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Influenza Vaccine Live Intranasal

Class: Vaccines
VA Class: IM100
Brands: FluMist

Medically reviewed by Drugs.com on Sep 7, 2020. Written by ASHP.

Introduction

Live, attenuated virus vaccine. 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.

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.

Influenza is an acute viral infection; influenza viruses spread from person to person mainly through large-particle respiratory droplet transmission. In the US, annual epidemics of seasonal influenza occur, usually during the fall or winter. Influenza viruses can cause illness in any age group; children have highest rate of infection. Influenza can exacerbate underlying medical conditions or lead to pneumonia in certain individuals. 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.

Annual vaccination is the primary means of preventing seasonal influenza and its complications. Annual influenza vaccination necessary since immunity declines in the year following vaccination and circulating influenza strains change from year to year.

CDC 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. 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.

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). All 3 vaccine types are available as quadrivalent formulations containing antigens representing 2 influenza A strains (H1N1 and H3N2) and 2 influenza B strains (B/Victoria lineage and B/Yamagata lineage). Influenza virus vaccine inactivated may also be available as a trivalent formulation containing antigens representing 2 influenza A strains (H1N1 and H3N2) and a single influenza B strain (B/Victoria lineage).

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. For many individuals, more than one vaccine type may be appropriate.

ACIP and AAP state that 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. ACIP and AAP do not state a preference for a quadrivalent or trivalent formulation. If an age-appropriate vaccine is available and there are no contraindications, do not delay vaccination to obtain a specific product.

Healthy Children ≥2 Years of Age: ACIP and AAP state that either parenteral influenza virus vaccine inactivated or influenza vaccine live intranasal can be used for prevention of seasonal influenza in healthy children ≥2 years of age, provided the specific vaccine is chosen based on FDA-labeled indications and contraindications.

Individuals with altered immunocompetence: Efficacy of influenza vaccine live intranasal not evaluated in individuals with altered immunocompetence. 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. (See Individuals with Altered Immunocompetence under Cautions.) Use age-appropriate seasonal influenza virus vaccine inactivated or influenza vaccine recombinant in such individuals.

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]). (See Close Contacts of Individuals with Altered Immunocompetence under Cautions.) Use age-appropriate influenza virus vaccine inactivated or influenza vaccine recombinant in such individuals.

Travelers: All travelers (including those at high risk for influenza complications) who were not vaccinated with the current seasonal influenza vaccine should consider vaccination against seasonal influenza ≥2 weeks before travel. Revaccination not recommended for travelers who received influenza vaccine during the preceding fall and will be traveling during the summer. Risk for exposure to seasonal influenza during travel depends on time of year and destination. In temperate regions, influenza typically circulates at higher levels during colder winter months (i.e., October to May in Northern Hemisphere and April to September in Southern Hemisphere). In many tropical and subtropical areas, influenza can occur throughout the year.

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. (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 Vaccination During the Coronavirus Disease 2019 (COVID-19) Pandemic

CDC and ACIP state that efforts to ensure influenza vaccination for all individuals ≥6 months of age for the 2020–2021 influenza season are of paramount importance to reduce influenza-related morbidity and mortality and reduce the impact of respiratory illnesses in the population and the resulting burdens on the health-care system. SARS-CoV-2 (causative agent of COVID-19) is expected to circulate in the US during the 2020–2021 influenza season; the extent of continued or recurrent SARS-CoV-2 circulation during the time influenza viruses are circulating is not known. Vaccination against influenza can reduce prevalence of influenza illness and reduce incidence of influenza symptoms that might be confused with COVID-19 symptoms (i.e., fever, cough, dyspnea). In addition, prevention of influenza and reduction in severity of influenza illness and associated outpatient visits, hospitalizations, and intensive care unit admissions could alleviate stress on the US health-care system.

Health-care providers should use every opportunity to communicate the importance of influenza vaccination and to administer an age-appropriate influenza vaccine to all eligible individuals for the 2020–2021 influenza season. This includes essential workers (e.g., health-care personnel such as nursing home, long-term care facility, and pharmacy staff, and other critical infrastructure workforce personnel), those at increased risk for severe illness due to COVID-19 (e.g., adults ≥65 years of age, residents in nursing homes or long-term care facilities, individuals with certain underlying medical conditions), and those at high risk for influenza complications (e.g., infants and young children, children with neurologic conditions, pregnant women, adults ≥65 years of age).

Stay-at-home orders and social distancing strategies aimed at reducing SARS-CoV-2 transmission have led to decreased use of routine preventive medical services, including immunization services. Routine vaccination is an essential preventive care service for children, adolescents, and adults (including pregnant women) that should not be delayed because of the COVID-19 pandemic. Ensuring that immunization services are maintained or reinitiated is essential for protecting individuals and communities from vaccine-preventable diseases and outbreaks and reducing the burden of respiratory illness during the 2020–2021 influenza season. Some settings usually used to provide influenza vaccination (e.g., workplaces) may not be available as a result of strategies used to limit spread of COVID-19 and influenza vaccination programs may need to adapt and consider different or additional vaccination strategies for the 2020–2021 influenza season. (See General under Dosage and Administration.)

Guidance for vaccination planning and interim guidance for administering routine immunizations, including influenza vaccine, during the COVID-19 pandemic is available at [Web].

Influenza Vaccine Live Intranasal Dosage and Administration

General

Administer seasonal influenza vaccine every year before exposure to seasonal influenza. In the US, localized outbreaks indicating start of the annual influenza season can occur as early as October and peak influenza activity (which often is close to the midpoint of influenza activity for the season) usually occurs in January or February or later.

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

When 2 doses of influenza vaccine are required in children 2 through 8 years of age, give first dose as soon as possible after vaccine becomes available since this allows second dose to be given by the end of October. For children and adults requiring only a single dose of influenza vaccine, there is some evidence that early vaccination (i.e., in July or August) is likely to be associated with suboptimal immunity (waning immunity) before the end of influenza season, particularly in older adults. Community vaccination programs should balance maximizing likelihood of persistence of vaccine-induced protection through the influenza season with avoiding missed opportunities for vaccination or vaccinating after influenza circulation has already started.

Because SARS-CoV-2 (causative agent of COVID-19) is expected to be circulating in the US at the same time influenza viruses are circulating, it is important that health-care providers use every opportunity to communicate the importance of influenza vaccination and to administer an age-appropriate influenza vaccine to all eligible individuals for the 2020–2021 influenza season. (See Influenza Vaccination During the Coronavirus Disease 2019 [COVID-19] Pandemic under Uses.) Some settings usually used to provide influenza vaccination (e.g., workplaces) may not be available as a result of strategies used to limit spread of COVID-19. In addition, organized influenza vaccination programs may need to adapt and consider different or additional vaccination strategies for the 2020–2021 influenza season, including starting vaccination campaigns early to allow sufficient time to vaccinate the population and avoid missed opportunities for influenza vaccination, using alternative vaccination sites (e.g., drive-through, curbside, mobile outreach units, home visits), and extending the duration of vaccination campaigns.

Guidance for vaccination planning and interim guidance for administering routine immunizations, including influenza vaccine, during the COVID-19 pandemic is available at [Web].

Administration

Intranasal Administration

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

The single-use sprayer is equipped with a nozzle that produces a fine mist that is primarily deposited in the nose and nasopharynx. Administration of intranasal vaccines is not considered an aerosol-generating procedure.

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

Must be administered by a health-care provider.

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

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

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

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

Dosage

Dosing schedule (i.e., number of doses) for prevention of seasonal influenza depends on individual’s age and vaccination history.

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

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. Each dose consists of 0.2 mL (0.1 mL in each nostril).

Did not receive a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2020: 2 doses administered at least 4 weeks apart. Each dose consists of 0.2 mL (0.1 mL in each nostril).

Received a total of ≥2 doses of any seasonal influenza vaccine before July 1, 2020: Single dose consisting of 0.2 mL (0.1 mL in each nostril).

Healthy Children and Adolescents 9 through 17 Years of Age
Intranasal

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

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).

Special Populations

Hepatic Impairment

No specific dosage recommendations.

Renal Impairment

No specific dosage recommendations.

Geriatric Patients

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

Cautions for Influenza Vaccine Live Intranasal

Contraindications

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

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

  • 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. (See Specific Drugs under Interactions.)

Warnings/Precautions

Sensitivity Reactions

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

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.

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

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

Egg Allergy

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

Manufacturer states that influenza vaccine live intranasal is contraindicated in individuals who have had a severe allergic reaction (e.g., anaphylaxis) to egg protein.

ACIP states that individuals with 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.

ACIP states that individuals with history of egg allergy involving symptoms other than urticaria (e.g., angioedema or swelling, 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, if an egg-based influenza vaccine is used, it should be administered 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.

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. (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. Increased risk of wheezing and hospitalization reported in this age group. (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.

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

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. 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.

AAP states do not use influenza vaccine live intranasal in children diagnosed with asthma. 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. 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.

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.

The 1976 swine influenza vaccine was associated with increased frequency of GBS. Evidence for causal relationship between other influenza vaccines and GBS inconclusive; if an excess risk exists, it probably is slightly more than 1 additional case of GBS per 1 million vaccinees.

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; clinicians might consider use of antiviral prophylaxis for such individuals. However, ACIP states that benefits of influenza vaccine may outweigh risks for certain individuals with a history of GBS within 6 weeks after a previous dose of influenza vaccine who are at high risk for severe complications from influenza.

Individuals with Altered Immunocompetence

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

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. In addition, immune responses to vaccines may be reduced in immunosuppressed individuals.

ACIP, AAP, IDSA, and others state do not use live, attenuated virus vaccines (including influenza vaccine live intranasal) in individuals with altered immunocompetence. ACIP states this includes, but is not limited to, individuals with congenital and acquired immunodeficiency states, those who are immunocompromised as the result of immunosuppressive therapy, and those with anatomic and functional asplenia (e.g., sickle cell anemia). When indicated, give live, attenuated virus vaccines prior to initiation of immunosuppressive therapy or defer until immunosuppressive therapy discontinued. (See Immunosuppressive Agents under Interactions.)

ACIP, AAP, CDC, NIH, HIV Medicine Association of IDSA, and others state do not use in HIV-infected individuals. 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. 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.

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]). 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).

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. This contact restriction following vaccination is not necessary for patients who are not severely immunosuppressed.

Individuals with Medical Conditions Involving CSF Leak

ACIP states do not use influenza vaccine live intranasal in individuals with medical conditions that involve active communication between CSF and the oropharynx, nasopharynx, nose, or ear or any other cranial CSF leak. In addition, ACIP states do not use the live vaccine in individuals with cochlear implants because of potential for CSF leak, which might exist for some period after implantation.

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.

ACIP states do not use influenza vaccine live intranasal in individuals with chronic pulmonary, cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus).

Transmission of Vaccine Virus

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

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; 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.

Transmission of vaccine virus has occurred rarely between recipients of influenza vaccine live intranasal and their contacts. 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.

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.

ACIP states mild acute illness does not preclude vaccination.

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

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; alternatively, use a different age-appropriate influenza vaccine.

Individuals with Coronavirus Disease 2019 (COVID-19)

CDC states defer influenza vaccination in individuals with suspected or confirmed COVID-19, regardless of symptoms, until criteria for discontinuance of COVID-19 isolation have been met. Although mild illness usually not considered a contraindication to vaccination, postpone vaccination in such individuals with suspected or confirmed COVID-19 to avoid exposing health-care personnel and other patients to the disease.

Limitations of Vaccine Effectiveness

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

May not protect all vaccine recipients from influenza.

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. Efficacy of seasonal influenza vaccine during any given year depends on how closely viral strains represented in the vaccine match viral strains circulating during the season.

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]).

Seasonal influenza vaccines will not provide protection against COVID-19.

Duration of Immunity

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

Do not administer influenza vaccine from a previous influenza season (e.g., 2019–2020) in an attempt to provide protection during a subsequent influenza season.

Improper Storage and Handling

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

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

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

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; also can consult CDC.

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. Animal reproduction studies have not revealed evidence of harm to the fetus.

ACIP, AAP, ACOG, and others state do not use influenza vaccine live intranasal in pregnant women. 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).

Lactation

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

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. Although live vaccine viruses can replicate in the mother, the majority of live vaccine viruses are not distributed into milk.

Pediatric Use

Safety and efficacy established only in children ≥2 years of age.

Not indicated in infants <24 months of age. 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.

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. AAP states do not use in any child with asthma. Both ACIP and AAP state do not use in certain children with a history of wheezing. (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. 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.

Adults 50–64 Years of Age

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

Geriatric Use

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

ACIP states use influenza virus vaccine inactivated or influenza vaccine recombinant in aduts ≥65 years of age.

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.

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.

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

Interactions for Influenza Vaccine Live Intranasal

Immunosuppressive Agents

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

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. (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.

Vaccines

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

Influenza vaccine live intranasal and other live vaccines generally may be administered concurrently on the same day. 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. 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.

Specific Drugs

Drug

Interaction

Comments

Antivirals active against influenza (baloxavir, oseltamivir, peramivir, zanamivir, amantadine, rimantadine)

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

Manufacturers state do not give influenza vaccine live intranasal until ≥48 hours after influenza antiviral discontinued and do not give influenza antiviral until ≥2 weeks after the vaccine; if influenza antiviral and influenza vaccine live intranasal given concomitantly, consider revaccination

ACIP states consider half-life of the specific influenza antiviral when assessing time period of potential interference; if influenza antiviral given at interval before or after influenza vaccine live intranasal that potentially could interfere with the vaccine, revaccinate using age-appropriate influenza virus vaccine inactivated or influenza vaccine recombinant

Baloxavir: Because of long half-life (approximately 79 hours), may interfere with the vaccine if given from 17 days before through 2 weeks after vaccination

Oseltamivir: May interfere with the vaccine if given from 48 hours before through 2 weeks after vaccination

Peramivir: Because of long half-life (approximately 20 hours), may interfere with the vaccine if given from 5 days before through 2 weeks after vaccination

Zanamivir: May interfere with the vaccine if given from 48 hours before through 2 weeks after vaccination

Aspirin

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

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

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 globulin

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 reactions

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

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

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 immunosuppression

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

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

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 discontinued

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 discontinued

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

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

Intranasal preparations (e.g., corticosteroids)

Concomitant administration not evaluated

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; safety and immunogenicity of concurrent administration not evaluated in infants >15 months of age

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

Rotavirus vaccine (RV)

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

Typhoid Vaccines

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

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)

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; safety and immunogenicity of concurrent administration not evaluated in infants >15 months of age

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

Stability

Storage

Intranasal Spray

Suspension

2–8°C; do not freeze.

Does not contain thimerosal or any other preservatives.

Actions

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

  • 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.

  • Influenza vaccines for the 2020–2021 influenza season contain different influenza A (H1N1), influenza A (H3N2), and influenza B (Victoria lineage) antigens, but the same influenza B (B/Yamagata lineage) antigen, contained in vaccines used for the 2019–2020 influenza season.

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

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

  • 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. (See Limitations of Vaccine Effectiveness under Cautions.)

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]).

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

  • Advise patient and/or patient’s parent or guardian that annual vaccination against seasonal influenza is necessary. Importance of receiving a 2020–2021 seasonal influenza vaccine, even if the individual received a 2019–2020 seasonal influenza vaccine.

  • 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. (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. 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. (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. (See Close Contacts of Individuals with Altered Immunocompetence under Cautions.)

  • Importance of informing clinicians of adverse effects. 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].

  • 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).

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

  • Importance of informing patients of other important precautionary information. (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 (2020–2021)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension

106.5–7.5 FFU (fluorescent focus units) each of A/Hawaii/66/2019 (H1N1), A/Hong Kong/2671/2019 (H3N2), B/Washington/02/2019 (B/Victoria lineage), and B/Phuket/3073/2013 (B/Yamagata lineage) per 0.2 mL

FluMist

MedImmune

AHFS DI Essentials™. © Copyright 2021, Selected Revisions September 7, 2020. 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.

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