• Vaccine Name: Influenza A (H1N1) 2009 Monovalent Vaccine from MedImmune LLC
• Target Pathogen: Influenza virus
• Target Disease: Influenza (flu)
• Product Name: Influenza A (H1N1) 2009 Monovalent Vaccine
• Manufacturer: MedImmune LLC
• Vaccine Ontology ID: VO_0000349
• Type: Live, attenuated vaccine
• Status: Licensed
• Location Licensed: USA
• Host Species for Licensed Use: Human
• Antigen: pandemic (H1N1) 2009 virus
• Preparation: Specific pathogen-free (SPF) eggs are inoculated with the reassortant strain and incubated to allow vaccine virus replication. The allantoic fluid of these eggs is harvested, pooled and then clarified by filtration. The virus is concentrated by ultracentrifugation and diluted with stabilizing buffer to obtain the final sucrose and potassium phosphate concentrations. The viral harvests are then sterile filtered to produce monovalent bulks. Each lot is tested for ca, ts, and att phenotypes and is also tested extensively by in vitro and in vivo methods to detect adventitious agents. Monovalent bulks are diluted as required to attain the desired potency with stabilizing buffers. The bulk vaccine is then filled directly into individual sprayers for nasal administration (FDA: MedImmune H1N1 vaccine).
• Immunization Route: Intramuscular injection (i.m.)
• Virulence: Activated
• Storage: INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE LIVE, INTRANASAL SHOULD BE STORED IN A REFRIGERATOR BETWEEN 2-8°C (35-46°F) UPON RECEIPT AND UNTIL USE. THE PRODUCT MUST BE USED BEFORE THE EXPIRATION DATE ON THE SPRAYER LABEL. DO NOT FREEZE (FDA: MedImmune H1N1 vaccine).
• Approved Age for Licensed Use: ages 18 years of age and older
• Contraindication: Hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or life threatening reactions to previous influenza vaccination. (4.1)
  Concomitant aspirin therapy in children and adolescents. (4.2) Safety and effectiveness of Influenza A (H1N1) 2009 Monovalent
• Description: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is a live monovalent vaccine for administration by intranasal spray. It is (a) cold-adapted (i.e., it replicates efficiently at 25 C, a temperature that is restrictive for replication of many wild- type influenza viruses); (b) temperature-sensitive (ts) (i.e., it is restricted in replication at 39 C, a temperature at which many wild-type influenza viruses grow efficiently); and (c) attenuated (it does not produce classic influenza-like illness in the ferret model of human influenza infection). The attenuated vaccine virus replicates in the nasopharynx to induce protective immunity (FDA: MedImmune H1N1 vaccine).

Bear Response

• Immune Response Assay Type: HI antibody assay
• Side Effects: Most common adverse reactions (≥ 10% in FluMist and at least 5% greater
  than in control) are runny nose or nasal congestion in all ages, fever >100°F in
  children 2-6 years of age, and sore throat in adults. (6.1)