Canada & Switzerland Clear Novartis Flu Vaccine For Use

 

# 6683

 

Last week (see Novartis Fluad And Agriflu Vaccines Suspended In Canada), Canada joined Italy, Switzerland, and France in temporarily suspending the use of two Flu vaccines produced by a Novartis plant in Italy pending a review after `protein clumping’ was observed in some vials.

 

Today  Reuters is reporting that Health Canada, and the Swiss government have lifted their suspensions, after being reassured of the vaccine’s safety.  

 

 

Italy, reportedly, is `cautiously positive’ that they will be able to lift their ban in the next few days as well.

 

As I mentioned on Saturday, the clumping of proteins is not uncommon in flu vaccines, and has never been associated with a health risk in the past.  But given ongoing fungal meningitis outbreak due to contaminated steroids in the United States, public health officials are understandably being cautious.

 

Here is the Health Canada announcement, released earlier today.

 

Voluntary Suspension of Flu Vaccines (Agriflu and Fluad) Lifted

Information Update
2012-164
October 31, 2012
For immediate release

OTTAWA - Health Canada has completed its review of safety information for Agriflu and Fluad and is releasing the two seasonal flu vaccines for immediate use. As a precautionary step, the products were temporarily pulled from distribution last week by the manufacturer and held from use in flu vaccination clinics at the request of Health Canada while it investigated any possible concerns.

 

Health Canada looked at the results of its own testing, conducted a health risk assessment, and reviewed information from its European partners and data submitted by Novartis in making its decision. None of the information reviewed indicated a safety issue.

 

The Public Health Agency of Canada is now advising health care professionals in possession of these vaccines that they can start using them once again. As such, those administering the vaccines are reminded to follow existing labelling directions as well as allowing the vaccine to come to room temperature before use. The products should also be shaken and checked for any white floating material before they are injected. Such material is not uncommon in vaccines and does not pose a risk to health.

 

The Public Health Agency of Canada closely monitors for vaccination-related adverse events to detect potential safety issues in a timely manner. To date it has received no reports of serious or unexpected adverse events related to these vaccines.

 

The Public Health Agency of Canada and Health Canada will continue to work with the company to monitor the safety and effectiveness of the vaccines used here in Canada. Should a safety concern be identified, immediate and appropriate action will be taken.

 

Agrippal is marketed in Canada as Agriflu and is authorized for use in people older than 6 months. Fluad is authorized for use in Canadians 65 years of age or older.

 

Flu season is upon us, and a seasonal influenza vaccine is a safe and effective way to protect children, families and communities from influenza viruses. Canadians can learn more about fighting flu by getting a copy of Fight Flu: Your Seasonal Flu Guide by contacting 1 800 O-Canada or visiting  Fight Flu.

 

Novartis Fluad And Agriflu Vaccines Suspended In Canada

 

# 6670

 

 

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.

 

Fluad, an adjuvanted vaccine, is not marketed in the United States. Agriflu is listed on the CDC’s Flu Vaccine Supply for the U.S. 2012-2013 as being approved for sale in the U.S..

 

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.

 

Novartis Suspends Distribution of Seasonal Flu Vaccines Agriflu and Fluad in Canada as a Precaution

Information Update
2012-162
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.

 

October 26, 2012

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.

 

Canada suspends dispersal of Novartis flu shots following similar move in Europe

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.