GlaxoSmithKline (GSK) has confirmed that the European Commission has granted marketing authorisation for its H1N1 influenza vaccine Pandemrix.
GSK Biologicals president Jean Stéphenne said that following the Commission’s approval, the company expects to begin shipments of Pandemrix to European governments from next week.
The approval was based on the results of clinical trials that demonstrated the vaccine can provide a strong immune response, exceeding the required immunogenicity criteria, after one dose.
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By GlobalData