Health Committee on Oct. 26th, 2009

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I met with people this past Friday. They were public health officials. I asked the question specifically around allergy and the paperwork that's required to roll the vaccines out. I had one answer from one group and another answer from another group. I think that speaks to the confusion that still exists.

[Dr. David Butler-Jones]

What was the advice you were given that was different?

[Kirsty Duncan, Liberal, Etobicoke North, ON]

One group of health officials was actually surprised that there was fish oil in the adjuvant. They didn't know. The other group--

[Dr. David Butler-Jones]

Well, they will. It will be in the materials they receive that have been rolling out through the provinces in terms of the product monograph, etc. They would be expected to read those materials before they actually immunize anybody. I'm surprised. Perhaps they don't watch the news.

There are materials that will be going with the product that nurses and others will read. I don't know if these are officials who actually give immunizations or just people who are working in public health. The materials are there. The materials will be there.

Public health units, every year, do immunization against influenza. This is another influenza vaccine. The only difference is the addition of the adjuvant that improves immunity. There are not issues with allergies with this adjuvant.

[Kirsty Duncan, Liberal, Etobicoke North, ON]

I have one other concern. The adjuvant--

[The Chair, Conservative, Joy Smith]

Dr. Duncan, your time is up.

We'll go to Mr. Malo right now.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Thank you, Madam Chair.

My question is addressed to Mr. Griffiths. The vaccine was authorized for distribution and administration in Canada after studies that were done in Europe. We know that the Europeans began to vaccinate their population well before we did. Consequently, I wonder what the guideline followed by Health Canada was when it authorized the vaccine on the basis of studies done in Europe although it waited, nonetheless, later than Europe to begin distributing the vaccine.

[Elwyn Griffiths]

The issue with authorizing on data generated in Europe is not quite true. It's a whole package of data, which I tried to express. The data from Europe was really on the efficacy of the H1N1; that was the early data coming in. The safety package was primarily from the H5N1, which has been tested in Europe and the United States and in Canada as well.

So the data are coming in, to start with from Europe, but there are data from Canada. There are safety data coming in from Canada as well. It's the same vaccine. So you cannot wait to get the data from Canada as well; you already have the data from European studies.

I think that's what you're asking.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Are you telling me that the vaccine administered in Canada is exactly the same as the vaccine being administered in Europe? This does not match the information that I received. Mr. Lucas, could you tell me if it's really the same vaccine?

[Paul Lucas]

With respect to the vaccine in Canada, the vaccine is basically the same as the one GSK makes in Europe. The only small difference is a slight difference in the manufacturing process, but for all intents and purposes it's the same vaccine.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Ms. Fletcher put a number of questions regarding the adjuvant, and regarding comments made by Mr. Griffiths on the number of candidates who were tested. Would you like to clarify the statements made by Ms. Fletcher?

[Elwyn Griffiths]

Could I answer that one?

I think she was referring to a group trial of 130 in Europe. It's bigger than that; there are two trials there. It's actually double that. I think the figures may have been mixed up somewhere. It's not just 130. There are two studies done in Europe with slightly different concentrations of the adjuvant and the antigen, essentially, so the numbers are not quite correct.

On the safety side, as I did explain originally, there is a whole safety database. For adjuvanted vaccines, it's H5N1, and then you switch over to the H1N1 virus for the actual efficacy part.

I think Paul wants to add to that.

[Paul Lucas]

As for the safety of the H1N1 adjuvanted vaccines, you would anticipate it to be the same as the H5N1 adjuvanted vaccine that has been approved in Europe. When you look at all of the adjuvanted vaccines, H5N1, H1N1, and adjuvanted seasonal vaccines, there are over 40,000 people who have been vaccinated with that adjuvant.

[Elwyn Griffiths]

With the annual seasonal flu vaccine, which is licensed, all that happens every year is that there's a strain change. There is a small clinical study of the same size that takes place. Some of them are in Europe, some of them are in Canada. Every year, it's the same. It's following the same pattern. There's nothing special about this.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

We heard comments from officials of the agency last week who said that pregnant women could, up to a certain stage, use the vaccine with the adjuvant. I simply wonder why 200,000 doses of vaccine without adjuvant were ordered from the Australian company CSL.

It does not seem clear to me. I feel that contradictory messages are being sent out from one week to the next. I think that it would be important to have one single clear message.

[Dr. David Butler-Jones]

It is the same message. The vaccine without the adjuvant is preferable because we have less data about the vaccine with the adjuvant during pregnancy. This is an option for women. This week and last week, the recommendation was the same, i.e. less than 20 weeks. The risk for pregnant women is the same as for other women of the same age group. However, after 20 weeks of pregnancy, the risks go up almost four-fold. If the illness is present in the community, the risk is greater than the theoretical risk of the vaccine.

[The Chair, Conservative, Joy Smith]

Thank you, Dr. Butler-Jones.

We'll now go to Ms. Wasylycia-Leis.

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

Thank you, Madam Chair, and thanks to all of you for your appearance here today.

I think the overriding purpose of this meeting is to get some clarity around testing and surveillance. If we are trying to get more Canadians interested and committed to taking the vaccine, then we have to be able to answer those questions. The more transparent and open we can be about what tests have been done and where, the better. I think obviously there was a change in the federal government, Health Canada, and the Public Health Agency's strategy vis-à-vis release of the vaccine, because it was on October 6 that your own handout suggested:

Because the current H1N1 strain has not been a component of any previous influenza vaccine, it presents unknown factors that could require changes to the standard manufacturing process for vaccines. Tests will be conducted to confirm basic information on the vaccine. A small clinical study with humans will also be conducted to establish the safety of the vaccine.

Based on that, the minister said repeatedly in the House that it would probably not be until November 1 that she would be able to authorize the vaccines, depending on those studies. Clearly, some shortcuts were taken and a decision was made to actually approve the vaccine without some of the studies that were indicated in this handout that went out publicly. I'd like to know how the normal regulatory process has been short-cutted and modified.

What clinical studies, what preclinical trials, can you tell us about today that have been done in Canada or internationally, separate and apart and independent from the company GSK, which is producing the actual vaccine?

[Elwyn Griffiths]

Could I first clarify the point about the timing?

I think the idea was—and Dr. Butler-Jones can help me with this one—that we didn't want to say we were going to be able to have a vaccine available in mid-October when we weren't really sure we would be. The conservative approach was to say November. However, the data that we were waiting for—some quality data and some early data in terms of the actual efficacy—came in early from GSK, so we could actually look at those data early on, much earlier than we had expected. There was no point, then, in waiting another month or so to move forward. Basically, the data were in early, we could evaluate those data, and everything looked fine.

As to the data you're asking for on the safety, as with all vaccines and all drugs, usually the manufacturer conducts all these activities. There are other activities now going to take place with already licensed vaccines, and the Public Health Agency will be doing some of these studies. Usually these are not done prior. It's usually the manufacturer that does these particular studies, because it's not a publicly available product, essentially.

Do you want to comment on that, Paul?

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

While you're commenting on that, let me just make the comment that the original document from the government said, in the section that I read, this testing will take approximately six weeks. So for it to be modified to one or two weeks is quite a significant leap.

Besides what you can tell us about your testing, I'm still curious to know what steps have been left out and why, and what studies have been done independent of GSK. In fact, that's the hallmark of our health protection model in Canada. We have prided ourselves in the past that the precautionary principle will prevail. I know we're talking about a risk management model here, and we understand that, and I'm not trying to dissuade anyone from taking the vaccine, but I think we'll have a fuller uptake if people fully understand what studies have been done and what risks are involved.

[Paul Lucas]

I can comment, first of all, on the clinical trials that we're doing on H1N1. We're doing 16 clinical trials around the world.

Just to the point about studies being done in Canada, those 16 trials will include over 10,000 subjects, and 2,000 of those will be Canadian—

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

Could I interrupt for a second? I appreciate this and I'd love to get it, but my time is limited. Mainly what I'm asking for is what studies have been done independent of the company, because I don't know how otherwise we can actually measure it. I take GSK's word for it, but I think we've always based our conclusions on independent scientific surveillance of existing drugs or vaccines.

[Elwyn Griffiths]

Not really. When products are licensed in Canada, the data from the manufacturer is usually assessed. It's not an independent assessment. It may involve independent investigators, which is a different issue, but it's all manufacturers' data.

[Dr. David Butler-Jones]

There are independent researchers who are contracted to do the research, but it is from the company. But it is transparent; the regulator sees all the data, good or bad, with it. So that's not an issue.

We are doing additional trials, and again, to be clear in terms of when we were talking before about what was planned, that has not changed. Nothing has been short-cut. But what we found is that after one dose there was good immunity. The six weeks would be required for two doses and the results of two doses before you'd know.

In Canada we have said, and I've been saying from the beginning, that we were working to have it available as soon as possible in terms of safe and effective vaccine, confident about the beginning of November. Nothing was shorted. The only additional thing the regulator might look for is immunity data following the second dose, etc., which would not change the decision about when to immunize.

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

Can I ask, then, how you make decisions about dosage for, say, young children less than three years of age, when GSK's own report says there is no data, no experience in children less than three years of age, and also with respect to elderly people? And I could go through the list.

In regard to pregnant women, “No data have been generated in pregnant women with Arepanrix™ H1N1 nor with the prototype ASO3 adjuvanted H5N1 vaccine.”