FluMist
FDA Approves New Seasonal Flu Vaccine Made Using Novel Technology »
"The U.S. Food and Drug Administration today announced that it has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the preve"...
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FluMist
FluMist Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
FluMist (Influenza Vaccine Live, Intranasal) is a vaccine sprayed into the nose to help protect against the flu. Common side effects include mild flu-like symptoms, like headache, low fever, nasal congestion, fatigue, or achiness.
FluMist is sprayed into a patient's nostrils with a small, needleless syringe and inhaled. It is given in 1 or 2 doses and administered under physician supervision. FluMist is recommended for healthy people 2 to 49 years of age. You should not get FluMist if you are allergic to eggs, gentamicin, gelatin, or arginine; or have ever had a life-threatening reaction to influenza vaccinations. Children or teens should not take aspirin for 4 weeks after getting FluMist. FluMist may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medications to treat autoimmune disorders. Tell your doctor all medications and supplements you take and other vaccines you have recently received. FluMist is not recommended for pregnant women. Consult your doctor before breastfeeding.
Our FluMist (Influenza Vaccine Live, Intranasal) Side Effects Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
FluMist in Detail - Patient Information: Side Effects
Nasal influenza virus (live virus) vaccine may cause you to have mild flu-like symptoms. However, you may have flu-like symptoms at any time during flu season that may be caused by strains of influenza virus that are not contained in the vaccine.
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first dose.
Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive another nasal influenza virus vaccine in the future, you will need to tell the doctor if the first vaccine caused any side effects.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine); or
- high fever, chills, body aches, flu symptoms.
Less serious side effects include:
- low fever, chills;
- runny or stuffy nose;
- sore throat, cough;
- headache;
- feeling tired or irritable;
- vomiting; or
- muscle pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
Read the entire detailed patient monograph for FluMist (Influenza Virus Vaccine) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
FluMist Overview - Patient Information: Side Effects
If your doctor has directed you to receive this vaccine, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for FluMist (Influenza Virus Vaccine)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
FluMist FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
FluMist is not indicated in children < 24 months of age. In a clinical trial, among children 6-23 months of age, wheezing requiring bronchodilator therapy or with significant respiratory symptoms occurred in 5.9% of FluMist recipients compared to 3.8% of active control (injectable influenza vaccine made by Sanofi Pasteur Inc.) recipients (Relative Risk 1.5, 95% CI: 1.2, 2.1). Wheezing was not increased in children ≥ 24 months of age.
Hypersensitivity, including anaphylactic reaction, has been reported post-marketing. [See WARNINGS AND PRECAUTIONS.]
Adverse Reactions in Clinical Trials
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 1-17 years of age and 3041 adults 18-64 years of age received FluMist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019, and AV009 described below. In addition, 4179 children 6-59 months of age received FluMist in Study MI-CP111, a randomized, active-controlled trial. Among pediatric FluMist recipients 6 months-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.
Adverse Reactions in Children and Adolescents
In a placebo-controlled safety study (AV019) conducted in a large Health Maintenance Organization (HMO) in children 1-17 years of age (n = 9689), an increase in asthma events, captured by review of diagnostic codes, was observed in children < 5 years of age (Relative Risk 3.53, 90% CI: 1.1, 15.7). This observation was prospectively evaluated in Study MI-CP111.
In MI-CP111, an active-controlled study, increases in wheezing and hospitalization (for any cause) were observed in children < 24 months of age, as shown in Table 1.
Table 1 : Percentages of Children with Hospitalizations and
Wheezing from MI-CP111
| Adverse Reaction | Age Group | FluMist | Active Controla |
| Hospitalizationsb | 6-23 months (n = 3967) |
4.2 % | 3.2 % |
| 24-59 months (n = 4385) |
2.1 % | 2.5 % | |
| Wheezingc | 6-23 months (n = 3967) |
5.9 % | 3.8 % |
| 24-59 months (n = 4385) |
2.1 % | 2.5 % | |
| a Injectable influenza vaccine
made by Sanofi Pasteur Inc. b From randomization through 180 days post last vaccination. c Wheezing requiring bronchodilator therapy or with significant respiratory symptoms evaluated from randomization through 42 days post last vaccination. |
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Most hospitalizations observed were gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post-hoc analysis, rates of hospitalization in children 6-11 months of age (n = 1376) were 6.1% in FluMist recipients and 2.6% in active control recipients.
Table 2 shows an analysis of pooled solicited events, occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo, post Dose 1 for Study D153-P501 and AV006, and solicited events post Dose 1 for Study MI-CP111. Solicited events were those about which parents/guardians were specifically queried after vaccination with FluMist. In these studies, solicited events were documented for 10 days post vaccination. Solicited events post Dose 2 for FluMist were similar to those post Dose 1 and were generally observed at a lower frequency.
Table 2 : Summary of Solicited Events Observed Within 10
Days after Dose 1 for Vaccinea and Either Placebo or Active Control
Recipients; Children 2-6 Years of Age
| Event | D153-P 501 & AV006 | MI-CP111 | ||
| FluMist N=876-1759c % |
Placebo N=424-1034c % |
FluMist N=2170c % |
Active Controlb N=2165c % |
|
| Runny Nose/ Nasal Congestion | 58 | 50 | 51 | 42 |
| Decreased Appetite | 21 | 17 | 13 | 12 |
| Irritability | 21 | 19 | 12 | 11 |
| Decreased Activity (Lethargy) | 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 | ||||
| 100-101°F Oral | 9 | 6 | 6 | 4 |
| 101-102°F Oral | 4 | 3 | 4 | 3 |
| a Frozen formulation used in AV006;
refrigerated formulation used in D153-P501 and MI-CP111. b Injectable influenza vaccine made by Sanofi Pasteur Inc. c Number of evaluable subjects (those who returned diary cards) for each event. Range reflects differences in data collection between the 2 pooled studies. |
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In clinical studies D153-P501 and AV006, other adverse reactions in children occurring in at least 1% of FluMist recipients and at a higher rate 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 compared to active control, was sneezing (2% FluMist vs. 1% active control).
In a separate trial (MI-CP112) that compared the refrigerated and frozen formulations of FluMist in children and adults 5-49 years of age, the solicited events and other adverse events were consistent with observations from previous trials. Fever of > 103°F was observed in 1 to 2%of children 5-8 years of age.
In a separate placebo-controlled trial (D153-P526) using the refrigerated formulation in a subset of older children and adolescents 9-17 years of age who received one dose of FluMist, the solicited events and other adverse events were generally consistent with observations from previous trials. Abdominal pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients and decreased activity was reported in 6% of FluMist recipients compared to 0% of placebo recipients.
Adverse Reactions in Adults
In adults 18-49 years of age in Study AV009, summary of solicited adverse events occurring in at least 1% of FluMist recipients and at a higher rate compared to 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 addition to the solicited events, other adverse reactions from Study AV009 occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo were: nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo).
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of FluMist. Because these reactions are reported voluntarily froma 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 systemdisorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema, and urticaria)
Nervous system disorders: Guillain-Barré syndrome, Bell's Palsy, meningitis, eosinophilic meningitis, vaccine-associated encephalitis
Respiratory, thoracic, and mediastinal disorders: Epistaxis
Skin and subcutaneous tissue disorders: Rash
Read the entire FDA prescribing information for FluMist (Influenza Virus Vaccine) »
Additional FluMist Information
FluMist - User Reviews
FluMist User Reviews
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