Preparing for more than the seasonal flu

The European Medicines Agency (EMEA), based in London, provides a vital link between the European Commission, national governments and research institutes about the pandemics that are likely to threaten public health, and industry, which manufactures the vaccines.

The EMEA’s role is to approve treatments for various illnesses, including the annual seasonal influenza strain and a potential flu pandemic based on avian influenza.

Martin Harvey of the EMEA says that the agency is preparing for the possible outbreak of a human form of bird flu in Europe by having on stand-by two mock-up vaccines, which are prototypes for the final vaccines, based on the scientists’ best guesses as to the form the flu might take. While there are already pre-pandemic anti-virals, such as Tamiflu, to treat certain types of human forms of bird flu, the EMEA is working to prepare for other strains which could develop.

The research and regulation issues have already been carried out for the two mock-up vaccines, Daronrix and Focetria, which were designed based on the experience of outbreaks of the disease among humans in Asia. Should a strain break out in Europe which fits these vaccines, the strain would be inserted into the treatment and their approval put on a fast track. The EMEA is prepared for the possibility that national experts might not be able to meet to discuss approval, because of possible travel restrictions, and has put in place contingency plans for national experts working remotely.

In order to encourage companies to get involved in this method of developing vaccines which may or may not be needed, the EMEA often waives its approval fee, which can be in excess of €200,000, says Harvey. "That way they don’t pay the fee unless a pandemic is declared," he says.

Should an outbreak occur, the EMEA will also carry out follow-up monitoring on the vaccines that are administered, which will involve staying in touch with national governments, hospitals and doctors to assess drug effectiveness and any possible side-effects, says Harvey. This information will then be relayed to companies involved in the manufacture of the vaccines.

For the more common seasonal flu, the EMEA is each year communicating to industry which particular strain is expected to hit.

The EMEA’s role in keeping industry up to date on the latest thinking on potential pandemics is part of an overall aim to provide a quick reaction to threatening illnesses. "If they have no guidance, industry does not know what to do," says Harvey.

The European Medicines Agency (EMEA), based in London, provides a vital link between the European Commission, national governments and research institutes about the pandemics that are likely to threaten public health, and industry, which manufactures the vaccines.