EU: No safety concerns as 10m people get H1N1 shots

LONDON

Some 10 million people across the European Union have now been vaccinated against H1N1 swine flu and so far no unexpected serious safety issues have been identified, the region's drugs watchdog said on Thursday.

The most frequent adverse reactions have been fever, nausea, headache, allergic reactions and injection site pain, but these were mostly non-serious and had been expected, the European Medicines Agency said.

The safety update is the first analysis of adverse reactions following the roll-out of three vaccines across Europe -- GlaxoSmithKline's Pandemrix, Novartis's Focetria and Baxter's Celvapan.

New clinical trial data did show a greater incidence of fever following the second dose of Pandemrix in babies from 6 to 35 months and an assessment of that data was ongoing, the agency added.

The Geneva-based World Health Organisation (WHO) said that around 150 million doses of pandemic H1N1 vaccine had now been distributed in more than 40 countries but did not say how many had actually been given to people.

"So far we have not seen any unexpected safety issues emerge. So far the safety profile seems to be similar to what we see for seasonal (flu) vaccines," WHO flu expert Keiji Fukuda told a briefing.

According to EMEA, of the 39.3 million doses of Pandemrix distributed in Europe an estimated 5.7 million had been used by Nov. 17.

For Focetria, just under half of the 10 million doses distributed had been administered, and for Celvapan there was no data on how much had been used.

-Reuters