Health Committee on Oct. 26th, 2009

[Carolyn Bennett, Liberal, St. Paul's, ON]

Maybe Ms. Davidson would ask my question then.

[The Chair, Conservative, Joy Smith]

Maybe she would.

[Carolyn Bennett, Liberal, St. Paul's, ON]

I think some special groups from Cross Country Checkup that really want to know that if they've got MS, AIDS, had cancer chemotherapy.... Can you tell us what you are recommending to these people--

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Yes, that's not my question.

[The Chair, Conservative, Joy Smith]

That's not your question. I'm sorry, Ms. Bennett.

Go ahead, Ms. Davidson, please.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Thank you very much, Madam Chair. Thank you for being here and presenting to us today.

I think we have been in a long learning curve in this committee, and what you have added here today has certainly helped us.

We've had a fair amount of discussion today about adjuvanted and non-adjuvanted. I would ask Dr. Griffiths to make some further comments about safety for pregnant women.

In your presentation you talked about how adjuvanted vaccines may also provide broader cross-protection across mutating flu virus strains. I think Mr. Lucas referred to that, as well as Dr. Butler-Jones. I would like you to speak to that mutation and try to explain it to a layperson here--and also, what the ramifications of immunization or non-immunization will have with this mutation, if there is any relationship.

[Elwyn Griffiths]

I'll deal with the pregnant women, to start with. This vaccine isn't contraindicated for pregnancy. We're not saying it should not be used in pregnant women. The regulators are saying that we don't.... No clinical trials were carried out in pregnant women, so therefore we cannot say you can't use it. It's left open to assess the severity of the epidemiological situation. It's a “use” situation at this stage . So the use of the non-adjuvanted has been a public health issue, really.

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

But both will be available?

[Elwyn Griffiths]

Both will be available; that's right.

On this issue of the mutations, as you know, seasonal flu is mutating all the time. This particular virus is fairly stable, strangely enough. It hasn't mutated very much. As I mentioned earlier on, changes have now been detected in the Netherlands, but they haven't affected what is called the antigenicity of the virus. That means when you have a vaccine for a seasonal flu, it recognizes a particular virus, and if a small change comes along, then it doesn't match very well. You're doing a best-case scenario to match. And every year the World Health Organization has a meeting in February and they do a little bit of crystal ball gazing. I used to be part of the group that is involved there. They look at the serology—that is, what antibodies are circulating in people's blood. They look also at what viruses are circulating and whether they are changing, and they try to match them up. And if they see the virus moving ahead and they don't match very well, then they say, well, this virus is going to be circulating in the next season. And it has worked quite well. So they make a recommendation of what the new vaccine should be.

This means a lot of work, basically. And it looks as if these small changes do weaken the.... If you've been immunized and there's a changed virus, then your resistance is not as good as it was for the original virus.

With these adjuvants present, it's been shown at least in the H5N1 data.... This is where we do our work, on this prototype, if I can put it that way, because the H1 hasn't changed yet. It did seem that the immune response that came from the adjuvanted vaccine did cross-react. It's called cross-reaction. It recognizes these changed types, essentially, so it would give you protection against these other varieties as well.

So during the season as this pandemic progresses, you would not have to change your vaccine, essentially. That's the idea. Otherwise, by the second wave and by the time you get to the third wave, you might have to change. We don't know that with the H1, but that's the prediction, that it would be giving you a broader cross-protection, as they call it. There's some evidence of that coming from the mock, which we did all our work on originally.

Does that help?

[Patricia Davidson, Conservative, Sarnia—Lambton, ON]

Yes, thank you very much. That's very good. But that's something we haven't seen in other seasonal flu immunizations?

[Elwyn Griffiths]

Yes, the seasonal flu is changing every year. That is changing. That is why you have to have a new vaccine every year. So this meeting that takes place for the northern hemisphere takes place in Geneva. The southern hemisphere does the same. It takes place in September. They decide what the new strains are. This is the reason, because these strains are drifting, they call it. They drift.

With a pandemic strain, it's slightly different. It's a completely new strain. Everybody is naive. There's no immunity there at all for these new stains. That's why they move around so fast. And this has been helped, of course, by air travel.

[The Chair, Conservative, Joy Smith]

I think Mr. Lucas wanted to make some comments on this.

[Paul Lucas]

Yes. I was just going to make the point that we are studying the same adjuvant in the seasonal flu vaccine. So you could anticipate that in a couple of years or so. You'll potentially see a seasonal flu vaccine with the adjuvant in it because of the benefits Dr. Griffiths is talking about. So that's coming along.

[The Chair, Conservative, Joy Smith]

Thank you.

Ms. Wasylycia-Leis.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Thank you.

Let me ask a question of Dr. Van Exan.

In your paper and in your presentation, you mentioned that you believe there should always be two sources of supply for the flu vaccine. Here we have a case where one company, GSK, has the total production, I believe, for the flu vaccine and for the H1N1. And maybe the government or somebody needs to answer this, not you, but you can all comment. Why did you get everything, and what do you say about that, Dr. Van Exan?

[Rob Van Exan]

My comments were based on the fact that we have had a two-supplier process in Canada for the regular seasonal vaccines since 1992, which predates GSK's involvement in this. I've been with Connaught for 30 years, so I remember this. In fact, Connaught was one of the ones that instigated and negotiated the two-supplier system because of the dangers inherent in having only one supplier.

This is a much trickier vaccine to produce on a seasonal basis than any other. The concerns are not only with the virus changing. What about the source of eggs, and what about viruses getting into the eggs or into the chickens? There are so many places for something to go wrong. At the time, in 1992, we suggested--and the government fully backed--the concept of having two suppliers for seasonal vaccine.

When we came to looking at a pandemic vaccine, another element was introduced in 2001. That was the concern about an embargo, a shortage worldwide of this pandemic vaccine. What if we couldn't get it in Canada? So we should have a company in Canada that makes the vaccine. As a result, all other manufacturers were excluded from participating in that contract.

While that may be a valid concern and may be the reason Canada did what it did, I find it hard to separate out the fact that having two suppliers is viewed as being very critical to security of supply on the regular seasonal vaccine and somehow isn't important when it comes to a pandemic. So our position, in terms of talking about safety of the Canadian population, was to talk about safety in respect to security of supply and the fact that Canada would benefit from having multiple suppliers--definitely have one that's manufacturing in Canada, but also add on one that has manufacturing capability outside of Canada and other capabilities inside. For example, our plant in Toronto is labelling and packaging flu vaccine for the U.S. market as we speak. We have the capacity to do that kind of work in Toronto, even though we do not make the box. And we have the capacity to fill vaccine in Toronto.

I'm just saying there's more to this vaccine than what we have with other vaccines, and from a strategic position, we feel Canada would be well served to have two suppliers.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Yes, go ahead and comment. Dr. Griffiths, can you speak for the government on this?

[Elwyn Griffiths]

Not on the purchasing side. That's the Public Health Agency. We regulate whatever vaccine comes to us, let's say. But it's a Public Health Agency issue. It's the supply part.

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Give us your take.

[Paul Lucas]

For seasonal vaccines, that's correct. We do split the supply for Canada. I wasn't involved with the company when we first purchased it. This company and the plants that are making this were owned by previous companies.

It's a tricky question on a tricky issue. The driving factor here was that Public Health wanted a secure source of domestic supply, not knowing what would happen in a pandemic around borders shutting down.

[The Chair, Conservative, Joy Smith]

The time is almost up. I know Ms. Fletcher also wants to say a couple of words.

Ms. Fletcher, quickly.

[Susan Fletcher]

Thank you.

I have here, from the year 2000, the U.S. national vaccine injury compensation program and vaccine injury table. It talks about vaccines for DPT, MMR, hepatitis B--all kinds of different vaccines. Each one says that any acute illness, disability, injury, or condition covered includes “any acute complication or sequela (including death)”.

In Canada, death is not recognized as an adverse vaccine event. Why is that? Why is it that it can happen in the States and not here?

[The Chair, Conservative, Joy Smith]

Thank you, Ms. Fletcher.

We'll now go to Mr. Brown.

[Patrick Brown, Conservative, Barrie, ON]

Thank you, Madam Chair.

I have a few questions to ask and hope you can answer within the time.

Ms. Fletcher made a comment a little while back about the vaccine potentially affecting autoimmune diseases. I thought maybe we'd get Mr. Griffiths' response to that, because we didn't have time allotted in that questioning for it. Second, could you expand upon the encouraging signs we've heard about from Australia with the H1N1 there?

I want to touch a little bit more upon domestic production. I've heard the comments about how there needs to be a second supplier. Would that production be 100% domestic as well? Could you also expand upon why the GSK has viewed that as important and could they handle all the production with a border shutdown?

[Paul Lucas]

Do you want to start with that one?