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Influenza Virus Vaccine (Live/Attenuated)

Medically reviewed by Drugs.com. Last updated on Jul 3, 2020.

Pronunciation

(in floo EN za VYE rus vak SEEN live ah TEN yoo aye ted)

Index Terms

  • Flu Vaccine
  • H1N1 Influenza Vaccine
  • Influenza Vaccine
  • LAIV
  • LAIV4
  • Live Attenuated Influenza Vaccine
  • Live Attenuated Influenza Vaccine (Quadrivalent)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Nasal [preservative free]:

FluMist Quadrivalent: (1 ea [DSC]) [contains disodium edta, gelatin (pork)]

FluMist Quadrivalent: (1 ea) [contains edetic acid (edta), gelatin (pork)]

FluMist Quadrivalent: (1 ea [DSC]) [contains egg white (egg protein), gelatin (pork)]

FluMist Quadrivalent: (1 ea [DSC]) [contains gelatin (pork)]

Brand Names: U.S.

  • FluMist Quadrivalent

Pharmacologic Category

  • Vaccine
  • Vaccine, Live (Viral)

Pharmacology

The vaccine contains live attenuated viruses which infect and replicate within the cells lining the nasopharynx. Promotes immunity to seasonal influenza virus by inducing specific antibody production. Preparations from previous seasons must not be used.

Distribution

Following nasal administration, vaccine is distributed in the nasal cavity (~90%), stomach (~3%), brain (~2%), and lung (0.4%)

Onset of Action

Most adults have antibody protection within 2 weeks of vaccination (CDC/ACIP [Grohskopf 2020])

Duration of Action

Vaccine effectiveness declines at a variable rate, depending on virus subtypes, patient age, and other confounding factors (CDC/ACIP [Grohskopf 2020]).

Use: Labeled Indications

Influenza disease prevention:

US labeling: Active immunization of individuals 2 to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

The Advisory Committee on Immunization Practices (ACIP) recommends routine annual vaccination with seasonal influenza vaccine for all persons ≥6 months of age who do not otherwise have contraindications to vaccination. Live attenuated influenza vaccine (LAIV4) is an option for the 2020-2021 influenza season in healthy persons aged 2 to 49 years (CDC/ACIP [Grohskopf 2020]). ACIP and American Academy of Pediatrics (AAP) recommend use of any age- and risk factor–appropriate product and do not have a preferential recommendation for an influenza vaccine product; in addition to LAIV4, the inactivated influenza vaccines may be used for persons ≥6 months of age and recombinant influenza vaccine (RIV) can be used in persons ≥18 years of age (AAP 2020; CDC/ACIP [Grohskopf 2020]).

Canadian labeling: Active immunization of individuals 2 to 59 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

The Canadian National Advisory Committee on Immunization (NACI) recommends the following (NACI 2020): Annual vaccination with seasonal influenza vaccine for all persons ≥6 months of age who do not otherwise have contraindications to the vaccine. Healthy, nonpregnant persons aged 2 to 59 years may receive vaccination with the seasonal live, attenuated influenza vaccine (LAIV) (nasal spray). The following influenza vaccine preferences should be considered:

• Persons 6 months to 23 months of age: Quadrivalent inactivated influenza vaccine (IIV4) is preferred; use trivalent inactivated influenza vaccine (IIV3) if IIV4 is not available.

• Persons 2 to 17 years of age: Either IIV4 or LAIV (if appropriate) is preferred; use IIV3 if neither IIV4 nor LAIV is available.

• Persons ≥65 years of age: IIV3-HD (high dose) is preferred over IIV3-SD (standard dose); however, any available IIV3 or IIV4 vaccine may be used for public health program-level decision making.

• Health care workers: Either IIV4 or IIV3 are recommended; LAIV should not be used.

When vaccine supply is limited, target groups for vaccination (those at higher risk of complications from influenza infection and their close contacts) include the following (CDC/ACIP [Grohskopf 2020]): Note: Only use LAIV if appropriate:

• All infants and children 6 to 59 months of age

• Persons ≥50 years of age

• Infants, children, and adolescents (6 months to 18 years of age) who are receiving long-term aspirin therapy, and therefore, may be at risk for developing Reye syndrome after influenza

• Women who are or will be pregnant during the influenza season

• Patients with chronic pulmonary disorders (including asthma) or cardiovascular systems disorders (except isolated hypertension), renal, hepatic, neurologic, or metabolic disorders (including diabetes mellitus)

• Persons who have immunosuppression due to any cause (including immunosuppression caused by medications or HIV)

• Residents of nursing homes and other long-term care facilities

• American Indians/Alaska Natives

• Persons who are extremely obese (BMI ≥40)

• Health care personnel including students in these professions who will have contact with patients and other persons not directly involved in patient care but who may be exposed to infectious agents (eg, clerical, housekeeping, volunteers)

• Household contacts (including children) and caregivers of neonates, infants, and children <5 years of age (particularly neonates and infants <6 months of age) and adults ≥50 years of age

• Household contacts (including children) and caregivers of persons with medical conditions which put them at high risk of complications from influenza infection

In addition, the NACI also recommends vaccination of patients with neurologic or neurodevelopment conditions including neuromuscular/neurovascular/neurodegenerative conditions and seizure disorders (including febrile seizures in pediatric patients and isolated developmental delay) but excluding migraines and psychiatric conditions without neurological conditions (NACI 2020).

Contraindications

Severe allergic reaction (eg, anaphylaxis) to any component of the vaccine, including egg protein, or to previous influenza vaccination; children and adolescents (2 to 17 years of age) receiving aspirin therapy or aspirin-containing therapy because of the association of Reye syndrome with aspirin and wild-type influenza infection.

Note: The Advisory Committee on Immunization Practices (ACIP) and Canadian National Advisory Committee on Immunization (NACI) do not consider an egg allergy to be a contraindication to influenza vaccination (CDC/ACIP [Grohskopf 2020]; NACI 2020).

In addition, the ACIP also considers the following to be contraindications: Children 2 to 4 years of age with asthma or wheezing within past 12 months; immunocompromising conditions (including immunosuppressive therapy, HIV, and anatomic or functional asplenia); close contacts of severely immunosuppressed persons who require a protected environment; pregnancy; persons with active communication between the cerebrospinal fluid (CSF) and the oropharynx, nasopharynx, nose, or ear or any other cranial CSF leak; persons with cochlear implants; use of oseltamivir or zanamivir within past 48 hours, use of peramivir within past 5 days, or use of baloxavir within past 17 days (CDC/ACIP [Grohskopf 2020]).

In addition to ACIP contraindications, the NACI also considers the following to be contraindications to LAIV: Age <24 months; severe asthma, active wheezing, or wheezing requiring medical attention in the 7 days prior to vaccination (NACI 2020).

Dosing: Adult

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should not be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, influenza vaccination in patients with suspected or confirmed COVID-19 infection (regardless of symptoms) should be postponed until the patient is no longer acutely ill and/or in isolation to avoid exposure to health care personnel and other patients (CDC/ACIP [Grohskopf 2020], CDC 2020). Additional information is available from the CDC, the American Academy of Pediatrics, and the Immunization Action Coalition.

Influenza seasons vary in the timing and duration from year to year. In general, vaccination should preferably occur in September and October (in the United States) to ensure optimal immunity prior to onset and for the full duration of influenza activity in the community. Early vaccination (in July or August) for an upcoming influenza season has been associated with suboptimal immunity before the end of an influenza season, particularly in older adults. Vaccination should continue throughout the influenza season as long as vaccine is available. The Centers for Disease Control and Prevention (CDC) does not recommend revaccination later in the season for those persons who have already been fully vaccinated (CDC/ACIP [Grohskopf 2020]).

Immunization: Intranasal:

US labeling: Adults ≤49 years: 0.2 mL/dose (0.1 mL per nostril) (1 dose per season).

Canadian labeling: Adults ≤59 years: 0.2 mL/dose (0.1 mL per nostril) (1 dose per season).

Not indicated for use in patients ≥50 years (US labeling) or ≥60 years (Canadian labeling).

Dosing: Geriatric

Not indicated for use in patients ≥50 years (US labeling) or ≥60 years (Canadian labeling).

Dosing: Pediatric

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should not be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, influenza vaccination in patients with suspected or confirmed COVID-19 infection (regardless of symptoms) should be postponed until the patient is no longer acutely ill and/or in isolation to avoid exposure to health care personnel and other patients (ACIP/CDC [Grohskopf 2020]; CDC 2020). Additional information is available from the CDC, the American Academy of Pediatrics, and the Immunization Action Coalition.

Note: Live attenuated influenza vaccine (LAIV4) is an option for the 2020-2021 influenza season in healthy persons aged 2 to 49 years. The ACIP and AAP recommend the use of any age and risk factor appropriate product and does not have a preferential recommendation for an influenza vaccine product; in addition to LAIV4, the inactivated influenza vaccines (IIV4) may be used for persons ≥6 months of age and recombinant influenza vaccine (RIV) can be used in persons ≥18 years of age (AAP 2020; CDC/ACIP [Grohskopf 2020]).

Influenza seasons vary in their timing and duration from year to year. In general, vaccination should preferably occur in September and October (in US) to ensure optimal immunity prior to onset and for the full duration of influenza activity in the community. Early vaccination (in July or August) for an upcoming influenza season has been associated with suboptimal immunity before the end of an influenza season, particularly in older adults. Vaccination should continue throughout the influenza season as long as vaccine is available (AAP 2020; CDC/ACIP [Grohskopf 2020]). According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Ezeanolue 2020]).

Immunization, annual:

Children 2 to 8 years: Intranasal: 0.2 mL per dose (0.1 mL per nostril); 1 or 2 doses per season. The number of doses needed per flu season is dependent upon vaccination history; see the following criteria (CDC/ACIP [Grohskopf 2020]):

One dose: If the patient received ≥2 doses of trivalent or quadrivalent influenza vaccine prior to July 1 preceding the current flu season start. The 2 doses need not have been received during the same season or consecutive seasons.

Two doses (separated by ≥4 weeks): If any of the following:

• Patient received ≤1 dose of trivalent or quadrivalent influenza vaccine prior to July 1 preceding the current flu season start (including no previous vaccination).

• If vaccination status cannot be determined.

Note: A child turning 9 years of age between the first and second dose should still receive 2 doses.

Children ≥9 years and Adolescents: Intranasal: 0.2 mL per dose (0.1 mL per nostril); 1 dose per season (CDC/ACIP [Grohskopf 2020]).

Administration

For intranasal administration only; do not inject. Half the dose (0.1 mL) is administered to each nostril; patient should be in upright position. A dose divider clip is provided to allow administration of 0.1 mL into each nostril. Place the tip of the sprayer inside the nostril and depress plunger as rapidly as possible to deliver the dose. Remove dose divider clip and repeat into opposite nostril. The patient does not need to inhale during administration (may breathe normally). If recipient sneezes or coughs following administration, the dose should not be repeated (ACIP [Ezeanolue 2020]). Defer immunization or use a different influenza vaccine if nasal congestion is present, which may impede delivery of vaccine (CDC/ACIP [Grohskopf 2020]; NACI 2020).

US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

Storage

Store in refrigerator at 2°C to 8°C (35°F to 46°F). Do not freeze; protect from light. The cold chain (2°C to 8°C [35°F to 46°F]) must be maintained when transporting intranasal influenza vaccine. The vaccine may be exposed to temperatures of up to 25°C for up to 12 hours without adverse impact; return to refrigerator as soon as possible; only a single excursion outside of the recommended storage conditions is permitted. Once intranasal influenza vaccine has been administered or has expired, the sprayer should be disposed of according to the standard procedures for medical waste (eg, sharps or biohazard container).

Drug Interactions

Antiviral Agents (Influenza A and B): May diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Management: Avoid anti-influenza antivirals during the period beginning 48 hours prior to and ending 2 weeks after live influenza virus vaccine administration. Consider therapy modification

AzaTHIOprine: May enhance the adverse/toxic effect of Vaccines (Live). AzaTHIOprine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose azathioprine (3 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of azathioprine should be avoided. Consider therapy modification

Belimumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Brexucabtagene Autoleucel: May enhance the adverse/toxic effect of Vaccines (Live). Brexucabtagene Autoleucel may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live vaccines during and for 1 month after therapy with immunosuppressive doses of corticosteroids (equivalent to prednisone >2 mg/kg or 20 mg/day in persons over 10 kg for at least 2 weeks). Give live vaccines prior to therapy whenever possible. Exceptions: Deflazacort. Consider therapy modification

Daclizumab: May enhance the adverse/toxic effect of Vaccines (Live). Daclizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Deflazacort: May enhance the adverse/toxic effect of Vaccines (Live). Deflazacort may diminish the therapeutic effect of Vaccines (Live). Management: Administer all vaccines according to immunization guidelines prior to initiating deflazacort. Live vaccines should be administered at least 4 to 6 weeks prior to initiating deflazacort. Consider therapy modification

Dimethyl Fumarate: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, Dimethyl Fumarate may increase the risk of vaccinal infection. Dimethyl Fumarate may diminish the therapeutic effect of Vaccines (Live). Management: Non-US labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. US labeling states that safety and effectiveness of live vaccines administered with dimethyl fumarate has not been assessed. Monitor therapy

Dupilumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Fingolimod: May enhance the adverse/toxic effect of Vaccines (Live). Vaccinal infections may develop. Fingolimod may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Guselkumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Immunosuppressants: May enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: AzaTHIOprine; Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Deflazacort; DexAMETHasone (Systemic); Fludrocortisone; Hydrocortisone (Systemic); Leflunomide; Mercaptopurine; Methotrexate; MethylPREDNISolone; PrednisoLONE (Systemic); PredniSONE; Triamcinolone (Systemic). Avoid combination

Leflunomide: May enhance the adverse/toxic effect of Vaccines (Live). Leflunomide may diminish the therapeutic effect of Vaccines (Live). Management: The ACIP guidelines state that live-attenuated vaccines should generally be avoided for at least 3 months after cessation of immunosuppressant therapy. However, the ACR does not recommend avoiding live vaccines in patients being treated with leflunomide. Consider therapy modification

Mercaptopurine: May enhance the adverse/toxic effect of Vaccines (Live). Mercaptopurine may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose 6-mercaptopurine (1.5 mg/kg/day or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns and is not a contraindication for administration of zoster vaccine. Higher doses of mercaptopurine should be avoided. Consider therapy modification

Methotrexate: May enhance the adverse/toxic effect of Vaccines (Live). Methotrexate may diminish the therapeutic effect of Vaccines (Live). Management: Low-dose methotrexate (0.4 mg/kg/week or less) is not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses of methotrexate should be avoided. Consider therapy modification

Ocrelizumab: May enhance the adverse/toxic effect of Vaccines (Live). Ocrelizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Risankizumab: May enhance the adverse/toxic effect of Vaccines (Live). Avoid combination

Salicylates: Influenza Virus Vaccine (Live/Attenuated) may enhance the adverse/toxic effect of Salicylates. Specifically, Reye's syndrome may develop. Avoid combination

Tildrakizumab: May enhance the adverse/toxic effect of Vaccines (Live). The risk for contracting an infection from the vaccine may be increased. Tildrakizumab may diminish the therapeutic effect of Vaccines (Live). Avoid combination

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, do administer a scheduled PPD skin test for at least 4-6 weeks following administration of the vaccine. Simultaneous administration of a parenteral live vaccine and PPD skin test is acceptable. Consider therapy modification

Vaccines (Live): May diminish the therapeutic effect of other Vaccines (Live). Management: Two or more injectable or nasally administered live vaccines not administered on the same day should be separated by at least 28 days (ie, 4 weeks). If not, the vaccine administered second should be repeated at least 4 week later. Exceptions: Adenovirus (Types 4, 7) Vaccine; Cholera Vaccine; Rotavirus Vaccine. Monitor therapy

Venetoclax: May enhance the adverse/toxic effect of Vaccines (Live). Venetoclax may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live, attenuated vaccines before, during, or after (prior to B-cell recovery) venetoclax treatment. Avoid combination

Test Interactions

Administration of the intranasal influenza virus vaccine (live, LAIV) may cause a positive result on the rapid influenza diagnostic test for the 7 days after vaccine administration; for a person with influenza-like illness during this time, the positive test could be caused by either the live attenuated vaccine or wild-type influenza virus (Ali 2004).

Adverse Reactions

Frequency of events reported within 10 days.

>10%:

Central nervous system: Headache (adults: 40%; children: 3% to 9%), irritability (children: 12% to 21%), lethargy (children: 7% to 14%)

Gastrointestinal: Sore throat (adults: 28%; children: 5% to 11%), decreased appetite (children: 13% to 21%), abdominal pain (children: 2% to 12%)

Neuromuscular & skeletal: Fatigue (adults: ≤26%), weakness (adults: ≤26%), myalgia (adults: 17%; children: 2% to 6%)

Respiratory: Nasal congestion (children: ≤58%; adults: ≤44%), rhinorrhea (children: ≤58%; adults: ≤44%), cough (adults: 14%)

1% to 10%:

Central nervous system: Chills (adults: 9%; children: 2% to 4%)

Otic: Otitis media (children: 3%)

Respiratory: Wheezing (children: 6 to 23 months: 6%; 24 to 59 months: 2%), sinusitis (adults: 4%), sneezing (children: 2%)

Miscellaneous: Fever (children: 100°F to 101°F: 6% to 9%; >101°F: 1% to 4%)

<1%, postmarketing, and/or case reports: Anaphylaxis, Bell's palsy, diarrhea, encephalitis (vaccine-associated), epistaxis, exacerbation of asthma, facial edema, Guillain-Barre syndrome, hypersensitivity reaction, meningitis (including eosinophilic meningitis), nausea, pericarditis, skin rash, subacute necrotizing encephalomyelopathy (Leigh syndrome exacerbation), urticaria, vomiting

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Ezeanolue 2020]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Ezeanolue 2020]).

• Asthma/wheezing: Children <24 months of age had increased wheezing and hospitalizations following administration in clinical trials; use of the nasal spray is not approved in this age group. The Advisory Committee on Immunization Practices (ACIP) considers live influenza virus vaccine (LAIV) contraindicated in adult patients with chronic pulmonary disorders (including asthma) and considers LAIV contraindicated in children 2 to 4 years of age who have had asthma or wheezing episodes within the past year. Use with caution in patients ≥5 years of age who have asthma (CDC/ACIP [Grohskopf 2020]). Canadian National Advisory Committee on Immunization (NACI) considers LAIV contraindicated in patients with severe asthma, active wheezing, or wheezing requiring medical attention in the 7 days prior to vaccination (NACI 2020). Risk of wheezing following vaccination is increased in children <5 years of age with a history of recurrent wheezing and in persons of any age with asthma. Patients with severe asthma or active wheezing were not included in clinical trials.

• Medical conditions predisposing to influenza complications: Safety of LAIV in patients with medical conditions predisposing to influenza complications (eg, chronic pulmonary, cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes]) has not been established; use with caution (CDC/ACIP [Grohskopf 2020]).

• Guillain-Barré syndrome: Use with caution in patients with history of Guillain-Barré syndrome (GBS); patients with history of GBS have a greater likelihood of developing GBS than those without. As a precaution, the ACIP recommends that patients with a history of GBS and who are at low risk for severe influenza complications and patients known to have experienced GBS within 6 weeks following previous vaccination should generally not be vaccinated (consider influenza antiviral chemoprophylaxis in these patients). Based on limited data, the benefits of vaccinating persons with a history of GBS who are also at higher risk for severe complications of influenza, may outweigh the risks (CDC/ACIP [Grohskopf 2020]). Recent studies of patients who received the trivalent inactivated influenza vaccine (IIV3) or the monovalent H1N1 influenza vaccine have shown the risk of GBS is lower with vaccination than with influenza infection (Baxter 2013; Greene 2013; Kwong 2013).

• Nasal congestion: Use another influenza vaccine or defer immunization with LAIV if nasal congestion is present which may impede delivery of vaccine (CDC/ACIP [Grohskopf 2020]).

Concurrent drug therapy issues:

• Oral influenza antiviral medications: LAIV should not be given until 48 hours after the completion of oseltamivir or zanamivir, 5 days after completion of peramivir, or 17 days after completion of baloxavir (CDC/ACIP [Grohskopf 2020]). Influenza antiviral therapy (influenza A and B) should not be administered for 2 weeks after receiving LAIV. If influenza antiviral therapy (influenza A and B) and LAIV are administered concomitantly, revaccination should be considered.

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible (ACIP [Ezeanolue 2020]).

Special populations:

• Adults: The safety and efficacy of the nasal spray have not been established in adults ≥50 years of age (US labeling) or ≥60 years of age (Canadian labeling).

• Pediatric: Due to association of Reye syndrome with aspirin, use of LAIV is contraindicated in pediatric patients on concurrent aspirin therapy; aspirin-containing products should be avoided for 4 weeks following vaccination in children and adolescents ≤17 years of age.

• Altered immunocompetence: Data on the use of LAIV in immunocompromised patients is limited. Avoid contact with severely immunocompromised individuals for at least 7 days following vaccination (at least 14 days per Canadian labeling). ACIP and NACI do not recommend the use of LAIV in immunosuppressed patients, including most patients with HIV (CDC/ACIP [Grohskopf 2020]; NACI 2020). Children and adolescents with HIV who have stable disease, are receiving highly active antiretroviral therapy, and have stable immune function may receive LAIV per NACI (NACI 2020). ACIP does not recommend the use of LAIV for persons who care for severely immunocompromised individuals who require a protective environment due to the theoretical risk of transmitting the live virus from the vaccine. Persons who care for the severely immunocompromised should receive either IIV or recombinant influenza vaccine (CDC/ACIP [Grohskopf 2020]). Live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible; live vaccines should not be administered for ≥3 months after immunosuppressive therapy (ACIP [Ezeanolue 2020]; IDSA [Rubin 2014]).

Dosage form specific issues:

• Arginine: Manufactured using arginine.

• Chicken egg protein: Manufactured with chicken egg protein. Allergy to eggs must be distinguished from allergy to the vaccine. Recommendations are available from the ACIP and NACI regarding influenza vaccination to persons who report egg allergies; however, ACIP states a prior severe allergic reaction to influenza vaccine, regardless of the component suspected, is a contraindication to vaccination. Per ACIP, patients with a history of egg allergy who have experienced only hives following egg exposure should receive influenza vaccine if otherwise appropriate. Patients with a history of egg allergy other than hives (eg, angioedema, respiratory distress) or who required emergency medical attention (eg, epinephrine) may receive influenza vaccine if otherwise appropriate and administered in an inpatient or outpatient medical setting with health care supervision able to recognize and manage severe allergic reactions (CDC/ACIP [Grohskopf 2020]). However, American Academy of Pediatrics; American Academy of Allergy, Asthma, and Immunology/American College of Allergy, Asthma, and Immunology; and NACI state that patients may receive vaccination regardless of severity of egg allergy and no special precautions are required (AAP 2020; Greenhawt 2018; NACI 2020).

• Gelatin: Manufactured using gelatin.

• Gentamicin: Manufactured with gentamicin.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Ezeanolue 2020]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: The safety of LAIV in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established. Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to Centers for Disease Control and Prevention [CDC] schedule for detailed information). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the Infectious Diseases Society of America (Rubin 2014).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).

• Other influenza vaccines: Influenza vaccines from previous seasons must not be used. Vaccines formulated for the northern hemisphere may differ in composition from the southern hemisphere vaccine; consult CDC Yellow Book for more information regarding travel vaccines (CDC/ACIP [Grohskopf 2020]).

Pregnancy Considerations

This vaccine is not systemically absorbed following maternal nasal administration and is not expected to result in exposure to the fetus. Information related to the use of influenza virus vaccine (live/attenuated) in pregnancy is limited (Haber 2015; Moro 2013; Moro 2017; Toback 2012).

The Advisory Committee on Immunization Practices contraindicates use of live attenuated influenza vaccine during pregnancy (CDC/ACIP [Grohskopf 2020]).

Patient Education

What is this drug used for?

• It is used to prevent the flu.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stuffy nose

• Runny nose

• Headache

• Muscle pain

• Loss of strength and energy

• Lack of appetite

• Chills

• Sore throat

• Cough

• Irritability (children)

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.