Regulatory Focus™ > News Articles > Novartis Vaccine Cleared by Canadian, Swiss Regulators after Quality Concerns

Novartis Vaccine Cleared by Canadian, Swiss Regulators after Quality Concerns

Posted 05 November 2012 | By

Regulators with Health Canada and Switzerland's Swissmedic are lifting their respective bans on Novartis' trivalent flu vaccines Agrippal and Fluad after independent testing found them to be safe for human use.

The vaccines had been suspended by the regulators of no fewer than five countries-Italy, Canada, Germany, Switzerland and Spain-after Novartis raised concerns with them regarding the presence of an unknown particulate aggregation, thought to be protein-based and not a contaminant. All regulators stressed that they had taken action not due to the presence of adverse event data, but rather out of an abundance of caution.

Now those fears seem to be subsiding after several regulators announced the outcomes of their testing on the vaccines.

"Health Canada has completed its review of safety information for Agriflu and Fluad and is releasing the two seasonal flu vaccines for immediate use," Canadian regulators wrote in a statement on 31 October. "[H]ealth care professionals in possession of these vaccines that they can start using them once again," it added.

Health Canada said its testing showed no signs of any safety issues occurring as a result of the protein aggregation. "Such material is not uncommon in vaccines and does not pose a risk to health," it said. It did not make any mention of whether the aggregation could affect the efficacy of the vaccine, however.

A concurrent statement by Swiss regulators also cleared the vaccines, saying its data showed the contaminants did not affect the efficacy or safety of the vaccine.

Italian regulators meanwhile said their preliminary testing had showed the same results as Swiss and Canadian regulators, but explained that they were still in the process of testing and would have more information available in "coming days."

Spanish and German regulators have not yet lifted their bans, and have posted no new information.

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