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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 releaseOTTAWA - 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.
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