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Influenza Vaccine Live Intranasal

Class: Vaccines
VA Class: IM100
Brands: FluMist

Medically reviewed on Nov 19, 2018

Introduction

Live, attenuated virus vaccine.1 Seasonal influenza vaccine live intranasal (LAIV; LAIV4) contains live (cold-adapted) influenza virus types A and B representing influenza strains likely to circulate in the US during the upcoming season and is used to stimulate active immunity to influenza strains contained in the vaccine.1

Uses for Influenza Vaccine Live Intranasal

Prevention of Seasonal Influenza A and B Virus Infections

Prevention of seasonal influenza virus infection in children ≥2 years of age, adolescents, and adults 18 through 49 years of age.1 100 112 577

Influenza is an acute viral infection;100 166 influenza viruses spread from person to person mainly through large-particle respiratory droplet transmission.100 166 In the US, annual epidemics of seasonal influenza occur, usually during the fall or winter.100 Influenza viruses can cause illness in any age group; children have highest rate of infection.100 166 Influenza can exacerbate underlying medical conditions or lead to pneumonia in certain individuals.100 166 Adults ≥65 years of age, children <2 years of age, and individuals with chronic medical conditions have highest risk of influenza-related complications and death.100 166

Annual vaccination is the primary means of preventing seasonal influenza and its complications.100

US Public Health Service Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine influenza vaccination for all adults, adolescents, children, and infants ≥6 months of age using an age-appropriate seasonal influenza vaccine, unless contraindicated.100 112 199 200 235 Vaccination against seasonal influenza recommended for otherwise healthy individuals as well as those who have medical conditions that put them at increased risk for influenza-related complications or at higher risk for influenza-related outpatient, emergency department, or hospital visits.100 112

For the 2018–2019 influenza season, several different types of influenza vaccines may be available in the US for prevention of seasonal influenza: influenza virus vaccine inactivated (IIV), influenza vaccine recombinant (RIV), and influenza vaccine live intranasal (LAIV).100 Influenza virus vaccine inactivated is available as trivalent formulations containing influenza antigens representing 2 influenza A strains (H1N1 and H3N2) and 1 influenza B strain (Victoria lineage) and quadrivalent formulations containing antigens representing these 3 influenza strains and another influenza B strain (Yamagata lineage).100 Influenza vaccine recombinant and influenza vaccine live intranasal are only available as quadrivalent formulations.100

Select specific seasonal influenza vaccine based on individual’s age and whether they have certain underlying medical conditions that put them at increased risk of influenza complications (e.g., pregnancy, immunocompromising disease or therapy), are in close contact with severely immunocompromised individuals, or have a personal history that contraindicates use of certain vaccines.100 112 For many individuals, more than one vaccine type may be appropriate.100 112

For prevention of influenza in adults, adolescents, children, and infants ≥6 months of age, ACIP states that when more than a single type of influenza vaccine is appropriate and available, there are no preferential recommendations for any specific vaccine type or trade name, provided an age-appropriate vaccine is chosen based on FDA-labeled indications and contraindications.100 577

AAP states that influenza virus vaccine inactivated is the vaccine of choice for prevention of influenza in children ≥6 months of age, but that influenza vaccine live intranasal may be used in healthy children ≥2 years of age who would not otherwise receive vaccination against seasonal influenza (e.g., refusal to receive parenteral influenza vaccine inactivated), provided the live intranasal vaccine is appropriate based on FDA-labeled indications and contraindications.112

ACIP and AAP do not state a preference for a trivalent or quadrivalent formulation for the 2018–2019 influenza season.100 112 If an age-appropriate vaccine is available and there are no contraindications, do not delay vaccination to obtain a specific product.100 112

Travelers: All travelers (including those at high risk for influenza complications) who were not vaccinated during the preceding fall or winter should receive seasonal influenza vaccine ≥2 weeks before departure if they will be traveling to the tropics, traveling to the Southern Hemisphere from April through September, or traveling with organized tourist groups at any time of the year.115 Revaccination not recommended for travelers who received influenza vaccine during the preceding fall and will be traveling during the summer.115 Risk for exposure to seasonal influenza during travel depends on time of year and destination.115 In the Northern Hemisphere, influenza season may begin as early as October and extend until May;115 in the Southern Hemisphere, influenza season may begin in April and last through September.115 In many tropical and subtropical areas, influenza viruses generally circulate throughout the year.115

Individuals with altered immunocompetence: Efficacy of influenza vaccine live intranasal not evaluated in individuals with altered immunocompetence.1 ACIP, IDSA, AAP, and others state that influenza vaccine live intranasal should not be used in children or adults who are immunocompromised because of disease or immunosuppressive therapy.100 105 134 135 (See Individuals with Altered Immunocompetence under Cautions.) Use age-appropriate seasonal influenza virus vaccine inactivated or influenza vaccine recombinant in such individuals.100 134 135

Close contacts of individuals with altered immunocompetence: ACIP, IDSA, AAP, and others state that influenza vaccine live intranasal should not be used in health-care workers, household members, or other individuals who have close contact with severely immunocompromised individuals who require care in a protective environment (e.g., hematopoietic stem cell transplant [HSCT] recipients within 2 months after transplant or with graft-versus-host disease [GVHD], individuals with severe combined immune deficiency [SCID]).100 105 134 135 235 (See Close Contacts of Individuals with Altered Immunocompetence under Cautions.) Use age-appropriate influenza virus vaccine inactivated or influenza vaccine recombinant in such individuals.100 134 135 235

Seasonal influenza vaccines not effective against all possible strains of influenza, but may be effective against those strains (and possibly closely related strains) represented in the vaccines.100 166 (See Limitations of Vaccine Effectiveness under Cautions.)

Current information regarding influenza surveillance and updated recommendations for prevention and treatment of seasonal influenza is available from CDC at [Web].

Influenza Vaccine Live Intranasal Dosage and Administration

Administration

Intranasal Administration

Administer intranasally using prefilled, single-use sprayer supplied by the manufacturer.1

Influenza vaccine live intranasal is a colorless to pale yellow suspension and is clear to slightly cloudy.1 Do not mix with any other vaccine or solution.134

Must be administered by a health-care provider.1

Place recipient in an upright position.1 Administer approximately one-half the contents of the prefilled, single-use sprayer into each nostril.1 Active inhalation (i.e., sniffing) by patient not required.1 Consult manufacturer’s labeling for specific information regarding use of the sprayer.1

Some experts state the vaccine dose does not need to be repeated if patient coughs or sneezes immediately after receiving the intranasal vaccine.100 134 Do not administer to individuals who have nasal congestion that might impede delivery of the vaccine to nasopharyngeal mucosa.100 112 (See Concomitant Illness under Cautions.)

After administering vaccine, carefully dispose of the sprayer (i.e., discard using standard procedures for medical waste).1

Administer seasonal influenza vaccine every year before exposure to seasonal influenza.100 112 In the US, localized outbreaks indicating start of the annual influenza season can occur as early as October;100 112 peak influenza activity (which often is close to the midpoint of influenza activity for the season) usually occurs in January through March;100 112 and influenza activity can continue until late spring (end of May).166

Offer influenza vaccination by the end of October, if possible, and continue to offer vaccination as long as influenza viruses are circulating and unexpired vaccine is available.100 112 Although vaccination in the fall is recommended, vaccination in December or later (even if influenza activity has begun) is likely to be beneficial in the majority of influenza seasons.100

May be given simultaneously with other age-appropriate vaccines during same health-care visit.134 (See Interactions.)

Dosage

Dosing schedule for prevention of seasonal influenza depends on individual’s age and vaccination history.1

A single dose consists of the entire contents (0.2 mL) of the sprayer (0.1 mL in each nostril).1

Pediatric Patients

Prevention of Seasonal Influenza A and B Virus Infections
Healthy Children 2 through 8 Years of Age
Intranasal

Has not previously received any doses of any seasonal influenza vaccine or has an uncertain history regarding influenza vaccination: 2 doses administered at least 1 month (4 weeks) apart.1 100 112 Each dose consists of 0.2 mL (0.1 mL in each nostril).1

Did not receive a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2018: 2 doses administered at least 4 weeks apart.100 112 Each dose consists of 0.2 mL (0.1 mL in each nostril).1

Received a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2018: Single dose100 112 consisting of 0.2 mL (0.1 mL in each nostril).1

Healthy Children and Adolescents 9 through 17 Years of Age
Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).1

Adults

Prevention of Seasonal Influenza A and B Virus Infections
Healthy Adults 18 through 49 Years of Age
Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).1

Special Populations

Hepatic Impairment

No specific dosage recommendations.1

Renal Impairment

No specific dosage recommendations.1

Geriatric Patients

Not indicated in adults ≥50 years of age, including geriatric adults.1

Cautions for Influenza Vaccine Live Intranasal

Contraindications

  • Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein.1 (See Sensitivity Reactions under Cautions.)

  • Severe allergic reaction (e.g., anaphylaxis) to previous dose of any influenza vaccine.1

  • Children and adolescents 2 through 17 years of age receiving aspirin or aspirin-containing therapy; possible association of Reye’s syndrome with aspirin use and wild-type influenza infection.1 (See Specific Drugs under Interactions.)

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity reactions (e.g., anaphylactic reaction, facial edema, urticaria) reported.1

Prior to administration, review patient’s history with respect to possible sensitivity reactions to the vaccine or vaccine components, including egg protein, and prior vaccination-related adverse effects and assess benefits versus risks.100 112 134

Appropriate medical treatment and supervision must be readily available in case anaphylaxis occurs.1

Do not administer additional vaccine doses to any individual who had a severe allergic reaction to a previous dose.1 100 112 (See Contraindications under Cautions.)

Egg Allergy

Seasonal influenza vaccine live intranasal is produced using eggs;1 contains residual egg protein (<0.024 mcg of ovalbumin per dose).1

Manufacturer states that influenza vaccine live intranasal is contraindicated in individuals who have had a severe allergic reaction (e.g., anaphylaxis) to egg protein.1 Although Vaccine Adverse Event Reporting System (VAERS) has received occasional reports of anaphylaxis in egg-allergic individuals after administration of influenza vaccines, ACIP and AAP state that influenza vaccines produced using eggs may be administered to individuals with a history of egg allergy under appropriate supervision as needed.100 112

Individuals who are able to eat lightly cooked eggs (e.g., scrambled eggs) without reaction are unlikely to be allergic.100 134 Egg-allergic individuals may tolerate egg in baked products (e.g., bread, cake).100 134 Tolerance to egg-containing foods does not exclude possibility of egg allergy.100 Egg allergy can be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods in addition to skin and/or blood testing for immunoglobulin E antibodies to egg proteins.100 134

ACIP states that individuals with a history of egg allergy involving only urticaria after exposure to eggs may receive any licensed and recommended influenza vaccine that is appropriate based on age and health status, including those produced using eggs.100

These experts state that individuals with a history of egg allergy involving symptoms other than urticaria (e.g., angioedema, respiratory distress, lightheadedness, recurrent emesis, reactions requiring epinephrine or another emergency medical intervention) also may receive any licensed and recommended influenza vaccine that is appropriate based on age and health status; however, administer the vaccine in an inpatient or outpatient medical setting (including but not necessarily limited to hospitals, clinics, health departments, and physician offices) under supervision of a health-care provider able to recognize and manage severe allergic reactions.100

A previous severe allergic reaction to influenza vaccine live intranasal, regardless of the component suspected of being responsible for the reaction, is a contraindication to future receipt of the vaccine.100 112 (See Contraindications under Cautions.)

Infants <24 Months of Age

Do not use in infants <24 months of age; increased risk of wheezing and hospitalization reported in clinical trials in this age group.1 Increased risk of wheezing and hospitalization reported in this age group.1 (See Pediatric Use under Cautions.)

Individuals with Asthma, Recurrent Wheezing, or Active Wheezing

Individuals of any age with asthma and children <5 years of age with history of recurrent wheezing may be at increased risk of wheezing after receiving influenza vaccine live intranasal.1

Manufacturer states that influenza vaccine live intranasal has not been studied in individuals with severe asthma or active wheezing.1

ACIP states do not use influenza vaccine live intranasal in children 2 through 4 years of age diagnosed with asthma and use with caution in individuals ≥5 years of age diagnosed with asthma.100 ACIP also states do not use in children 2 through 4 years of age if the parent or caregiver states that a health-care provider told them during the preceding 12 months that the child had wheezing or asthma or if the child’s medical record indicates a wheezing episode occurred during the preceding 12 months.100

AAP states do not use influenza vaccine live intranasal in children diagnosed with asthma.112 AAP also states do not use in children 2 through 4 years of age with a history of recurrent wheezing or a medically attended wheezing episode during the previous 12 months because of potential for increased wheezing after receipt of the vaccine.112 When considering use in children 24 through 59 months of age, AAP recommends asking the parent or caregiver if the child had any wheezing during the previous 12 months; if there is such a history, use age-appropriate parenteral influenza virus vaccine inactivated (not influenza vaccine live intranasal) in such children.112

Guillain-Barré Syndrome (GBS)

If GBS occurred within 6 weeks after previous influenza vaccination, manufacturer states base decision to administer influenza vaccine on careful consideration of potential benefits and risks.1

Temporal association was noted between administration of 1976 swine influenza vaccine and GBS.1 100 Investigations to date suggest no large increase in GBS associated with influenza vaccine (other than 1976 swine influenza vaccine) and if influenza vaccine does pose a risk it probably is quite small (i.e., approximately 1 additional case of GBS per 1 million vaccinees).1 100

ACIP states that, as a precaution, individuals who are not at high risk for severe influenza complications and who developed GBS within 6 weeks of a previous dose of influenza vaccine generally should not receive influenza vaccination;100 clinicians might consider use of antiviral prophylaxis for such individuals.100 However, ACIP states that benefits of influenza vaccine may outweigh risks for certain individuals with a history of GBS who are at high risk for severe complications from influenza.100

Individuals with Altered Immunocompetence

Manufacturer states efficacy of influenza vaccine live intranasal not studied in immunocompromised individuals.1

Use of live, attenuated virus vaccines in individuals with altered immunocompetence may be associated with increased risk for adverse reactions because of uninhibited growth of the live, attenuated vaccine virus.100 134 135 In addition, immune responses to vaccines may be reduced in immunosuppressed individuals.100 134 135

ACIP, IDSA, AAP, and others state do not use live, attenuated virus vaccines (including influenza vaccine live intranasal) in individuals with altered immunocompetence.100 105 112 134 135 When indicated, give live, attenuated virus vaccines prior to initiation of immunosuppressive therapy or defer until immunosuppressive therapy discontinued.100 105 134 135 (See Immunosuppressive Agents under Interactions.)

ACIP, CDC, NIH, HIV Medicine Association of IDSA, AAP, and others state do not use in HIV-infected individuals.100 112 155 156 Use age-appropriate influenza virus vaccine inactivated or influenza vaccine recombinant in HIV-infected adults and use age-appropriate influenza virus vaccine inactivated in HIV-infected pediatric patients.100 112 135 155 156 Although efficacy of influenza vaccine live intranasal not evaluated in HIV-infected individuals, there is some limited evidence that adverse effects and frequency and duration of vaccine virus shedding in HIV-infected individuals who receive the vaccine are similar to that reported in healthy individuals.1

ACIP states do not use in children with asplenia;134 IDSA states do not use in individuals with asplenia or sickle cell disease.135

Close Contacts of Individuals with Altered Immunocompetence

Because of possible transmission of live vaccine viruses, ACIP and others state do not use in close contacts of severely immunocompromised individuals who require care in a protective environment (e.g., HSCT recipients within 2 months after transplant or with GVHD, individuals with SCID]).100 134 135 235 The live intranasal vaccine may be administered to household members or other close contacts of less severely immunocompromised individuals (e.g., those not requiring a protective environment, HIV-infected individuals).100 134 156 235

ACIP and others state that health-care workers, hospital visitors, and household or other close contacts who have received influenza vaccine live intranasal should avoid contact with severely immunocompromised patients who require care in a protective environment for 7 days after vaccination.100 105 134 135 This contact restriction following vaccination is not necessary for patients who are not severely immunosuppressed.100

Individuals with Medical Conditions that Increase Risk of Influenza Complications

Safety not established in individuals with underlying medical conditions that increase risk for complications following wild-type influenza infection.1

Transmission of Vaccine Virus

Influenza vaccine live intranasal contains live, attenuated virus.1 Vaccine virus capable of infection and replication is present in nasal secretions of vaccine recipients1 and viral shedding occurs in adults and children who have received the live intranasal vaccine.1

Data from several studies indicate that 50–69% of children 2–9 years of age, 29% of children and adolescents 9–17 years of age, and 20% of adults 18–49 years of age may shed vaccine virus within 28 days after receiving influenza vaccine live intranasal;1 majority of shedding occurs within 2–3 days after vaccination and only 1–3% of vaccine recipients 2–49 years of age shed vaccine virus after day 11.1

Transmission of vaccine virus has occurred rarely between recipients of influenza vaccine live intranasal and their contacts.1 Limited data from a study in a day-care setting indicate that the frequency of transmission of vaccine virus from young children who received the vaccine to unvaccinated young children is estimated to be 0.6–2.4% in such a setting.1

Concomitant Illness

Base decision to administer or delay vaccination in an individual with a current or recent acute illness on severity of symptoms and etiology of the illness.134

ACIP states minor acute illness does not preclude vaccination.134

ACIP states moderate or severe acute illness (with or without fever) is a precaution for vaccination;134 defer vaccines until individual has recovered from the acute phase of the illness.134 This avoids superimposing vaccine adverse effects on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccine administration.134

ACIP and AAP state defer administration of influenza vaccine live intranasal if nasal congestion is present that might impede delivery of the intranasal vaccine to nasopharyngeal mucosa;100 112 alternatively, use a different age-appropriate influenza vaccine.100

Limitations of Vaccine Effectiveness

Following seasonal influenza vaccination, up to 2 weeks may be required to develop antibody protection against infection.100

May not protect all vaccine recipients from influenza.1

Seasonal influenza vaccines are formulated annually to contain influenza A and B antigens predicted to represent strains of influenza virus likely to circulate in the US during the upcoming influenza season.1 100 575 (See Actions.) Efficacy of seasonal vaccine during any given year depends on how closely viral strains represented in the vaccine match viral strains circulating during the season.100 166

Seasonal influenza vaccines not expected to provide protection against human infection with animal-origin influenza viruses, including avian influenza A viruses (e.g., avian influenza A [H5N1], avian influenza A [H7N9]).115

Duration of Immunity

Immunity declines during the year after seasonal influenza vaccination.100 In addition, circulating strains of seasonal influenza virus change from year to year.100 Annual vaccination is needed for prevention of seasonal influenza.100

Do not administer influenza vaccine from a previous influenza season (e.g., 2017–2018) in an attempt to provide protection during a subsequent influenza season.100 112

Improper Storage and Handling

Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.134

Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.134 (See Storage under Stability.)

Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.1 134

If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable.134

Specific Populations

Pregnancy

Manufacturer states influenza vaccine live intranasal not absorbed systemically following intranasal administration and use in pregnant women not expected to result in fetal exposure.1 Animal reproduction studies have not revealed evidence of harm to the fetus.1

ACIP, ACOG, AAP, and others state do not use influenza vaccine live intranasal in pregnant women.100 112 134 These experts state that all women who are pregnant or who might become pregnant during the influenza season should be vaccinated using any licensed, age-appropriate, inactivated influenza vaccine (i.e., influenza virus vaccine inactivated or influenza vaccine recombinant).100 112

Lactation

Manufacturer states influenza vaccine live intranasal not absorbed systemically following intranasal administration and distribution into milk not expected.1

ACIP states that live, attenuated virus vaccines generally do not pose any unusual risks for women who are breast-feeding or their breast-fed infants.134 Although live vaccine viruses can replicate in the mother, the majority of live vaccine viruses are not distributed into milk.134

Pediatric Use

Safety and efficacy established only in children 2 years of age or older.1

Not indicated in infants <24 months of age.1 Increased incidence of wheezing and hospitalization reported in a clinical trial in infants 6 through 23 months of age who received influenza vaccine live intranasal compared with those who received parenteral influenza virus vaccine inactivated.1

ACIP states do not use in children 2 through 4 years of age with asthma and use with caution in children ≥5 years of age with asthma.100 AAP states do not use in any child with asthma.112 Both ACIP and AAP state do not use in certain children with a history of wheezing.100 (See Individuals with Asthma, Recurrent Wheezing, or Active Wheezing under Cautions.)

Protection of young infants against seasonal influenza virus depends on immunization of their close contacts.100 112 All household contacts, health-care and day-care providers, and other close contacts of young infants should receive seasonal influenza vaccination appropriate for their age and target group.100 112

Adults 50–64 Years of Age

Not indicated for use in adults 50–64 years of age.1 Efficacy not demonstrated in adults 50–64 years of age.1

Geriatric Use

Not indicated for use in geriatric individuals ≥65 years of age.1

Common Adverse Effects

Children 2 through 6 years of age: Runny nose/nasal congestion, decreased appetite, irritability, lethargy, sore throat, fever, headache, muscle aches, chills.1

Older children and adolescents through 17 years of age: Adverse effects similar to those reported in younger children; in addition, abdominal pain and decreased activity.1

Adults 18 through 49 years of age: Runny nose, headache, sore throat, tiredness/weakness, muscle aches, cough, chills, nasal congestion, sinusitis.1

Interactions for Influenza Vaccine Live Intranasal

Immunosuppressive Agents

Immune responses to vaccines may be reduced in individuals receiving immunosuppressive therapy.100 134 135 In addition, increased risk of adverse effects if live, attenuated virus vaccines used in individuals receiving immunosuppressive therapy.100 134 135

Generally give live, attenuated virus vaccines ≥2–4 weeks before initiation of immunosuppressive therapy and do not give during and for certain periods of time after immunosuppressive therapy discontinued.100 105 134 135 (See Specific Drugs under Interactions.)

Time to restoration of immune competence varies depending on type and intensity of immunosuppressive therapy, underlying disease, and other factors; optimal timing for vaccine administration after discontinuance of immunosuppressive therapy not identified for every situation.105

Vaccines

Although specific studies not available,1 influenza vaccine live intranasal can be administered concurrently with or at any interval before or after inactivated vaccines or toxoids.134

Influenza vaccine live intranasal and other live vaccines generally may be administered concurrently on the same day.100 134 However, because of theoretical concerns that immune responses to other live virus vaccines might be impaired if given within 4 weeks (28 days) of another live virus vaccine, ACIP states that if influenza vaccine live intranasal and other live vaccines are not given on the same day, give ≥4 weeks apart.100 134 If another live vaccine is given <4 weeks after a previous live vaccine, ACIP states repeat the dose of the second live vaccine ≥4 weeks later.134

Specific Drugs

Drug

Interaction

Comments

Antiviral agents active against influenza (amantadine, rimantadine, oseltamivir, peramivir, zanamivir)

Concomitant use not evaluated;1 406 influenza antivirals may inhibit the vaccine virus and could decrease immune responses to the vaccine1 100 406

Do not give influenza vaccine live intranasal until ≥48 hours after influenza antiviral discontinued; do not give influenza antiviral until ≥2 weeks after the vaccine1 100 134 406

If influenza antiviral and influenza vaccine live intranasal are given concomitantly, consider revaccination;1 if influenza antiviral given within 2 days before through 14 days after the live intranasal vaccine, ACIP states repeat the vaccine dose ≥48 hours after last dose of the antiviral agent or revaccinate using age-appropriate parenteral inactivated influenza vaccine100 134

Aspirin

Association of Reye’s syndrome with aspirin and wild-type influenza infection 1

Contraindicated in children and adolescents 2 through 17 years of age receiving aspirin or aspirin-containing therapy;1 avoid aspirin-containing products in children and adolescents 2 through 17 years of age for 4 weeks following influenza vaccination1

Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV], immune globulin sub-Q) or specific hyperimmune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])

May give concurrently with or at any interval before or after immune globulin or specific hyperimmune globulin134

Immunosuppressive agents (e.g., cancer chemotherapy, certain biologic response modifiers, corticosteroids, radiation)

Possible decreased antibody responses to influenza vaccine live intranasal and increased risk of adverse reactions134

Anti-B-cell antibodies (e.g., rituximab): Optimal time to administer vaccines after such treatment unclear135

Corticosteroids (high-dose systemic therapy): Prednisone or equivalent in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks considered immunosuppressive134

Corticosteroids (lower-dose therapy): Short-term (<2 weeks) or low- to moderate-dose systemic therapy (<20 mg prednisone or equivalent daily); long-term, alternate-day systemic therapy using short-acting drugs; maintenance physiologic doses (replacement therapy); topical therapy (e.g., cutaneous, ophthalmic); oral inhalation; or intra-articular, bursal, or tendon injections are not considered immunosuppressive or are associated with low-level immunosuppression134

Cancer chemotherapy or radiation: Generally give live, attenuated virus vaccines ≥2–4 weeks before such therapy or defer until ≥3 months after such therapy discontinued134 135

Immunosuppressive anti-rejection therapies in solid organ transplant recipients: Defer live, attenuated virus vaccines until ≥2 months after such therapies discontinued134

Anti-B-cell antibodies (e.g., rituximab): Generally give live, attenuated virus vaccines ≥2–4 weeks before such therapy or defer until ≥6 months after such therapy discontinued105 134 135

Certain biologic response modifiers (e.g., colony-stimulating factors, interleukins, tumor necrosis factor [TNF] blocking agents): ACIP states give live, attenuated virus vaccines ≥2 weeks before such therapy or defer until ≥3 months after such therapy discontinued134

Corticosteroids (high-dose systemic therapy): Defer live, attenuated virus vaccines until ≥1 month after such therapy discontinued134 135

Corticosteroids (lower-dose therapy): ACIP states live, attenuated virus vaccines may be given concurrently with or any time before or after such therapy;134 IDSA states do not give influenza vaccine live intranasal to patients with chronic inflammatory conditions receiving corticosteroids (including regimens associated with low-level immunosuppression)135

Intranasal preparations (e.g., corticosteroids)

Concomitant administration not evaluated1

Measles, mumps, and rubella vaccine (MMR)

Concurrent administration of influenza vaccine live intranasal with MMR and monovalent varicella vaccine in infants 12 through 15 months of age did not interfere with immune responses to any of the antigens and did not increase frequency of adverse effects;1 25 safety and immunogenicity of concurrent administration not evaluated in infants >15 months of age1

May be given concurrently with influenza vaccine live intranasal;100 134 if not given concurrently, give ≥4 weeks apart 100 134

Rotavirus vaccine (RV)

Concurrent administration not studied;26 rotavirus vaccine not indicated in children ≥2 years of age (the age group that can receive influenza vaccine live intranasal)26

Typhoid Vaccines

Oral live typhoid vaccine (Vivotif): Specific data regarding concurrent administration not available134

Oral live typhoid vaccine (Vivotif): If live typhoid vaccine warranted, do not delay; may be given concurrently with or at any interval before or after other live vaccines (e.g., influenza vaccine live intranasal)134

Varicella vaccine (VAR)

Concurrent administration of influenza vaccine live intranasal with monovalent varicella vaccine and MMR vaccine in infants 12 through 15 months of age did not interfere with immune responses to any of the antigens and did not increase frequency of adverse effects;1 25 safety and immunogenicity of concurrent administration not evaluated in infants >15 months of age1

May be given concurrently with influenza vaccine live intranasal;100 134 if not given concurrently, give ≥4 weeks apart whenever possible134

Stability

Storage

Intranasal Spray

Suspension

2–8°C; do not freeze.1

Does not contain thimerosal or any other preservatives.1

Actions

  • Influenza vaccine live intranasal contains live, attenuated (cold-adapted) influenza virus types A and B,1 and is prepared by culturing live attenuated influenza virus reassortants in specific pathogen-free eggs.1

  • Seasonal influenza vaccines are formulated annually to contain antigens representative of the influenza A (H1N1), influenza A (H3N2), and influenza B viruses likely to circulate during the upcoming influenza season.1 100 575 For the 2018–2019 season, antigenic components recommended by FDA for US formulations of seasonal influenza vaccines are the same as those recommended by WHO (Northern Hemisphere).575 576

  • For the 2018–2019 influenza season, influenza vaccine live intranasal for the US is a quadrivalent vaccine containing A/Slovenia/2903/2015 (H1N1) (an A/Michigan/45/2015 (H1N1)pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2), B/Colorado/06/2017 (B/Victoria lineage), and B/Phuket/3073/2013 (B/Yamagata lineage) virus antigens.1

  • Influenza vaccines stimulate active immunity to influenza virus strains represented in the vaccines.1

  • Following administration of influenza vaccine live intranasal, vaccine virus replicates in cells lining the nasopharynx.1 Protective mechanism not completely understood; may involve both serum and nasal secretory antibodies and cell-mediated immune responses (influenza-specific T-cells).1

  • Efficacy of influenza vaccines in preventing seasonal influenza virus infection depends on whether the virus strains represented in the vaccines are antigenically similar to influenza virus strains circulating during the influenza season.100 166

Advice to Patients

  • Prior to administration of seasonal influenza vaccine live, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient’s legal representative (VISs are available at [Web]).1 20

  • Advise patient and/or patient’s parent or guardian of the risks and benefits of influenza vaccine live intranasal.1

  • Advise patient and/or patient’s parent or guardian that annual vaccination against seasonal influenza is necessary.100 Importance of receiving a 2018–2019 seasonal influenza vaccine, even if the individual received a 2017–2018 seasonal influenza vaccine.100 112

  • Advise patient and/or patient’s parent or guardian that a single dose of seasonal influenza vaccine is necessary each year in adults, adolescents, and children ≥9 years of age, but that 2 doses of seasonal influenza vaccine may be necessary in some children 2 through 8 years of age.1 100 112 (See Pediatric Patients under Dosage and Administration.)

  • Ask patient and/or patient’s parent or guardian if vaccinee has a history of asthma or recurrent wheezing.1 Advise patient’s parent or guardian that a history of recurrent wheezing may be an asthma equivalent in children <5 years of age and that individuals of any age with asthma and children <5 years of age with recurrent wheezing may be at increased risk for wheezing after receiving the intranasal vaccine.1 (See Pediatric Use under Cautions.)

  • Advise patient and/or patient’s parent or guardian that seasonal intranasal influenza vaccine is a live, attenuated virus vaccine and that vaccine virus can be transmitted to close contacts.1 (See Close Contacts of Individuals with Altered Immunocompetence under Cautions.)

  • Importance of informing clinicians of adverse effects.1 Clinicians or individuals can report any adverse reactions that occur following vaccination to the manufacturer at 877-633-4411 or Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or [Web].1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses (i.e., asthma, recurrent wheezing, GBS).1

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Influenza Vaccine Live Intranasal Quadrivalent (2018–2019)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension

106.5-7.5 FFU (fluorescent focus units) each of A/Slovenia/2903/2015 (H1N1), A/Singapore/INFIMH-16-0019/2016 (H3N2), B/Colorado/06/2017, and B/Phuket/3073/2013 per 0.2 mL

FluMist

MedImmune

AHFS DI Essentials™. © Copyright 2018, Selected Revisions November 19, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. MedImmune LLC. FluMist Quadrivalent (influenza vaccine live, intranasal 2018–2019 formula) intranasal spray prescribing information. Gaithersburg, MD; 2018 Aug.

20. Centers for Disease Control and Prevention. Influenza vaccine live, intranasal vaccine information statement. 2015 Aug 7. From CDC website. http://www.cdc.gov/vaccines/hcp/vis/vis-statements/flulive.html

25. Nolan T, Bernstein DI, Block SL et al. Safety and immunogenicity of concurrent administration of live attenuated influenza vaccine with measles-mumps-rubella and varicella vaccines to infants 12 to 15 months of age. Pediatrics. 2008; 121:508-16. http://www.ncbi.nlm.nih.gov/pubmed/18310199?dopt=AbstractPlus

26. Committee on Infectious Diseases, American Academy of Pediatrics. Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics. 2009; 123:1412-20. http://www.ncbi.nlm.nih.gov/pubmed/19332437?dopt=AbstractPlus

100. Grohskopf LA, Sokolow LZ, Broder KR et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices-United States, 2018-19 Influenza Season. MMWR Recomm Rep. 2018; 67:1-20. http://www.ncbi.nlm.nih.gov/pubmed/30141464?dopt=AbstractPlus

105. American Academy of Pediatrics. Red Book: 2015 Report of the Committee on Infectious Diseases. 30th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2015.

112. Committee on Infectious Diseases. Recommendations for Prevention and Control of Influenza in Children, 2018-2019. Pediatrics. 2018; http://www.ncbi.nlm.nih.gov/pubmed/30177511?dopt=AbstractPlus

115. Centers for Disease Control and Prevention. CDC health information for international travel, 2018. Atlanta, GA: US Department of Health and Human Services. Updates may be available at CDC website. http://wwwnc.cdc.gov/travel/page/yellowbook-home

134. Kroger AT, Duchin J, Vazquez M. General best practice guidelines for immunization. Best practices guidance of the Advisory Committee on Immunization Practices (ACIP). From CDC website. Accessed 2018 Aug 15. Updates may be available at CDC website. https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf

135. Rubin LG, Levin MJ, Ljungman P et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014; 58:309-18. http://www.ncbi.nlm.nih.gov/pubmed/24421306?dopt=AbstractPlus

155. Panel on Opportunistic Infection in HIV-infected Adults and Adolescents, US Department of Health and Human Services (HHS). Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Accessed August 1, 2018. Updates may be available at HHS AIDS Information (AIDSinfo) website. http://www.aidsinfo.nih.gov

156. Panel on Opportunistic Infection in HIV-exposed and HIV-infected children, US Department of Health and Human Services (HHS). Guidelines for the prevention and treatment of opportunistic infections in HIV-exposed and HIV-infected children: recommendations from the National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. Accessed August 1, 2018. Updates may be available at HHS AIDS Information (AIDSinfo) website. http://www.aidsinfo.nih.gov

166. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 13th ed. Washington DC: Public Health Foundation; 2015. Updates may be available at CDC website. http://www.cdc.gov/vaccines/pubs/pinkbook/flu.html

199. Centers for Disease Control and Prevention. Recommended immunization schedules for children and adolescents aged 18 years or younger, United States, 2018. Updates may be available at CDC website. http://www.cdc.gov/vaccines/schedules/index.html

200. Centers for Disease Control and Prevention. Recommended immunization schedule for adults aged 19 years or older United States, 2018. Updates may be available at CDC website. http://www.cdc.gov/vaccines/schedules/index.html

235. Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention (CDC). Immunization of health-care personnel: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011; 60(RR-7):1-45.

296. Ambrose CS, Levin MJ, Belshe RB. The relative efficacy of trivalent live attenuated and inactivated influenza vaccines in children and adults. Influenza Other Respir Viruses. 2011; 5:67-75. http://www.ncbi.nlm.nih.gov/pubmed/21306569?dopt=AbstractPlus

297. Belshe RB, Edwards KM, Vesikari T et al. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007; 356:685-96. http://www.ncbi.nlm.nih.gov/pubmed/17301299?dopt=AbstractPlus

298. Fleming DM, Crovari P, Wahn U et al. Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J. 2006; 25:860-9. http://www.ncbi.nlm.nih.gov/pubmed/17006278?dopt=AbstractPlus

299. Ashkenazi S, Vertruyen A, Arístegui J et al. Superior relative efficacy of live attenuated influenza vaccine compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. Pediatr Infect Dis J. 2006; 25:870-9. http://www.ncbi.nlm.nih.gov/pubmed/17006279?dopt=AbstractPlus

406. BioCryst Pharmaceuticals, Inc. Rapivab (peramivir) injection for intravenous use prescribing information. Durham, NC: 2017 Sep.

575. Garten R, Blanton L, Elal AIA et al. Update: Influenza Activity in the United States During the 2017-18 Season and Composition of the 2018-19 Influenza Vaccine. MMWR Morb Mortal Wkly Rep. 2018; 67:634-642. http://www.ncbi.nlm.nih.gov/pubmed/29879098?dopt=AbstractPlus

576. World Health Organization. Recommended composition of influenza virus vaccines for use in the 2018–2019 northern hemisphere influenza season. Wkly Epidemiol Rec. 2018; 93:133-41. http://www.ncbi.nlm.nih.gov/pubmed/29569429?dopt=AbstractPlus

577. Grohskopf LA, Sokolow LZ, Fry AM et al. Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) - United States, 2018-19 Influenza Season. MMWR Morb Mortal Wkly Rep. 2018; 67:643-645. http://www.ncbi.nlm.nih.gov/pubmed/29879095?dopt=AbstractPlus

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