown; use with caution

 

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.

 

Pharmacology of Fluzone, Afluria (influenza virus vaccine trivalent)

Mechanism of action

Inactivated influenza virus types A & B subunits

Convey active immunity via stimulation of production of endogenously produced antibodies

 

Pharmacokinetics

Onset: days

Duration: few months

Effectiveness: 70-90%

 

Administration

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 ≥5 years) 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 dosing algorithm)
  • Dosing algorithm for children aged 6 months through 8 years
    • Did the child receive at least 1 dose of the previous year’s seasonal influenza vaccine?
    • If yes, give 1 dose
    • If no or don’t know, did the child receive a total of at least 2 doses of seasonal influenza vaccine since July 1, 2010?
    • If yes, give 1 dose or if no or don’t know, give 2 doses
    • From ACIP recommendations: MMWR 2014 Aug 15 / 63(32);691-697