Health Committee on Oct. 26th, 2009

[Colin Carrie, Conservative, Oshawa, ON]

Thank you, Madam Chair.

I want to thank all the witnesses for taking the time to be with us here today. I want to thank Ms. Fletcher for being here on video conference.

This is something I'm reading about in the papers daily. I think there's a lot of information out there. I was in Washington this past week at a convention with a lot of International physicians and they were talking about what a good job we were doing on the economy and on H1N1. So it's nice to hear these compliments. Sometimes you have to go outside the country to hear them.

I want to talk a little more about the contradictory reports and the hesitation of Canadians to get the vaccine. I think I read today in the Ottawa paper that 51% do not think they will get the vaccine.

I wonder if Dr. Griffiths could comment a little more on the safety aspect of things. Then maybe Ms. Fletcher would like to comment too.

[The Chair, Conservative, Joy Smith]

Dr. Griffiths.

[Elwyn Griffiths]

On the safety aspect, this adjuvant type of vaccine has been used in up to 40,000 people without any significant effect. With a vaccine like Prevnar, which is the pneumococcal vaccine, virtually all the trials were done in the United States and Africa. In the United States trial there were about 37,000 individuals, and Prevnar is licensed in Canada and many other countries. That's a large study. These studies take a long time to do.

The Menactra study involved only about 10,000 to 12,000 individuals. That's the meningitis vaccine. The figures we have for this type of vaccine--the H5N1, which is the mock vaccine--plus data now being generated on the H1N1 vaccine are now getting into the same ballpark on safety and efficacy as you normally see for a vaccine. So although we say we're moving forward, this is what has happened.

In Europe and the United States there are questions about not just the adjuvant but the antigen as well. In 1976, as we heard from Dr. Butler-Jones, they came out with an H1N1 vaccine--the swine flu saga--but at that time they didn't have a real pandemic.

So it's a balance as you go forward. I think the safety margin is considerable now for moving forward with these vaccines.

Paul Lucas might have a comment on that as well.

[Paul Lucas]

Yes, I'm just commenting on the adjuvant.

It has three elements in it. They're all kind of natural ingredients. Squalene is the first, and it appears naturally in plants, animals, and humans. This isn't something that the human isn't used to. It also includes tocopherol, which is vitamin E, and most people are familiar with it. The third ingredient is polysorbate, which is an emulsifier that is actually put in ice cream. So these are three elements that are pretty common types of chemicals.

One shouldn't suspect that you're going to have a problem, and the H5N1 studies that we have done and the 40,000 patients that we've had this adjuvant in have seen no unusual side effects.

[Colin Carrie, Conservative, Oshawa, ON]

Ms. Fletcher, you seem to be the odd man out. I read in your presentation that squalene seems to be a problem, or thimerosal, and I've heard of that before in regard to autism. You don't seem to be looking at the same science as these other gentlemen, and I was wondering why you think it is not safe.

[Susan Fletcher]

I have here Gary Matsumoto's list, and you can get this on his website. I have the website listed in my references to our presentation, if you have it there. It lists 30 peer-reviewed studies—these are animal studies, mind you—showing that squalene produces autoimmune disease. This is the other thing about safety testing. Autoimmune disease, like MS, typically takes a long time to develop. My question is how long have these safety tests been carried out?

According to the Arepanrix product information leaflet that I looked at quickly on the weekend, the longest period I could see was six months. Now, MS can take a lot longer than six months. Diabetes can take up to 10 years. That's one aspect of this safety testing. The other—

[Colin Carrie, Conservative, Oshawa, ON]

Is Mr. Matsumoto a researcher?

[The Chair, Conservative, Joy Smith]

I'm sorry, your time is up, Ms. Fletcher.

We'll now go to Dr. Bennett. She can continue that if she chooses.

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

Maybe, Mr. Pless, you could tell us what your responsibility is in terms of the Canadian field epidemiology program.

[Dr. Robert Pless, Program Director, Canadian Field Epidemiology Program, Public Health Agency of Canada]

Madam Chair, given that the agency has increased the number of staff who are working on the pandemic file, I have a history in vaccine safety and so I was asked to come and help out with the vaccine safety section. Unfortunately, Dr. Barbara Law, who is the head of the section, was out of the country and couldn't make it.

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

Is it your responsibility to now track what's happening with the vaccine in terms of safety and efficacy?

[Dr. Robert Pless]

Yes. It's the vaccine safety section within the Public Health Agency that is going to be looking after the post-market surveillance of vaccine as it's rolled out.

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

The European Union said this week about the data from GSK and Novartis that the adjuvanted ones were too limited to warrant recommending a single dose schedule, but added that one dose might be sufficient in adults. How are we going to track that? How are we going to find out if people really are protected after one dose? When will that decision get made? And will you then have to remount a campaign for those for whom a second dose is being recommended?

[Dr. Robert Pless]

I can speak a little bit to vaccine efficacy, in terms of studies that are going to get under way to look at that very question, and perhaps Mr. Griffiths can elaborate on those. But there are plans in place to conduct additional studies to look at populations and their immunogenicity to the vaccine.

[Elwyn Griffiths]

I think this has been the big issue. Trials have been done so far in an age group from the middle group, if you like. There's a top end, where we're not really sure what the dose should be. Yes, these have to be tracked. They've got to be going off with one dose, but they will be doing immunogenicity studies on small subgroups here. This is important not just for Canada; the data will be shared globally. It would be the data from Europe, and that would be shared with us as well.

This is the advantage. It has never happened before on the regulator's side. This is something unusual.

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

But you'll have to do two studies--on the adjuvanted and the non-adjuvanted.

[Elwyn Griffiths]

That's right. Everybody is pooling their data from all the different countries, and that has never happened before on the regulatory side. It has always been confidentiality and this sort of thing. So we are all sharing. So you can imagine that from a safety point of view you have a much larger database than from the Canadian population.

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

My concern is that in the groups we've been advising to be careful, would somebody who is worried about fish oil not take it now, as they know it's in there? Would they be entitled to get the non-adjuvanted vaccine?

[Elwyn Griffiths]

Dr. Butler-Jones should answer that one.

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

We'll get him back on Wednesday.

I guess, Dr. Griffiths, because you're the regulator you probably can't answer the question on vaccine injury compensation. Maybe Mr. Lucas or Rob could. I know Quebec had a vaccine injury compensation package, as does the U.S. A lot of people feel that if the compensation package is still with regular tort law and the burden of proof is on the victim, they have to go to court and do all of that, and it just isn't as effective as what I think Ms. Fletcher was describing as a no-fault approach.

Is there a reason why the government didn't go straight to no-fault and has done this middle ground that worries people even more?

[Paul Lucas]

I can't speak on behalf of the government on that one, sorry.

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

It sounds as if other countries have no-fault as opposed to this business where you'd have to sue the government, and who on earth is going to have pockets deep enough to do that?

[Rob Van Exan]

A number of countries have no-fault insurance. My understanding is that they're all a bit different and a lot of different things need to be considered in developing that. Quebec has had a policy for some years and there was some discussion, and I believe some research was started on no-fault insurance this year through CIHR. The challenge is that it's such a complex issue it's not something you can just pull together in the middle of a pandemic.

The other concern, having talked with some of the experts in the field, is that rolling it out in the middle of a pandemic is a way to create more confusion and concern than is already there.

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

Dr. Griffiths, I just want one question about patients with AIDS--

[The Chair, Conservative, Joy Smith]

Ms. Davidson, you are next.