Skip to content Ontario.ca Français

Novartis Flu Vaccines – Back in Use

Questions and Answers

Why is Ontario resuming the use of Agriflu and Fluad in its flu immunization campaign?

On October 31, 2012, Health Canada advised the provinces and territories that it is lifting its directive to hold distribution and use of Agriflu and Fluad.

As a precautionary step, the products were temporarily pulled from distribution last week by Novartis, and held from use in flu vaccination clinics, at the request of Health Canada, while Health Canada investigated potential concerns.

Health Canada looked at the results of its own testing, conducted a health risk assessment, reviewed information from its European partners and data submitted by Novartis before making its decision.

None of the information reviewed indicated a safety issue.

All vaccines authorized for use in Canada are carefully tested for safety and effectiveness before being allowed on the market.

 

What is the problem with Agriflu and Fluad in Italy?

According to the Italian health regulator, one lot of Agriflu and Fluad showed clumping of particles. This lot was never released to the market.

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.

 

Why is Health Canada releasing the vaccines before Italy?

Health Canada found no safety issues with the vaccines based on its own testing, information provided by its European partners and the manufacturer, and its past experience with possible clumping of vaccine products.

 

What is the government of Ontario doing to respond to this situation?

As soon as Health Canada informed Ontario of its decision, the province's Chief Medical Officer of Health issued notification to all health care providers involved in flu immunization in the province to resume the distribution and administration of the two vaccines.

 

Should I still get my flu shot if I haven't gotten one yet?

Absolutely. The Chief Medical Officer of Health strongly recommends that Ontarians get their seasonal flu shot. The earlier you get immunized, the earlier you're protected against influenza and its possible serious complications.

 

If I received Agriflu or Fluad before the suspension was lifted, do I need to be re-immunized?

All vaccines administered before the suspension were safe and effective, so individuals who received the vaccine do not need to be re-immunized.

 

Do I have to get a Novartis flu vaccine?  When I go to get a flu shot, can I choose from among the four publicly funded flu vaccines?

All of the vaccines that are used in Ontario are approved for use in Canada and are safe and effective, including the Novartis vaccines. If someone is concerned about any of the vaccines offered, they should speak to their health care provider about what options are available to them.

 

Did the temporary suspension of the two vaccines create a shortfall in supply, hampering the flu campaign in Ontario?

At no time was there a shortage of flu vaccine in Ontario. Flu immunization clinics continued to be held across the province.  There is enough flu vaccine in Ontario to immunize all Ontarians who wish to receive the vaccine.  To find a flu clinic near you, visit www.ontario.ca/flu.

 

What flu vaccines are administered in Ontario?

There are four vaccines currently used for flu immunization in Ontario :

• Vaxigrip
• Fluviral
• Agriflu
• Fluad 

Vaxigrip, Fluviral and Agriflu are authorized for use on individuals six months of age and older. Fluad is targeted to individuals 65 years or older.

 

Who should get immunized against the flu?

All individuals six months of age and older, who have no contraindications, are encouraged to get the flu shot.

Anyone, six months of age and older, who lives, works or attends school in Ontario can receive the flu vaccine free of charge.

 

Why is it important to get the flu shot?  How many Ontarians get sick with the flu yearly?  How many are hospitalized?  How many die?

Each year, it is estimated that between 10 to 20% of the population becomes infected with influenza each year.In Ontario, influenza results in up to 1,000 hospitalizations.

While most people recover completely, approximately 1,600 Ontarians die each year as a result of influenza and its complications.

 

Why does Ontario offer free flu immunization?

A recent study by scientific experts showed that, every year, Ontario's free flu shot program saves approximately–

• 300 deaths
• 1,000 hospitalizations
• 30,000 visits to hospital emergency departments
• 200,000 physician consultations for illness