*A/Bolivia was the A/H1N1 strain used in the 2014/2015, 2015/2016, and 2016/2017 FluMist Quadrivalent formulations. A/Slovenia replaced A/Bolivia in 2017/2018.
†The percentage of patients with hemagglutination inhibition (HAI) antibody seroconversion was 23.4% with the A/Slovenia formulation vs 5.4% with the A/Bolivia quadrivalent formulation (P=0.006) after dose 1, and 45.2% vs 12.5% (P<0.001) respectively, after dose 2.
FluMist Quadrivalent is contraindicated in persons who have had a severe allergic reaction (eg, anaphylaxis) to any vaccine component, including egg protein, or after a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy
In clinical trials, the risks of hospitalization and wheezing were increased in children <24 months of age who received trivalent FluMist (Influenza Vaccine Live, Intranasal)
Children <5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following FluMist Quadrivalent administration. FluMist Quadrivalent has not been studied in persons with severe asthma or active wheezing
If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Quadrivalent should be based on careful consideration of the potential benefits and risks
FluMist Quadrivalent has not been studied in immunocompromised persons
The safety of FluMist Quadrivalent in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications has not been established
FluMist Quadrivalent may not protect all individuals receiving the vaccine
The most common solicited adverse reactions (occurring ≥10% in vaccine recipients and at least 5% greater than in placebo) reported after FluMist were runny nose or nasal congestion in all persons 2-49 years, fever >100°F in children 2-6 years, and sore throat in adults 18-49 years. Among children 2-17 years who received FluMist Quadrivalent, 32% reported runny nose or nasal congestion and 7% reported fever >100°F. Among adults 18-49 years who received FluMist Quadrivalent, 44% reported runny nose or nasal congestion and 19% reported sore throat
FluMist Quadrivalent is a vaccine indicated for active immunization of persons 2-49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluMist Quadrivalent is for intranasal administration only.
Please see full Prescribing Information for FluMist Quadrivalent, including Patient Information.
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