EU authorises first bird flu vaccine for humans

The first pre-pandemic vaccine for avian influenza is expected to provide intermediary protection against the deadly H5N1 virus strain until a final vaccine becomes available to health services.

Following a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) in February 2008, the Commission last week granted market authorisation for Prepandrix™ – the first pre-pandemic vaccine for humans against influenza caused by the H5N1 virus. The vaccine is manufactured by the British pharmagiant GlaxoSmithKline Biologicals.

It is feared that the so-called avian influenza or bird flu virus strain, currently transmissible only from birds to humans, will evolve into a strain that is easily transmitted between people, triggering a worldwide pandemic like the Spanish influenza pandemic of 1918–1919, which caused up to 50 million deaths worldwide. After Asia, the highly pathogenic avian flu strain H5N1 has been ravaging poultry populations in Europe since October 2005, causing the Commission and the member states to step up their preparedness and join the worldwide race to combat the disease.

A pre-pandemic vaccine like Prepandrix™ is produced in advance of a pandemic and can be administered either before or during an official influenza pandemic to trigger an immune response to the H5N1 strain of the influenza virus while awaiting the final vaccine. The development and large-scale commercial production of a true pandemic vaccine can not start before the virus has mutated into its pandemic strain. 

According to EMEA, it takes some 12 weeks to develop the final vaccine once the flu strain is known. According to the European Centre for Disease Prevention and Control (ECDC), such a vaccine would not arrive in the hands of primary care services until at least six months after the start of the pandemic. Therefore, pre-pandemic vaccines are considered to be an important element of being prepared for pandemic influenza. 

EMEA believes that Prepandrix™ “will provide a clinically useful degree of cross-protection against the strain that causes the next pandemic,” as it is a mix of antigens from various currently circulating virus strains.  

GlaxoSmithKline has announced its intention to donate 50 million doses of Prepandrix™  to the WHO to help establish a stockpile of pre-pandemic vaccines that can be quickly distributed to the world’s poorest countries.

Prepandrix™ was authorised using the centralised procedure, which allows a company to apply for marketing authorisation in all EU countries. 

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