influenza virus vaccine quadrivalent, intranasal (FluMist Quadrivalent): Dosing and Uses

Dosing and uses of FluMist Quadrivalent (influenza virus vaccine quadrivalent, intranasal)

• Adult
• Pediatric

Adult dosage forms and strengths

intranasal suspension

• 0.2mL (prefilled single use sprayer)

Influenza Prophylaxis

Indicated for prevention of influenza A and B infection in individuals aged 2-49 years

2-49 years: 0.2 mL/dose (0.1 mL/nostril); 1 dose/season

Intranasal administration for age ≥50 years: Safety and efficacy not established

ALERT: ACIP states intranasal flu vaccine should NOT be used for 2016-2017 season

• June 22, 2016: CDC’s Advisory Committee on Immunization Practices (ACIP) voted that live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine, should not be used during the 2016-2017 flu season
• This ACIP vote is based on data showing poor or relatively lower effectiveness of LAIV from 2013 through 2016
• In late May 2016, preliminary data on the effectiveness of LAIV among children aged 2-17 yr during 2015-2016 season became available from the U.S. Influenza Vaccine Effectiveness Network
• That data showed the estimate for LAIV VE among study participants in that age group against any flu virus was 3% (with a 95% Confidence Interval (CI) of -49% to 37%); this 3% estimate means no protective benefit could be measured
• In comparison, IIV (flu shots) had a VE estimate of 63% (with a 95% CI of 52-72%) against any flu virus among children aged 2-17 yr
• https://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

Dosing Considerations

Contains the following 4 viral strains for 2016-2017 northern hemisphere season:

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

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

B/Phuket/3073/2013-like virus (B/Yamagata lineage)

B/Brisbane/60/2008-like (B/Victoria lineage vaccine virus)

Pediatric dosage forms and strengths

intranasal suspension

• 0.2mL (prefilled single use sprayer)

Influenza Prophylaxis

Indicated for prevention of influenza A and B infection individuals aged 2-49 years

<2 year: Safety and efficacy not established

2-8 years: 0.2 mL/dose (0.1 mL in each nostril) x1-2 doses/season (see Administration)

≥9 years: As in adults; 0.2 mL/dose (0.1 mL/nostril); 1 dose/season

ALERT: ACIP states intranasal flu vaccine should NOT be used for 2016-2017 season

• June 22, 2016: CDC’s Advisory Committee on Immunization Practices (ACIP) voted that live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine, should not be used during the 2016-2017 flu season
• This ACIP vote is based on data showing poor or relatively lower effectiveness of LAIV from 2013 through 2016
• In late May 2016, preliminary data on the effectiveness of LAIV among children aged 2-17 yr during 2015-2016 season became available from the U.S. Influenza Vaccine Effectiveness Network
• That data showed the estimate for LAIV VE among study participants in that age group against any flu virus was 3% (with a 95% Confidence Interval (CI) of -49% to 37%); this 3% estimate means no protective benefit could be measured
• In comparison, IIV (flu shots) had a VE estimate of 63% (with a 95% CI of 52-72%) against any flu virus among children aged 2-17 yr
• https://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

Dosing Considerations

Contains the following 4 viral strains for 2016-2017 northern hemisphere season:

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

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

B/Phuket/3073/2013-like virus (B/Yamagata lineage)

B/Brisbane/60/2008-like (B/Victoria lineage vaccine virus)

FluMist Quadrivalent (influenza virus vaccine quadrivalent, intranasal) adverse (side) effects

>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%)

Warnings

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

Pregnancy and lactation

Pregnancy category: C

Live virus vaccine; indicated for nonpregnant adolescents and adults

Lactation: unknown; avoid intranasal live vaccine while breastfeeding newborn

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 FluMist Quadrivalent (influenza virus vaccine quadrivalent, intranasal)

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

Administration

Instructions

Administer at beginning of influenza season

Dosing algorithm for children aged 2 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 and if no or don’t know, give 2 doses
• From ACIP recommendations: MMWR 2014 Aug 15 / 63(32);691-697