Jordan Heath-Rawlings: Late last year, the entire world was simply holding its breath, praying that vaccines against COVID-19 would work. And they did. As soon as approval was reached, countries like Canada, who were lucky enough to have access to supply, got moving quickly. In this country, we began with people over the age of 80, and we worked our way down from there. In the late spring, vaccine appointments became available for anyone ages twelve and up. And since then, nothing further.
News Clip: Drugmakers insist vaccines for kids will be thoroughly tested, but it’s almost certain they’ll be going back to school next September without a vaccine.
Jordan Heath-Rawlings: If you are not a parent of a child under twelve and you don’t know any, I will fill you in. School is starting. Their kids are not vaccinated, and most of the parents are terrified. Why haven’t vaccines been approved for kids under twelve yet? And what is a realistic timeline for first getting shots into younger kids, but then a timeline for toddlers or infants? And while we have an expert here, how has the full FDA approval of the Pfizer vaccine impacted vaccine? Hesitancy have mandates and passports helped with that. And if we’re being honest, can anything help with this at this point?
News Clip: [anti-vax crowd chanting]
Jordan Heath-Rawlings: I’m Jordan Heath-Rawlings. This is The Big Story. Sabina Vohra-Miller is a clinical pharmacologist who has spent, I guess, more than a year now working on vaccine education, combating vaccine hesitancy and just living in this world. Right?
Sabina Vohra-Miller: Yes, that’s exactly it.
Jordan Heath-Rawlings: So the first thing I want to hit you with is just we’ve heard, I think, for a while now that we are close to approval for a vaccine for under-twelve. Where is that at? And is there an actual timeline we can discuss here?
Sabina Vohra-Miller: Yeah, that’s a great question. And the reason is because it’s been a bit of a moving target. So originally, the way these pediatric trials are designed, they’re meant to be step wise in a stepwise fashion. So you start with the twelve to 17, which we have data for, and it’s approved. Then you go into the age group below that. So that’s five to eleven, and then it would be two to five, and then it would be six months to two years. And with each of this is also dose de-escalation. So there’s a different dose for the five to eleven range. And there’s another a lower dose for the six months to the five range. And so all of these they’re done in the very stepwise fashion for a reason, because we want to make sure that the vaccine, the dose of the pediatric the children are getting is actually the right dose for them. So it’s not too low and it’s not too high at the same time.
So what happened is that originally, with the way the trials were designed, we had anticipated we would have data available, in fact, by August. However, the FDA had requested the manufacturers to go back and actually increase the trial size. So with the concerns that we’ve been seeing with the myocarditis, which is essentially that inflammation of the heart muscle generally occurs due to an immune mediated reason, and we see more of this occurring in younger versus older people. And so we wanted to make sure that there was absolutely no concerns with the myocarditis in these younger age groups. And if there is, then we wanted to know what’s the incidence of this occurring, whether they’re mild for the most part or not, and just get more details on this adverse event in the pediatric population.
And so because of that, the FDA basically said to the the drug manufacturers that we want you to increase the trial size. So the number of people who were enrolled in these pediatric trials, and so they did that. And because of that, the timelines have now shifted. What had then happened subsequently. So the FDA is now also asking for more than two months of safety data. So typically for vaccines, we collect two months of data. And that’s because within eight weeks, we have a really good idea of what the side effects are going to look like, given that majority of the side effects are immune related. And by eight weeks, everything has sort of simmer down, and your body has kind of gone back into pre vaccine mode in terms of the immune response. And so we have a really good understanding of what things are at the two month mark.
The FDA, however, has come back and said that perhaps they might actually want six months of safety data. This is actually a point of contention because the American Academy of Pediatricians, which is a large body of the consensus farming pediatricians and the US, wrote a letter submitted to the FDA saying that six months is not necessary for vaccines. We have a good idea, given how many doses we’ve given up these vaccines across the world and children are being impacted by Delta, it’s so timely for them, given that they’re going to school that we should have these vaccines available sooner rather than later. Of course, due diligence is important. And so that’s the point that we actually don’t have much clarity, because what we don’t know is whether because the FDA has requested this information, whether the drug manufacturers would actually provide interim data, so would they provide data with the original sample size? The manufacturers so far said no. Will they provide data with the two months safety? We don’t know that they haven’t really said anything on that front. So there’s a bit of question mark in some of these timelines.
The last that we’ve heard so far is that we should have data available by end of September, which means that we would have approval likely by end of November. And I think that is really the timeline we’re looking at here in Canada, because, again, the Canada does not have to follow FDA stipulations. We can essentially have our own requirements that the Health Canada has for pediatric approvals. So five to eleven, we’re expecting data to be available by end of September, approval by approximately end of November. Following that, we will see approval in the age of range just underneath a two to five and then following that. So some time, perhaps first quarter of next year is when we’re going to see approvals for the 6th month to two. But that, of course, is, you know, as long as everything goes according to plan.
Jordan Heath-Rawlings: That all seems very chaotic. But just to clear it up and put it plainly for parents, the current hope, then, is five to twelve by end of the year, hopefully by Christmas time?
Sabina Vohra-Miller: Yes.
Jordan Heath-Rawlings: Two to five by perhaps early next year and the end of winter, early spring for infants. Is that about right?
Sabina Vohra-Miller: Yeah, that sounds about right. That’s, of course, if everything goes according to plan, we don’t ask for six months of safety data, and we actually have these trials completed in time as well.
Jordan Heath-Rawlings: I’m also going to ask it because I’m sure people are worrying about it right now. You kind of casually mentioned it a couple times. Is there a risk that if the FDA insists on six months of data, that knocks everything back that we just discussed by another four months?
Sabina Vohra-Miller: There’s always that potential. I think that for us in Canada, that’s the place where we may have more leeway. We can, in fact, ask with the manufacturer to submit with the two month data, and we can, in fact, make a decision using that two month data. So I think that a lot of this is still up in the air. Health Canada has not come out and said anything either that they’re supportive of the six months or that they’re okay with the two months. So some of that is still up in the air, but we don’t have to follow FDA’s regulations. That is where we will have some leeway in terms of having a potentially earlier approval than in the US, which we actually did see with the twelve to 17 age groups. Canada actually approved the vaccines before the US did.
Jordan Heath-Rawlings: One of the other questions and you mentioned it very briefly, is, what do we know now that we didn’t know yet in the spring about the inflamed heart condition? The myocarditis?
Sabina Vohra-Miller: Yeah. So with the myocarditis, I think that first of all, myocarditis, it’s just something that we don’t really understand what the actual, even baseline risk is, because a lot of times it can occur sub clinically. So without any actual clinical symptoms. So we have seen some instances of this occurring. What we see it happening is generally it happens with younger people and usually after dose two and more often in men versus in women. We don’t actually have a really good idea of what the incident is. With respect to the vaccines, there are a couple of different rates that are being currently thrown out, but we don’t have a good idea of what the actual incidence is with the vaccines. But what we do know is that when they do occur with the vaccines, they are far milder than when they actually occur after COVID infection. So that’s the key part and that COVID infections themselves have a risk of myocarditis, and usually with COVID infections, these risks of myocarditis are much more severe with COVID infections. What we see with the vaccines is generally a milder version of it, and for the most part, treated easily, either in the hospital or at home with support of care. But we’re still trying to understand what the actual core incidence is in Canada as well as across the world.
Jordan Heath-Rawlings: In terms of vaccine rates and what we need to get to in order to achieve herd immunity and hopefully get out of this thing. I wanted to ask you about the full FDA approval of the Pfizer vaccine and what it means to people who have been on the fence. I know you’re someone that talks daily to a lot of people in real time who were trying to decide whether or not to get the vaccine or not. And has this made an impact?
Sabina Vohra-Miller: Yeah. Great question. I do personally, I feel that those who actually use that as a reason to not get vaccinated are generally the kind of people that you may not necessarily be able to reason with logic. So I personally don’t actually think that this full FDA approval is going to move the needle very much in those who are not vaccinated because of that. I think that with the full approval, it really is a process technicality. It’s similar here in Canada, we use the interim order pathway to approve COVID-19 related drugs or vaccines. It’s a temporary pathway that has been created to make sure that we’re doing more efficient and quicker reviews, such as making rolling reviews possible. So it just makes it a lot more timely, which is necessary in the time of a pandemic.
But in both the EUA, the Emergency Use Authorization in the US, as well as the interim order pathway that we’re using in Canada, due diligence is still exactly the same in that there is requirement of robust data for both efficacy as well as for safety. There is still surveillance postmarket of the products that are approved. All of that still occurs. And so if anyone’s actually using this as a reason to not get vaccinated, I don’t think that the full approval is actually going to move the needle, so to speak with them. I think that might just be an avenue for a change in goal post. But of course, I have to be proven wrong on that.
Jordan Heath-Rawlings: In terms of the people who haven’t been vaccinated yet. And now looking at general data, I’m not going to pick it apart. But we’re up in the high 70s in some places. When we spoke about vaccine hesitancy back in the spring, you know, we talked about a lot of people who you were speaking to and other people were trying to convince who were on the fence, who had concerns, or there were accessibility issues. And when we spoke back then, there was a belief that the actual hardcore anti vaxxers who would never get vaccinated, the really loud ones, were actually a very small percentage. Now that it’s been available to everyone who is eligible for months now. How many of those people are left and how much more convincing can we do, or are we getting to the point where we’ve hit that line and everybody left is just unwilling?
Sabina Vohra-Miller: Yeah. I think there is still room for reaching people that have not yet been vaccinated. And I can say that personally from the work that I’ve been doing. In the last couple of weeks, I’ve already spoken to several that have changed their mind. There was one person who I spoke to, in fact, just this past weekend who finally got vaccinated. But it took four months of continued conversations and dialogues with this person person to get them convinced. And the reason why they didn’t want to get vaccinated was just because they’d heard about all of these rumours and they were terrified of getting vaccinated. And their opinion was that when they’re young and they’re healthy, why do they need the vaccine? But it took four months of conversations, and I think that’s really what we’re coming down to now. Those who are not vaccinated, it’s going to take ten times more effort to actually reach them. And so even with the accessibility, these are the people that have serious accessibility barriers, and so a lot more needs to be done to reach them.
And it’s the same with those who have the hesitancies. There is still a significant percentage of people who have hesitancies, and it could be for a variety of different reasons. And the things that I get very often right now is in pregnant people, just because in pregnancy there’s that heightened awareness of not just making sure everything you’re doing is safe for yourself. It’s also safe for the fetus, the baby that you’re carrying. And the pregnancy is one of the areas that I’ve been putting a lot of effort in to try and reach people to get them to see what the data looks like, especially because of how pregnancy puts them at a much higher risk for severe outcomes from COVID. So there’s definitely people that we have to reach. It’s just that the people that we still need to reach is going to take a lot more effort to get through to them. And, of course, the ones that are staunchly anti-tax, I don’t think anything I say is going to change their opinion. But what I’m hopeful for is that there’s continued discussions and dialogue so that we’re building that vaccine confidence over the course of time, and maybe not this year, but maybe next year we might be able to convince them.
Jordan Heath-Rawlings: What have you seen work, especially now for the hold out. I know we’ve heard a lot recently about vaccine mandates and passports having an impact. Is that something that you’re seeing in your work? And if not, what is working? What got that person off the fence after four months?
Sabina Vohra-Miller: Yeah. So vaccine mandates play a role in the entire getting people to get vaccinated, but it’s for a very specific type of person. You have to understand that when it comes down to vaccine hesitancy, there are so many layers. And so you need these targeted efforts for each one of these layers. So mandates help those who are complacent, you know, people who are just, “Oh I don’t think it’s a big deal. I’m young. I’m fine. I don’t really need the vaccine. I think vaccines are important, but maybe not just for me, or I don’t really want to take time out of my day to go get vaccinated”. So mandates would help people like that, then they’re generally in the younger age group. And we’ve seen this in BC, in Quebec once they actually had these vaccine mandates at we saw a dramatic increase in first doses, two to three times higher than they would normally see in any given day. And they’re generally people who are in the ages twelve to 29 age group.
And so those who are essentially complacent, yeah, it would probably work for them. But who have, say, for instance, distrurst with health care systems, those who actually have these hesitance and questions, you’re not going to actually be able to change their mind based on mandates, or if they do get vaccinated begrudgingly, you are possibly eroding vaccine confidence in the long run. So the next time they need to get vaccinated, it’s going to take double the effort to get them convinced. But in terms of those who are still hesitant, honestly, it’s a matter of having that continued discussion and having it with so much compassion and respect that, I’ll be honest, is exhausting. For example, this one person that I just convinced this constant conversations. We started with fertility, that was their biggest concern. Then we started talking about these adverse events that they would show. Well, this person said that this happened to them, and then it would just be conversations to get them to think about things. And I’m like, well, have any of your friends got vaccinated? Have any of them had any side effects? Okay. Do you know anyone who’s had COVID? And how has that impacted their lives? And it’s really allowing them to put these pieces together and make them have a say, an informed decision for themselves, but they’re actually using the right data to make that informed decision for themselves. But it does take a lot of work these conversations that I’ve had that people can take upwards of an hour, and they’re always one on one, but progress is being made. And I think that’s the key part.
Jordan Heath-Rawlings: Well, I’m really glad there are people like you out there having those conversations that I just can’t. The last thing I want to ask you about before we let you go is I we’ve had a conversation on a couple of episodes about global vaccine equity. And I wanted to ask you first, how is that coming along? I’m presuming, still not well. And second, how would you balance the discussion we’re hearing about booster shots for some of us in the fall who are at risk versus initial doses in what’s got to still be like half the world?
Sabina Vohra-Miller: Yeah. That’s a great question. So first of all, we are not doing nearly enough. Whatever we’re doing is a drop in the bucket. The WHO basically asked for a moratorium on booster shots up until end of September to allow countries around the world to at least get 10% of their population vaccinated, 10%. We’re not even talking more than that. At the end of the day, when it comes to variants, we’ll see more, more variants coming up if we are having uncontrolled spread of the virus, right. And so it really isn’t our own best interest to make sure that there is a global vaccine equity, because it really, really impacts us as well. I mean, the whole Delta curve ball that we’ve been thrown was because of uncontrolled spread of the virus. And so there’s always that risk that the next variant coming is going to be able to evade the vaccines even more. And so that is really, really key and critical.
When it comes on to boosters for the Canadian population, those that are the immunocompromised. So we have some data to show that those, for instance, that have solid transplant patients. We have data to show that giving a third booster, in fact, does improve their response or immune responses. And it’s other types of either diseases or therapies that you are that, for instance, B cell depleting therapies or diseases that impact your B cells, such as certain types of blood cancers. We know that in these populations that it’s very hard for them to actually mount an adequate immune response. What we don’t know is whether third dose is actually going to help them mount an immune response or not. And then the second aspect of this is that we have some data from the manufacturer is showing that these are just immunogenicities to study. So just showing that, okay, you’re neutralizing antibodies go up after your booster shot. But we don’t really know what that means in terms of actual efficacy. Does it actually increase meaningfully efficacy against symptomatic disease? We don’t know.
But what we do know right now is that with two doses of the vaccine, we may see a decline in symptomatic efficacy. But we’re also seeing that they still work in incredibly well to prevent severe illness. So we see that essentially 90% plus of those who are hospitalized, who are ventilated, those who are dying are essentially those who are unvaccinated. So we know that vaccines are working incredibly well. So really, what we need to be doing and focusing right now is to get the rest of the world vaccinated so that we’re not going to see new variants come into play. And for all you know, over the course of time, you may actually have a booster shot that is more targeted towards a newer variant and may actually be more helpful and useful to do that. All of this to say this is for the general Canadian population. I’m not talking those who are immunocompromised, those who are elderly, who live in congregate settings, in these situations, it actually might be prudent to give them a booster shot sooner rather than later to make sure that they are really protected as we go into our fourth wave. I say as we go into a fourth wave, but we are in a fourth wave, but it would be really important to protect those who are more vulnerable to severe illness from COVID.
Jordan Heath-Rawlings: Sabina, thank you, as always, for your knowledge and your patience as we ask you all sorts of questions about vaccines.
Sabina Vohra-Miller: It’s my absolute pleasure.
Jordan Heath-Rawlings: That was Sabina Vohra-Miller. And that was The Big Story. For more from us, head to thebigstorypodcast.ca, find us on Twitter, as always, at @TheBigStoryFPN. Send us an email with your vaccine questions, we will have Sabina back every once in a while to answer them. You can find us at thebigstorypodcast, all one word, @rci.rogers.com [click here!]. The Big Story is available in any podcast player. It is available on your smart speaker. You can just ask your device to play The Big Story podcast.
Thanks for listening. I’m Jordan Heath-Rawlings. We’ll talk tomorrow.
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