Add GlaxoSmithKline to the list of approved vaccine makers here in the United States. I have previously written about GlaxoSmithKline's H1N1 "swine flu" vaccine when I discussed the Pandemrix™ vaccine available in Europe and Saudi Arabia. Pandemrix™ is also one of the EU666 and US666 biodefense stockpile products according to Biopharma.com. I have no idea who created these particular codes, but the EU666 and US666 codes are not defined in the index as other codes, so it could be simply someone's idea of a sick joke.
However in the United States of America, GSK's H1N1 approved vaccine will likely be called FLULAVAL®. You can read the FLULAVAL® package insert by clicking this sentence.
The article mentions that the vaccine will be produced at a facility in Quebec, but does not mention that the vaccine will be manufactured by ID Biomedical Corporation of Quebec. You can link to the official FDA page by clicking here or read the press release by clicking here. Or if you just want to see what's in the FLULAVAL® vaccine, then read below (this is taken from Section 11 of the package insert).
Source: The Triangle Business Journal; GlaxoSmithKline ; FDA
However in the United States of America, GSK's H1N1 approved vaccine will likely be called FLULAVAL®. You can read the FLULAVAL® package insert by clicking this sentence.
The U.S. Food and Drug Administration has granted approval to GlaxoSmithKline’s H1N1 swine flu vaccine, the British pharmaceutical giant announced Tuesday.
The U.S. government has ordered 7.6 million doses of the H1N1 vaccine from GlaxoSmithKline, which bases its North American operations in Research Triangle Park. GSK (NYSE: GSK), which will produce the vaccine at a facility in Quebec, says it expects to begin shipping vials of the vaccine next month and fill the full U.S. order by the end of the year.
The article mentions that the vaccine will be produced at a facility in Quebec, but does not mention that the vaccine will be manufactured by ID Biomedical Corporation of Quebec. You can link to the official FDA page by clicking here or read the press release by clicking here. Or if you just want to see what's in the FLULAVAL® vaccine, then read below (this is taken from Section 11 of the package insert).
FLULAVAL® is a trivalent, split-virion, inactivated influenza virus vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs. Each of the influenza virus strains is produced and purified separately. The virus is inactivated with ultraviolet light treatment followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate.
FLULAVAL® is a homogenized, sterile, colorless to slightly opalescent suspension in a phosphate-buffered saline solution. FLULAVAL® has been standardized according to USPHS requirements for the 2009-2010 influenza season and is formulated to contain 45 mcg hemagglutinin per 0.5-mL dose in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/Brisbane/59/2007, IVR-148 (H1N1), A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus), and B/Brisbane/60/2008. Thimerosal, a mercury derivative, is added as a preservative. Each dose contains 25 mcg mercury. Each dose may also contain residual amounts of egg proteins (≤1 mcg ovalbumin), formaldehyde (≤25 mcg), and sodium deoxycholate (≤50 mcg). Antibiotics are not used in the manufacture of this vaccine.
Source: The Triangle Business Journal; GlaxoSmithKline ; FDA
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