Regulatory Focus™ > News Articles > Italian Regulators Affirm Safety of Novartis' Vaccines

Italian Regulators Affirm Safety of Novartis' Vaccines

Posted 12 November 2012 | By

Italy's Agenxia Italiana del Farmaco (AIFA) has joined Canadian and Swiss regulators in affirming the safety of Novartis' Agrippal (alternately known as Agriflu) and Fluad after concerns were raised about the safety effects of a protein aggregation within vials of the vaccine.

The concerns were first brought to regulators' attention in late October 2012, leading several regulatory agencies-including those of Italy, Spain, Switzerland, Canada, Germany and France-to suspend the sale of the products or their import. No regulatory agency made note of any adverse event signals, but rather said they were taking action out of an abundance of caution.

Shortly thereafter, Canadian and Swiss regulators said they would lift their respective bans on the vaccines after safety testing confirmed the protein aggregation by itself posed no harm to consumers.

"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. "Health care professionals in possession of these vaccines can start using them once again," it added. Switzerland's Swissmedic released a similar statement regarding the vaccine's safety and efficacy, noting it showed no effect on either.

At the time of those statements, AIFA said it was still awaiting the final results of its own testing, though it said its preliminary testing had been in line with Canadian and Swiss regulators' results.

Now, though, AIFA's results have been confirmed. In a 9 November 2012 statement, the agency said it had "removed the ban on the use of vaccines manufactured by Novartis V&D."

"This was made ​​possible as a result of careful checks made ​​on the documentation produced by the Company in response to requests to conduct in-depth investigation of a possible lack of quality found in some batches of the vaccine and the concomitant analysis by [Novartis] and the National Institute of Health," AIFA said in a statement translated by Google Translate.

Italian regulators said the episode was indicative of the, "Extreme caution and rigor of the checks that are carried out on all vaccines, such that, even where there is found the remote possibility of the presence of a minimum quality defect, precautionary measures are readily adopted to protect public health concerns." Those measures extend to the whole production process, it added.

Other countries, including France, have since lifted their suspensions on the vaccine as well, but the product remains suspended in Spain and Germany for the time being.


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