• Product Name: Influenza A (H1N1) 2009 Monovalent Vaccine
• Manufacturer: CSL Limited
• Vaccine Ontology ID: VO_0000348
• Type: Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA
• Host Species for Licensed Use: Human
• Antigen: pandemic (H1N1) 2009 virus
• Preparation: Influenza A (H1N1) 2009 Monovalent Vaccine is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using a continuous flow zonal centrifuge. The purified virus is inactivated with beta-propiolactone. The virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution (FDA: CSL H1N1 vaccine).
• Immunization Route: Intramuscular injection (i.m.)
• Virulence: Inactivated.
• Storage: store at 2−8°C (36−46°F)
• Approved Age for Licensed Use: ages 18 years of age and older
• Contraindication: Hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or life-threatening reaction to previous influenza vaccination.
• Description: Influenza A (H1N1) 2009 Monovalent Vaccine, for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension (FDA: CSL H1N1 vaccine).

Bear Response

• Vaccination Protocol: A single 0.5 mL intramuscular injection (FDA: CSL H1N1 vaccine).
• Immune Response Assay Type: HI antibody assay
• Side Effects: The most common (≥ 10%) local (injection-site) adverse reactions are tenderness, pain, redness, and swelling. The most common (≥ 10%) systemic adverse reactions are headache, malaise, and muscle aches (FDA: CSL H1N1 vaccine).