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news.GlaxoSmithKline's mock-up pandemic influenza vaccine, Daronrix, has received a recommendation from the European Medicines Agency.
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Daronrix is intended for the prevention of influenza during a pandemic situation, once the pandemic viral strain has been included. The mock-up pandemic influenza vaccine is not expected to be used or stockpiled in its current form. Daronix is the first mock-up vaccine to receive backing.
A mock-up influenza vaccine mimics the future influenza strain in terms of composition and manufacturing method. The objective is to have marketing authorization in place that can be changed in the event of a pandemic to include the virus strain responsible, once it has been identified.
The EMEA positive opinion on Daronrix will now be forwarded to the European Commission, which takes the final decision on the granting of a marketing authorization.
GlaxoSmithKline also has a second-generation vaccine against the H5N1 virus strain that causes bird flu and it plans to submit this product for regulatory approval within the next few weeks.