Evidence of meeting #20 for Health in the 43rd Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was nrc.
A recording is available from Parliament.
12:30 p.m.
Conservative
Michelle Rempel Conservative Calgary Nose Hill, AB
Thanks very much.
With the time I have remaining, I will go to Dr. Bernstein.
When you were on the vaccination task force—I know you sit on there now—did you recommend that the government enter into the CanSino agreement?
12:30 p.m.
President and Chief Executive Officer, CIFAR
The CanSino collaboration between the NRC and CanSino actually started before the vaccine task force was formed. When they came in front us it was partly an FYI but partly for us to comment on the science behind—
12:30 p.m.
President and Chief Executive Officer, CIFAR
There were two things. There was good news and bad news.
The good news was that at that point, CanSino was actually way out in front of any vaccine developer in terms of having a vaccine for human use for COVID-19.
12:30 p.m.
President and Chief Executive Officer, CIFAR
The bad news was with the science in it. I can go as deep into it as you would like. Because it was an adenoviral vector, and we all have antibodies to the adenovirus type-5 vector that was used in the CanSino vaccine, there was a worry that there would be antibodies to the vector itself, the vaccine itself, that we would naturally have already been making. There was a question of how effective that vaccine would be. We provided that information back to them.
When we saw the data later on in the summer, we then recommended that the collaboration end.
12:30 p.m.
Liberal
The Chair Liberal Ron McKinnon
Thank you, Ms. Rempel Garner.
We go now to Ms. Sidhu.
Ms. Sidhu, please go ahead for six minutes.
12:30 p.m.
Liberal
Sonia Sidhu Liberal Brampton South, ON
Thank you, Mr. Chair.
Thank you to all the doctors for your insight.
Dr. Sharma, very briefly, can you take us through the process that goes into giving a new vaccine full authorization in Canada so it is safe for all Canadians? Please give us a very short answer.
12:30 p.m.
Chief Medical Advisor, Department of Health
Mr. Chair, there's a review process that involves review teams with a lot of experience. Each review team has about seven to 10 people on it, in a variety of different scientific domains. They look at the preclinical, or the lab and animal data, they look at the clinical trial information, and they have detailed examination of the manufacturing data in separate groups and in areas of expertise, and then all of that comes back together to see if that vaccine will meet the appropriate standards for safety, efficacy and quality, as well as whether the benefits of that vaccine outweigh the potential risk.
In addition to that, there's a group that looks at what we call the “risk management plan”, that's the plan for post-market monitoring of the vaccine. We have teams in Health Canada that also look at all of the assessments of the facilities the vaccines will be manufactured in to make sure that they adhere to good manufacturing practices and standards.
Once all of that comes together, there are [Technical difficulty—Editor] that look at the labelling, the post-market commitments, the terms and conditions on the vaccine and the plans for monitoring, and all of that goes into the authorization. All of that [Technical difficulty—Editor] in the Canadian product monograph, a summary of our review, and all the information that we based the review on then goes up on the website so that it is accessible to all Canadians.
12:30 p.m.
Liberal
Sonia Sidhu Liberal Brampton South, ON
Thank you.
Dr. Sharma, the federal government provided almost 23 million rapid tests to support provincial and territorial partners. There are millions currently collecting dust at provincial facilities. What do you think should be improved to make sure these procured tests are used by our provinces and territories?
12:35 p.m.
Chief Medical Advisor, Department of Health
Certainly, from the regulatory standpoint, we've done expedited reviews to make sure that, whether it's a point-of-care test, an immunology test or a lab-based test, those are reviewed and authorized if they meet the Health Canada standards.
The Government of Canada, as you noted, has gone through a lot of procurement of rapid tests and has deployed those on the basis of need in the provinces and territories. In terms of the deployment, it is really up to the provincial and territorial level to see where those rapid tests and, indeed, other rapid tests that they may have procured, fit into their overall testing and contact tracing programs. Certainly, it's an essential part of the track and trace for cases of COVID-19 and helps a lot in terms of the response to the pandemic.
12:35 p.m.
Liberal
Sonia Sidhu Liberal Brampton South, ON
Thank you.
A few days ago, Dr. Tam said we can be very optimistic about the performance of the vaccines so far based on the data collected. There's growing evidence that one dose provides a fairly high level of protection. Can you tell us about how the first phase of our vaccination provides effectiveness?
Very briefly, please.
12:35 p.m.
Chief Medical Advisor, Department of Health
The two vaccines that are authorized so far in Canada, the Pfizer-BioNTech and Moderna vaccines, are both two-dose vaccines. The reason that they're two-dose vaccines is really based on all of the developmental tests that have gone into the development of those vaccines, from animal studies and through lab studies to the clinical trials. The concern with only using one dose is that potentially that immunity could wane after a period of time. That's why one of the terms and conditions on both of those vaccine manufacturers is to continue to monitor the people in the clinical trial for up to two years.
The research that was done both in British Columbia and in Quebec is very important; we absolutely need research in the real-world application of the vaccination program. It was reassuring on two points, one is that we didn't have clinical trial information for people in the older age groups who were in long-term care facilities, so were potentially more frail. The concern in those groups is that potentially you could see less efficacy. One reassuring thing that this data has shown is that we are seeing a good response in those groups.
The vaccine effectiveness of the one dose was calculated using something called “crude vaccine effectiveness”; it's not comparing people who got the vaccine and who didn't get the vaccine, it's really looking at time frames within the groups who got the vaccine. It is useful, but it is limited. Right now, it's good information. I think the authors themselves noted that before they would recommend that we only have one dose more research needs to be done, but it is reassuring that if there is a delay for that second dose, it likely does not have a significant effect. The companies would have to come in if they wanted to change their vaccine to a one-dose vaccine with evidence to Health Canada. We would review that, and if it was suitable, we would change the labels.
12:35 p.m.
Liberal
12:35 p.m.
Liberal
Sonia Sidhu Liberal Brampton South, ON
Dr. Bernstein, there are few groups that were not part of vaccine trials, such as teens or pregnant women. Can you provide insight on any research that has been done to make sure these vulnerable groups are protected?
12:35 p.m.
President and Chief Executive Officer, CIFAR
Typically in vaccine trials, teens and pregnant women are not included in the first instance because they represent a high-risk group. There's a concern that they not be exposed to a vaccine until it's been tested to be safe and effective by the regulator. However, as we speak, there are now trials going on with younger-aged volunteers in those trials to see whether the vaccines are safe, as well as being effective in younger children.
I think the same will be true for pregnant women shortly. Both the WHO and that U.S. FDA have issued guidelines around that, which are somewhat contradictory. On balance, I think the view is that it's probably safe and effective for pregnant women to take the vaccine, especially because there is good evidence that being affected with the virus when you're pregnant makes you particularly susceptible to a serious disease outcome.
Again, the trial has not yet been done.
12:40 p.m.
Bloc
Luc Thériault Bloc Montcalm, QC
Thank you, Mr. Chair.
Dr. Sharma, because AstraZeneca cannot deliver its vaccine before April, some believe that approval is lagging behind, while the vaccine is being administered elsewhere. Is approval dragging on for scientific or political reasons? If so, what is missing?
12:40 p.m.
Chief Medical Advisor, Department of Health
The review of the AstraZeneca submission is ongoing. We have gone through the bulk of the scientific information. This submission was a bit more complicated than the ones we've seen with Pfizer and BioNTech because of the way the data was collected.
We also note that different regulators are taking different approaches to how the AstraZeneca vaccine should be used. Currently, we're still going back and forth with the company with respect to some data. We just had some conversations with them today. It is in the final stages. That end process around the product monograph, the labelling, the indications, the risk management plan and the potential terms and conditions on the vaccine are still under discussion.
We know the European Medicines Agency has authorized the vaccine. The other largest regulatory authority, the U.S. FDA, is still waiting.
12:40 p.m.
Bloc
Luc Thériault Bloc Montcalm, QC
As I understand it, even if this was the only vaccine candidate available, it would still be a long way off and you would not have given your approval yet.
Some believe that the mRNA technology is more appropriate to react quickly to variants. What do you think?
12:40 p.m.
Chief Medical Advisor, Department of Health
So far, the data we've seen for both Pfizer and Moderna have shown that their vaccines are quite effective against the 1.1.7 variant, which is the U.K. variant. In laboratory studies, both of those mRNA vaccines have shown some decreased activity against the 501 variant, which is the South Africa variant.
Because it was starting with such a high level of efficacy, it was still at levels that were protected. Both those mRNA vaccines, at this point in time, are deemed to still be protective against the variants we know of so far.
12:40 p.m.
Bloc
Luc Thériault Bloc Montcalm, QC
The issue is not whether vaccines are good, although it is relevant to know that. Rather, the question is about technology. The mRNA technology is more appropriate because it would allow modifications to be added to the vaccines to respond to variants later. Indeed, there are going to be mutations.
What do you think? If you don't wish to share an opinion, that's okay.
12:40 p.m.
Chief Medical Advisor, Department of Health
Absolutely. Of all of the vaccine platforms, the thought is the mRNA technology would be the quickest to redesign in terms of changing the vaccine to respond to variants.
The viral vector vaccines can also be changed quite rapidly, but you're right that the mRNA vaccines would likely be the ones that would be the quickest to change.
12:40 p.m.
Bloc
Luc Thériault Bloc Montcalm, QC
Dr. Bernstein, you stated that the idea of a mixed vaccine regimen, that is, a first dose of an mRNA vaccine followed by a second dose of an adenovirus vaccine, was scientifically sound and worth further study.
What do you think are the advantages, disadvantages and risks of such a combination? Do we have any evidence on this—