France halts sale of Novartis flu vaccine
Fri, 26 Oct 2012 14:18 GMT
(Adds comment from European Medicines Agency)
PARIS, Oct 26 (Reuters) – France said it was halting sales of an influenza vaccine made by Swiss drugmaker Novartis as a precaution after potential impurities were found in batches of the product in Italy.
Health Minister Marisol Touraine said on Friday she had asked for all doses of Agrippal to be withdrawn from the market.
“At this stage no impurities have been found in France … There is no known risk for patients who have used this brand in France,” Touraine said in a statement.
France said it had taken the action pending a decision by the European Medicines Agency (EMA), although the London-based agency said it was not taking a lead in investigations since the flu vaccine was authorised by national governments.
The EMA is responsible for medicines that are authorised centrally, although it may be called on to help with issues concerning nationally approved products if requested by the European Commission or governments.
“At the moment there is no regulatory action from our side,” an EMA spokeswoman said.
The French decision follows the announcement by Swiss and Italian authorities on Wednesday that they were banning some flu vaccines produced by Novartis after small white particles were discovered in Italy in injections.
German and Spanish authorities also imposed a ban on certain Novartis flu vaccines on Thursday.
Agrippal is the only Novartis flu vaccine marketed in France. The ban in Switzerland concerns Novartis’ Fluad as well as Agrippal, while Italy has also withdrawn subunit Influpozzi and adjuvanted Influpozzi.
Novartis said on Thursday it believed its flu vaccines were safe, despite the discovery of aggregated protein in a batch of vaccine which was not released to the market. (Reporting By Vicky Buffery and Ben Hirschler; Editing by Keiron Henderson and Helen Massy-Beresford)