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Canada and Switzerland lift Novartis flu vaccines ban

Independent tests confirm safety following contamination fears

Novartis building 

Health authorities in Canada and Switzerland have lifted their bans on the sale of Novartis flu vaccines.

Both countries had previously issued a precautionary halt on the distribution of Agrippal and Fluad after white particles were discovered in certain batches of the product in Italy, but independent testing by each country has deemed the products safe for use.

Health Canada, the medicines regulator for Canada, said that as a result of its own testing, as well as further information provided by European health authorities and Novartis, both vaccines would now be available for immediate use.

“None of the information reviewed indicated a safety issue,” said the body in a statement.

The Public Health Agency of Canada has now advised doctors they can use both Fluad and Agrippal, which is known as Agriflu in Canada, although all products should be shaken and checked for white floating material before being injected.

It was a similar story in Switzerland, which was one of the first countries to declare a ban on the vaccines.

The country's drug regulator Swissmedic said that Novartis had provided it with extra information that allowed them to conclude the white particles in the vaccines were not external impurities, but were in fact protein clumps of the vaccine.

In addition, a separate analysis by Swissmedic itself also confirmed the safety of the vaccines.

“Those who choose to be vaccinated have no fear of side effects other than those already known,” said the regulator.

Novartis welcomed both decisions, and said further analysis had reaffirmed the safety of both products, claiming that one million doses had been administered so far during the 2012-2013 flu season, and no unexpected adverse events had been reported.

“We have remained confident in the safety and efficacy of our vaccines; now we are focused on resuming distributions as soon as possible to protect against seasonal influenza,” said Andrin Oswald, head of Novartis Vaccines and Diagnostics.

Other countries where ban on either or both Agrippal and Fluad remains in place include Spain, France, Germany, the UK and Italy.

2nd November 2012

From: Regulatory, Healthcare

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