Influenza Virus Vaccine Live Intranasal

Class: Vaccines
VA Class: IM100
Brands: FluMist

Introduction

Live, attenuated virus vaccine.1 Seasonal influenza vaccine live intranasal 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.1 100

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.1 100 112

Influenza is an acute viral infection; influenza viruses spread from person to person mainly through large-particle respiratory droplet transmission.100 105 488 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.100 105 488 Influenza can exacerbate underlying medical conditions or lead to pneumonia in certain individuals.100 105 488 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.100 105 488

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.100 112 199 200 336 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.100 112

For the 2013–2014 influenza season, 3 different types of influenza vaccines are commercially available in the US for prevention of seasonal influenza: parenteral inactivated influenza vaccine (IIV),100 103 104 106 107 186 187 188 189 190 intranasal live attenuated influenza vaccine (LAIV),1 100 and parenteral recombinant influenza vaccine (RIV).100 158 Some of these are available as trivalent formulations containing 2 influenza A antigens and 1 influenza B antigen100 103 158 160 161 186 187 188 189 190 and some are available as quadrivalent formulations containing 2 influenza A antigens and 2 influenza B antigens.1 100 104 106 107

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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 (e.g., egg allergy).100 112 For many individuals, more than one vaccine type may be appropriate.100 112 ACIP and AAP state 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.100 112 In addition, ACIP and AAP do not state a preference for a trivalent or quadrivalent formulation for the 2013–2014 influenza season.100 112 If an age-appropriate vaccine is available and there are no contraindications, do not delay influenza vaccination to obtain a specific product.100 112

Possible advantages of the intranasal live vaccine include its potential to induce a broad mucosal and systemic immune response, ease of administration, and improved acceptance of intranasal rather than parenteral administration;100 possible disadvantages include restrictions based on age or medical conditions and risk that the live vaccine virus could be transmitted from the vaccinee to close contacts who are severely immunocompromised.100 (See Transmission of Vaccine Virus under Cautions.)

ACIP, AAP, and others state that either seasonal intranasal live influenza vaccine or an age-appropriate parenteral seasonal vaccine can be used for prevention of seasonal influenza infection in healthy, nonpregnant individuals 2 through 49 years of age who do not have underlying medical conditions that put them at higher risk for influenza complications.100 112 199 200 336 This includes health-care personnel, household contacts, and other individuals (e.g., day-care providers) who are in close contact with individuals at high risk of influenza complications or in close contact with certain immunocompromised individuals (e.g., those not requiring a protective environment, those with diabetes or HIV infection, asthma patients taking corticosteroids).100

Do not use seasonal intranasal live influenza vaccine in health-care workers, household members, or other individuals who have close contact with severely immunocompromised individuals who are hospitalized and require care in a protective environment (e.g., hematopoietic stem cell transplant [HSCT] recipients).100 336 (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.) Use an age-appropriate parenteral seasonal influenza vaccine in these individuals.100

Travelers (especially those at high risk for influenza complications) should receive seasonal influenza vaccine ≥2 weeks before departure.117 551 Risk for exposure to seasonal influenza during travel depends on the time of year and destination.117 In the Northern Hemisphere, influenza season may begin as early as October and extend until May;117 in the Southern Hemisphere, influenza season may begin in April and last through September.117 In tropical and subtropical areas, influenza may occur throughout the year, but most countries will have defined seasonal peaks.117 Travelers may be exposed to influenza at any time of the year if they are traveling on a cruise or as part of a large tourist group that includes individuals from areas of the world where influenza is circulating.117 551

HIV-infected individuals may be at high risk for influenza-related complications and should receive annual vaccination against seasonal influenza.100 105 155 156 However, antibody response may be reduced in HIV-infected individuals and is inversely correlated with severity of the disease.100 105 Inactivated influenza vaccine (not intranasal live influenza vaccine) is recommended in HIV-infected individuals.155

Safety and efficacy of seasonal intranasal live influenza vaccine not established in children <24 months of age or adults ≥50 years of age;1 use an age-appropriate parenteral seasonal influenza vaccine in these age groups.100

Safety of seasonal intranasal live influenza vaccine not established in individuals with underlying medical conditions that may predispose them to severe disease following influenza infection;1 100 use age-appropriate parenteral seasonal influenza vaccine in these individuals.100

Seasonal influenza vaccines not effective against all strains of influenza, but may be effective against those strains (and possibly closely related strains) represented in the vaccines.100

Seasonal influenza vaccines for the 2013–2014 influenza season are expected to provide protection against the influenza A (H1N1)pdm09 virus and influenza A (H3N2) and influenza B viruses represented in the vaccines.100 112 551

Seasonal influenza vaccines for the 2013–2014 influenza season do not provide protection against influenza A (H3N2) variant viruses (H3N2v).551

Seasonal influenza vaccines for the 2013–2014 influenza season not expected to provide protection against avian influenza A viruses, including avian influenza A (H5N1) and avian influenza A (H7N9).551 Although an inactivated influenza A (H5N1) monovalent vaccine has been approved by FDA, the vaccine is not available commercially but has been purchased by the US Federal Government for inclusion in the National Stockpile.470

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

Administration

Intranasal Administration

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

Do not administer IM, IV, or intradermally.100

Intranasal live influenza vaccine 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 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

If vaccine recipient sneezes after receiving a dose, do not repeat the dose.100

If nasal congestion might impede delivery of vaccine to nasopharyngeal mucosa, defer administration until symptoms subside.100 Alternatively, use a parenteral seasonal influenza vaccine.100

Administer seasonal influenza vaccine every year before exposure to seasonal influenza.100 Begin annual vaccination efforts by October (or as soon as influenza vaccine for current season is available);100 continue vaccination efforts throughout influenza season (even in December or after influenza activity has begun in the community).100 In the US, localized outbreaks indicating start of the annual influenza season can occur as early as October;100 peak influenza activity often occurs in January or February,100 but has occurred as late as April or May.488

May be given simultaneously with other age-appropriate vaccines during same health-care visit.100 112 134 (See Interactions.)

Dosage

Dosing schedule for prevention of seasonal influenza depends on individual’s age and vaccination history.1 100 112 199 200

A single-dose regimen of seasonal influenza vaccine is used in children ≥9 years of age, adolescents, and adults 18 through 49 years of age.1 100 112 199 200

A 2-dose regimen of seasonal influenza vaccine is necessary in children 2 through 8 years of age who have not previously received any doses of seasonal influenza vaccine or have an uncertain history regarding prior influenza vaccination.1 100 112 199 (See Pediatric Patients under Dosage and Administration.)

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 type of 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

Received <2 doses of any seasonal influenza vaccine since July 1, 2010: ACIP and AAP recommend 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 ≥2 doses of any seasonal influenza vaccine since July 1, 2010: ACIP and AAP recommend a 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).1 100 112

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).1 100 200

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 Virus Vaccine Live Intranasal

Contraindications

  • Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, gentamicin, gelatin, or arginine.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

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.)

Egg Allergy

Seasonal intranasal live influenza vaccine is produced using eggs;1 100 112 contains residual egg protein (<24 mcg of ovalbumin per dose)1 that may induce immediate hypersensitivity reactions, including anaphylaxis, in individuals with severe egg allergy.100 112

When considering use of influenza vaccine in patients who report a history of egg allergy, determine whether the presumed egg allergy is based on a mild reaction (i.e., urticaria alone) or severe reaction (i.e., anaphylaxis involving cardiovascular changes, respiratory symptoms, and/or GI symptoms; reactions requiring use of epinephrine).100 112

ACIP and AAP state that individuals with a history of egg allergy who have experienced only urticaria after eating eggs or egg-containing foods may receive influenza vaccine; however, age-appropriate parenteral inactivated influenza vaccine or parenteral recombinant influenza vaccine is preferred over intranasal live influenza vaccine since relatively limited data available regarding use of the live vaccine in individuals with egg allergy.100 112 Recombinant influenza vaccine is egg-free and may be used in adults 18 through 49 years of age with a history of egg allergy who have no other contraindications.100 112 If inactivated influenza vaccine is used in an individual with a history of only urticaria after exposure to eggs, the vaccine should be administered by a health-care provider familiar with potential manifestations of egg allergy and the vaccine recipient should be observed for ≥30 minutes following vaccination.100 112

Individuals with a history of severe reaction to eggs, including angioedema, respiratory distress (e.g., wheezing, throat swelling), lightheadedness, cardiovascular changes (e.g., hypotension), or GI symptoms (e.g., nausea, vomiting), or any previous reaction requiring epinephrine or other emergency intervention (particularly reactions that occurred within minutes to hours following egg exposure), are more likely to have a serious systemic or anaphylactic reaction following reexposure to egg protein.100 112 Such individuals may receive the recombinant influenza vaccine if they are 18 through 49 years of age and there are no other contraindications.100 If the recombinant vaccine is not available or recipient is not within the indicated age range for the recombinant vaccine, refer the individual to a clinician with expertise in management of allergic conditions for further risk assessment to determine whether influenza vaccine should be administered.100 112

Individuals who are able to eat lightly cooked eggs (e.g., scrambled eggs) without reaction are unlikely to be allergic and may receive influenza vaccination per usual protocols.100 However, tolerance to egg-containing foods does not exclude the possibility of egg allergy since some egg-allergic individuals may tolerate egg in baked products (e.g., bread, cake). Egg allergy can be confirmed by a consistent 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

Consultation with a clinician experienced in management of allergic conditions is recommended prior to administration of inactivated influenza vaccine in individuals with no known history of egg exposure, but who are suspected of being egg-allergic on the basis of prior allergy testing.100 Alternatively, recombinant influenza vaccine may be used if recipient is 18 through 49 years of age.100

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.1 100 112 The vaccine has not been studied in individuals with severe asthma or active wheezing.1

ACIP and AAP 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.100 112 (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 Alternatively, ACIP states 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; however, the parenteral inactivated influenza vaccine (not the intranasal live vaccine) should be used for prevention of seasonal influenza in HIV-infected individuals.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); the vaccine may be administered to close contacts of less severely immunocompromised individuals (e.g., those not requiring a protective environment).100 336

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.1 100 112

Individuals at increased risk of influenza complications include those with chronic pulmonary (including asthma), cardiovascular (except hypertension), renal, hepatic, neurologic, hematologic, or metabolic (including diabetes mellitus) disorders and those who are immunosuppressed (including immunosuppression caused by drug therapy or HIV infection).100 (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.)

Transmission of Vaccine Virus

Intranasal influenza vaccine contains live, attenuated virus.1 100 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.1 100

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.1 100

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 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.1 100 551 (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

Intranasal live influenza vaccine for the 2013–2014 influenza season expected to provide protection against the influenza A (H1N1)pdm09 virus and influenza A (H3N2) and influenza B viruses represented in the vaccine.100 112 551

Seasonal influenza vaccines for the 2013–2014 influenza season do not provide protection against influenza A (H3N2) variant viruses (H3N2v).551

Seasonal influenza vaccines for the 2013–2014 influenza season not expected to provide protection against avian influenza A viruses, including avian influenza A (H5N1) and avian influenza A (H7N9).551

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 in an attempt to provide protection during a subsequent influenza season.100

Concomitant Illness

Delay administration in individuals with moderate to severe acute illness (with or without fever) until symptoms have subsided.100 134

ACIP states that mild diarrhea or mild upper respiratory tract illness or other acute illness (with or without fever) does not preclude vaccination.134 However, if nasal congestion will impede delivery of intranasal live vaccine to the nasopharyngeal mucosa, defer administration of the vaccine until illness resolves or, alternatively, use an age-appropriate parenteral influenza vaccine.100

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

Category B.1

Manufacturer states use in pregnant women only when clearly needed.1

ACIP, ACOG, American College of Physicians (ACP), NIH, IDSA, 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.100 134 155 200

Lactation

Not known whether influenza virus live is distributed into milk.1 Manufacturer recommends caution.1

Pediatric Use

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 and AAP recommend that intranasal live influenza vaccine 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).100 112

When considering use in children 24 through 59 months of age, ACIP and AAP recommend that clinicians screen for possible reactive airways diseases by consulting the child's medical record and asking the child's parent or guardian if wheezing or asthma episodes were identified by a health-care provider within the past 12 months.100 112 Use age-appropriate seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in such children.100 112

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 Use age-appropriate parenteral seasonal inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in this age group.100

Geriatric Use

Not indicated for use in geriatric individuals ≥65 years of age.1 Use age-appropriate parenteral seasonal inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in geriatric adults.100

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.100

Live Vaccines

Intranasal influenza vaccine is a live, attenuated virus vaccine.1 100 112 134 ACIP states that influenza vaccine live intranasal and other live vaccines generally may be administered simultaneously on the same day.100 134

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.100 134 (See Specific Drugs under Interactions.)

Specific Drugs

Drug

Interaction

Comments

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

Concomitant use of intranasal live influenza vaccine and antivirals used for treatment or prevention of influenza not studied; these antivirals potentially could decrease response to the live vaccine1 100

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 100

If influenza antiviral agent and intranasal live influenza vaccine are administered concomitantly, consider revaccination if appropriate1

ACIP recommends revaccination if an influenza antiviral was given within 14 days after intranasal live influenza vaccine;100 alternatively, if influenza antiviral given 2 days before to 14 days after the intranasal live vaccine, revaccinate using parenteral inactivated influenza vaccine or parenteral recombinant influenza vaccine100

Aspirin

Association of Reye's syndrome with aspirin and wild-type influenza infection 1 100

Contraindicated in children and adolescents 2–17 years of age receiving aspirin or aspirin-containing therapy;1 100 avoid aspirin-containing products in children and adolescents 2–17 years of age for 4 weeks following vaccination1

Blood products

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 therapy112 134

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 possible100 134

Rotavirus vaccine (RV)

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

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 25 100 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 possible100 134

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 used for prevention of seasonal influenza contains live, attenuated (cold-adapted) influenza virus types A and B.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.1 100 551 552 For the 2013–2014 season, the antigenic components recommended by FDA for US formulations of seasonal influenza vaccines are the same as those recommended by WHO (Northern Hemisphere).551 552

  • The 2013–2014 seasonal intranasal live influenza vaccine for the US is a quadrivalent vaccine containing 2 influenza type A antigens (H1N1 and H3N2) and 2 influenza type B antigens.1 551 The quadrivalent formulation available for the 2013–2014 influenza season may offer improved protection against circulating influenza B since it contains antigens representing both the B/Victoria and B/Yamagata lineages.100 112

  • The 2013–2014 seasonal intranasal live influenza vaccine for the US contains A/California/7/2009 (H1N1)pdm09-like, A/Texas/50/2012 (H3N2) (an A/Victoria/361/2011-like virus), B/Massachusetts/2/2012 (B/Yamagata/16/88 lineage), and B/Brisbane/60/2008 (B/Victoria/2/87 lineage) virus antigens.1 100 551

  • For the 2013–2014 influenza season, ACIP and AAP state 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.100 112 In addition, ACIP and AAP do not state a preference for a trivalent or quadrivalent formulation for the 2013–2014 influenza season.100 112 (See Prevention of Seasonal Influenza A and B Virus Infections under Uses.)

  • 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.1 100 Protective mechanism not completely understood; may involve both serum and nasal secretory antibodies and cell-mediated immune responses (influenza-specific T-cells).1 100

  • 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

  • Seasonal influenza vaccines for the 2013–2014 influenza season are expected to provide protection against the influenza A (H1N1)pdm09 virus and influenza A (H3N2) and influenza B strains represented in the vaccines.112 100 551 (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 ).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 2013–2014 seasonal influenza vaccine, even if the individual received a 2012–2013 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).1 100 112 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 Necessity of vaccine recipient avoiding close contact with severely immunocompromised individuals for 7 days following vaccination.100 (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.)

Preparations

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

Influenza Vaccine Live Intranasal Quadrivalent (2013–2014)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension

106.5-7.5 FFU (fluorescent focus units) each of A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012, and B/Brisbane/60/2008 per 0.2 mL

FluMist (available in 0.2-mL prefilled single-use sprayers)

MedImmune

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions November 1, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, 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 2013–2014 formula) intranasal spray prescribing information. Gaithersburg, MD; 2013 Jul.

20. Centers for Disease Control and Prevention. Influenza vaccine live, intranasal 2013–2014 information statement. 2013 Jul 26. From CDC website.

23. Centers for Disease Control and Prevention. Interim within-season estimate of the effectiveness of trivalent inactivated influenza vaccine- Marshfield, Wisconsin, 2007–08 influenza season. MMWR Morb Mortal Wkly Rep. 2008; 57(15):1–32.

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. [PubMed 18310199]

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. [PubMed 19332437]

100. Influenza Division, National Center for Immunization and Respiratory Diseases, CDC. Prevention and control of seasonal influenza with vaccines. MMWR Recomm Rep. 2013; 62(RR-07):1-43.

103. Sanofi Pasteur Inc. Fluzone (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Swiftwater, PA; 2013 Apr.

104. Sanofi Pasteur Inc. Fluzone Quadrivalent (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Swiftwater, PA; 2013 Jun.

105. American Academy of Pediatrics. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

106. GlaxoSmithKline. Fluarix Quadrivalent (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Research Triangle Park, NC; 2013 May.

107. GlaxoSmithKline. Flulaval Quadrivalent (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Research Triangle Park, NC; 2013 Aug.

112. Committee on Infectious Disease. Recommendations for Prevention and Control of Influenza in Children, 2013–2014. Pediatrics. 2013; :.

117. Centers for Disease Control and Prevention. CDC health information for international travel, 2014. Atlanta, GA: US Department of Health and Human Services. Updates may be available at CDC website.

134. National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011; 60:1-64.

155. Panel on Opportunistic Infections in HIV-infected Adults and Adolescents. Guidelines for 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 (May 7, 2013). Updates may be available at HHS AIDS Information (AIDSinfo) website.

156. Mofenson LM, Brady MT, Danner SP et al. Guidelines for the Prevention and Treatment of Opportunistic Infections among HIV-exposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. MMWR Recomm Rep. 2009; 58:1-166. [PubMed 19730409]

158. Protein Sciences Corporation. Flublok (influenza vaccine) sterile solution for intramuscular injection prescribing information. Meriden; CT. 2013 Jan.

160. Sanofi Pasteur Inc. Fluzone high-dose (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Swiftwater, PA; 2013 Apr.

161. Sanofi Pasteur Inc. Fluzone intradermal (influenza virus vaccine 2013–2014 formula) suspension for intradermal injection prescribing information. Swiftwater, PA; 2013 Apr.

186. Novartis Vaccines and Diagnostics. Fluvirin (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Cambridge, MA; 2013 Feb 26.

187. GlaxoSmithKline. Fluarix (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Research Triangle Park, NC; 2013 May.

188. GlaxoSmithKline. Flulaval (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Research Triangle Park, NC; 2013 Aug.

189. Merck & Co. Afluria (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Whitehouse, NJ; 2013 Apr.

190. Novartis Vaccines and Diagnostics. Flucelvax (influenza virus vaccine 2013–2014 formula) suspension for intramuscular injection prescribing information. Cambridge, MA; 2013 Jul.

199. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedules for persons aged 0 through 18 years–United States, 2013. Updates may be available at CDC website.

200. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices (ACIP) recommended immunization schedule for adults aged 19 years and older–United States, 2013. Updates may be available at CDC website.

336. 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.

470. US Food and Drug Administration. FDA approves first U.S. vaccine for humans against the avian influenza virus H5N1. April 19, 2007. From FDA web site.

488. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable diseases. 12th ed. Washington DC: Public Health Foundation; 2012 May. Updates may be available at CDC website.

551. Centers for Disease Control and Prevention (CDC). Influenza activity--United States, 2012-13 season and composition of the 2013-14 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2013; 62:473-9. [PubMed 23760189]

552. . Recommended composition of influenza virus vaccines for use in the 2013–2014 northern hemisphere influenza season. Wkly Epidemiol Rec. 2013; 88:101-14. [PubMed 23544236]

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