Influenza Virus Vaccine (Live/Attenuated)

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) [contains disodium edta, gelatin (pork)]

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

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

Pharmacology

Mechanism of Action

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.

Pharmacokinetics/Pharmacodynamics

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 2019])

Duration of Action

Vaccine effectiveness declines at a variable rate, depending on virus subtypes, patient age, and other confounding factors (CDC/ACIP [Grohskopf 2019]).

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 2019-2020 influenza season in healthy persons aged 2 to 49 years (CDC/ACIP [Grohskopf 2019]). ACIP and American Academy of Pediatrics (AAP) do not express any preference for an influenza vaccine product when age and risk factors are accounted for (AAP 2019; CDC/ACIP [Grohskopf 2019]).

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 2019): 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 or trivalent inactivated influenza vaccine (IIV3) if IIV4 is not available.
• Persons 2 to 17 years of age: Either IIV4 or LAIV is preferred (IIV3 may be considered if neither IIV4 nor LAIV are 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 2019]): 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
• 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 may be exposed to infectious agents (eg, clerical, housekeeping, volunteers)
• Household contacts (including children) and caregivers of neonates, infants, and children <5 years (particularly neonates and infants <6 months) and adults ≥50 years
• 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, seizure disorders (including febrile seizures in pediatric patients and isolated developmental delay), but excluding migraines and psychiatric conditions without neurological conditions (NACI 2019).

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 2019]; NACI 2019).

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 or HIV); close contacts of severely immunosuppressed persons who require a protected environment; pregnancy; use of influenza antivirals within past 48 hours (CDC/ACIP [Grohskopf 2019]).

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 2019).

Dosage and Administration

Dosing: Adult

Influenza seasons vary in the timing and duration from year to year. In general, vaccination should begin preferably 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 2019]).

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: Live attenuated influenza vaccine (LAIV4) is an option for the 2019-2020 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 may be used for persons ≥6 months of age and recombinant influenza vaccine (RIV) can be used in persons ≥18 years of age (AAP 2019; CDC/ACIP [Grohskopf 2019]).

Influenza seasons vary in their timing and duration from year to year. In general, vaccination should begin preferably 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 2019; CDC/ACIP [Grohskopf 2019]). 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 [Kroger 2017]).

Immunization, annual:

Children 2 to 8 years: Intranasal: 0.2 mL per dose (half dose 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 2019]):

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 (half dose per nostril); 1 dose per season (CDC/ACIP [Grohskopf 2019]).

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 [Kroger 2017]). Defer immunization or use a different influenza vaccine if nasal congestion is present, which may impede delivery of vaccine (CDC/ACIP [Grohskopf 2019]; NACI 2019).

US law requires that the date of administration, name of the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address and documentation of the vaccine information statement (VIS; date on VIS, and date given to patient) be entered into the patient's permanent medical record.

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, 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

Axicabtagene Ciloleucel: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of infection may be increased. Axicabtagene Ciloleucel may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live virus vaccines for at least 6 weeks prior to initiation of lymphodepleting therapy, during axicabtagene ciloleucel infusion, and after treatment until full immune recovery is achieved. 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

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Vaccines (Live). Corticosteroids (Systemic) may diminish the therapeutic effect of Vaccines (Live). Management: Doses equivalent to less than 2 mg/kg or 20 mg per day of prednisone administered for less than 2 weeks are not considered sufficiently immunosuppressive to create vaccine safety concerns. Higher doses and longer durations should be avoided. Consider therapy modification

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

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: Canadian labeling for dimethyl fumarate states that live attenuated vaccine administration is not recommended during treatment. U.S. labeling does not mention this. Consider therapy modification

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; Beclomethasone (Oral Inhalation); Betamethasone (Systemic); Budesonide (Systemic); Corticotropin; Cortisone; Cytarabine (Liposomal); Deflazacort; DexAMETHasone (Systemic); Fludrocortisone; Fluticasone (Oral Inhalation); 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

Tisagenlecleucel: May enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of infection may be increased. Tisagenlecleucel may diminish the therapeutic effect of Vaccines (Live). Management: Avoid live virus vaccines for two weeks prior to initiation of lymphodepleting therapy, during tisagenlecleucel infusion, and after treatment until full immune recovery is achieved. Consider therapy modification

Tuberculin Tests: Vaccines (Live) may diminish the diagnostic effect of Tuberculin Tests. Management: If a parenteral live vaccine has been recently administered, a scheduled PPD skin test should not be administered for at least 4-6 weeks following the administration of the vaccine. 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 [Kroger 2017]).

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 [Kroger 2017]).
• 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 2019]). 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 2019). 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 2019]).
• 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 2019]). 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 2019]).

Concurrent drug therapy issues:

• Oral influenza antiviral medications: LAIV should not be given until 48 hours after the completion of influenza antiviral therapy (influenza A and B). 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 [Kroger 2017]).

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 HIV (CDC/ACIP [Grohskopf 2019]; NACI 2019). 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 2019]). 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 [Kroger 2017]; 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 conditions (CDC/ACIP [Grohskopf 2019]). 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 2019; Greenhawt 2018; NACI 2019).
• 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 [Kroger 2017]). 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 [Kroger 2017]).
• 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 2019]).

Pregnancy

Pregnancy Considerations

The Advisory Committee on Immunization Practices contraindicates use of live attenuated influenza vaccine during pregnancy (CDC/ACIP [Grohskopf 2019]).

This vaccine is not systemically absorbed following maternal nasal administration and is not expected to result in exposure to the fetus.

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience stuffy nose, runny nose, headache, muscle pain, loss of strength and energy, lack of appetite, sore throat, cough, or irritability (children) (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.