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CHMP recommends marketing authorization for GSK’s influenza vaccine

The Committee for Medicinal Products for Human Use or CHMP has recommended a marketing authorization for GlaxoSmithKline Biologicals's Pandemrix, 3.75g HA, suspension and emulsion for emulsion for injection intended for prophylaxis of influenza in an officially declared pandemic situation in accordance with official guidance.

The benefits with Pandemrix are that it can mount an appropriate immune response in individuals that are immunologically naive against the mock-up vaccine strain. It is an adjuvanted vaccine that induces an immune response (circulating antibodies) against the H5N1 antigen. This vaccine will only be used in an officially declared influenza pandemic and after inclusion of the exact matching pandemic influenza vaccine strain into the vaccine.