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Home Industry News GlaxoSmithKline H1N1 vaccine approved by the FDA

GlaxoSmithKline H1N1 vaccine approved by the FDA

12th November 2009

GlaxoSmithKline has announced that its H1N1 influenza virus vaccine has been approved by the Food and Drug Administration.

The firm filed a supplemental biologics licence with the organisation for the compound, which was filed as a strain change supplement to its FluLaval seasonal flu vaccine, which enables the company to manufacture a flu vaccine for use in adults to tackle the H1N1 influenza A strain.

So far, the department of health and human services has ordered 7.6 million does of the unadjuvanted product.

It will be manufactured in multi-dose vials and the firm expects to begin shipping the vaccine in December to provide the compound to the government before the onset of 2010.

Earlier this month, GlaxoSmithKline revealed that the World Health Organization approved its pneumococcal conjugate vaccine, 10-Valent Synflorix.

This marked the first pre-qualification for a vaccine against pneumococcal disease, which is a life-threatening condition affecting many children under the age of five in developing nations.

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