FLUMIST- influenza vaccine live intranasal_spray

Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood; serum antibodies, mucosal antibodies, and influenza-specific T cells may play a role. FluMist contains live attenuated influenza viruses that must infect and replicate in cells lining the nasopharynx of the recipient to induce immunity. Vaccine viruses capable of infection and replication can be cultured from nasal secretions obtained from vaccine recipients (shedding) [see Clinical Pharmacology (12. Shedding Studies Shedding of vaccine viruses within 28 days of vaccination with FluMist was evaluated in (1) multi-center Study MI‑CP129 which enrolled healthy individuals 6 through 59 months of age (N = 200); and (2) multi-center Study FM026 which enrolled healthy individuals 5 through 49 years of age (N = 344). In each study, nasal secretions were obtained daily for the first 7 days and every other day through either Day 25 and on Day 28 or through Day 28. In Study MI‑CP129, individuals with a positive shedding sample at Day 25 or Day 28 were to have additional shedding samples collected every 7 days until culture negative on 2 consecutive samples. Results of these studies are presented in Table 3. Table 3: Characterization of Shedding with FluMist in Specified Age Groups by Frequency, Amount, and Duration (Study MI-CP129 NCT00344305; see www. clinicaltrials. gov NCT00192140; see www. gov Age Number of Subjects % Shedding Proportion of subjects with detectable virus at any time point during the 28 days. Peak Titer (TCID 50 Peak titer at any time point during the 28 days among samples positive for a single vaccine virus. % Shedding After Day 11 Day of Last Positive Culture 6-23 months FluMist is not approved for use in children younger than 24 months of age [see Adverse Reactions (6. 1) 99 89 < 10 10 10 10 10 7. 0 Day 23 A single subject who shed previously on Days 1-3; TCID 50 10 A single subject who did not shed previously; TCID 50 10 A single subject who did not shed previously; TCID 50 10 The highest proportion of subjects in each group shed one or more vaccine strains on Days 2-3 post vaccination. After Day 11 among individuals 2 through 49 years of age (n = 443), virus titers did not exceed 1. 5 log 10 50 Studies in Immunocompromised Individuals Safety and shedding of vaccine virus following FluMist administration were evaluated in 28 HIV‑infected adults [median CD4 cell count of 541 cells/mm 3 Safety and shedding of vaccine virus following FluMist administration were also evaluated in children in a randomized (1:1), cross-over, double-blind, AF-SPG placebo-controlled trial in 24 HIV-infected children [median CD4 cell count of 1013 cells/mm 3 Twenty mild to moderately immunocompromised children and adolescents 5 through 17 years of age (receiving chemotherapy and/or radiation therapy or who had received chemotherapy in the 12 weeks prior to enrollment) were randomized 1:1 to receive FluMist or AF-SPG placebo. Frequency and duration of vaccine virus shedding in these immunocompromised children and adolescents were comparable to that seen in healthy children and adolescents. The effectiveness of FluMist in preventing influenza illness in immunocompromised individuals has not been evaluated. Transmission Study A prospective, randomized, double-blind, placebo-controlled trial was performed in a daycare setting in children younger than 3 years of age to assess the transmission of vaccine viruses from a vaccinated individual to a non-vaccinated individual. A total of 197 children 8 through 36 months of age were randomized to receive one dose of FluMist (N = 98) or AF-SPG placebo (N = 99). Virus shedding was evaluated for 21 days by culture of nasal swab specimens. Wild-type A (A/H3N2) influenza virus was documented to have circulated in the community and in the study population during the trial, whereas Type A (A/H1N1) and Type B strains did not. At least one vaccine strain was isolated from 80% of FluMist recipients; strains were recovered from 1-21 days post vaccination (mean duration of 7. 6 days +/- 3. The ca ts ca ts att Assuming a single transmission event (isolation of the Type B vaccine strain), the probability of a young child acquiring vaccine virus following close contact with a single FluMist vaccinee in this daycare setting was 0. 58% (95% CI: 0, 1. 7) based on the Reed-Frost model. With documented transmission of one Type B in one placebo subject and possible transmission of Type A viruses in four placebo subjects, the probability of acquiring a transmitted vaccine virus was estimated to be 2. 4% (95% CI: 0. 6) using the Reed-Frost model.

FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine [see Description (11) FluMist is approved for use in persons 2 through 49 years of age. FluMist is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. ( 1 11 FluMist is approved for use in persons 2 through 49 years of age.

For intranasal use. (2) Age Dose Schedule 2 years through 8 years 1 or 2 doses 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines. 2 mL Administer as 0. 1 mL per nostril. If 2 doses, administer at least 1 month apart 9 years through 49 years 1 dose, 0. 2 mL - “-” indicates information is not applicable. Administer FluMist according to the following schedule: Age Dose Schedule 2 years through 8 years 1 or 2 doses 1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines. Administer as 0. Each sprayer contains a single dose (0. 2 mL) of FluMist; administer approximately one half of the contents of the single-dose intranasal sprayer into each nostril. When administered by a healthcare provider in a healthcare setting, refer to Figure 1 for step-by-step administration instructions. Following administration, dispose of the sprayer according to the standard procedures for medical waste (e. , sharps container or biohazard container). Instruct vaccine recipients or caregivers who administer FluMist to follow the directions provided in the “Instructions for Use” for administration and disposal of FluMist. Individuals 2 through 17 years of age should not self‑administer FluMist. Figure 1 figure_1.

The most common solicited adverse reactions (>=10% in vaccine recipients and at least 5% greater than in placebo recipients) reported after FluMist were runny nose or nasal congestion (ages 2 years through 49 years), fever over 100°F (children ages 2 years through 6 years), and sore throat (adults ages 18 years through 49 years). 1 To report SUSPECTED ADVERSE REACTIONS, contact MedImmune at 1-877-633-4411 or VAERS at 1-800-822-7967 or http://vaers. gov Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. A total of 9537 children and adolescents 1 through 17 years of age and 3041 adults 18 through 64 years of age received FluMist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019, and AV009 [3 used Allantoic Fluid containing Sucrose-Phosphate-Glutamate (AF-SPG) placebo, and 2 used saline placebo] described below. In addition, 4179 children 6 through 59 months of age received FluMist in Study MI-CP111, a randomized, active-controlled trial. Among pediatric FluMist recipients 6 months through 17 years of age, 50% were female; in the study of adults, 55% were female. In MI-CP111, AV006, D153-P526, AV019, and AV009, subjects were White (71%), Hispanic (11%), Asian (7%), Black (6%), and Other (5%), while in D153-P501, 99% of subjects were Asian. FluMist in Children and Adolescents The safety of FluMist was evaluated in an AF-SPG placebo-controlled Study (AV019) conducted in a Health Maintenance Organization (HMO) in children 1 through 17 years of age (FluMist = 6473, placebo = 3216). An increase in asthma events, captured by review of diagnostic codes, was observed in children younger than 5 years of age who received FluMist compared to those who received placebo (Relative Risk 3. 53, 90% CI: 1. In Study MI-CP111, children 6 through 59 months of age were randomized to receive FluMist or inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. Wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia was prospectively monitored from randomization through 42 days post last vaccination. Hospitalization due to all causes was prospectively monitored from randomization through 180 days post last vaccination. Increases in wheezing and hospitalization (for any cause) were observed in children 6 months through 23 months of age who received FluMist compared to those who received inactivated Influenza Virus Vaccine, as shown in Table 1. Table 1: Percentages of Children with Hospitalizations and Wheezing from Study MI-CP111 NCT00128167; see www. clinicaltrials. gov Adverse Reaction Age Group FluMist (n/N) Active Control Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. , administered intramuscularly. (n/N) Hospitalizations Hospitalization due to any cause from randomization through 180 days post last vaccination. 6-23 months 4. 2% 24-59 months 2. 5% Wheezing Wheezing requiring bronchodilator therapy or accompanied by respiratory distress or hypoxia evaluated from randomization through 42 days post last vaccination. 6-23 months 5. 8% 24-59 months 2. 5% Most hospitalizations observed were due to gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post-hoc analysis, rates of hospitalization in children 6 through 11 months of age were 6. 1% (42/684) in FluMist recipients and 2. 6% (18/683) in inactivated Influenza Virus Vaccine recipients. Table 2 shows pooled solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (>=1% rate difference after rounding) compared to placebo post Dose 1 for Studies D153-P501 and AV006, and solicited adverse reactions post Dose 1 for Study MI-CP111. Solicited adverse reactions were those about which parents/guardians were specifically queried after receipt of FluMist, placebo, or control vaccine. In these studies, solicited reactions were documented for 10 days post vaccination. Solicited reactions following the second dose of FluMist were similar to those following the first dose and were generally observed at a lower frequency. Table 2: Summary of Solicited Adverse Reactions Observed Within 10 Days after Dose 1 for FluMist and Either Placebo or Active Control Recipients in Children 2 through 6 Years of Age Studies D153-P501 NCT00192244; see www. gov & AV006 Study MI-CP111 NCT00128167; see www. gov FluMist Placebo Study D153-P501 used saline placebo; Study AV006 used AF-SPG placebo. FluMist Active Control Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. N = 876-1759 Number of evaluable subjects (those who returned diary cards) for each reaction. Range reflects differences in data collection between the 2 pooled studies. N = 424-1034 N = 2170 N = 2165 Event % % % % Runny Nose/ Decreased Appetite 21 17 13 12 Irritability 21 19 12 11 Decreased Activity 14 11 7 6 Sore Throat 11 9 5 6 Headache 9 7 3 3 Muscle Aches 6 3 2 2 Chills 4 3 2 2 Fever > 100°F Oral 16 11 13 11 In clinical studies D153-P501 and AV006, unsolicited adverse reactions in children occurring in at least 1% of FluMist recipients and at a higher rate (>=1% rate difference after rounding) compared to placebo were abdominal pain (2% FluMist vs. 0% placebo) and otitis media (3% FluMist vs. 1% placebo). An additional adverse reaction identified in the active-controlled trial MI-CP111 occurring in at least 1% of FluMist recipients and at a higher rate (>=1% rate difference after rounding) compared to active control was sneezing (2% FluMist vs. 1% active control). In a separate saline placebo-controlled trial (D153-P526) in a subset of older children and adolescents 9 through 17 years of age who received one dose of FluMist, the solicited adverse reactions as well as unsolicited adverse reactions reported were generally consistent with observations from the trials in Table 2. In Study AV018, in which FluMist was concomitantly administered with Measles, Mumps, and Rubella Virus Vaccine Live (MMR, manufactured by Merck & Co. ) and Varicella Virus Vaccine Live (manufactured by Merck & Co. ) to children 12 through 15 months of age, adverse reactions were similar to those seen in other clinical trials of FluMist. FluMist in Adults In adults 18 through 49 years of age in Study AV009, solicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (>=1% rate difference after rounding) compared to AF-SPG placebo include runny nose (44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo). In Study AV009, unsolicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (>=1% rate difference after rounding) compared to placebo were nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo). The following events have been spontaneously reported during post approval use of FluMist or FluMist Quadrivalent. Data for FluMist Quadrivalent are relevant to FluMist because both vaccines are manufactured using the same process and have overlapping compositions. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Cardiac disorders: Pericarditis Congenital, familial, and genetic disorders: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome) Gastrointestinal disorders: Nausea, vomiting, diarrhea Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria) Nervous system disorders: Guillain-Barré syndrome, Bell’s Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis, syncope Respiratory, thoracic, and mediastinal disorders: Epistaxis Skin and subcutaneous tissue disorders: Rash.

1 11 4. 1 Do not administer FluMist to persons who have had a severe allergic reaction (e. , anaphylaxis) to any component of the vaccine [see Description (11) Do not administer FluMist to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of Reye’s syndrome with aspirin and wild-type influenza infection [see Drug Interactions (7.

In clinical trials, in children 6 through 23 months of age, FluMist was associated with an increased risk of hospitalization and wheezing. 4) Risk Summary FluMist is not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug. Risk Summary FluMist is not absorbed systemically by the mother following intranasal administration and breastfeeding is not expected to result in exposure of the child to FluMist. FluMist is not approved for use in children younger than 24 months of age because use of FluMist in children 6 through 23 months has been associated with increased risks of hospitalization and wheezing in clinical trials [see Warnings and Precautions (5. 1) Adverse Reactions (6. 1) The effectiveness of FluMist in children 6 years through 17 years of age is supported by demonstration of efficacy in younger children 6 through 71 months of age and effectiveness in adults 18 through 49 years of age [see Clinical Studies (14) FluMist is not approved for use in persons 65 years of age and older because in a clinical study (AV009), effectiveness of FluMist to prevent febrile illness was not demonstrated in adults 50 through 64 years of age [see Clinical Studies (14.

Antiviral drugs that are active against influenza A and/or B may reduce the effectiveness of FluMist if administered within 48 hours before, or within 2 weeks after, receipt of the vaccine. 2) Do not administer FluMist to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of Reye’s syndrome with aspirin and wild-type influenza [see Contraindications (4. 2) Antiviral drugs that are active against influenza A and/or B viruses may reduce the effectiveness of FluMist if administered within 48 hours before, or within 2 weeks after vaccination. The concurrent use of FluMist with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. If antiviral agents and FluMist are administered concomitantly, revaccination should be considered when appropriate.

NONCLINICAL TOXICOLOGY
FluMist has not been evaluated for its carcinogenic or mutagenic potential.
CLINICAL STUDIES
A multi-national, randomized, double-blind, active-controlled trial (MI-CP111) was performed to assess the efficacy of FluMist compared to an intramuscularly administered, inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. (active control) in children 6 months to less than 5 years of age during the 2004-2005 influenza season. A total number of 3916 children without severe asthma, without use of bronchodilator or steroids, and without wheezing within the prior 6 weeks were randomized to FluMist and 3936 were randomized to active control. Children who previously received any influenza vaccine received a single dose of study vaccine, while those who never previously received an influenza vaccination (or had an unknown history of influenza vaccination) received two doses. Participants were then followed through the influenza season to identify illness caused by influenza virus. As the primary endpoint, culture-confirmed modified CDC-ILI (CDC-defined influenza-like illness) was defined as a positive culture for a wild-type influenza virus associated within +/-7 days of modified CDC-ILI. Modified CDC-ILI was defined as fever (temperature >=100°F oral or equivalent) with cough, sore throat, or runny nose/nasal congestion on the same or consecutive days. In the primary efficacy analysis, FluMist demonstrated a 44. 5% (95% CI: 22. 6) reduction in influenza rate compared to active control as measured by culture-confirmed modified CDC-ILI caused by wild-type strains antigenically similar to those contained in the vaccine. See Table 4 for a description of the results by strain and antigenic similarity. Table 4: Comparative Efficacy Against Culture-Confirmed Modified CDC-ILI Modified CDC-ILI was defined as fever (temperature >= 100°F oral or equivalent) plus cough, sore throat, or runny nose/nasal congestion on the same or consecutive days. In children 6 months through 5 years of age. NCT00128167; see www. clinicaltrials. gov FluMist Active Control Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc. , administered intramuscularly. % Reduction in Rate for FluMist Reduction in rate was adjusted for country, age, prior influenza vaccination status, and wheezing history status. 95% CI N # of Cases Rate (cases/N) N # of Cases Rate (cases/N) Matched Strains All strains 3916 53 1. 4% 3936 93 2. 6 A/H1N1 3916 3 0. 1% 3936 27 0. 4 A/H3N2 3916 0 0. 0% 3936 0 0. 0% -- -- B 3916 50 1. 3% 3936 67 1. 9 Mismatched Strains All strains 3916 102 2. 6% 3936 245 6. 0 A/H1N1 3916 0 0. 0% -- -- A/H3N2 3916 37 0. 9% 3936 178 4. 7 B 3916 66 1. 7% 3936 71 1. 3 Regardless of Match All strains 3916 153 3. 9% 3936 338 8. 9 A/H1N1 3916 3 0. 4 A/H3N2 3916 37 0. 7 B 3916 115 2. 9% 3936 136 3. 7 ATP Population. A randomized, double-blind, saline placebo-controlled trial (D153-P501) was performed to evaluate the efficacy of FluMist in children 12 through 35 months of age without high-risk medical conditions against culture-confirmed influenza illness. This study was performed in Asia over two successive seasons (2000-2001 and 2001-2002). The primary endpoint of the trial was the prevention of culture-confirmed influenza illness due to antigenically matched wild-type influenza. Respiratory illness that prompted an influenza culture was defined as at least one of the following: fever (>=100. 4°F rectal or >=99. 5°F axillary), wheezing, shortness of breath, pulmonary congestion, pneumonia, or otitis media; or two of the following: runny nose/nasal congestion, sore throat, cough, muscle aches, chills, headache, irritability, decreased activity, or vomiting. During the second year of Study D153-P501, for children who received two doses in Year 1 and one dose in Year 2, FluMist demonstrated 84. 3% (95% CI: 70. 4) efficacy against culture-confirmed influenza illness due to antigenically matched wild-type influenza. Study AV006 was a second multi-center, randomized, double-blind, AF-SPG placebo-controlled trial performed in U. children without high-risk medical conditions to evaluate the efficacy of FluMist against culture-confirmed influenza over two successive seasons (1996-1997 and 1997-1998). The primary endpoint of the trial was the prevention of culture-confirmed influenza illness due to antigenically matched wild-type influenza in children who received two doses of vaccine in the first year and a single revaccination dose in the second year. Table 5: Efficacy D153-P501 and AV006 data are for subjects who received two doses of study vaccine. In children 12 through 35 months of age. In children 15 through 71 months of age. D153-P501 NCT00192244; see www. gov AV006 NCT00192179; see www. gov FluMist n Number and percent of subjects in per-protocol efficacy analysis population with culture-confirmed influenza illness. (%) Placebo n (%) % Efficacy (95% CI) FluMist n (%) Placebo n (%) % Efficacy (95% CI) N Number of subjects in per-protocol efficacy analysis population of each treatment group of each study for the “any strain” analysis. = 1653 N = 1111 N = 849 N Any strain 56 (3. 4%) 139 (12. 9% For D153-P501, influenza circulated through 12 months following vaccination. 10 (1%) 73 (18%) 93. 4% A/H1N1 23 (1. 9% Estimate includes A/H1N1 and A/H1N2 strains. Both were considered antigenically similar to the vaccine. 0 0 -- A/H3N2 4 (0. 5%) 48 (12%) 96. 7%) 31 (7%) 90. 5% During the second year of Study AV006, children remained in the same treatment group as in Year 1 and received a single dose of FluMist or placebo. During the second year, the primary circulating strain was the A/Sydney/05/97 H3N2 strain, which was antigenically dissimilar from the H3N2 strain represented in the vaccine, A/Wuhan/359/95; FluMist demonstrated 87. 0% (95% CI: 77. 6) efficacy against culture-confirmed influenza illness. AV009 was a U. multi-center, randomized, double-blind, AF-SPG placebo-controlled trial to evaluate effectiveness of FluMist in adults 18 through 64 years of age without high-risk medical conditions over the 1997-1998 influenza season. Participants were randomized 2:1 (vaccine:placebo). Cultures for influenza virus were not obtained from subjects in the trial, thus efficacy against culture-confirmed influenza was not assessed. The A/Wuhan/359/95 (H3N2) strain, which was contained in FluMist, was antigenically distinct from the predominant circulating strain of influenza virus during the trial period, A/Sydney/05/97 (H3N2). Type A/Wuhan (H3N2) and Type B strains also circulated in the U. during the study period. The primary endpoint of the trial was the reduction in the proportion of participants with one or more episodes of any febrile illness, and prospective secondary endpoints were severe febrile illness and febrile upper respiratory illness. Effectiveness for any of the three endpoints was not demonstrated in a subgroup of adults 50 through 64 years of age. Primary and secondary effectiveness endpoints from the age group 18 through 49 years are presented in Table 6. Effectiveness was not demonstrated for the primary endpoint in adults 18 through 49 years of age. Table 6: Effectiveness of FluMist to Prevent Febrile Illness in Adults 18 through 49 Years of Age During the 7-Week Site-Specific Outbreak Period (Study AV009) Endpoint FluMist N = 2411 Number of evaluable subjects (92. 0% of FluMist and placebo recipients, respectively). Placebo N = 1226 Percent Reduction (95% CI) Participants with one or more events of: The predominantly circulating virus during the trial period was A/Sydney/05/97 (H3N2), an antigenic variant not included in the vaccine. 7 Effectiveness was shown in a post-hoc analysis using an endpoint of CDC-ILI in the age group 18 through 49 years of age. In Study AV018, concomitant administration of FluMist, MMR (manufactured by Merck & Co. ) and Varicella Virus Vaccine Live (manufactured by Merck & Co. ) was studied in 1245 subjects 12 through 15 months of age. Subjects were randomized in a 1:1:1 ratio to MMR, Varicella vaccine and AF-SPG placebo (group 1); MMR, Varicella vaccine and FluMist (group 2); or FluMist alone (group 3). Immune responses to MMR and Varicella vaccines were evaluated 6 weeks post-vaccination while the immune responses to FluMist were evaluated 4 weeks after the second dose. No evidence of interference with immune response to measles, mumps, rubella, varicella and FluMist vaccines was observed.
REFERENCES
1.
Patient Package Insert
Information for Patients and Their Caregivers FluMistregistered (FLEW-mĭst) (Influenza Vaccine Live, Intranasal) Please read this Patient Information carefully before getting FluMist. This is a summary of information about FluMist. It does not take the place of talking with your healthcare provider about influenza vaccination. If you have questions or would like more information, please talk with your healthcare provider. What is FluMist? FluMist is a vaccine that is sprayed into the nose to help protect against influenza. It can be used in children, adolescents, and adults ages 2 through 49 years. FluMist may not prevent influenza in everyone who gets vaccinated. Who should not get FluMist? You should not get FluMist if you: Please talk to your healthcare provider if you are not sure if the items listed above apply to you or your child. Children under 2 years of age have an increased risk of wheezing (difficulty with breathing) after getting FluMist. Before getting FluMist, tell your healthcare provider about all your medical conditions, including if you: If you or your child cannot get FluMist, you may still be able to get an influenza vaccine. Talk to your healthcare provider about this. How is FluMist given? If you are giving FluMist to yourself or someone else, read the “Instructions for Use” that comes with FluMist. Individuals 2 through 17 years of age should not give themselves FluMist. What are the possible side effects of FluMist? There is a very small chance that FluMist could cause a severe allergic reaction The most common side effects are: Other possible side effects include: These are not all the possible side effects of FluMist. For more information, talk to your healthcare provider. Call your healthcare provider for medical advice about side effects. You may report side effects to VAERS at 1-800-822-7967 or http://vaers. gov What are the ingredients in FluMist? Active Ingredient Inactive Ingredients FluMist does not contain preservatives. How is FluMist stored? If you are giving FluMist to yourself or someone else, read the storage information in the “Instructions for Use” that comes with FluMist. Keep FluMist out of the reach of children. If you would like more information about FluMist, talk to your healthcare provider or visit www. com FluMist registered Other brands listed are registered trademarks of their respective owners and are not trademarks of MedImmune, LLC. Manufactured by: MedImmune, LLC Gaithersburg, MD 20878 Issue date: August 2025 RAL-FLUV16 This Patient Information has been approved by the U. Food and Drug Administration. Issued: August 2025 medimmune_image.

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FLUMIST- influenza vaccine live intranasal_spray Product manual source documgent