Canada latest country to suspend sales of Novartis vaccines
pharmafile | October 30, 2012 | News story | Manufacturing and Production |Â Â Canada, Novartis, vaccinesÂ
Canada has said it will suspend sales of two flu vaccines made by Novartis – following in the footsteps of several EU countries – because of a problem with visible particles in vials.
The country’s regulatory authority Health Canada has halted distribution of Novartis’ Fluad and Agriflu vaccines while it undertakes a review of the affected products, which were made at a Novartis facility in Italy.
Dr Paul Gully, senior medical advisory for Health Canada, told CBC News that the move was ‘prudent’ in light of the action taken by EU countries including France, Spain, Italy, Germany and Switzerland.
The agency has also advised doctors not to administer the two vaccines to patients, although it stressed there was no indication of any risk to patients from the particles. The investigation seems to centre on whether the efficacy of the vaccine is affected.
In a statement, Novartis said that recent clinical trials of these influenza vaccines and administration during seasonal vaccination campaigns have shown no unexpected adverse events to date, and said it “confirms its confidence in the safety and efficacy of its seasonal influenza vaccines”.
The company believes the particles are formed by aggregation of vaccine components and are known to occur sometimes during the vaccine manufacturing process.
“Novartis voluntarily provided the Italian health authorities with its assessments supporting the quality, efficacy and safety of the specific vaccines in question,” said the company, adding that it “will continue to work with the Italian Ministry of Health and AIFA to understand the reasons for their decision and to clarify any questions”.
Novartis provides around 20% of Canada’s seasonal flu vaccine stocks, according to CBC News, with the remainder coming mainly from GlaxoSmithKline.
Phil Taylor
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