Important Safety Information

FluMist®Quadrivalent is contraindicated in persons who have had a severe allergic reaction (e.g., 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.

INDICATION

FluMist®Quadrivalent (Influenza Vaccine Live, Intranasal) 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.