BETHESDA, MD 19 August 2013—GlaxoSmithKline plc on August 16 announced the licensing of a quadrivalent version of the company's FluLaval influenza virus vaccine.
FluLaval Quadrivalent is prepared from two influenza virus type A strains and two type B strains grown in chicken eggs, as is the company's other quadrivalent flu vaccine, Fluarix. Each vaccine is produced using different inactivation and purification methods. Both are administered by intramuscular injection.
The newly licensed vaccine is manufactured in Canada and is available in limited quantities for the 2013–14 flu season, according to the company.
for FluLaval Quadrivalent states that the vaccine is indicated for use in people 3 years of age or older for the prevention of influenza caused by the viral subtypes in the vaccine.
The vaccine is contraindicated in people with a history of severe allergic reaction, such as anaphylaxis, to any component of the vaccine or after the receipt of a previous dose of influenza vaccine.
In clinical trials involving adults, the most commonly reported adverse events among vaccine recipients were injection-site pain, muscle aches, headache, and fatigue. Adverse events in children varied by age and included pain, muscle aches, irritability, fatigue, drowsiness, and headache.
FluLaval Quadrivalent is packaged in 5-mL multidose vials, each of which contains sufficient volume to prepare 10 0.5-mL doses of the vaccine. The product should be refrigerated at 2–8 °C until use and never frozen. Once the vial stopper has been punctured, the contents should be used within 28 days and any remaining portion discarded.