Over the past several days Italy, Germany, France, and Switzerland have all temporarily suspended the use of two Novartis seasonal flu vaccines (Fluad & Agriflu) due to reports of `clumping of proteins’ observed in one batch produced at their facility in Italy.
Both flu shots are distributed in single-dose, thimerosal free, pre-loaded syringes.
Yesterday Canada announced that they would join with a number of other European nations in suspending the use of these two vaccines until a proper safety review could be completed.
Here is the Health Canada statement.
October 26, 2012
For immediate release
OTTAWA - Health Canada would like to provide further information to Canadians about its assessment of the voluntary suspension of use in Europe of the seasonal flu vaccines Agriflu and Fluad.
Agriflu and Fluad are two of the seasonal flu vaccines produced by Novartis that have been pulled from use in several European countries pending further examination of white floating material discovered clumping in the vaccines.
Health Canada rigorously reviewed Agriflu and Fluad for safety and effectiveness before it was authorized for use in Canada.
Clumping of the kind noted in Europe is common in vaccines. Health Canada has previously seen such particles before in other vaccines and has observed no impact on their safety or effectiveness. The Public Health Agency of Canada monitors for adverse events following immunization. To date it has received no reports of serious or unexpected adverse events related to these vaccines.
As a precautionary step, Health Canada asked Novartis to suspend distribution of the vaccines in Canada until a full review of the situation is completed. Novartis has agreed. The Public Health Agency of Canada is also recommending that health care professionals in possession of these vaccines refrain from using them until the review is complete.
The Public Health Agency of Canada and Health Canada will continue to work with the company to monitor the safety and effectiveness of the vaccine used here in Canada. Should a safety concern be identified, immediate and appropriate action will be taken.
Novartis reports that well over a million shots have already been administered in Europe, with no signs of increased adverse effects.
This statement appeared on their website yesterday.
To date, data from the ongoing seasonal vaccination campaign have shown no unexpected adverse events.
Novartis is confident in the safety and efficacy of its seasonal influenza vaccines Agrippal® and Fluad® manufactured in Italy. Patient safety is of the highest priority to Novartis. Novartis internal assessments and the clinical data gathered during the 2012-2013 seasonal influenza studies required for European licensure of Agrippal and Fluad demonstrate a safety and immunogenicity profile similar to that of prior years.
The protein aggregates observed in the one batch that led to precautionary measures in some markets can occur in the normal vaccine manufacturing process and have no impact on the safety or efficacy of the vaccines.
The company is proactively engaging with local health authorities to answer remaining open questions and is fully committed to providing high quality vaccines to patients.
For more on this story we turn to Helen Branswell of The Canadian Press, who has the following report.
Helen Branswell, Friday, October 26, 2012 9:21 PM
Given that we’ve seen this sort of protein clumping in the past with no ill effect, these suspensions may eventually be lifted.
But given the nightmare surrounding contaminated steroid injections in the United States in recent months – a proactive stance by public health officials – even if there is only a hint of a problem, is not unreasonable.