Generic Name: Influenza Virus Vaccine Live Intranasal
VA Class: IM100
Live, attenuated virus vaccine.1 100 Seasonal influenza virus vaccine live intranasal contains 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
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
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.100 199 200 539 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 vaccine containing inactivated virus subunits.100 103 186 187 188 189 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 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, American Academy of Family Physicians (AAFP), and other experts state that either seasonal intranasal live influenza vaccine or age-appropriate 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.100 105 199 200 336 539 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 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 at least 2 weeks before departure.100 117 Risk for exposure to seasonal influenza during travel depends on the time of year and destination.100 117 In tropical and subtropical areas, influenza occurs throughout the year.100 117 In temperate regions, influenza activity generally occurs from October to May in the northern hemisphere and from April through September in the southern hemisphere.100 117 However, 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.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 <24 months of age or adults ≥50 years of age;1 use an age-appropriate 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 age-appropriate parenteral inactivated 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 closely related strains) represented in the vaccines.100
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 and now referred to as influenza A (H1N1)pdm09 (pH1N1), is likely to continue to circulate during the 2012–2013 season.105 539 Seasonal influenza vaccines for the 2012–2013 influenza season are expected to provide protection against the influenza A (pH1N1) virus and influenza A (H3N2) and influenza B viruses represented in the vaccines.105 539 544
Seasonal influenza vaccines for the 2012–2013 influenza season do not provide protection against influenza A (H3N2) variant viruses (H3N2v).550
Seasonal influenza vaccines 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
Administer intranasally using prefilled, single-use sprayer supplied by the manufacturer.1
Do not administer IM, IV, or intradermally.100
Administer every year before exposure to seasonal influenza.100 Begin annual vaccination efforts by October (or as soon as the seasonal influenza vaccine is available); 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; peak influenza activity often occurs in January or February, but has occurred as late as April or May.100
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
If vaccine recipient sneezes after receiving a dose, do not repeat the dose.100
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.1 100 105 539 (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
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 type of seasonal influenza vaccine or has an uncertain history regarding influenza vaccination: 2 doses administered at least 1 month (4 weeks) apart.1 105 539 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.105 539 Each dose consists of 0.2 mL (0.1 mL in each nostril).1
Manufacturer states that a single dose can be used in those who previously received influenza vaccination.1
Healthy Children and Adolescents 9 through 17 Years of AgeIntranasal
Prevention of Seasonal Influenza A and B Virus Infections
Healthy Adults 18 through 49 Years of AgeIntranasal
No specific dosage recommendations.1
No specific dosage recommendations.1
Not indicated in adults ≥50 years of age, including geriatric adults.1
Cautions for FluMist
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.)
Hypersensitivity reactions (e.g., anaphylactic reaction, facial edema, urticaria) reported.1
Appropriate medical treatment and supervision must be readily available in case anaphylaxis occurs.1
Do not administer additional doses to any individual who had a severe allergic reaction to a previous dose.1 (See Contraindications under Cautions.)
Seasonal intranasal live influenza vaccine is produced using eggs;1 100 105 539 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.100 539
ACIP states that 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.539 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).539 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.539
ACIP and AAP state that individuals who have less severe reactions (i.e., hives only) after eating eggs or egg-containing foods may receive influenza vaccine; however, parenteral inactivated influenza vaccine is preferred over intranasal live influenza vaccine since data are lacking regarding use of the live vaccine in individuals with egg allergy.105 539 Additionally, if influenza vaccine is used in such individuals, the vaccine should be administered by a health-care provider familiar with potential manifestations of egg allergy and recipients should be observed for at least 30 minutes following vaccination.105 539 Other measures, such as skin testing or administration of the vaccine in 2 steps (e.g., 10% of the dose initially, followed by remainder of dose if no reaction occurs during 30 minutes of observation), are not necessary in individuals with a history of less severe reactions (i.e., hives only) to eggs.105 539
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.105 539 ACIP and AAP recommend that such individuals be referred to a clinician with expertise in the management of allergic conditions for further risk assessment to determine whether the vaccine should be administered.105 539
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.1 100 105 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.100 105 (See Pediatric Use under Cautions.)
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 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
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.105 155 156
ACIP states that live viral vaccines (including intranasal live influenza vaccine) usually should not be used in immunocompromised individuals, except in certain circumstances.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.)
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
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
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 2012–2013 influenza season expected to provide protection against the influenza A (pH1N1) virus and influenza A (H3N2) and influenza B viruses represented in the vaccine.105 539 544
Seasonal intranasal influenza vaccine for the 2012–2013 influenza season does not provide protection against influenza A (H3N2) variant viruses (H3N2v).550
Seasonal influenza vaccines 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.100 In addition, circulating strains of seasonal influenza virus change from year to year.23 100 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
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
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 reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees.118
Do not administer vaccine that has been mishandled or has not been stored at the recommended temperature.1 118 119 (See Storage under Stability.) 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.118 119
Manufacturer states use in pregnant women only when clearly needed.1
ACIP, American Congress 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
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
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 inactivated seasonal 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).100 105
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.100 105 Use age-appropriate 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 age-appropriate seasonal parenteral inactivated influenza vaccine (not intranasal live influenza vaccine) for prevention of seasonal influenza in this age group.100
Not indicated for use in geriatric individuals ≥65 years of age.1 Use age-appropriate seasonal parenteral 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 FluMist
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
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.)
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
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
May be administered simultaneously with or at any time before or after whole blood, packed red blood cells, plasma, and platelet products118
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 globulin118
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
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 does not 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
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 25 100 safety and immunogenicity of concomitant administration not evaluated in infants >15 months of age1
2–8°C; do not freeze.1
Does not contain thimerosal or any other preservatives.1
Influenza virus 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 in the US during the upcoming influenza season.1 544
Seasonal intranasal live influenza vaccine is considered antigenically equivalent to seasonal parenteral inactivated influenza vaccine.100
The 2012–2013 seasonal intranasal live influenza vaccine for the US is a trivalent vaccine containing 2 influenza type A antigens (H1N1 and H3N2) and a single influenza type B antigen.1 539 544 Quadrivalent seasonal intranasal live influenza vaccine containing 2 influenza B antigens in addition to the 2 influenza A antigens received FDA approval, but is not expected to be available in the US during the 2012–2013 influenza season.539
The 2012–2013 seasonal intranasal live influenza vaccine for the US contains A/California/7/2009-like (pH1N1), A/Victoria/361/2011-like (H3N2), and B/Wisconsin/1/2010-like (B/Yamagata lineage) antigens.1 539 544 The influenza A (H1N1) antigen is derived from the influenza A (pH1N1) virus and was included in the vaccine used during the previous influenza season (2011–2012).105 539 544 The influenza A (H3N2) and influenza B antigens differ from those contained in the 2011–2012 vaccine.105 539 544
Following administration of intranasal live influenza vaccine, vaccine virus replicates in cells lining the nasopharynx.1 100 Protective mechanism not completely understood; may involve serum antibodies, mucosal antibodies, and influenza-specific T-cells.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 2012–2013 influenza season are expected to provide protection against the influenza A (pH1N1) virus and influenza A (H3N2) and influenza B strains represented in the vaccines.105 539 544
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 ).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
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.1 100 105 (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).1 100 105 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.1 100 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 .1 100
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 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.
106.5-7.5 FFU (fluorescent focus units) each of A/California/7/2009 (pH1N1), A/Victoria/361/2011 (H3N2), and B/Wisconsin/1/2010 per 0.2 mL
FluMist (available in 0.2-mL prefilled single-use sprayers)
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions October 24, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. MedImmune. FluMist (influenza virus vaccine live, intranasal) intranasal spray prescribing information. Gaithersburg, MD; 2012 Jul.
20. Centers for Disease Control and Prevention. Influenza vaccine live, intranasal 2012–2013 information statement. 2012 Jul 2. 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. Fiore AE, Uyeki TM, Broder K et al. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep. 2010; 59(RR-8):1-62.
103. Sanofi Pasteur Inc. Fluzone (influenza virus vaccine 2012–2013 formula) suspension for intramuscular injection prescribing information. Swiftwater, PA; 2012 Jun.
105. Committee on Infectious Disease. Recommendations for Prevention and Control of Influenza in Children, 2012-2013. Pediatrics. 2012; :.
117. Centers for Disease Control and Prevention. Health information for international travel, 2012. Atlanta, GA: US Department of Health and Human Services; 2012. Updates available from CDC website.
118. 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.
119. Centers for Disease Control and Prevention. Vaccine management: recommendations for storage and handling of selected biologicals. 2007 Nov. From CDC website. Accessed 2008 Apr 7.
155. Kaplan JE, Benson C, Holmes KH et al. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep. 2009; 58:1-207; quiz CE1-4. [PubMed 19357635]
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]
186. Novartis Vaccines and Diagnostics. Fluvirin (influenza virus vaccine 2012–2013 formula) suspension for intramuscular injection prescribing information. Cambridge, MA; 2012 Jun 1.
187. GlaxoSmithKline. Fluarix (influenza virus vaccine 2012–2013 formula) suspension for intramuscular injection prescribing information. Research Triangle Park, NC; 2012 May.
188. GlaxoSmithKline. Flulaval (influenza virus vaccine 2012–2013 formula) suspension for intramuscular injection prescribing information. Research Triangle Park, NC; 2012 May.
189. Merck & Co. Afluria (influenza virus vaccine 2012–2013 formula) suspension for intramuscular injection prescribing information. Whitehouse, NJ; 2012 Apr.
199. Centers for Disease Control and Prevention. Recommended immunization schedules for persons aged 0 through 18 years–United States, 2012. Updates may be available at CDC website.
200. Centers for Disease Control and Prevention. Recommended adult immunization schedule–United States, 2012. 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.
539. Centers for Disease Control and Prevention (CDC). Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) - United States, 2012-13 Influenza Season. MMWR Morb Mortal Wkly Rep. 2012; 61:613-8. [PubMed 22895385]
540. . Recommended composition of influenza virus vaccines for use in the 2011-2012 northern hemisphere influenza season. Wkly Epidemiol Rec. 2011; 86:81-92.
541. Centers for Disease Control and Prevention (CDC). Update: influenza activity--United States, 2010-11 season, and composition of the 2011-12 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2011; 60:705-12. [PubMed 21637185]
544. Centers for Disease Control and Prevention (CDC). Update: influenza activity - United States, 2011-12 season and composition of the 2012-13 influenza vaccine. MMWR Morb Mortal Wkly Rep. 2012; 61:414-20. [PubMed 22672977]
545. . Recommended composition of influenza virus vaccines for use in the 2012–2013 northern hemisphere influenza season. Wkly Epidemiol Rec. 2012; 87:83-95. [PubMed 22462202]
550. Centers for Disease Control and Prevention (CDC). Update: influenza activity - United States and worldwide, May 20-September 22, 2012. MMWR Morb Mortal Wkly Rep. 2012; 61:785-9. [PubMed 23034586]