Statistics as of 30 September show that since the beginning of the influenza H1N1 (swine flu) outbreak in April 2009, in all EU countries plus Norway, Switzerland and Iceland there have been 55,044 confirmed cases, including 174 deaths.

Globally there have been 350,000 confirmed cases and 4,160 deaths. Infection is highest in the of 5–24 age group and hospitalisation rates are higher in the under 4's.

Some experts suggest that there could be a second, more deadly, wave of the virus this winter if an appropriate vaccination program does not begin soon. “The European Centre for Disease Prevention and Control estimated that in the worst case scenario up to 30% of  the EU population could get infected with the virus during the winter season,” according to Health Commissioner Androulla Vassiliou.

Green light for two new vaccines

On Tuesday, 29 September, after months of human clinical trials, the European Commission gave final marketing authorisation for two pandemic influenza vaccines: Focetria® (Novartis) and Pandemrix® (GlaxoSmithKline). The vaccines will be used in all EU member states as well as in Iceland, Liechtenstein and Norway.

Some MEPs are concerned about the safety of the vaccines given the speed of the approval process. “Is it safe for children and people in risk groups? We need some clear information,” said German Christian Democrat Peter Liese. Many MEPs were especially concerned about pregnant women.

Meanwhile, German Socialist Dagmar Roth-Behrendt said that people in most countries are afraid of being vaccinated because of potential side-effects. “What will people have to expect?” she asked.

“The side effects of this vaccine are minimal compared to those people who will be infected with the virus,” said Thomas Lönngren, Executive Director of the European Medicines Agency, explaining why the agency had fast tracked clinical approval for the vaccines.  

Not all MEPs had major concerns. Françoise Grossetête, a French Member of the EPP group said: “Loads of people say that seasonal flu is not that dangerous and not that many people die per year. If the N1H1 is similar to that why make such a fuss about it?”

More clinical data needed?

French Green Michèle Rivasi raised concerns about the contradiction between “the authorisation....and the lack of clinical data.”

“It is quite obvious that we do not have any clinical data because this strain has just been discovered. This should not be seen as a completely new vaccine, it is more or less seasonal flu vaccine with a new strain,” Mr Lönngren said.

A (H1N1) is a new virus subtype of influenza affecting humans. It contains a mixture of genetic material from human, pig and bird flu. This is a new variety of flu, which people are therefore unlikely to have much immunity to.