EMEA RECOMMENDS APPROVAL OF 'MOCK-UP' PANDEMIC FLU VACCINE

The European Medicines Agency (EMEA) has adopted a positive opinion recommending approval of a "mock-up" pandemic influenza vaccine. The objective behind a mock-up vaccine is to have a marketing authorization in place that can be changed quickly in the event of a pandemic to include the virus strain responsible, once it has been identified.

The vaccine, Daronrix made by GlaxoSmithKline Biologicals, is intended for the prevention of influenza during an officially declared pandemic situation, once the pandemic viral strain has been included. The vaccine is not expected to be used or stockpiled in its current form.

The availability of vaccines in the event of an outbreak of pandemic influenza is essential for protecting the public from the disease. However, it is impossible to prepare an appropriate vaccine in advance of an outbreak, because the strain of the virus responsible for it is unknown until after the outbreak has started, the agency said.

A mock-up pandemic influenza vaccine mimics the future pandemic influenza vaccine in terms of its composition and manufacturing method. Instead of the pandemic influenza virus strain, the vaccine contains a strain that the population has never been exposed to. In the event of an influenza pandemic, the manufacturer will submit data the actual pandemic virus strain in the vaccine.

The EMEA's opinion will be forwarded to the European Commission, which will decide whether to approve the vaccine.