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GlaxoSmithKline Gets FDA Approval To Ship Quadrivalent Influenza Vaccine

tetano

Editor, Senior Moderator
GlaxoSmithKline plc (GSK, GSK.L) said Monday that it has received U.S. Food and Drug Administration approval to start shipping 2013-2014 Fluarix Quadrivalent to CDC distribution centers and U.S. healthcare providers.

This is the first season that vaccines protecting against more than three strains of influenza will be commercially available.

Fluarix Quadrivalent was the first intramuscular quadrivalent influenza vaccine approved by the FDA for the immunization of children (three years and older) and adults to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine.

Before vaccine manufacturers can begin shipping influenza vaccines each season, the FDA first must certify that the supplies to be provided to healthcare providers meet the agency's quality and safety standards.

With today's FDA lot release, GSK's Fluarix Quadrivalent influenza vaccine soon will be supplied to U.S. healthcare providers who placed orders for the new vaccine after it was approved late last year. The U.S. Centers for Disease Control and Prevention placed the largest order for Fluarix Quadrivalent - for more than four million doses - and will allocate those doses to U.S. state and local healthcare providers.

http://www.rttnews.com/2166075/glax...l-to-ship-quadrivalent-influenza-vaccine.aspx
 
Re: GlaxoSmithKline Gets FDA Approval To Ship Quadrivalent Influenza Vaccine

Does this vaccine have adjuvant in it?
 
Re: GlaxoSmithKline Gets FDA Approval To Ship Quadrivalent Influenza Vaccine

Full description of the vaccine is available on FDA website: (PDF) http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM220624.pdf


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FLUARIX QUADRIVALENT is standardized according to United States Public Health
279 - Service requirements for the 2013-2014 influenza season and is formulated to contain
280 - 60 micrograms (mcg) hemagglutinin (HA) per 0.5-mL dose, in the recommended ratio of 15 mcg
281 - HA of each of the following 4 influenza virus strains: A/Christchurch/16/2010 NIB-74XP
282 - (H1N1) (an A/California/7/2009-like virus), A/Texas/50/2012 NYMC X-223A (H3N2) (an
283 - A/Victoria/361/2011-like virus), B/Massachusetts/2/2012 NYMC BX-51B, and
284 - B/Brisbane/60/2008.
285 - FLUARIX QUADRIVALENT is formulated without preservatives. FLUARIX
286 - QUADRIVALENT does not contain thimerosal. Each 0.5-mL dose also contains octoxynol-10
287 - (TRITON? X-100) ≤0.115 mg, α-tocopheryl hydrogen succinate ≤0.135 mg, and polysorbate 80
288 - (Tween 80) ≤0.550 mg. Each dose may also contain residual amounts of hydrocortisone
289 - ≤0.0016 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤0.05 mcg, formaldehyde ≤5 mcg, and
290 - sodium deoxycholate ≤65 mcg from the manufacturing process.

(...)

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