Novartis says Canada and Switzerland lift vaccines ban
pharmafile | November 2, 2012 | News story | Manufacturing and Production |Â Â Canada, Novartis, Switzerland, vaccinesÂ
A temporary suspension on the distribution of flu vaccines made by Novartis has been lifted in Canada and Switzerland.
The ban on vaccine shipments and dosing was implemented in Canada, Switzerland and various EU countries after particulate contamination was observed in a batch of flu vaccine made at Novartis’ facility in Siena, Italy.
Novartis said after the regulatory actions that the white particles observed in some vials of the Agrippal and Fluad vaccines were a by-product of the manufacturing process, and had no impact on their safety or efficacy.
In a statement, Health Canada said it had carried out testing and a health risk assessment on the vaccines, as well as reviewing information from European regulators and data provided by Novartis, and concluded that “none of the information reviewed indicated a safety issue”.
Swissmedic arrived at the same conclusion after conducting its own tests and reviewing Novartis data, said the firm.
A statement from the Swiss agency confirmed that the white particles “are in no way external impurities, but are clumps of ordinary protein components of the vaccine”. The particles dissolve if the vaccines are shaken before use, in accordance with manufacturer instructions, it added.
Novartis’ division head for vaccines and diagnostics, Andrin Oswald, said: “We have remained confident in the safety and efficacy of our vaccines; now we are focused on resuming distribution as soon as possible to protect against seasonal influenza.”
The company said that it is working with health authorities who suspended sales of the vaccines to address their questions and “restore distribution as soon as possible”.
Oswald said on Novartis’ third-quarter results call that the company is in the midst of a strategy to upgrade what is essentially a fairly old manufacturing network in its vaccine business, for example with the construction of a new cell culture production facility in the US.
Phil Taylor
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