Influenza Virus Vaccine Live Intranasal
VA Class: IM100
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 Virus 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
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, and infants and children ≥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
In June 2016, ACIP issued an interim recommendation stating that the seasonal intranasal live attenuated influenza vaccine (LAIV; LAIV4) should not be used for the 2016–2017 influenza season.100 ACIP made this interim recommendation after reviewing newly available data (unpublished observational studies) regarding the effectiveness of the vaccine during the 2015–2016 influenza season.100 AAP supports this decision and states that the intranasal vaccine should not be used in any setting during the 2016–2017 influenza season.112 ACIP acknowledges that influenza vaccine live intranasal might still be available and some health-care providers might elect to use the intranasal vaccine for the 2016–2017 influenza season.100 The interim recommendation regarding use of the intranasal vaccine will be reevaluated as subsequent data become available.100 112
Current information regarding influenza surveillance and updated recommendations for prevention and treatment of seasonal influenza is available from CDC at .
Influenza Virus Vaccine Live Intranasal Dosage and Administration
Administer intranasally using prefilled, single-use sprayer supplied by the manufacturer.1
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 Consult manufacturer’s labeling for specific information regarding use of the sprayer.1
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
May be given simultaneously with other age-appropriate vaccines during same health-care visit.134 (See Interactions.)
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
Prevention of Seasonal Influenza A and B Virus Infections
Healthy Children 2 through 8 Years of AgeIntranasal
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
Healthy Children and Adolescents 9 through 17 Years of AgeIntranasal
Single dose consisting of 0.2 mL (0.1 mL in each nostril).1
Prevention of Seasonal Influenza A and B Virus Infections
Healthy Adults 18 through 49 Years of AgeIntranasal
Single dose consisting of 0.2 mL (0.1 mL in each nostril).1
No specific dosage recommendations.1
No specific dosage recommendations.1
Not indicated in adults ≥50 years of age, including geriatric adults.1
Cautions for Influenza Virus Vaccine Live Intranasal
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.)
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
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 (See Contraindications under Cautions.)
Manufacturer states that seasonal intranasal live influenza vaccine 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 states that influenza vaccines produced using eggs may be administered safely to individuals with a history of egg allergy.100
Individuals who are able to eat lightly cooked eggs (e.g., scrambled eggs) without reaction are unlikely to be allergic.100 Egg-allergic individuals may tolerate egg in baked products (e.g., bread, cake).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
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
ACIP states that a previous severe allergic reaction to influenza vaccine, regardless of the component suspected of being responsible for the reaction, is a contraindication to future receipt of influenza vaccine.100 112
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 (See Pediatric Use under Cautions.)
Individuals with Asthma or Recurrent Wheezing
Individuals of any age with asthma and children <5 years of age with history of recurrent wheezing or a recent wheezing episode (i.e., during the past 12 months) may be at increased risk of wheezing after receiving intranasal live influenza vaccine.1
Manufacturer states that intranasal live influenza vaccine has not been studied in individuals with severe asthma or active wheezing.1
ACIP states that data are insufficient to determine the level of severity of asthma for which administration of intranasal live influenza vaccine would be inadvisable.100 These experts state that intranasal live influenza vaccine should not be used in individuals with asthma or in children 24 through 59 months of age who have had a wheezing episode within the past 12 months.100 (See Pediatric Use under Cautions.)
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
Unclear whether influenza vaccination increases risk of recurrence of GBS.100 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 and Their Close Contacts
Efficacy not studied in immunocompromised individuals.1 Limited data in immunocompromised adults, adolescents, and children with HIV or cancer indicate adverse effects and frequency and duration of vaccine virus shedding in such individuals are similar to that reported in healthy individuals.1
CDC, NIH, IDSA, AAP, and other experts state that HIV-infected children, adolescents, and adults should receive annual vaccination against seasonal influenza with parenteral inactivated influenza vaccine (not the intranasal live vaccine).100 112 155 156
ACIP states that live viral vaccines (including intranasal live influenza vaccine) usually should not be used in immunocompromised individuals, except in certain circumstances.134 These experts state that use of live virus vaccines can be considered in patients with leukemia, lymphoma, or other malignancies if the disease is in remission and chemotherapy was terminated at least 3 months prior to vaccination.134 (See Specific Drugs under Interactions.)
Because of possible transmission of live vaccine viruses, intranasal live influenza vaccine should not be administered to close contacts of severely immunocompromised individuals who are hospitalized and require care in a protective environment (e.g., HSCT recipients);100 235 the vaccine may be administered to close contacts of less severely immunocompromised individuals (e.g., those not requiring a protective environment).100 235
In addition, because of possible transmission of live vaccine viruses, ACIP states that health-care workers who have received the intranasal vaccine should avoid contact with severely immunocompromised patients requiring a protective environment (e.g., HSCT recipients) for 7 days after vaccination.100 Hospital visitors who have received the vaccine should avoid contact with severely immunosuppressed patients for 7 days after vaccination but may visit 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
Intranasal influenza vaccine 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 intranasal live vaccine.1
Relationship between vaccine virus replication in vaccine recipients and transmission of vaccine virus to other individuals not established.1 Transmission of vaccine virus has occurred rarely between recipients of intranasal influenza vaccine and their contacts.1
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 against 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.1 567 (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
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
Delay administration in individuals with moderate to severe acute illness (with or without fever) until symptoms have subsided.134
ACIP states that mild diarrhea or mild upper respiratory tract illness or other acute illness (with or without fever) does not preclude vaccination.134
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
Manufacturer states use in pregnant women only when clearly needed.1
ACIP, ACOG, American College of Physicians (ACP), and other experts state that parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) should be used for prevention of seasonal influenza in pregnant women.100 134
Safety and efficacy established only in children ≥2 years of age.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 intranasal live influenza vaccine compared with those who received parenteral seasonal inactivated influenza vaccine.1
ACIP states that intranasal live influenza vaccine should not be used in children with asthma or children 24 through 59 months of age with a history of recurrent wheezing or recent wheezing episode (i.e., during the past 12 months) and should be used with caution in those ≥5 years of age with asthma.100
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 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 Virus Vaccine Live Intranasal
Inactivated Vaccines and Toxoids
Safety and immunogenicity of intranasal live influenza vaccine administered concomitantly with age-appropriate inactivated vaccines not specifically studied.1
ACIP states that, in the absence of specific data indicating interference, inactivated vaccines or toxoids can be administered simultaneously with or at any interval before or after seasonal intranasal live influenza vaccine.134
Intranasal influenza vaccine is a live, attenuated virus vaccine.1 134 ACIP states that influenza live intranasal vaccine and other live vaccines generally may be administered simultaneously on the same day.134
ACIP states that some oral live vaccines (e.g., typhoid vaccine live oral) can be administered concomitantly with or at any interval before or after intranasal live influenza vaccine.134 However, because of theoretical concerns that the immune response to other live virus vaccines might be impaired if given within 30 days of another live virus vaccine, ACIP states that if intranasal live influenza vaccine and other live vaccines are not administered on the same day, they should be administered at least 4 weeks apart.134 (See Specific Drugs under Interactions.)
Antiviral agents active against influenza (amantadine, rimantadine, oseltamivir, peramivir, zanamivir)
Concomitant use may inhibit the vaccine virus and could decrease immune response to the vaccine; no specific studies1
Do not administer intranasal live influenza vaccine until at least 48 hours after influenza antiviral agent discontinued; do not administer influenza antiviral agent until at least 2 weeks after the vaccine, unless medically necessary1 406
If influenza antiviral agent and intranasal live influenza vaccine are administered concomitantly, consider revaccination if appropriate1
Association of Reye's syndrome with aspirin and wild-type influenza infection 1
Contraindicated in children and adolescents 2–17 years of age receiving aspirin or aspirin-containing therapy;1 avoid aspirin-containing products in children and adolescents 2–17 years of age for 4 weeks following vaccination1
May be administered simultaneously with or at any time before or after whole blood, packed red blood cells, plasma, and platelet products134
Immune globulin (immune globulin IM [IGIM], immune globulin IV [IGIV]) or specific hyperimmune globulin (hepatitis B immune globulin [HBIG], rabies immune globulin [RIG], tetanus immune globulin [TIG], varicella zoster immune globulin [VZIG])
May be given simultaneously with or at any interval before or after immune globulin or specific hyperimmune globulin134
Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)
Potential for decreased antibody response to intranasal live influenza vaccine and increased risk of adverse reactions134
Should not be used in those receiving immunosuppressive therapy134
Optimum interval between discontinuance of immunosuppressive therapy and subsequent administration of a live viral vaccine has not been determined134
Live viral vaccines generally should not be administered for at least 3 months after immunosuppressive therapy is discontinued, including chemotherapy or radiation for leukemia, other hematopoietic malignancies, or solid tumors, or after solid organ transplant 134
Systemic corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks is considered immunosuppressive;134 delay administration of live vaccines for at least 1 month after such therapy is discontinued134
Corticosteroid therapy involving short-term (<2 weeks), 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); inhalation; or intra-articular, bursal, or tendon injections does not contraindicate use of live vaccines134
Intranasal preparations (e.g., corticosteroids)
Concomitant administration not evaluated1
Measles, mumps, and rubella vaccine (MMR)
Simultaneous administration of intranasal live influenza vaccine with MMR and monovalent varicella vaccine in infants 12–15 months of age did not interfere with the immune response to any of the antigens and did not increase frequency of adverse effects;1 25 safety and immunogenicity of simultaneous administration not evaluated in infants >15 months of age1
If not given simultaneously, give at least 4 weeks apart whenever possible134
Rotavirus vaccine (RV)
Varicella vaccine (VAR)
Simultaneous administration of intranasal live influenza vaccine with monovalent varicella vaccine and MMR vaccine in infants 12–15 months of age did not interfere with the immune response to any of the antigens and did not increase frequency of adverse effects;1 25 safety and immunogenicity of concomitant administration not evaluated in infants >15 months of age1
If not given simultaneously, give at least 4 weeks apart whenever possible134
2–8°C; do not freeze.1
Does not contain thimerosal or any other preservatives.1
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.1 100 567 For the 2016–2017 season, antigenic components recommended by FDA for US formulations of seasonal influenza vaccines are the same as those recommended by WHO (Northern Hemisphere).567 568
Intranasal live influenza vaccine 2016–2017 is a quadrivalent vaccine containing 2 influenza type A antigens (H1N1 and H3N2) and 2 influenza type B antigens (B/Yamagata lineage and B/Victoria lineage).1
Intranasal live influenza vaccine 2016–2017 for the US contains A/Bolivia/559/2013 (H1N1) (an A/California/7/2009 (H1N1)pdm09-like virus), A/New Caledonia/71/2014 (H3N2) (an A/Hong Kong/4801/2014-like virus), B/Phuket/3073/2013 (B/Yamagata/16/88 lineage), and B/Brisbane/60/2008 (B/Victoria/2/87 lineage) virus antigens.1
Influenza vaccines stimulate active immunity to influenza virus strains represented in the vaccines.1
Following administration of intranasal live influenza vaccine, 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 ).1 20
Advise patient and/or patient's parent or guardian of the risks and benefits of vaccine administration.1
Advise patient and/or patient's parent or guardian that annual vaccination against seasonal influenza is necessary.100 Importance of receiving a 2016–2017 seasonal influenza vaccine, even if the individual received a 2015–2016 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 or has had a recent wheezing episode (within the past 12 months).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.)
Importance of informing clinicians of any severe or life-threatening allergies, including severe allergy to eggs, or any history of severe reaction after prior influenza vaccination.20
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 Individuals with Altered Immunocompetence and Their Close Contacts 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 .1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant medical problems (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.)
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.
106.5-7.5 FFU (fluorescent focus units) each of A/Bolivia/559/2013 (H1N1), A/New Caledonia/71/2014 (H3N2), B/Phuket/3073/2013, and B/Brisbane/60/2008 per 0.2 mL
FluMist (available in 0.2-mL prefilled single-use sprayers)
AHFS DI Essentials. © Copyright 2017, Selected Revisions November 8, 2016. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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