Approved September 15, 2009

INFLUENZA A VIRUS VACCINE, H1N1, LIVE
(FDA Category 1)

Live influenza A H1N1 virus vaccine (Medimmune, LLC) induces antibodies that neutralize the influenza A H1N1 virus.

DOSING INFORMATION: The recommended dose of the live influenza A H1N1 virus vaccine is two 0.2 milliliters (mL) intranasal (0.1 mL/nostril) doses given approximately 1 month apart for patients 2 through 9 years (yr) of age and one 0.2 mL intranasal (0.1 mL/nostril) dose for patients 10 to 49 yr of age.

CAUTIONS: Contraindicated in patients with a history of a life-threatening reaction with previous administration of any influenza vaccine, children and adolescents taking concomitant aspirin therapy, and patients with a hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine. The most common adverse reactions (based on studies using the intranasal seasonal trivalent live influenza vaccine) include runny nose or nasal congestion, fever greater than 100 degrees F in children 2 to 6 yr of age, and sore throat in adults. Evaluate benefit versus risk of post-vaccination wheezing in patients with asthma or children less than 5 yr of age with recurrent wheezing; do not administer to patients with severe asthma or active wheezing.

FDA APPROVED INDICATIONS: The live influenza A H1N1 virus vaccine is indicated for active immunization of patients 2 to 49 yr of age against influenza caused by the pandemic H1N1 virus.