FDA approval of GSK vaccine

GSK gets approval

Yesterday, GlaxoSmithKline announced the US Food and Drug Administration (FDA) have approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine, allowing the company to manufacture a flu vaccine for use in adults.

The approval of the sBLA, which was filed as a strain change supplement to the firm's FluLaval seasonal flu vaccine, is good news for GSK and will see the London-based company manufacturing a vaccine to prevent influenza caused by the 2009 pandemic H1N1 influenza A strain.

Unadjuvanted

According to reports, the vaccine from GSK will account for approximately 250 million doses secured by the US government after the United States Department of Health and Human Services placed an order to fill 7.6 million doses of unadjuvanted H1N1 pandemic vaccine from GSK.

From here, the vaccine will now be produced in multi-dose vials from bulk vaccines manufactured at GSK's facility in Quebec, Canada; the firm expects to begin shipping the vaccine in December, with hopes of providing all 7.6 million doses by the end of the year.

A global effort

The approval now means that, on a global scale, GSK manufactures both adjuvanted and unadjuvanted vaccines to protect against the H1N1 influenza. In North America, Europe and Japan, for instance, clinical trails for both GSK's adjuvanted and unadjuvanted vaccines are ongoing, while now, following the FDA approval, the firm will supply a vaccine containing a standard dose (15 ug) of inactive influenza virus antigens without an adjuvant for use in the US.

The difference between adjuvanted and unadjuvated vaccines is simple: an adjuvant is a substance that boosts the individual's immunity response to the vaccine. It is added in vaccines to lessen the need for more virus or "antigen," allowing a smaller dose to be used.

The interesting point is that it is highly recommended by the World Health Organization (WHO) to use as less material as possible, whilst allowing the community to be immunized against an outbreak in the most time-efficient manner.

Relevant articles:

FDA approval for GSK's Arzerra | R&D: Lessons learned at GSK | GSK set for FDA approval?

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