Italy lifts ban on Novartis vaccines
The company said authorities in Italy have lifted a ban on a number of Novartis vaccines there. Italy had imposed the bans two weeks ago after the company informed authorities that it had pulled one batch of the vaccine because it contained elevated protein aggregates. The vaccine is made at a plant in Siena, Italy.
At the time, the Italian Medicines Agency said it was "banning" the sale of Novartis' Agrippal, Fluad and Influpozzi, based on information it received from the company that the vaccines "can produce collateral effects." The agency said it would carry out further tests to determine the "quality and safety" of the nearly half a million doses of vaccine. It warned citizens against using Agrippal, Fluad, subunit Influpozzi and adjuvanted Influpozzi until further notice.
Novartis assured authorities that there was no danger from the vaccines, but after Italy took its action, a whole host of countries jumped on the bandwagon and halted use of whatever Novartis flu vaccines they had. Spain, Germany, Singapore, Canada, even Novartis home country Switzerland balked at using the vaccines until further review.
Novartis quickly responded and within a week, Switzerland and Canada reversed their actions. In fact, a Canadian health official told the Calgary Herald, had authorities there realized upfront what the situation was, it might not have halted the vaccines' use in the first place.
Novartis today said it welcomes Italy's decision. "Within the European Union (EU), Italy is the regulatory reference country for Agrippal and Fluad. Novartis will continue to work with other countries to lift remaining precautionary measures and resume supply as soon as possible."
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