When will Canadian kids get vaccinated? And are oral Covid pills really a “game-changer”?

Jordan There haven’t been many times during this pandemic when Canadians have been jealous of our American neighbours. This past week, though? Oh, yes.

News Clip Associated Press reporting in the past few seconds that kids between the ages of five and eleven are now eligible to get Pfizer’s COVID shot. Just moments ago, the head of the CDC, Dr. Rochelle Walensky, approved the shot for emergency use, and that means millions of young children can get their first dose, right now.

Jordan The United States is now more than a week into their vaccination program for five to eleven year olds, while Canadian parents wait for Health Canada to approve the shot. How long will that take? Well, depending on when you ask Health Canada, the answer is either days or months. The month’s timeline was posted to Twitter last week and immediately sent Canadian parents into such fits of rage that Health Canada walked it back the next day. So sometime in the coming weeks, it appears these shots will indeed be approved for children five to eleven. What happens next? Is the country ready for a massive child immunization program? Where will these shots be given? What questions will parents have, and are our public officials ready to answer them with the kind of transparency that will reassure parents rather than creating more hesitancy? And for adults who are still being diagnosed with COVID-19 right now, are the recently announced oral treatments really a game changer?

Yes, once again, it’s time for a COVID-19 science FAQ.

I’m Jordan Heath-Rawlings, this is the Big Story. Sabina Vohra-Miller is a clinical pharmacologist, cofounder of the Vohra-Miller Foundation, and mostly she has spent almost two years now talking vaccines to people who are hesitant about them. Hi, Sabina.

Sabina Hi, Jordan. Thanks for having me.

Jordan You’re most welcome. And I realize that for this first question that you are not representing Health Canada, but why hasn’t the vaccine been approved for five to elevens in this country yet? I know a lot of parents are really ticked off. We’re now at least a couple of weeks behind the United States.

Sabina I know, I think a lot of people are really waiting on the edge of their seat for these paediatric approvals, but due diligence is exceptionally important. First of all, our submission was a week later, and we are expecting Health Canada authorization in the next two weeks. I think that it’s really important that every country does their own thorough due diligence and that we don’t rely on another country’s due diligence because there could be things that we catch that someone else has not caught. And I have full trust that Health Canada is doing a really thorough and really critical review because ultimately, Health Canada is responsible for the health of their citizens. And so it’s a little delayed, but it’s coming.

Jordan So I get that. And it’s fair enough. I want to ask you about the messaging around this, though, I’m imagining that you heard about this as well, because this is your business. I certainly heard about it from a few people. Last week there was a Health Canada tweet that said they would be doing their review in the coming months and people freaked out.

Sabina I remember that very distinctly. I think I got in the span of ten minutes, more than 100 frantic messages from people. I actually also retweeted that and said, ‘okay, health Canada, it’s time for you to correct this typo.’ And so it was the very next day corrected to coming weeks. But the issue here that we have in Canada is the lack of transparency. So in the US, we’ve had these really open deliberations. The dates are set well in advance. They’re open to the public to attend, to ask questions at. The process is known, so we know what to expect.

But in Canada, things are very tight lipped, and a lot of this happens behind closed doors. And so that ends up causing a lot of chaos when there’s a small mistweet that occurs. Honestly, I think that I’ve been doing this long enough to know that you in fact build public confidence when things are done transparently. So again, I have no doubt that Health Canada is working really hard around the clock to do that thorough, critical review, but it would be really nice to get insight into timelines and such so that parents know when to expect things, they know what’s going to happen, and they’re not caught off guard. People just want information.

Jordan Well, I’m going to ask you for that in the absence of transparency from Health Canada, and I think a lot of parents, I include myself in this, are anxiously awaiting these vaccines, also probably have a lot of questions about them now that it seems to be around the corner. So first of all, this review is for a paediatric dose of the Pfizer vaccine, right? Are there going to be other vaccines available for kids? Are they in that process or is this just the one we’re going with?

Sabina So at this time, I know that Pfizer has indeed submitted a data package to Health Canada to review for the paediatric five to eleven. We also do have data from Moderna in the six to eleven age range, so their age range is slightly different than Pfizers, theirs was for six through eleven. But I do not know whether they’ve actually submitted this to Health Canada yet or not. I know that in the US, the FDA has still not approved Moderna for 12 to 16. So they’re holding back on putting the application for the younger age range. So I don’t know if that’s going to impact us in Canada or not. But at this point, we’re looking at the approval for Pfizer, which is very imminent in the next week or two.

Jordan When it is available, and hopefully that’s the next couple of weeks, what’s your impression on how ready we are to get those shots into kids arms? I know the first rollout was kind of a mess because we’d never done it before in various provinces. This is a whole different beast. We’re talking about kids, different scenarios, different questions. Is there a plan?

Sabina Yeah. And I think that’s another thing that I wish that we had a lot more transparency on. I know that I’ve really tried to push for this information, especially given that we will be needing to use paediatric vials. You can’t use adult vials for these dosages because it’s a different dose for five to eleven. And I think that we finally have some clarity on it. So we know that Health Canada is working to pre-position these vials, i.e. they should be available for distribution within a week of approval, which I think is fantastic. Normally, this process takes several weeks to months, in fact.

What we need to be doing right now is actually planning an efficient and equitable rollout. And to me, that actually means having a rollout in school systems because we know that 99% of children have access to schools in Canada, and the way to actually ensure that we’re not having Hunger Games: Junior Edition is to have a rollout that occurs in schools. And that way, you know that children are not left behind. In parallel, we should also have things like vaccines at pharmacies and at family practices, so your family doctors, for those who need special accommodations or for those who might have specific fears with respect to getting vaccinated without their parents. So you do need a multi pronged approach, but I think the primary way this should be done should be through a school roll out.

Jordan I’m going to be thinking about Hunger Games: Junior Edition for a while. Let’s talk about school roll out, though. I have heard some questions from parents on this. On the one hand, I totally understand it’s the easiest way to get vaccines to every kid. On the other hand, does that mean that kids are going to be getting these needles at school without their parents? How does that impact parents who might be hesitant? I’m just going to say that my daughter is not quite five yet. If she was five, I’d want to be there with her while she gets her vaccine, while she gets her needle. She’s a little kid. I know a lot of parents feel the same way. How do you manage something like that in schools efficiently without it turning into a mess?

Sabina Yeah. And so definitely you need to have approval from the parents before you actually vaccinate their child in school. And we do that for other vaccinations as well. We have routine vaccinations that occur in schools for several other vaccines, and it would follow a similar process to that. I think that’s exactly why we need to have other modalities in place as well, so that if you want to be there for your child or your child wants you to be there with them, you can actually get it, say, at your family doctors clinic.

But I think that very often when we do think about vaccine rollout, we forget about those who just don’t have the same support systems that perhaps your child has, and my child has. And there are quite a few people who just simply don’t have that privilege. And I think for those children who may not have access to a family doctor who might have a parent who’s working three jobs and might not be able to take them elsewhere to get vaccinated, having that option in school, it would be just incredible. And that’s really why I advocate for having a multi pronged approach, to have it in schools, for those where it’s actually more accessible for them to get it. And if that doesn’t work for you, then have other options also available in parallel.

Jordan That makes sense. When this does happen, what do we expect the uptake to be? Do we have any numbers around that? Any idea? I imagine just because we’re talking about younger kids here, there will be a little more hesitancy.

Sabina Yeah, I was looking at recent numbers, and I don’t know how reflective they really are, but a solid 50% to 60% of parents, some surveys have said up to 70% of parents are really looking forward to getting their child vaccinated the second it’s approved. And then you, of course, have a fair amount of parents who are wanting to take that wait and see approach. So they themselves are vaccinated. They’re just a little apprehensive about it in children, and they just want some time to think about it, to look at how the roll out is going and then make that decision to get their child vaccinated or not. And then, of course, you have a small subset of parents who are simply not going to vaccinate their child. They themselves are not vaccinated, and they don’t plan to get their child vaccinated either. But I would say that over 50% of parents are at this time waiting for their child to get vaccinated the moment they’re eligible for it.

Jordan How do you talk to the wait and see parents to get them to move into that first cohort? When you hear from those parents, are you hearing different questions from them than you did from people who are adults who are hesitant to get the vaccine for themselves? I guess I’m trying to figure out if public opinion tilts when it comes to kids or if it’s the exact same stuff, and people are just nervous.

Sabina I mean, for the most part, the underlying reasons are similar, but at the same time, there’s just more apprehension about vaccinating children, and it’s understandable as parents, you’re responsible for someone else’s life. It’s a huge responsibility to carry and have, right? But the underlying apprehensions that I’m hearing from parents are very similar to what I heard from the early days in adults. Do we have enough long term data on it? Concerns on some side effects, such as myocarditis. And I think I often have to talk about how the risk of myocarditis is, in fact, higher with COVID infections, 6 to 16 times higher. And they tend to be more severe with infections versus vaccinations, where they tend to be much milder.

And then you have concerns about things like fertility that are 100% unfounded and based on just simply rumours. And then I also talked to a lot of parents who feel that COVID is not a big deal in children. And I think that fallacy has come to be here in Canada because we, at least in Ontario, have had our schools shut for the majority of the last year and a half. So we don’t have that same case load here in Canada. But if you look at what is happening with our neighbours in the US, for instance, just in the 5 to 11 age range, you have 1.8 million children who got COVID, of which there were more than 8000 hospitalizations, more than 5000 kids who had MIS-C and 10% to 20% of children who have even mild COVID go on to have long COVID symptoms.

And so when we talk about risks versus benefits, which is really the way I always look at anything related to vaccinations, we can see here that the benefits of the vaccine far outweigh these risks that may exist, say, with myocarditis, because the burden of illness in the paediatric population is, in fact, not a joke with COVID, and I think we’ve just minimized it for far too long.

I also love putting things in perspective. And if you look at the other diseases we routinely vaccinate our children against, such as rubella or meningococcal disease, COVID actually causes significantly more deaths in children than either of those two. And so again, putting it into perspective really tells you that COVID is not nothing in children. In fact, it does carry a high burden of illness. We also don’t know who is going to be impacted by severe disease, given that a third of children who are hospitalized have zero underlying conditions either. And so I think that it’s really important to put all of these things into perspective and context.

Jordan Last question I have for you about vaccines is going to involve me pushing the timeline even further. So let’s hope five to elevens next couple of weeks, we start getting kids vaccinated. Maybe many of them are vaccinated by Christmas time. What about the under fives? Let’s say it turns to January, first of all, what timeline are we looking for in terms of approval for vaccines for them? But then, second of all, because I know this was an issue when we approved vaccines for twelve and up. Do we know yet what we’ll be doing for kids who turn five in 2022? Are they eligible to get the vaccine, for instance, in January? And is that a possibility?

Sabina Yeah. Great question. So the last that I’ve heard from Pfizer in their Q3 quarterly earnings call, they basically said data for the two to five age range will be available by end of this year, which means that approval is likely going to be only February or March of next year, and the six- months to two is going to be after that. So that approval is likely going to be around the May-June time frame. So still a couple of months ahead of us.

And as for your question regarding birth year, I don’t actually foresee that happening for many reasons. First of all, the dosages are different for the different age groups. So the two to five, for instance, they have a further step-wise de escalation on dosage. So what I assume it’s going to be out the door, is that it’s going to be based on birth date and not birth year. Of course, these things can change over the next few weeks. But out the gate, I don’t anticipate it being birth year based.

And I know that on the flip side, I also get questions from people saying, well, my child is on the cusp, should they get the higher dose or not? And again, it’s a great question, but I think we need to think of vaccines differently because vaccines are not like your typical medications. They’re not actually based on weight, they’re based on your immune system, and your immune response is not based on weight. And so that’s why sticking to the age range is a lot more important when it comes to vaccines. I mean, of course, someone who’s on the cusp, it’s not like as though you’re five years and one day you’re going to have a different response necessarily than four years and 364 days. But at the same time, we know that when we did the studies, we had a lot of children in the different age groups, and we know that they were effective in all of these age groups. And so I think that it might actually end up being important to stick with birth date, at least out the gate. And once we have more information down the road, that might change.

Jordan That hurts me personally, because my kid doesn’t turn five until June.

Sabina Yeah, I hear you, same with mine. I have an under five year old and he doesn’t turn five until February. So similar boat as you and I absolutely get it.

Jordan The last thing I want to ask you about is different from paediatric vaccines, and it’s something that I will admit I haven’t dug into deeply and might not really understand. But there have been a number of headlines over the past few weeks about early approval or pending approval for different kinds of COVID treatments. Mostly, it seems like pill forms, and I guess my first question is, what are these drugs? What are they claiming to do?

Sabina Yeah. First of all, I think that I personally am very excited to see new drugs in our arsenal that can treat COVID. Vaccines are incredibly important, so these do not replace vaccinations at all. But these are new oral antivirals. And so far, all the treatments we have for COVID, such as the monoclonal antibodies, they’re all intravenous. And so it makes it a lot more cumbersome to actually deliver. But having oral antivirals are, frankly, in my opinion, a game changer. The only caveat with these oral antivirals is that they have to be used within three to five days of symptom onset. So it does mean that you have to also ramp up testing and especially rapid antigen testing. To be honest, I think that we need to be using them a lot more ubiquitously, and I think this would be a great reason why we should ramp up rapid testing as well.

Jordan So how effective are they? And when you call it a game changer, explain how that works.

Sabina Yeah. And again, for me, the game changing part is the fact that it’s actually oral and it’s not intravenous. So there’s two currently that we have that are available. One is Molnupiravir, and the second is Paxlovid, and they’re slightly different in that one is a nucleocide analogue, and the other is a protease inhibitor. So they work slightly differently, but they’re both antivirals, and trials for both of them were actually halted early because they were found to be so efficacious. We’re still waiting to see some of the data coming out, but the absolute risk reduction looks fantastic for both of them, and that’s why they were stopped early.

So trials are stopped early for many reasons. It could be safety reasons, it could be futility in that there was no difference found against the placebo. Or if you know that what you’re testing is so highly efficacious that it almost becomes unethical to continue having that study because you’re now giving a placebo group placebo versus something that actually works. It makes it unethical to continue to study. So both of them were actually halted because of how efficacious they are.

Of course, none of this data is available for me to read, it’s all science by press release at this point, so we have to wait to see what the full data looks like. But I think that we’re actually close to getting to a point where COVID can become a more manageable disease. We have vaccines that are efficacious, we have boosters that we’re now looking at, and then now we actually have a whole range of therapies that we can add into our arsenal as well. So I think we’re getting to a point where things will become a lot more manageable with COVID, and I personally feel closer to an end within our reach.

Jordan I’m so tempted to end it on that optimistic note. But I have one more question just about approval for these oral drugs and how quickly we could find ourselves in a situation where they are helping quite a bit like you described. I feel crappy. I take a test, it comes back positive. I walk over to the drugstore, I get some pills, I start taking them and everything’s okay. That’s the end game, right?

Sabina Yeah, so Molnupiravir I think is already approved in the UK. I know they’ve applied for EUA (Emergency Use Approval) with the FDA as well. I’m assuming that we’re pretty similar here in Canada as well. So I do anticipate that by end of Q1 next year, we should have these hopefully approved in Canada. But the issue in Canada is that we have an extra step. We have the step of drug reimbursement. So we have drug reimbursement bodies called CADTH that then have to recommend use, which only happens if they see a cost/benefit analysis. I think that’s the one thing, that I’m waiting to see what they do say. So they have to essentially say that the drug is in fact cost effective to be used. And this is important because we want to ensure that we don’t have a two tier system here in Canada and that those who can afford it with private insurance or paying out of pocket have access to it, and others don’t.

So I think it’s still wait and watch to see what happens here in Canada. I’m very hopeful that we will have approval, and I personally feel that we will also have drug reimbursement that occurs for it, but it’s all up in the air at this point.

Jordan Those are at least some hopeful signs on the horizon. Let’s just get through these next couple of months, and then we’ll have the vaccines. We’ll have the pills and off we go.

Sabina Yes, exactly. And especially with vaccines now being given to kids shortly. And these new therapies in our Arsenal, I feel very hopeful about 2022. I think we’re going to turn the corner, finally.

Jordan Sabina, this has been the most pleasant conversation me and you’ve had possibly through this whole thing. Thank you so much.

Sabina Thank you so much for having me.

Jordan Sabina Vohra-Miller, a clinical pharmacologist and the first person we turn to with our vaccine questions.

That was the bigstory Podcast. For more from us, head to thebigstorypodcast.ca. Find us on Twitter at @TheBigStoryFPN. Talk to us via email at thebigstorypodcast@rci.rogers.com [click here!]. Whatever podcast player you prefer, you can find us there. You can like us, rate us, review us, subscribe to us, whatever they let you do, and make sure to ask your smart speaker or even your personal assistant to “play the Big Story podcast”, to listen to us hands free.

Thanks for listening. I’m Jordan Heath-Rawlings. We will talk tomorrow.

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