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Flu Vaccine, Ca

November 1, 2012 by  

Flu Vaccine, Ca, Health Canada lifted its hold on Novartis flu vaccines on Wednesday, saying a review of the products reassured the department the vaccines are safe to use. Switzerland, which had also suspended use of the vaccines last week, followed suit. And it was reported that even Italy, which was the first in a chain of countries to halt use of the Novartis vaccines, is now reviewing its decision.

In fact, a senior official of Health Canada admitted the regulatory body might never have put a hold on the products if it had had details last week about why its Italian counterpart had blocked delivery of Novartis vaccines in that country.

Health Canada was finally able to get that information from Italy on Tuesday, and also used other sources of data to conduct a risk assessment on the products, sold in Canada under the brand names Fluad and Agriflu.

It turned out that Italy had taken the action based solely on a report from the company that it had found one batch of vaccine made at its Siena, Italy, plant that contained a higher-than-normal level of protein aggregates.

Novartis pulled that batch from the distribution pipeline. Protein aggregates – which are tiny pieces of the killed viruses used to make flu vaccine – were not seen in other lots of the vaccines made at Siena, the company has said.

“Once we confirmed that the information that the Italian regulator had made its decision on was the same as that which we got from Novartis and the same that the Swiss had got, then we felt comfortable with the decision,” Dr. Paul Gully, Health Canada’s senior medical adviser, said in an interview.

“If we had reassured ourselves very quickly that we were all working from the same information, then yes, it is likely that we would never have been in this situation.”

Switzerland’s drug safety agency Swissmedic said in a release Wednesday that it had placed a hold on use of Novartis flu vaccines after Italian health authorities reported there might have been contaminants found in the products.

But the agency said it was persuaded the visible particles were not external contaminants, but rather bits of viral proteins.

The proteins are a critical component of the vaccine. They provoke the immune system to create antibodies that should protect the recipient from catching the flu. Normally the proteins in flu vaccine are in a suspension and are not visible to the nkd eye. But from time to time they fall out of suspension and can be seen.

It is not uncommon, nor is it a sign that there is something wrong with the vaccine, Dr. Vas Narasimhan, the global head of vaccines development for Novartis Vaccines and Diagnostics, told The Canadian Press earlier this week.

The company welcomed Health Canada’s decision that the vaccines are safe for use.

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