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Pre-pandemic bird flu vaccine approved for Europe

This week (May 2008) the first marketing authorisation for an H5N1 pre-pandemic vaccine for humans — GlaxoSmithKline’s Prepandrix — has been granted by the European Commission.

Pre-pandemic vaccines are based on the currently circulating avian H5N1 influenza virus strains considered likely to cause a pandemic. They can be administered either before or during an official pandemic to trigger an immune response which will provide some cross protection while awaiting development of a pandemic vaccine.

Once the flu strain is known it is expected to take 12 weeks to develop a final vaccine. However, the European Centre for Disease Prevention and Control says that a pandemic vaccine would not be available to administer to the general population until at least six months after the start of a pandemic.

The EC approval of Prepandrix means that it is now licensed in all 27 EU member states for active immunisation against H5N1 subtype of influenza A virus in adults from 18 to 60 years old. GSK has already signed contracts for pre-pandemic vaccine orders with the US and several EU countries, including Switzerland and Finland but not the UK.

A spokesman for the Department of Health told The Journal: “We have no specific plans at present to buy Prepandrix. However, the science underpinning the further development and potential use of pre-pandemic vaccine is cutting edge and has just been reviewed by UK, and other international experts. We are actively considering their findings and the implications for our policy to inform future decisions.”

Tamiflu resistance

Pandemic stockpiles of oseltamivir (Tamiflu) should be augmented with additional antiviral drugs, including zanamivir (Relenza), according to researchers from the Medical Research Council and the University of St Andrews. The researchers studied the detailed structure and properties of neuraminidase mutants from H5N1 patients and found that they were resistant to oseltamivir but still strongly inhibited by zanamivir.

The reason for resistance to oseltamivir was an altered hydrophobic pocket in the active site of the enzyme required for oseltamivir binding, say the researchers.

In response, Roche, manufacturer of Tamiflu, pointed out that the paper does not establish the clinical relevance of molecular-level resistance.

Citation: The Pharmaceutical Journal URI: 10014939

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