Sunday 7 October 2012

FluMist


Generic Name: Influenza Virus Vaccine Live Intranasal
Class: Vaccines
VA Class: IM100

Introduction

Live, attenuated virus vaccine.1 100 Seasonal influenza virus vaccine live intranasal is a trivalent vaccine containing live (cold-adapted) influenza virus types A and B and is used to stimulate active immunity to influenza virus strains contained in the vaccine.1 100


Uses for FluMist


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.1 100 200


Influenza is an acute viral infection; influenza viruses spread from person to person mainly through large-particle respiratory droplet transmission.100 In the US, epidemics of seasonal influenza occur annually, usually during late fall through early spring.100 Influenza viruses can cause illness in any age group; children have highest rate of infection.100 Influenza can exacerbate underlying medical conditions or lead to pneumonia in certain individuals.100 Individuals ≥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


Annual vaccination is the most effective strategy for preventing seasonal influenza and its complications.100


Beginning in the 2010–2011 influenza season, the US Public Health Service Advisory Committee on Immunization Practices (ACIP) recommends 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 However, seasonal influenza vaccination efforts should continue to target individuals at higher risk of influenza or influenza-related complications and those who live with or care for such individuals (e.g., health-care personnel, household or other close contacts).100


For prevention of seasonal influenza infection, 2 different types of influenza vaccine are commercially available in the US: intranasal vaccine containing live, attenuated virus1 100 and parenteral (IM) vaccine containing inactivated virus subunits.3 5 12 15 17 18 100 Both vaccine types contain influenza virus strains antigenically equivalent to the annually recommended seasonal influenza strains.100 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 IM 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, American Academy of Family Physicians (AAFP), and other experts state that either seasonal intranasal live influenza vaccine or seasonal parenteral inactivated 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.100 105 200 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).100 200


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 requiring a protective environment (e.g., hematopoietic stem cell transplant [HSCT] recipients).100 (See Individuals with Altered Immunocompetence and Their Close Contacts under Cautions.) Use the seasonal parenteral inactivated influenza vaccine in these individuals.100


Travelers who want to reduce their risk for influenza infection should receive vaccination with seasonal influenza vaccine, preferably at least 2 weeks before departure.100 117 The risk for exposure to seasonal influenza during travel depends on the time of year and destination.100 117 In the tropics, influenza can occur throughout the year.100 117 In temperate regions of the southern hemisphere, influenza activity generally occurs from April through September; in temperate climates, travelers also may be exposed to influenza during the summer (especially when traveling as part of large tourist groups that include individuals from areas of the world where influenza is circulating).100 117 ACIP recommends that travelers (especially those at high risk for influenza complications) be vaccinated against seasonal influenza before travel if they were not vaccinated during the preceding fall or winter, will be traveling to the tropics, traveling with organized tourist groups at any time of year, or traveling to the southern hemisphere between April and September.100


Safety and efficacy of seasonal intranasal live influenza vaccine not established in children <2 years of age or adults ≥50 years of age;1 use the parenteral inactivated 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 the parenteral inactivated seasonal influenza vaccine in these individuals.100


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


Seasonal influenza vaccines for the 2010–2011 influenza season are expected to provide protection against infection with the 2009 pandemic influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) virus or swine-origin influenza A (H1N1) virus.100


Individuals who received the influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 influenza season should receive the 2010–2011 seasonal influenza vaccine, unless contraindicated. The 2009 pandemic influenza A (H1N1) virus is expected to continue to circulate during the 2010–2011 season and the duration of protection after receipt of the monovalent vaccine is unknown and likely declines over time.100 In addition, the seasonal vaccine also provides protection against influenza A (H3N2) and influenza B.100 ACIP states that there is no harm in administering 2010–2011 seasonal influenza vaccine to an individual who was previously infected with the 2009 pandemic influenza A (H1N1) virus.100


Seasonal influenza vaccines are not expected to provide protection against infection with avian influenza A viruses, including avian influenza A (H5N1).100


Information regarding influenza surveillance and updated recommendations for prevention and treatment of seasonal influenza is available from CDC at .


FluMist Dosage and Administration


Administration


Intranasal Administration


Administer intranasally using the 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 liquid and may be clear to slightly cloudy.1 Do not mix with any other vaccine or solution.118


Administer every year before exposure to seasonal influenza.1 100 Optimum time for annual vaccination against seasonal influenza cannot be determined since influenza seasons vary in timing and duration and more than one outbreak might occur in a single community during a single year.100 In the US, localized outbreaks indicating start of the annual influenza season can occur as early as October; peak influenza activity often occurs in January or February, but has occurred as late as April or May.100 Begin vaccination efforts each year by October or as soon as the seasonal influenza vaccine is available; continue vaccination efforts throughout influenza season, even after influenza activity has begun in the community.100


Intranasal live influenza vaccine must be administered by a health-care provider.1 Severely immunosuppressed individuals should not administer the vaccine.100 (See Administration Precautions under Cautions.) Other individuals at high risk of influenza complications (e.g., those with underlying medical conditions, pregnant women, individuals with asthma, individuals >50 years of age) may administer the vaccine.100


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).1 119


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 the parenteral inactivated seasonal influenza vaccine.100


May be given simultaneously with other age-appropriate vaccines during same health-care visit.100 105 118 200 (See Interactions.)


Dosage


Dosing schedule for prevention of seasonal influenza depends on individual’s age and vaccination status.1 100 105


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.1 100 105 200


ACIP and AAP state that a single-dose regimen of 2010–2011 seasonal influenza vaccine can be used in children 2 through 8 years of age who received 2 doses of any type of seasonal influenza vaccine during the 2009–2010 influenza season and received at least 1 dose of any type of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season.100 105 A single-dose regimen also can be used in children 2 through 8 years of age who were vaccinated against seasonal influenza prior to the 2009–2010 influenza season and received at least 1 dose of any type of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season.100 105


However, ACIP and AAP state that a 2-dose regimen of 2010–2011 seasonal influenza vaccine should be used in children 2 through 8 years of age who did not receive any doses of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 influenza season or have an uncertain history regarding vaccination with the influenza A (H1N1) 2009 monovalent vaccine.100 105


A 2-dose regimen of 2010–2011 seasonal influenza vaccine also is necessary in children 2 through 8 years of age who have not previously received any type of seasonal influenza vaccine,100 105 received seasonal influenza vaccine for the first time during the 2009–2010 season but received only a single dose,100 105 or have an uncertain history regarding vaccination with seasonal influenza vaccine.100 105


ACIP states that there is no harm in administering 2 doses of 2010–2011 seasonal influenza vaccine to a child who was previously infected with the 2009 pandemic influenza A (H1N1) virus.100 However, at the clinician's discretion, children with a history of laboratory-confirmed 2009 pandemic H1N1 virus infection (i.e., confirmed with reverse transcription polymerase chain reaction [PCR] testing or virus culture specific for 2009 pandemic influenza A [H1N1] virus) can be considered to have been vaccinated against this virus when determining whether a single- or 2-dose regimen of seasonal influenza vaccine is needed.100 Children 2 through 8 years of age who had a febrile respiratory illness during 2009–2010 and did not receive specific diagnostic testing for the 2009 pandemic influenza A (H1N1) virus (i.e., were not tested or were tested with a rapid antigen test) cannot be assumed to have had influenza A (H1N1) virus infection and, therefore, should receive 2 doses of 2010–2011 seasonal influenza vaccine.100


A single dose consists of the entire contents of the sprayer (0.2 mL).1


Pediatric Patients


Prevention of Seasonal Influenza A and B Virus Infections

Children 2 through 8 Years of Age

Intranasal

Received 2 doses of any type of seasonal influenza vaccine during the 2009–2010 influenza season and received at least 1 dose of any type of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season100 105 : Single dose consisting of 0.2 mL (0.1 mL in each nostril).1 100 105


Received any type of seasonal influenza vaccine prior to the 2009–2010 influenza season and received at least 1 dose of any type of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season100 105 : Single dose consisting of 0.2 mL (0.1 mL in each nostril).1 100 105


Did not previously receive any type of seasonal influenza vaccine or received seasonal influenza vaccine for the first time during the 2009–2010 season and received only a single dose: 2 doses administered at least 1 month apart.100 105 Each dose consists of 0.2 mL (0.1 mL in each nostril).1 100 105


Did not receive any doses of influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 influenza season: 2 doses administered at least 1 month apart.100 105 Each dose consists of 0.2 mL (0.1 mL in each nostril).1 100 105


Uncertain history of previous vaccination with any type of seasonal influenza vaccine and/or uncertain history regarding vaccination with influenza A (H1N1) 2009 monovalent vaccine during the 2009–2010 season: 2 doses administered at least 1 month apart.100 105 Each dose consists of 0.2 mL (0.1 mL in each nostril).1 100 105


Children and Adolescents 9 through 17 Years of Age

Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).1 100 105


Adults


Prevention of Seasonal Influenza A and B Virus Infections

Adults 18 through 49 Years of Age

Intranasal

Single dose consisting of 0.2 mL (0.1 mL in each nostril).1 100


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 FluMist


Contraindications



  • History of hypersensitivity (especially anaphylactic reactions) to egg or egg proteins, gentamicin, gelatin, or arginine.1




  • Life-threatening reaction to previous dose of influenza vaccine.1




  • Children and adolescents 2–17 years of age receiving aspirin or aspirin-containing therapy because of association of Reye's syndrome with aspirin use and wild-type influenza infection.1



Warnings/Precautions


Sensitivity Reactions


Hypersensitivity Reactions

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


Seasonal intranasal live influenza vaccine is produced using eggs,1 100 105 118 and can contain residual egg protein that may induce immediate hypersensitivity reactions, including anaphylaxis, in individuals with severe egg allergy.100 118 The manufacturer, ACIP, and AAP state that influenza vaccines should not be used in individuals with a history of anaphylactic or other immediate hypersensitivity reaction (e.g., hives, angioedema, allergic asthma) to eggs or egg proteins.1 100 105 118 (See Contraindications under Cautions.) AAP states that less severe or local manifestations of allergy to eggs or feathers are not contraindications to routine administration of influenza vaccine.105 ACIP states that asking patients if they can eat eggs without adverse effects is a reasonable way to identify those who may be at risk for allergic reactions if they receive the vaccine.100 118 Those who can eat eggs or egg products safely usually can receive influenza vaccine; those with a history of anaphylactic or other immediate hypersensitivity reaction (e.g., hives, angioedema, allergic asthma) to eggs or egg proteins should not receive the vaccine.118


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 life-threatening reaction to a previous dose.1 (See Contraindications under Cautions.)


Infants <24 Months of Age


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


Individuals with Asthma or Recurrent Wheezing


Do not use in individuals with asthma or in children <5 years of age with history of recurrent wheezing or a recent wheezing episode (i.e., during the past 12 months)1 100 105 unless potential benefits outweigh risks;1 increased risk of wheezing in such individuals.1 (See Pediatric Use under Cautions.)


Do not use under any circumstances in individuals with severe asthma or active wheezing; not evaluated to date in such individuals.1


Guillain-Barré Syndrome


Carefully consider possible benefits and potential risks of intranasal live influenza vaccine in individuals who experienced Guillain-Barré syndrome (GBS) within 6 weeks of previous influenza vaccination.1


Unclear whether influenza vaccination increases risk of recurrence of GBS.100 105 AAP states that influenza vaccines should not be used in children who developed GBS within 6 weeks after a previous dose of any influenza vaccine.105 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 avoid influenza vaccination.100 Although data are limited, ACIP states that use of influenza vaccine can be considered in 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


Only limited data available regarding safety and efficacy in immunocompromised individuals.1 Carefully consider possible benefits and potential risks in such individuals.1


ACIP states that live viral vaccines (including intranasal live influenza vaccine) usually should not be used in immunocompromised individuals, except in certain circumstances.118 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.118 (See Specific Drugs under Interactions.)


Has been used in a limited number of HIV-infected adults (asymptomatic or mildly symptomatic) in a clinical study;1 no serious adverse effects reported, but efficacy not evaluated.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.105 155 156


Because of possible transmission of live vaccine viruses, intranasal live influenza vaccine should not be administered to close contacts of severely immunocompromised individuals requiring a protective environment (e.g., HSCT recipients); however, ACIP states that the vaccine may be administered to close contacts of less severely immunocompromised individuals (e.g., those not requiring a protective environment).100


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.1 100 105


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.) Do not use in these individuals unless possible benefits outweigh risks.1


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


Duration of vaccine virus replication and shedding in vaccine recipients not established.1


Limitations of Vaccine Effectiveness


May require up to 2 weeks for protection to develop following seasonal influenza vaccination.100


May not protect all vaccine recipients against influenza.1


Seasonal influenza vaccine is 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 (See Actions.) Efficacy of the 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 influenza vaccine for the 2010–2011 influenza season is expected to provide protection against the 2009 pandemic influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) virus or swine-origin influenza A (H1N1) virus,100 but is not expected to provide protection against infection with avian influenza A viruses, including avian influenza A (H5N1).100


Duration of Immunity


Immunity declines during the year after seasonal influenza vaccination.1 In addition, circulating strains of seasonal influenza virus change from year to year.1 23 100 Annual vaccination is needed for prevention of seasonal influenza.1 100


Do not administer influenza vaccine from a previous influenza season in an attempt to provide protection during a subsequent influenza season.100


Concomitant Illness


ACIP states that minor acute illness, such as mild diarrhea or mild upper respiratory tract infection (with or without fever), generally does not preclude vaccination.100 118 If nasal congestion will impede delivery of the vaccine to the nasopharyngeal mucosa, defer administration until illness resolves.100


Administration Precautions


Health-care personnel who are severely immunosuppressed should not administer intranasal live influenza vaccine to patients.100 Small amounts of vaccine virus are likely to be introduced into the environment; the risk of acquiring vaccine virus from the environment is unknown, but presumed to be low.100


Improper Storage and Handling


Improper storage or handling of vaccines may result in loss of vaccine potency and reduced immune response in vaccinees.118


Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained.118 119


Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.1 118 (See Storage under Stability.) If there are concerns about mishandling, contact the manufacturer or state or local health departments for guidance on whether the vaccine is usable.118 119


Specific Populations


Pregnancy

Category C.1


Manufacturer states that the vaccine should be used in pregnant women only when clearly needed.1


ACIP, American College of Obstetricians and Gynecologists (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.100 118 155 200


Lactation

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


ACIP states that either seasonal intranasal live influenza vaccine or seasonal parenteral inactivated influenza vaccine can be used for prevention of seasonal influenza in nursing women, unless contraindicated.100


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 6–23 months of age who received intranasal live influenza vaccine compared with those who received parenteral inactivated seasonal influenza vaccine.1


Do not use in children with asthma or in children 2 through 4 years of age with a history of recurrent wheezing or a recent wheezing episode (i.e., during the past 12 months).1 100 105


When considering use in children 2 through 4 years 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.100 105 Use seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in such children.100 105


Protection of young infants against seasonal influenza virus depends on immunization of their close contacts.100 105 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.100 105


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 seasonal parenteral 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 seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in geriatric adults.100


Common Adverse Effects


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


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


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


Interactions for FluMist


Inactivated Vaccines and Toxoids


Safety and immunogenicity of intranasal live influenza vaccine administered concomitantly with age-appropriate inactivated vaccines not determined.1 Manufacturer states risks versus benefits of concomitant administration of the intranasal live influenza vaccine and inactivated vaccines should be considered.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.1 100 105 118 ACIP states that influenza virus vaccine live intranasal and other live vaccines generally may be administered simultaneously on the same day.100 118


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.118 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.100 118 (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 appropriate;1 ACIP recommends revaccination if an influenza antiviral was given 2 days before to 14 days after intranasal live influenza vaccine100



Aspirin



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



Contraindicated in children and adolescents receiving aspirin or aspirin-containing therapy1 100



Blood products



Intranasal live influenza vaccine may be administered simultaneously with or at any time before or after whole blood, packed red blood cells, plasma, and platelet products without substantially decreasing antibody response to the vaccine118



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



No evidence that immune globulin preparations interfere with immune response to intranasal live influenza vaccine118



Intranasal live influenza vaccine may be given simultaneously with or at any interval before or after immune globulin preparations118



Immunosuppressive agents (e.g., alkylating agents, antimetabolites, corticosteroids, radiation)



Potential for decreased antibody response to intranasal live influenza vaccine and increased risk of adverse reactions118



Intranasal live influenza vaccine should not be used in those receiving immunosuppressive therapy105 118


Optimum interval between discontinuance of immunosuppressive therapy and subsequent administration of a live viral vaccine has not been determined118


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 118


Systemic corticosteroid therapy (prednisone or equivalent) in a dosage ≥2 mg/kg daily or ≥20 mg daily given for ≥2 weeks is considered immunosuppressive;118 delay administration of live vaccines for at least 1 month after such therapy is discontinued118


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 should not be immunosuppressive and does not usually contraindicate use of live vaccines118



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 25 100 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 118



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 118


Stability


Storage


Intranasal Spray


Suspension

2–8°C; do not freeze.1


Does not contain thimerosal or any other preservatives.1


ActionsActions



  • Influenza virus vaccine live intranasal that is used for prevention of seasonal influenza is a trivalent vaccine containing live, attenuated (cold-adapted) influenza virus types A and B.1 100




  • 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 in the US during the upcoming influenza season.1 100 104




  • Seasonal intranasal live influenza vaccine is considered antigenically equivalent to seasonal parenteral inactivated influenza vaccine.100




  • The 2010–2011 seasonal intranasal live influenza vaccine for the US contains A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008.1 100 104 The A/California/7/2009 (H1N1) antigen is derived from the pandemic 2009 influenza A (H1N1) virus and is the same antigen used in the previously available intranasal live influenza A (H1N1) 2009 monovalent vaccine.100




  • Only 1 of 3 antigens contained in the 2010–2011 seasonal influenza vaccine (the influenza type B component) is the same as that contained in the seasonal influenza vaccine used during the previous influenza season (2009–2010).100 104




  • Influenza vaccines stimulate active immunity to influenza virus strains represented in the vaccines.1 100




  • 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 mucosal antibodies.1 100




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




  • Seasonal influenza vaccines for the 2010–2011 influenza season are expected to provide protection against the 2009 pandemic influenza A (H1N1) virus, previously referred to as the novel 2009 influenza A (H1N1) or swine-origin influenza A (H1N1) virus.100



Advice to Patients



  • Prior to administration of seasonal influenza virus 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 ).20




  • Advise patient and/or patient's parent or guardian of the risks and benefits of vaccine administration.1




  • Importance of annual vaccination against seasonal influenza.1 100




  • 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 a

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