Health Committee on March 11th, 2021

[Luc Thériault, Bloc, Montcalm, QC]

I understand that—

[Dr. Marc Berthiaume]

—thromboembolic events that will be—

[Luc Thériault, Bloc, Montcalm, QC]

I understand that, Mr. Berthiaume. I don't have much time.

However, in terms of the precautionary principle, just because we can administer the vaccine safely here doesn't mean that we can't wait for developments related to an issue elsewhere. What's the rush?

Put yourself in the shoes of a 70-year-old person who sees all this in the news and who is told no, there's no consent to sign for the vaccine, you just take what you're given.

Don't you think that the public health message could create uncertainty among people who feel safe?

Are you taking this into account?

What does this take away from the vaccination process, when we wait for clarification on the adverse effects of the vaccine, which are quite significant?

[Dr. Marc Berthiaume]

The thromboembolic events in Europe that you're referring to are being reviewed.

Health Canada is in direct contact with the European agencies. If a safety issue were to come up in relation to this matter, Health Canada would take the necessary steps with respect to the vaccination—

[Luc Thériault, Bloc, Montcalm, QC]

What do you know about it right now?

You can't say anything definitive about this matter.

[The Chair, Liberal, Ron McKinnon]

Thank you, Mr. Thériault.

[Luc Thériault, Bloc, Montcalm, QC]

Since you can't say anything definitive about this matter, you should temporarily withdraw the vaccine as a precaution.

[The Chair, Liberal, Ron McKinnon]

Thank you, Mr. Thériault.

We'll now go to Mr. Davies.

Mr. Davies, please go ahead for six minutes.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you, Mr. Chair.

Dr. Quach-Thanh, on March 1, about 10 days ago, NACI said this about the Oxford-AstraZeneca vaccine: “NACI does not recommend the use of this vaccine in individuals 65 years of age and older due to limited information on the efficacy of this vaccine in this age group at this time.”

Do you stand by this statement?

[Dr. Caroline Quach-Thanh]

You are asking if I still stand by the statement we issued on March 1. As we said, we are reviewing the data. We met yesterday—

[Don Davies, NDP, Vancouver Kingsway, BC]

I'm not asking if you're reviewing the data. I'm asking if you stand by that statement.

[Dr. Caroline Quach-Thanh]

As of now, yes, because we're reviewing it at this point in time.

[Don Davies, NDP, Vancouver Kingsway, BC]

Thank you.

Ms. Elmslie, you talked about changing over time. The reason we're having this meeting tonight is that there is a simultaneous contradiction in advice, because at about the same time there was Health Canada's summary of the rationale for its February 26 authorization. Just days before NACI said what it said, Health Canada said this: “Efficacy in individuals 65 years of age and older is supported by immunogenicity data, emerging real world evidence and post-market experience in regions where the vaccine has been deployed, which suggest at this point in time a potential benefit and no safety concerns.”

How do you square that? We have NACI telling us there's insufficient evidence of efficacy, and Health Canada, at the very same time, is telling Canadians that efficacy is supported by data. Help me understand that contradiction and whom Canadians should believe.

[Kimberly Elmslie]

What I would say to that is that data are being looked at by NACI and its experts and by Health Canada and their experts. From the point of view of the regulatory approach, Dr. Berthiaume can speak very well to that in the context of making decisions on the safety, efficacy and quality of vaccines to be authorized for use in Canada. NACI is going to look at this from the perspective of the use of the vaccine, the optimal use of the vaccine in Canada.

[Don Davies, NDP, Vancouver Kingsway, BC]

No, that's not the case. I read a direct quote where both groups were speaking about efficacy. One was not talking about use and the other about efficacy; both were talking about efficacy. NACI said there's no sufficient evidence; Health Canada said there is.

I'm going to move toward what Dr. Nathalie Grandvaux, professor in biochemistry and molecular medicine, told this committee this week. She said:

PHAC authorizes vaccines based on the clinical trial data, and the NACI subsequently adjusts the recommendations for their use based on real-life data as it becomes available.

It goes without saying that the different messages emitted by these two organizations lately induce a major confusion that is incomprehensible for the majority of the population. This is without taking into account the additional confusion induced by the different opinions of the provincial advisory committees.

...It is important to understand that inconsistent messages will likely lead to a loss of confidence in the population in the vaccination campaign and one cannot risk losing the adhesion of the population to immunization with the safe and effective vaccines that we have.

Is she wrong, Ms. Elmslie?

[Kimberly Elmslie]

I would say she's not wrong. I think it is important that we always strive for clarity and consistency in messaging. That is our objective, for sure.

In this situation, as science is evolving, it is just sometimes not possible to be there at exactly the same time, and we need to accept that. Canadians need to understand, and I think they do understand, that science is evolving very rapidly, at a very fast pace, and experts at NACI and experts at Health Canada are very seized with looking at this on an ongoing basis and making their best recommendations for the benefit of all Canadians.

[Don Davies, NDP, Vancouver Kingsway, BC]

Let's turn to real-time evidence, then.

Dr. Berthiaume, today Denmark, Norway and Iceland announced that they will temporarily suspend the use of the Oxford-AstraZeneca vaccine as a precaution after “reports of severe cases of blood clots” in people who have been vaccinated with the COVID-19 vaccine from AstraZeneca. This follows a similar move by Austria at the start of this week, where authorities are investigating the death of one person and the illness of another after they received doses.

Is Health Canada currently investigating these reports of potential adverse effects? In your view, should Health Canada temporarily suspend use of the Oxford-AstraZeneca vaccine as a precaution while these reports are investigated? If not, why not?

[Dr. Marc Berthiaume]

Thank you for your question.

As very well explained by Dr. Quach, the clinical trial data is very robust. When you look at the data that was generated for the AstraZeneca vaccine, you see that 24,000 people were in the clinical trials, and the level of severe adverse events that were identified was no different between the vaccine and the people who got the control, so we have strong data to support the fact that there is no safety concern with the vaccine itself.

There have been reports in Europe of thromboembolic events, and they're investigating them. What will have to be determined by the regulatory authorities is whether or not there's a causal relationship between those situations and the vaccine.

[Don Davies, NDP, Vancouver Kingsway, BC]

I know what happened. It's not that they're investigating; they've suspended it. I just named you four countries that have suspended the use of that vaccine. It's not just investigation.

I want to move to something else. Last week—

[The Chair, Liberal, Ron McKinnon]

Mr. Davies, thank you.

[Don Davies, NDP, Vancouver Kingsway, BC]

I have to say, Mr. Chair, you gave the Liberals an extra two full minutes, and you also gave the Bloc an extra full minute. I was timing and I know that's the case. I would like to get one more question in, in fairness.

[The Chair, Liberal, Ron McKinnon]

I don't think it's correct that I gave the Liberals two minutes. Certainly, sometimes it happens that answers go over the time and I try not to cut people off, but you'll have another opportunity in the next round.

That ends round one. We'll go to round two, starting with Mr. Barlow for five minutes, please.

[John Barlow, Conservative, Foothills, AB]

Thank you very much, Mr. Chair.

I will continue on with Mr. Davies' questions. Do we know, either Dr. Berthiaume or Dr. Quach, if we have any of the same batch of the AstraZeneca vaccine that has caused the problems in Europe and Scandinavia with the blood clots? Do we know if we have any of that same batch in Canada?

[Dr. Marc Berthiaume]

Thank you for your question.

Yes, we know the answer to that, and the answer is no, we don't have the same batches here in Canada.

[John Barlow, Conservative, Foothills, AB]

The WHO and the FDA have set minimum standards of efficacy of the AstraZeneca vaccine of 50%. Do we have a similar standard that has been set by Health Canada or PHAC?