News Conference with Minister of Health and Chief Public Health Officer

 

The Honourable Leona Aglukkaq, Minister of Health
October 21, 2009 - 12:30 EDT

Good afternoon everyone.

It’s my pleasure to make an announcement that many Canadians have been waiting to hear.  With the arrival of the flu season, many Canadians are anxious to get vaccinated against the H1N1 flu virus.  And I’m happy to say that, today, Health Canada authorized the H1N1 flu virus vaccine.  This means that the adjuvanted vaccine has been judged safe and effective for use in Canada by both the Canadian manufacturer, GlaxoSmithKline,  as well as by the Health Canada regulator.  This is a milestone in our efforts to fight the H1N1 flu virus. Thanks to careful planning we now have a safe and effective vaccine being distributed to provinces and territories that they will be rolling out in a matter of days.  And what’s more Canada is in the enviable position to be able to offer vaccine to every citizen who needs and wants it. 

The authorization is the result of an exhaustive review process. Our scientists have reviewed the best available science, clinical trial data, information and evidence about the H1N1 flu virus and vaccines from Canada and from around the world. I would like to thank Dr. Elwyn Griffiths and his team for their tireless work during this important process.  And, as soon as the vaccine is available in your community, I encourage all Canadians to get vaccinated since there is simply no better way of fighting the H1N1 flu virus. 

H1N1 is a novel strain of the influenza virus.  For some people, it has meant a few days in bed – for a small minority it has meant serious illness, complications requiring time in hospital, and, in rare cases, death.  Because it’s a novel strain, no one has immunity.  And that is why this vaccine was developed.  We are urging Canadians to get vaccinated because this is the best way to protect our health and the health of our loved ones.  It’s also the surest way to limit the spread of the virus in our communities.

We have been preparing for a pandemic influenza outbreak for several years.  Recognizing that in a pandemic situation the need for speed is important, we have been working to make a safe and effective vaccine available as quickly as possible without skipping any steps.  Our overriding objective since the beginning has been to best protect the health and safety of Canadians.  That is why in addition to all the preparatory work we have done Health Canada and the Public Health Agency of Canada will also be monitoring the use of the vaccine on an ongoing basis and exchanging information with international regulators on any new developments.

Dr. David Butler-Jones, Chief Public Health Officer of Canada

Thank you, Minister.

This is a very important announcement.  It means the H1N1 flu virus vaccine is both safe and effective, and that in the next few days health professionals in the provinces and territories will begin immunizing Canadians against H1N1.  Today’s announcement means that this vaccine has performed as we expected it would in clinical testing.   This means that most people will start to develop immunity within 10 days with just one dose of vaccine. 

Based on the latest available scientific research, seasonal flu vaccine and H1N1 vaccine can be safely administered either separately (in any order), or concurrently.  Along with this authorization of the vaccine for use, we are making recommendations on how it should be used.  The recommendations were developed in collaboration with, and are supported by, senior health officials from all jurisdictions.  Provincial and territorial Chief Medical Officers of Health for each jurisdiction will use the recommendations to inform their vaccine strategies.

These recommendations include:

• Young children, between six months and 9 years-old, should get two half doses of the adjuvanted vaccine administered at least 21 days apart.
• Everyone else, 10 years of age and older, should get one dose of the adjuvanted vaccine.
• Pregnant women should get one full dose of unadjuvanted vaccine.
• However, if the unadjuvanted vaccine is NOT available and H1N1 flu rates are high or increasing in the community, we recommend that women more than 20 weeks pregnant discuss getting the adjuvanted vaccine with their health care provider.
• As with other vaccines, the H1N1 flu vaccine is not authorized for use in children less than six months of age.

As we have said before, we have ordered enough vaccine – over 50 million doses - to immunize everyone who needs and wants it.  Most of the doses are of the adjuvanted vaccine but there will be a supply of unadjuvanted vaccine for pregnant women and children between the ages of six months and three years.  We are on track to deliver this unadjuvanted vaccine in early November.

I would like to say a few words about the similarities and differences of the two vaccines.  First off, both versions are safe, as Health Canada regulators have determined.  Both versions of the H1N1 vaccine contain a dead version of the H1N1 flu virus.  Like all vaccines, what it does is train our immune system to fight off the infection but without actually infecting us with the virus.  That is a very important fact because we know that a popular myth is that the vaccine can make you sick by infecting you with the flu.  This is not true.  Global H1N1 vaccine safety testing and clinical trials indicates both adjuvanted and unadjuvanted vaccines offer protection against H1N1 infection.  The WHO has advised that both adjuvanted and unadjuvanted vaccines may be safely used to protect against H1N1 virus infection.  

What is an adjuvant?  The adjuvant is an additive that boosts the immune system’s response and makes it more effective, especially if the virus mutates during the fall flu season.  The adjuvant used in Canada’s H1N1 vaccine is made of all natural products: shark oil, vitamin E and water.  The safety and efficacy of the adjuvant has been proven.  It was safely tested in 45,000 people worldwide.  Adjuvant has been used since the 1920s and is included in such common vaccines as the Tetanus, Hep A/B and Diphtheria vaccines.  

Looking forward, the provinces and territories can look forward to receiving more and more doses of vaccine.  Our supplier has been in production for weeks and, as I said, millions of doses have already been shipped across the country. Millions more will follow every week.  It will now be up to the provinces and territories to start administering the vaccine according to the plans for their own jurisdictions.   They have been preparing for this day and we believe they are ready.  Even though the H1N1 vaccine has been authorized, we realize some Canadians may still have questions about its safety.  But I think the more Canadians know, the more they will realize the vaccine is safe, and the more they will realize that it’s worth it to get vaccinated.  Even though clinical tests are complete, we will keep monitoring the vaccine for any adverse reactions.  Once immunization begins, the Public Health Agency of Canada will work with provinces and territories to produce weekly summaries of reported adverse events associated with the H1N1 flu vaccine.  This reporting will be done through the existing programs that are used to monitor other vaccines and drugs.

Serious adverse events following immunization are rare.  For the seasonal flu shot, the rate of reported serious adverse events is about one for every 100,000 people immunized.  Therefore the benefits of immunization – the prevention of serious illness and death – far outweigh any risks associated with being immunized.  It is true that some people should not get the vaccine and each province or territory will be screening everyone who comes through.  For example, those who have a very high fever, have a hyper-sensitivity to eggs, or have had a severe reaction to any element of the vaccine before will not be immunized.  The vast majority of people, however, should get the vaccine because the risks associated with the H1N1 flu virus are real.

So far, this virus has contributed to 83 deaths in Canada. I say that not to be an alarmist but to remind Canadians that the more people that get immunized, the less infection we’ll see across our country.  I say it because we are dealing with a new strain of the flu that is different than the seasonal flu. Remember that the seasonal flu kills between two thousand and eight thousand people every year.  And this strain has the same potential.  But where this one differs, is that it seems to be particularly dangerous for young people who would not normally be affected by the seasonal flu.  As I have said before, I will be getting the H1N1 vaccine and I encourage everyone to do the same.  It is our best defense against being infected by this virus and spreading it to others.

Thank you.