Suspected Defect Prompts Some EU Member States to Halt Vaccine Use

Because of a "suspected quality defect," some European Union (EU) Member States have stopped the use of some anti-influenza vaccines manufactured by Novartis Vaccines, the European Medicines Agency (EMA) reports in a press release. "The suspected defect involves the aggregation of proteins that are a normal part of the vaccines," the EMA states. It adds that halting use is a precautionary action because to date there are no reports that the suspected defect affects vaccine safety or efficacy.

According to the EMA, the Italian Medicines Agency (AIFA) was first informed of the suspected quality defect by the manufacturer (Novartis Vaccines) located in Italy. "The Italian authorities took prompt precautionary action and AIFA alerted all other Member States, the European Commission and the European Medicines Agency using the established mechanisms," EMA states.

AIFA is leading the investigation to determine whether it affects the safety and efficacy of these vaccines, and whether the affected batches should be permanently removed from the market, EMA states. 

This press release, together with all relevant documents, is available on the Agency's Web site:

http://www.ema.europa.eu/ema/index.jsp?url=pages/news_and_events/news/20...


Info on the European Medicines Agency can be found on its website: www.ema.europa.eu

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