Front Burner - A vaccine's approved. What's in the shot?

Episode Date: December 10, 2020

Health Canada has approved the Pfizer-BioNTech after scientists wrapped up a two-month review of the company's clinical trial data. The approval is a crucial step in what will be the largest vaccination campaign in Canadian history. Today, host Jayme Poisson goes through what we know about the vaccine with Dr. Maria Sundaram, an infectious disease epidemiologist based in Toronto.

In the Dragon's Den, a simple pitch can lead to a life-changing connection. Watch new episodes of Dragon's Den free on CBC Gem. Brought to you in part by National Angel Capital Organization, empowering Canada's entrepreneurs through angel investment and industry connections. This is a CBC Podcast. Hello, I'm Jamie Poisson. This is a critical milestone in our fight against COVID-19 and in our efforts to provide every Canadian with access to a vaccine. Canadians can have confidence in our rigorous review process and that the vaccine was authorized only after a thorough assessment

of the evidence demonstrated that it met Health Canada's strict standards for safety, efficacy, and quality. So that was Dr. Supriya Sharma, Chief Medical Advisor at Health Canada, announcing that Pfizer-BioNTech's vaccine is now approved for use here in Canada. It was created on a record timeline to fight COVID-19 and it is so hard to believe that in the same year that we were introduced to the virus that an incredibly effective vaccine would also be made and approved to fight it. The approval on Wednesday is a crucial step in what will be the largest vaccination campaign in Canadian history. Today what we know about the approval of the Pfizer-BioNTech vaccine

and how safe it is. This is Fromperner. Dr. Maria Sundaram is with me. She's an infectious disease epidemiologist who studies vaccines. Hi, Maria. Thank you so much for being here. Hey. So what's happened with this vaccine is completely unprecedented, right? Like in one year, we have a pandemic, and then now we have a vaccine for it that is 95% effective. And as someone who does this for a living, who studies vaccines, what is going through your head right now? I'm so curious. It's just amazing to be able to see in the space of a year, the discovery of a completely new

pathogen and then a vaccine to protect against it that's 95% effective. That is absolutely crazy to me and so incredible. And today, I want to take a part with you in the most accessible way that we possibly can here, what we know about this vaccine. And the FDA has released a bunch of information. They did that on Tuesday. That goes through the contents of the vaccine, details about the clinical trials. And Health Canada has also released a lot of additional information. They did that on Wednesday. And I know that you've looked at all of this. And

what's your overall impression of the quality of the data that we have right now? It's really good quality. And I'm really happy to be able to see this level of detail in the report. And I know that there will be more information coming out. I'm sure the phase three trial results will eventually be published in a peer-reviewed journal. I really look forward to reading that as well. But information even about the protocol and exactly how the study was done is also available. So it's really great to have all of this information at our fingertips. And can you give me an example of, you know, maybe something that you're looking at that you're thinking, like, this is great, this really buoys you? Yeah. So one example is that I think a natural question that a lot of people are asking is, is this vaccine safe? And one of the things that this data supports is really very much that this vaccine has a really great safety profile. And I can know that by looking at the report to the FDA and the information from Health Canada that shows exactly the number of safety outcomes, exactly the percentages of people in

each group, the treatment arm and the control or placebo arm that experienced everything from kind of, you know, like an unpleasant, like allergic reaction all the way down to like feeling slightly tired. So there's an incredible amount of detail in that safety information. I think that's really great. Right. And I want to get to the side effects that you just mentioned in a few minutes. But first, you know, the clinical trials that you're talking about here, like, is it, these are good clinical trials to you? Do you feel like they have enough people in them? We're talking about 44,000 people in the Pfizer-BioNTech one. that we're getting the right outcomes, that we're asking the right questions. And even before any of this starts, a group of statisticians, doctors, and scientists like me, epidemiologists, sit down in a room at a table and they say, okay, so here's the number of cases we

want to find. Here's the percentage that we need to say, um, is effective. Um, here's what we're going to shoot for. And if we don't get what we're shooting for, then we have to stop. Um, and they, they save those things. They write down those rules even before they start the trial. So there's no moving of goalposts during the trial. There's no kind of reassessment. There's no changing your mind during the trial about what's important kind of reassessment. There's no changing your mind during the trial

about what's important and what you're looking for. An analysis of about 36,000 participants in this trial who are randomized 50-50 to get the vaccine or a placebo. We saw eight cases of COVID-19 in the vaccine group and then 162 in the placebo group. And so that's another really helpful piece of information for us to say, okay, this is an effective vaccine. I know that it usually takes 10 to 15 years to develop a vaccine, but this vaccine obviously has taken less than a year. And should people be worried about how quickly this all happened? I think it is a totally understandable question to say, you know, what the heck? There's other diseases out there like HIV and malaria that we've been trying to get a vaccine out for a really long time.

How is it possible that we have a vaccine for COVID in under a year? And I think there's a lot of different things at play here. So I'll just run through a couple of them. that, I want to sort of re-emphasize that all of the steps that, if this had taken 10 or 15 years, all of the steps that would have gone into that are exactly the same steps that we did do on this way shorter time scale. So the phase one and the phase two and the phase three trials are all happening. All of the rules about patient safety, all of the rules about ethical treatment of the participants, all of those are still in place. So absolutely no corners have been cut. It just happened way faster.

And the reason it happened way faster is because of a couple of different things. And tell me about those things. One really important reason why this happened so fast was that there was an incredible amount of political will and monetary support to get this going as quickly as possible. Normally, when vaccine companies try to develop a vaccine, that represents a really big financial risk for them because they could invest millions of dollars and then find out in a phase two study that the vaccine either doesn't have the safety profile that they want or isn't as effective as would be helpful. And so they have to abandon then that project. And that represents a huge loss for them. In this case, in the case of this global pandemic, we all kind of as a society agreed that we really need a vaccine and we're prepared to invest a lot in the development of that vaccine. And that really helps clinical trial development and enrollment happen way faster. And then I will say also, this isn't the first coronavirus that we have seen that can cause severe disease. Those disease epidemics kind of encouraged us to find a vaccine for coronaviruses in general. encouraged us to find a vaccine for coronaviruses in general. And so we already had a little bit of an idea of where to start, and we had the support as well. And that enabled us to really hit the ground running with regard to vaccine development. Right. Is it fair for me to say, too, that in

addition to what you just mentioned, you know, the political will, money, people coming forward, and then, you know, also the sort of dry run that we had with other coronaviruses, this data was also coming forward on like a rolling basis, which isn't typical, right? Right, right. So because this is a really special, unique time, we're looking at this data kind of as quickly as we can. In a lot of cases, the regulatory considerations, which might have been tied up in red tape for other things, those are being really emphasized and they're trying to take those red tape things down and get out of the way so that this can be approved on the timeline that we need it. And the one thing that I forgot to mention that I really

do want to make sure that I emphasize is that none of this would be possible without the 44,000 participants in the Pfizer trial and many more in other vaccine trials who agreed to be participants. They are absolutely heroes and we owe them a debt of gratitude. Without their participation, this would have taken a lot longer. I want to talk a bit more about the process that health regulators like the FDA in the States or Health Canada here go through when they're evaluating the vaccine. The data that they're looking at, is it peer reviewed? So the data, some of it has been peer reviewed, but that's kind of also on a rolling basis, right? Some of this information that's already available to the researchers and to the sponsors of the trial, Pfizer, Moderna, et cetera, has not been published in a peer-reviewed journal yet.

But the information is very, very carefully recorded and is constantly monitored by this sort of external committee called the Data Safety and Monitoring Board, or DSMB. So that's the information that's being provided to FDA. Some of it has been published already, and some of it will be published very soon, I'm sure. And is that normal for like any other vaccine that they would approve? It's really hard to say what exactly is normal. You know, sometimes there's enough time between the end of a phase three study and FDA licensure to publish information in a peer-reviewed journal. FDA doesn't need to see that peer-reviewed journal article. What they really need to see is the cold hard numbers, and that's what they're getting from Pfizer and Moderna and others.

Let's move to the vaccine itself and what's in it. One element of it is this mRNA, messenger RNA technology. It essentially gives your body instructions to mount a defense against the virus. My understanding is this is new technology in the vaccine world, but I do know that messenger RNA is not new itself. It's been around for a long time. And are there any concerns about the fact that we have no long-term studies about its use in vaccines? So I think you bring up a really important point about new vaccine modalities like this mRNA vaccine. And certainly what's going to be happening, even after these vaccines are licensed, even after you and I have had them, we're going to continue to look at these safety outcomes and we're going to continue to search really hard

for super, super rare safety events that we really want to know about. But that being said, something like 38,000 people have already gotten this vaccine and they've been okay for two months, which is kind of the time frame in which we would expect most of our safety outcomes to occur, because that's the kind of time frame in which your immune system is really responding maximally. Something kind of important about mRNA is that it's, as you said, it's a set of instructions that kind of degrades over time. So it's kind of like a book that you read, you know, like the first maybe like,

you know, a couple of times you read it, it's really fresh and then it starts to get a little dog-eared and then eventually it degrades and it can't be read anymore. And that's part of the consideration for developing this vaccine. The investigators of these clinical trials have done a very careful job

of identifying exactly how much our mRNA and exactly how long they want it to last for us to mount a good immune response, but not have any long-term outcomes. Oh, that's interesting. Does it just kind of like disintegrate from your body or leave your body? Yeah, it disintegrates. Yeah. picking up on that i want to talk to you about uh the ingredients essentially being injected into my arm um and i see that health canada released the ingredients today i can't pronounce some of them but maybe first let's let's spend a little bit of time talking a little bit more about mRNA, which they say is the quote, medicinal ingredient in the vial. And what is mRNA made of? Like what material is it made of? So mRNA is a biological thing. It's not plastic or anything. It's made out of a nitrogen containing biological compounds. And we have some very similar compounds in our own genetic material.

In this case, this mRNA that's in the vaccine is grown in a lab. So it's not from an animal. It's not from another human being. But it has the same kind of nitrogen containing biological compounds that you and I both already have. Okay. And what about the other ingredients in the vial? You know, I'm looking at the list here, cholesterol, dibasic sodium phosphate, dehydrate, potassium chlorified sucrose water. What do you make of those ingredients? Are they fairly standard? Do any of them give you any pause?

None of these give me any pause. They are fairly standard. And I will say one of the ways that we protect the mRNA from degrading before it gets to our immune system is that this vaccine is kind of encasing it in some lipids, some fats. And so that's part of what's in this vaccine that's not an antigen, not the kind of active ingredient, is just kind of this little shell of fats that protects the mRNA until our immune systems can interact with it. And then a lot of these other things are kind of allowing that fat-covered particle to exist in a suspension of water. So you can think about, you know, maybe when you make salad dressing, how it separates because there's oil and there's water. So you can think about, you know, maybe when you make salad dressing, how it separates because there's oil and there's water. So there are some compounds called surfactants that allow those two things to mix. So there's some of those things in here as well.

That was a super helpful explanation. Thank you so much for that. I'm really glad. So let's talk about side effects now. Health Canada says very common side effects, which may affect more than one in 10 people, include things like pain at the site of injection, tiredness, headache, muscle pain, chills, fever, joint pain. But is it fair for me to say that's pretty normal stuff, right? It seems like flu shot stuff, more or less. Yeah, it's pretty normal stuff. I will say, you know, because a vaccine is enabling our immune systems to respond, you know, we're going to feel the effects a little

bit of our immune system responding. I don't think that I've ever had a shot that didn't hurt a little bit. And that's what most of the people in the trial also experienced. You know, sometimes after I get my flu shot every year, I feel a little tired. I maybe have a headache towards the end of the day. And by the next day, I'm feeling better. I think that was about 50 to 60% of the people in the trial. And then, you know, these slightly more uncomfortable ones, you know, some muscle pain, some chills, that's less common, maybe 30 to 40% of people. And it does seem like if people are experiencing it, it's a little bit more likely after the second dose. Okay. You know,

there are some less common side effects. Up to one in 100 people could experience enlarged lymph nodes, Health Canada says. And there were also four cases of Bell's palsy among trial volunteers, which is essentially like a facial muscle paralysis. But can you put those numbers into perspective for me? Yes, definitely. So with the Bell's palsy, and folks who are listening, if you've been pregnant, you may have experienced Bell's palsy. It's kind of this facial weakness that comes back after a while. Your face, you know, does go back to normal, but it kind of can take a while. And sometimes it's a little bit of a hassle. And I should say, I have actually had Bell's palsy. Oh, wow. My face is totally fine now.

Oh, great. I'm really happy to hear that. Yeah, a few of my friends have also had Bell's palsy. And I think their experience has largely been, well, it was a hassle, but it was otherwise completely fine. Yes, not fun, but totally fine. So yeah, but this is really important for us to be looking at. And so the Pfizer vaccine results did report that four people in the vaccine group and no people in the control group had this experience of Bell's palsy. But this is not more than we would normally expect in the general population. So on any given day, out of a group of, let's say, 40,000 people, we could expect four people just, you know, on average to have Bell's palsy. So that's why they didn't report it to be a potential vaccine side effect, but they did make sure to note, hey, we did see this and let's keep an eye out for it in the future.

And that will be really helpful for us to look for when we're doing this like really super lightning fast safety ascertainment. And what about the enlarged lymph nodes? Right. So anyone who has had a childhood like mine and has had strep throat like 15 times knows that enlarged lymph

nodes are not super comfortable. It's unfortunate and it's not comfortable, but it's also a sign that your immune system is working really well. So if you have those enlarged lymph nodes, that's where your T cells live. Those T cells are cells that remember different pathogens. And so your body is developing that memory to protect you later. It's a sign that the vaccine is working, even though it's not very comfortable. In the Dragon's Den, a simple pitch can lead to a life-changing connection. Watch new episodes of Dragon's Den free on CBC Gem. Brought to you in part by National Angel Capital Organization.

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That's because money is confusing. In my new book and podcast, Money for Couples, I help you and your partner create a financial vision together. To listen to this podcast, just search for Money for Couples. You know, I know you mentioned before that you weren't necessarily concerned about a lack of like long-term studies on the effects. And, you know, in part because the mRNA sort of degrades over time. But I do want to ask you, the UK is already vaccinating people and it was announced that two people

had experienced allergic reactions after receiving the vaccine. This is something that wasn't picked up in the clinical trials. And so now health authorities there say people with significant history of allergic reactions shouldn't take this vaccine. And Health Canada is saying, look, if you're allergic to one of the ingredients in the vial, you shouldn't take the vaccine. And what do you make of the fact

that that didn't initially come up in the clinical trials of this vaccine? And does that give you any concern or pause? That's a great question to be asking. So just to give everyone a little bit of background. So this is that allergic reaction, which is kind of similar to the reaction you might have if you're super allergic to nuts, you have like a swollen face or trouble breathing. That is the kind of reaction that we're talking about, not necessarily just like a mild kind of like, oh, I'm feeling like a little bit of hay fever. So in the Pfizer vaccine data, we saw that there were some people in the placebo group and some people in the treatment group that had this, a very, very small number in both groups. And they weren't different

between the groups. And that's why we said, okay, you know, we think this is equally safe for both of these groups. But that being said, it is really important to remember that vaccines are something that we're giving to our immune system. And we need to make sure that our immune system responds correctly. And that's why we're saying, you know, if you are allergic to some of these things in the vaccine, we want you to hold off for now. So with regard to the allergy cases in the UK, I think this is, again, another really good sign of like super lightning fast safety information reporting. So we want to make sure that this vaccine is safe for everyone that we're extending it to.

And if there's any even remote possibility that it might not be safe for people who have had this kind of severe allergic reaction, for example, people who generally carry EpiPens on them, then we want to make sure that we know as soon as possible. Do you think it's possible that another very serious side effect like these allergic reactions or something even more serious could develop with this vaccine? I certainly never want to say it's impossible. What I can say is that, you know, we've done everything we possibly can to eliminate that possibility. And we're going to continue to identify super rare one in a million type of safety events, just in case that is the case.

type of safety events, just in case that is the case. And as we're seeing with the UK, we'll be able to respond to those as quickly as possible. So that's, I think that's the best we can do without having a crystal ball. And on that note, you know, obviously, people need to feel like they can trust this vaccine. And, you know, I imagine that answering straightforward questions like you just have here will go a long way in helping people understand this vaccine and trust it. But do you think that's enough to get a wide uptake for it, the kind of uptake we need to reach herd immunity here? That's a really tough one. You know, obviously, the more people that get vaccinated, the better off we will all be. Obviously, the more people that get vaccinated, the better off we will all be.

And of course, me as a vaccine epidemiologist, I would love if everyone would get vaccinated. And functionally, I know that some people just won't get vaccinated. So we want the highest number of people possible. And I think that in order to get that high number, we have to do everything that we can to address people's fears and concerns and to explain, yeah, like I get why you have this question. That makes perfect sense to me. Let me tell you about the reason that I'm confident that this vaccine is safe and effective. You and I both want you to be happy and healthy and safe. And I've done a lot of work to make sure that that can happen.

All right. Maria, thank you so much for this conversation. It was very helpful. Oh, I'm so glad to hear that. and healthy and safe. And I've done a lot of work to make sure that that can happen. All right. Maria, thank you so much for this conversation. It was very helpful. Oh, I'm so glad to hear that. Thanks very much. All right. So a little more information on the vaccine rollout before we say goodbye today. Pfizer indicated that it would be prepared to ship by Friday. So assuming Friday, we could see vaccines arrive Monday, probably Tuesday. Well, we'll know more as we move forward in the next 36 hours. We just don't have that fidelity just yet. forward in the next 36 hours. We just don't have that fidelity just yet. But now that Pfizer knows that the vaccine is approved, they can actually push a button on moving forward on that plan.

That's Major General Danny Fortan, the military commander in charge of logistics to get the vaccine out to Canadians. The long-term plan is to have a COVID-19 vaccine available for all Canadians who want it by the end of September 2021. That rollout begins with 30,000 doses of the Pfizer BioNTech vaccine that Fortin says will be shipped from a Belgian Pfizer plant on Friday and could possibly be available to select Canadians by the middle of the week. Things are happening quickly. By the time the initial doses of the first vaccine doses are delivered, we will have completed the first step toward making COVID-19 vaccines available to every Canadian from whom it has been authorized and recommended. Canada's Deputy Chief Public Health Officer, Dr. Howard New, is projecting that by the end of the

year, 249,000 doses of the Pfizer-BioNTech vaccine will be in Canada and ready to be delivered to long-term care residents and staff. After that, about 6 million doses are scheduled to arrive in the first three months of 2021 and deliver to vulnerable populations. Of course, the Pfizer-BioNTech vaccine takes two doses, so that's enough for 3 million people. the Pfizer-BioNTech vaccine takes two doses, so that's enough for 3 million people. Dr. New also said that millions of more doses are expected to be available following the approval of other vaccine candidates from Moderna and AstraZeneca. So what about everyone else? Well, this is very much a moving target.

Dates could be pushed back or moved up, but the Public Health Agency of Canada says that right now their target is to start offering immunization to non-priority groups in April. We're still waiting to learn more about when it can be available to other groups like pregnant women, breastfeeding women, and children under 16. These groups were not part of the Pfizer-BioNTech clinical trials, but this is something that we are following closely and we're going to keep you posted on. But that is all for today. I'm Jamie Poisson, and thank you so much for listening to FrontBurner. We'll talk to you tomorrow. For more CBC Podcasts, go to cbc.ca slash podcasts.