Influenza Virus Vaccine

Pronunciation: (IN-floo-EN-za)
Class: Vaccine, viral

Trade Names

Afluria
- Injection, suspension (purified split-virus) 15 mcg hemagglutinin (HA) each of A/California/7/2009 NYMC X-181 (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like strain), and B/Brisbane/60/2008 per 0.5 mL

Fluarix
- Injection, suspension (purified split-virus) 15 mcg HA each of A/California/7/2009 NYMC X-181 (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008 per 0.5 mL

FluLaval
- Injection, suspension (purified split-virus) 15 mcg HA each of A/California/7/2009 NYMC X-179A (H1N1), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008 per 0.5 mL

FluMist
- Spray, intranasal 10 ^6.5-7.5 fluorescent focus units of A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008 per 0.2 mL actuation

Fluvirin
- Injection, suspension (purified split-virus) 15 mcg HA each of A/Christchurch/16/2010, NIB-74 (H1N1) (an A/California/7/2009-like virus), A/Victoria/210/2009 NYMC X-187 (H3N2) (an A/Perth/16/2009-like strain), and B/Brisbane/60/2008 per 0.5 mL

Fluzone
- Injection, suspension (purified split-virus) 15 mcg HA each of A/California/7/2009 X-179A (H1N1), A/Victoria/210/2009 X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008 per 0.5 mL

Fluzone High-Dose
- Injection, suspension (purified split-virus) 60 mcg HA each of A/California/7/2009 X-179A (H1N1), A/Victoria/210/2009 X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008 per 0.5 mL

Fluzone Intradermal
- Injection, suspension (purified split-virus) 9 mcg HA each of A/California/7/2009 X-179A (H1N1), A/Victoria/210/2009 X-187 (H3N2) (an A/Perth/16/2009-like virus), and B/Brisbane/60/2008 per 0.1 mL

Vaxigrip (Canada)

Pharmacology

Induces formation of specific antibodies that protect against virus strains from which the vaccines are prepared, or closely related strains.

Indications and Usage

Induction of active immunity against the specific influenza viruses corresponding to strains in current-year vaccine formula. Fluvirin is not indicated for children younger than 4 y. FluMist is not indicated in persons younger than 2 y or older than 49 y. Afluria and Fluzone are not indicated in children younger than 6 mo. Fluarix is not indicated in children younger than 3 y. Fluzone High-Dose is indicated only in persons 65 y of age and older. Fluzone Intradermal is not indicated in persons younger than 18 y or older than 64 y. FluLaval is not indicated in persons younger than 18 y.

Contraindications

Hypersensitivity to any component of the vaccine, including thimerosal; hypersensitivity to egg proteins (eg, eggs, egg products); life-threatening reaction to previous influenza vaccination.

Afluria

Hypersensitivity to neomycin or polymyxins.

FluMist

Hypersensitivity to gentamicin, gelatin, or arginine; children and adolescents 2 to 17 y of age receiving aspirin therapy or aspirin-containing therapy.

Dosage and Administration

Afluria
Adults and Children 9 y and older

IM 0.5 mL as a single dose.

Children 3 to 8 y of age

IM 0.5 mL as a single dose. Repeat the dose approximately 4 wk later for those who are receiving the influenza vaccine for the first time or were vaccinated for the first time last season with only 1 dose.

Children 6 to 35 mo of age

IM 0.25 mL as a single dose. Repeat the dose approximately 4 wk later for those who are receiving the influenza vaccine for the first time or were vaccinated for the first time last season with only 1 dose.

FluLaval
Adults

IM 0.5 mL as a single dose.

Fluarix
Adults and Children 9 y and older

IM 0.5 mL as a single dose.

Children 3 to younger than 9 y

IM 0.5 mL as a single dose. Repeat the dose at least 1 mo later for those who are receiving the influenza vaccine for the first time or were vaccinated for the first time last season with only 1 dose.

FluMist
Adults and Children 9 to 49 y of age

Nasal inhalation 0.2 mL dose (0.1 mL per nostril).

Children 2 to 8 y of age Nasal inhalation Previously vaccinated with influenza vaccine

0.2 mL dose (0.1 mL per nostril).

Not previously vaccinated with influenza vaccine

0.2 mL dose (0.1 mL per nostril) followed by a second 0.2 mL dose (0.1 mL per nostril) given at least 1 mo later.

Fluvirin
Adults and Children 9 y and older

IM 0.5 mL as a single dose.

Children 4 to 8 y of age

IM 0.5 mL as a single dose. Repeat the dose at least 1 mo later for those who are receiving the influenza vaccine for the first time or were vaccinated for the first time last season with only 1 dose.

Fluzone
Adults and Children 9 y and older

IM 0.5 mL as a single dose.

Children 3 to 8 y of age

IM 0.5 mL as a single dose. Repeat the dose at least 1 mo later for those who are receiving the influenza vaccine for the first time or were vaccinated for the first time last season with only 1 dose.

Children 6 to 35 mo of age

IM 0.25 mL as a single dose. Repeat the dose at least 1 mo later for those who are receiving the influenza vaccine for the first time or were vaccinated for the first time last season with only 1 dose.

Fluzone High-Dose
Adults 65 y and older

IM 0.5 mL as a single dose.

Fluzone Intradermal
Adults 18 to 64 y of age

Intradermal 0.1 mL as a single dose.

General Advice

• Do not use vaccine prepared for a previous season to provide protection for the current season.
• The 2010-2011 seasonal flu vaccine includes the H1N1 strain derived from the pandemic strain that circulated in 2009-2010.
• Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration and name and title of person administering vaccine.
• Children who were given 2 doses of influenza vaccine last season or at least 1 dose 2 or more years ago should only receive 1 dose of influenza vaccine.
• Children 6 mo to 8 y of age who did not receive at least 1 dose of 2009 H1N1 vaccine should receive 2 doses of 2010 seasonal flu vaccine.

• Parenteral
• For IM ( Afluria , Fluarix , FluLaval , Fluvirin , Fluzone , Fluzone High-Dose ) or intradermal ( Fluzone Intradermal ) administration only. Not for subcutaneous, IV, or intra-arterial administration.
• Do not inject into the gluteal region or into areas where there may be a major nerve trunk.
• May be coadministered with childhood vaccines.
• May be coadministered with pneumococcal vaccine using separate syringes and at different sites.
• There are insufficient data to assess coadministration of influenza vaccine with other vaccines.
• Do not mix influenza vaccine with any other vaccine in the same syringe or vial.
• Shake multidose vial well before withdrawing dose.
• Shake prefilled syringe well before administering dose.
• Do not administer if solution is discolored or if particulate matter is noted.
• Administer IM vaccine to adults in deltoid muscle using needles 1 inch or longer to ensure penetration of muscle mass.
• Administer IM vaccine to children with adequate deltoid muscle mass in deltoid muscle using needles 7/ 8 to 1¼ inch in length to ensure penetration of muscle mass.
• Administer IM vaccine to infants older than 6 mo and young children in anterolateral aspect of thigh using needles 7/ 8 to 1 inch in length to ensure penetration of muscle mass.

• Intranasal spray
• For nasal use only. Not for parenteral administration.
• Administer 50% of dose (a single spray) into each nostril while the patient is in an upright position. Insert tip of sprayer just inside nostril and depress plunger to spray. Remove dose divider clip and administer remaining 50% of dose into the other nostril.
• Dispose of used sprayer following approved procedures for disposal of biohazardous waste.

Storage/Stability

Store in the refrigerator between 36° and 46°F; do not freeze. Protect from light. Once entered, a multidose vial should be discarded after 28 days. Between uses, return the multidose vial to the refrigerator between 36° and 46°F.

Drug Interactions

Antivirals

Do not administer FluMist until 48 h after cessation of antiviral therapy; do not administer antivirals until 14 days after giving FluMist unless medically indicated.

Aspirin

Contraindicated in children or adolescents receiving FluMist .

Immunosuppressant drugs (eg, high-dose corticosteroids), radiation therapy

May result in inadequate response to immunization. Because FluMist is a live vaccine, the risk of dissemination may be increased in immunocompromised patients or in patients receiving immunosuppressants; avoid use.

Phenytoin, theophylline, warfarin

Use with caution in patients receiving flu vaccine because studies have yielded inconsistent results.

Adverse Reactions

Cardiovascular

Fluarix

Henoch-Schönlein purpura, tachycardia, vasculitis (postmarketing).

FluLaval

Flushing, pallor, syncope (postmarketing).

FluMist

Pericarditis (postmarketing).

Fluvirin

Hypertension (5%); hot flashes/flushes, syncope, vasculitis (postmarketing).

Fluzone

Syncope, vasculitis, vasodilation/flushing (postmarketing).

CNS

Afluria

Irritability (48%); headache (26%); malaise (20%); convulsions (including febrile seizures), encephalopathy, Guillain-Barré syndrome, neuralgia, neuritis or neuropathy, paresthesia, transverse myelitis (postmarketing).

Fluarix

Fatigue, irritability (21%); headache (20%); drowsiness (13%); malaise (up to 10%); migraine (1%); asthenia, convulsions, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia, vertigo (postmarketing).

FluLaval

Headache (18%); fatigue (17%); malaise (10%); abnormal gait, asthenia, convulsions/seizures, dizziness, encephalopathy, facial or cranial paralysis, Guillain-Barré syndrome, hypoesthesia, hypokinesia, insomnia, limb paralysis, paresthesia, somnolence, tremor (postmarketing).

FluMist

Headache (40%); tiredness/weakness (26%); decreased appetite, irritability (21%); lethargy (14%); decreased activity (6%); Bell palsy, eosinophilic meningitis, Guillain-Barré syndrome, meningitis, vaccine-associated encephalitis (postmarketing).

Fluvirin

Headache (33%); malaise (19%); fatigue (18%); migraine (6%); asthenia, confusion, dizziness, febrile convulsions, Guillain-Barré syndrome, myelitis (including encephalomyelitis and transverse myelitis), neuralgia, neuropathy (including neuritis), paralysis (including Bell palsy), paresthesia (postmarketing).

Fluzone

Headache, malaise (14%); Guillain-Barré syndrome; asthenia/fatigue, brachial neuritis, convulsions, dizziness, facial palsy (Bell palsy), myelitis (including encephalomyelitis and transverse myelitis), optic neuritis/neuropathy, paresthesia (postmarketing).

Fluzone High-Dose

Malaise (18%); headache (17%).

Fluzone Intradermal

Headache (31%); malaise (23%).

Dermatologic

Afluria

Pruritus, rash, urticaria (postmarketing).

Fluarix

Sweating (up to 10%); angioedema, erythema, erythema multiforme, facial swelling, pruritus, rash, Stevens-Johnson syndrome, urticaria (postmarketing).

FluLaval

Localized or generalized rash, periorbital edema, pruritus, sweating, urticaria (postmarketing).

FluMist

Rash (postmarketing).

Fluvirin

Sweating (9%); facial edema, pruritus, rash (including nonspecific, maculopapular, and vesiculobullous), Stevens-Johnson syndrome, urticaria (postmarketing).

Fluzone

Pruritus, Stevens-Johnson syndrome (postmarketing).

EENT

Afluria

Rhinitis (48%); sore throat (11%); nasopharyngitis (8%); nasal congestion (7%); pharyngolaryngeal pain (5%); earache (4%).

Fluarix

Rhinitis (up to 10%); nasopharyngitis (3%); nasal congestion, otitis media, pharyngolaryngeal pain (2%); conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling, pharyngitis, tonsillitis (postmarketing).

FluLaval

Sore throat (9%); reddened eyes (6%); pharyngolaryngeal pain (2%); nasal congestion, nasopharyngitis (1%); conjunctivitis, eye pain, laryngitis, pharyngitis, photophobia, rhinitis, throat tightness (postmarketing).

FluMist

Nasal congestion/runny nose (58%); sore throat (28%); otitis media (3%); sneezing (2%).

Fluvirin

Pharyngitis (13%); sore throat (8%); rhinitis (7%); rhinorrhea (6%).

Fluzone

Pharyngitis, rhinitis (postmarketing).

GI

Afluria

Vomiting/diarrhea (15%); nausea (6%); vomiting (5%).

Fluarix

Diarrhea, vomiting (3%); upper abdominal pain (1%); abdominal pain or discomfort, nausea, swelling of the mouth, tongue, and/or throat (postmarketing).

FluLaval

Diarrhea, nausea (1%); dysphagia, vomiting (postmarketing).

FluMist

Abdominal pain (12%); diarrhea, nausea, vomiting (postmarketing).

Fluvirin

Nausea (7%); abdominal pain, diarrhea, vomiting (postmarketing).

Genitourinary

Afluria

Vasculitis with transient renal involvement (postmarketing).

Fluarix

Dysmenorrhea (1%).

Fluvirin

Vasculitis with transient renal involvement (postmarketing).

Hematologic-Lymphatic

Afluria

Transient thrombocytopenia (postmarketing).

Fluarix

Lymphadenopathy (postmarketing).

FluLaval

Lymphadenopathy (postmarketing).

Fluvirin

Lymphadenopathy, transient thrombocytopenia (postmarketing).

Fluzone

Lymphadenopathy, thrombocytopenia (postmarketing).

Hypersensitivity

Afluria

Allergic reactions, including anaphylactic shock and serum sickness (postmarketing).

Fluarix

Anaphylactic reaction (including shock), anaphylactoid reaction, hypersensitivity, serum sickness (postmarketing).

FluLaval

Allergic edema of the face, mouth, and throat, anaphylaxis (postmarketing).

FluMist

Hypersensitivity reactions, including anaphylactic reaction, facial edema, and urticaria (postmarketing).

Fluvirin

Hypersensitivity reactions, including anaphylaxis, throat and mouth edema, and death (postmarketing).

Fluzone

Allergic reactions, including anaphylaxis, angioedema, and urticaria.

Local

Afluria

Pain (62%); tenderness (60%); erythema (46%); swelling (27%); redness (23%); bruising (5%).

Fluarix

Pain (56%); redness (23%); swelling (14%); ecchymosis, induration (up to 10%); injection-site abscess, injection-site cellulitis, injection-site mass, injection-site reaction, injection-site warmth (postmarketing).

FluLaval

Pain (24%); redness (11%); swelling (10%); injection-site erythema (1%); injection-site bruising, injection-site inflammation, injection-site rash, injection-site sterile abscess (postmarketing).

Fluvirin

Pain (55%); erythema (22%); induration, swelling (15%); mass (11%); inflammation (9%); ecchymosis (7%); edema (6%); injection-site reaction (5%); hemorrhage, pruritus (1%); pain limiting limb movement, redness, warmth (postmarketing).

Fluzone

Pain (24%); erythema (11%); swelling (6%).

Fluzone High-Dose

Pain (36%); erythema (15%); swelling (9%).

Fluzone Intradermal

Erythema (76%); induration (58%); swelling (57%); pain (51%); pruritus (47%); ecchymosis (9%).

Metabolic-Nutritional

Afluria

Loss of appetite (24%).

Fluarix

Loss of appetite (13%).

FluMist

Decreased appetite (21%).

Fluvirin

Loss of appetite (postmarketing).

Musculoskeletal

Afluria

Muscle aches, myalgia (14%); back pain (2%).

Fluarix

Muscle aches (29%); musculoskeletal pain, neck pain (up to 10%); arthralgia (9%); back pain (2%); pain in extremities (1%).

FluLaval

Myalgia (13%); arthralgia, back pain (1%); arthritis, muscle weakness, rigors (postmarketing).

FluMist

Muscle aches (17%).

Fluvirin

Myalgia (21%); arthralgia, back pain (7%); myasthenia (postmarketing).

Fluzone

Myalgia (18%); pain in extremities (postmarketing).

Fluzone High-Dose

Myalgia (21%).

Fluzone Intradermal

Myalgia (27%).

Respiratory

Afluria

Cough (32%); upper respiratory tract infection (10%); wheezing/shortness of breath (9%); lower respiratory tract infection (1%).

Fluarix

Upper respiratory tract infection (6%); cough (5%); upper respiratory tract congestion (1%); asthma, bronchospasm, dyspnea, respiratory distress, stridor (postmarketing).

FluLaval

Cough (6%); upper respiratory tract infection (1%); bronchospasm, dysphonia, dyspnea (postmarketing).

FluMist

Cough (14%); wheezing (6%); sinusitis (4%); epistaxis (postmarketing).

Fluvirin

Cough (6%); increased cough (5%); difficulty breathing, wheezing (1%); chest pain, dyspnea (postmarketing).

Fluzone

Dyspnea (postmarketing).

Miscellaneous

Afluria

Fever (23%); influenza-like illness (14%); chills/shivering (7%).

Fluarix

Fever (7%); shivering (3%); influenza-like illness (2%); body aches, chest pain, chills, feeling hot (postmarketing).

FluLaval

Fever (11%); chills (5%); chest tightness (3%); facial swelling (1%); cellulitis, chest pain, influenza-like symptoms (postmarketing).

FluMist

Chills, fever (9%); exacerbation of symptoms of mitochondrial encephalomyopathy (postmarketing).

Fluvirin

Chills (7%); fever, infection (5%); chest tightness, shivering (1%).

Fluzone

Fever (2%); chest pain (postmarketing).

Fluzone High-Dose

Fever (4%).

Fluzone Intradermal

Shivering (7%); fever (4%).

Precautions

Pregnancy

Category B ( Fluarix , FluLaval , Fluzone Intradermal ); Category C ( Afluria , FluMist , Fluvirin , Fluzone , Fluzone High-Dose ). According to the Advisory Committee on Immunization Practices (ACIP), vaccination is recommended in women who will be pregnant during the influenza season.

Lactation

Undetermined. The ACIP recommends vaccination in breast-feeding women who are in contact with infants or children younger than 5 y.

Children

Safety and efficacy not established in children younger than 6 mo ( Afluria , Fluzone ). Safety and efficacy not established in children younger than 4 y ( Fluvirin ). Safety and efficacy not established in children younger than 3 y ( Fluarix ). Safety and efficacy not established in children younger than 2 y ( FluMist ). FluLaval , Fluzone High-Dose , and Fluzone Intradermal are not indicated for use in children.

Elderly

H1 antibody responses are lower.

FluMist

Not indicated for persons 50 to 65 y of age; safety and efficacy not established in persons 65 y and older.

Fluzone Intradermal

Safety and efficacy not established in persons 65 y and older.

Hypersensitivity

Anaphylactic reactions have been reported.

Asthma

FluMist

Do not administer to persons with asthma or to children younger than 5 y with recurrent wheezing unless the benefit outweighs the risk.

Bleeding disorders

Because of the risk of hematoma, do not administer parenteral influenza virus vaccine to persons with bleeding disorders, such as hemophilia or thrombocytopenia, or to persons receiving anticoagulants.

Efficacy

Influenza vaccination may not protect all persons.

Guillain-Barré syndrome

If Guillain-Barré syndrome has occurred within 6 wk after a previous influenza vaccination, base the decision to give the influenza vaccine on careful consideration of the potential benefits and possible risks.

High-risk persons

Intranasal influenza vaccine is not indicated for persons with underlying medical conditions that could predispose them to severe complications following wild-type influenza infection.

Impaired immune response

Patients with impaired immune responsiveness, whether caused by genetic defect, immunodeficiency disease, or immunosuppressive therapy, may have a reduced antibody response to inactivated influenza vaccine and may remain susceptible despite immunization.

FluMist

Because this product is a live virus vaccine, use it with caution in immunocompromised persons.

Latex sensitivity

Tip caps of Fluarix , Fluvirin , Fluzone , and Fluzone High-Dose prefilled syringes contain natural latex rubber that may cause allergic reactions in latex-sensitive persons.

Patient Information

• Review benefits and risks of the vaccine and the importance of completing the immunization series.
• Provide patient, parent, or guardian with immunization history record and record this immunization in patient immunization record.
• Provide and review patient information leaflet prior to immunization.
• Advise patient, parent, or caregiver that vaccine will be prepared and administered by a health care provider.
• Remind patient, parent, or caregiver that vaccine needs to be administered every year in order to provide ongoing protection.
• Instruct patient to report any severe or unusual adverse reactions to health care provider.
• Instruct patient that the full effect of the vaccine is generally achieved approximately 3 wk after vaccination.

• Parenteral
• Inform patient, parent, or caregiver that the vaccine contains noninfectious killed viruses and cannot cause influenza, but coincidental respiratory disease unrelated to influenza vaccine can occur after vaccination.
• Advise patient receiving parenteral vaccine that soreness at injection site is the most common adverse reaction and may last for up to 2 days.
• Advise patient, parent, or caregiver that fever, general body discomfort, and muscle pain can develop, and to use nonnarcotic analgesics and antipyretics (eg, ibuprofen) for symptomatic relief. Advise patient, parent, or caregiver to report severe or persistent symptoms to a health care provider.
• Advise patient, parent, or caregiver to notify health care provider immediately if unusual neurologic reactions (eg, abnormal skin sensations, paralysis, unexplained change in thinking or behavior) are noted.
• Advise parent or guardian of children younger than 9 y who have not previously received influenza vaccine that a second dose, at least 4 wk after the first dose, is required to obtain max protection.

• Intranasal spray
• Caution patient, parent, or caregiver to have vaccine recipient avoid close contact (eg, within same household) with immunocompromised persons for at least 21 days following vaccination.
• Caution health care worker who receives vaccine to avoid contact with severely immunocompromised patients for 7 days following vaccination.
• Advise parent or guardian of children 2 to 8 y of age who have not previously received intranasal flu vaccine that a second dose, at least 4 wk after the first dose, is required to obtain max protection.

Copyright © 2009 Wolters Kluwer Health.