EU countries suspend sales of Novartis flu vaccines
pharmafile | October 29, 2012 | News story | Manufacturing and Production, Sales and Marketing |Â Â EU, Novartis, vaccinesÂ
Contamination of Novartis flu vaccines with white particles has resulted in regulatory actions from various authorities in the EU, including France, Spain, Italy, Germany and Switzerland.
France has asked for all supplies of Novartis’ Agrippal to be taken off the market as a precautionary measure, following in the footsteps of the Italian authorities which temporarily banned the sale of Agrippal and other flu vaccine products sold under the Influpozzi brand name.
France’s regulatory authority – the ANSM – said that the suspension of Agrippal’s marketing was a precaution and came at the request if France’s Health and Social Affairs Minister Marisol Touraine.
It stressed that no cases of particle contamination have been encountered among vaccines distributed in the country, and that Agrippal only accounts for around 2% of the flu vaccine market in France.
Last week Germany had ordered a recall of five batches of Novartis’ Fluad and Begripal vaccines – both of which are manufactured in Italy – following the reports of particle contamination in a batch of products that had not been released for distribution.
Meanwhile, Switzerland also suspended marketing of the affected products while the problem is investigated, and Spain has followed suit with a ban on the sale of Novartis’ Chiromas and Chiroflu brand flu vaccines.
“This measure is intended to protect patients from possible side effects after the administration of vaccines,” said Germany’s Paul Ehrlich Institute in a statement.
The ANSM said it was waiting for an opinion on the case from the European Medicines Agency (EMA), although the agency told Reuters it as not taking the lead in this case as the vaccines had all been approved via the national regulatory route.
In a statement, Novartis said it was aware that particles can occur in the manufacturing process, but it was confident that “there is no impact on the safety or efficacy of the vaccine”.
Phil Taylor
Related Content
Novartis receives SMC approval for early breast cancer treatment
Novartis has announced that its treatment for early breast cancer, Kisqali (ribociclib), has received approval …
Sharp invests $100m in US and EU manufacturing and packaging facilities
Sharp Services, a pharmaceutical packaging and sterile manufacturing specialist, has announced investments totalling $100m across …
Novartis candidate for Sjögren’s disease presents positive results
Novartis has reported positive results from two phase 3 clinical trials – NEPTUNUS-1 and NEPTUNUS-2 …
