Published on Mar 11, 2021

Video Transcript

[MUSIC PLAYING] JOHN WHYTE: Welcome, everyone. You're watching "Coronavirus in Context." I'm Dr. John Whyte, Chief Medical Officer at WebMD. Are you going to get your kids vaccinated against COVID? Should you get your kids vaccinated against COVID?

To help answer these questions and provide some insights, I've asked one of the world's most renowned experts on childhood vaccinations, Dr. Paul Offit. He's the Director of the Vaccine Education Center at CHOP and a pediatrician at the University of Pennsylvania. Dr. Offit, thanks for joining me again.

PAUL OFFIT: My pleasure. I thought you were going to say I asked one of the renowned experts in the world, but I couldn't get them. So instead, we've got Dr. Offit.

JOHN WHYTE: So I got Dr. Offit. Thank you. Let's remind our viewers, how often does COVID occur in kids? And how serious is it?

PAUL OFFIT: Well, so first of all, if you look at who dies from this virus, from SARS-CoV-2, 92% of the deaths occur in people over 55 years of age. If you look at the population less than 21 years of age, which accounts for 26% of the United States population, that population accounts for 0.08% of the deaths. So it is true that children get infected less frequently. When they get infected, they get infected less severely.

But nonetheless, this virus does infect children. The number of children who died this past year of SARS-CoV-2 was roughly the same number as die of influenza, typically, every year, which is between 150 and 200. And children can suffer other problems, a so-called longer-term disease called multisystem inflammatory disease of children which can be disabling. So it's certainly worth preventing this disease in children.

JOHN WHYTE: Let's talk about this poll we recently did at WebMD, where we asked parents who have children under the age of 16 living at home would they vaccinate their kids. And 53% of parents with kids 12 through 16 said they would have their children vaccinated within a year of a shot being approved. 18% said they definitely wouldn't get their teens inoculated against COVID. But for parents who have kids under the age of five, 41% said they'd have their kids vaccinated, and 22% said they definitely would not get their kids vaccinated. Does this surprise you at all?

PAUL OFFIT: No, I think it's perfectly reasonable, to be honest with you. The studies that were done for the Johnson & Johnson and Moderna vaccines were done in those over 18 years of age, so you have no data less than 18. The Pfizer studies were done down to 16 years of age, but again, that subgroup of 16 to 17-year-olds was not large.

So I think it's reasonable to be somewhat skeptical of this vaccine in children initially. I mean, you want to see the data. You want to see the data in children 12 to 18 years of age, which are studies that are being done now, to make sure that it's consistently immunogenic and to make sure that it's safe, at least in thousands of children. I think that's fair.

And then I think when those studies are done, then I think what's going to happen is you're going to see studies in the six to 12-year-old. I'm not so sure that we're going to see studies in the less than six-year-old. But in any case, so those other two groups, the 12 to 18-year-old, the six to 12-year-old, I think we can certainly start vaccinating older children by the summer, because I think those studies likely will be finished by then.

JOHN WHYTE: What do you consider older children? Over the age of 12?

PAUL OFFIT: Right. That's right. By older children, I mean children 12 to 18 years of age.

JOHN WHYTE: How important are these age cutoffs? And why? We see that in other vaccinations for children, we give certain vaccines at certain ages. Is it because of their developing immune system? Is it lack of data? Why do we have these age cutoffs?

PAUL OFFIT: For some children, you want to protect them as infants. So you give them vaccines at two months of age, four months of age, six months of age, 12 to 15 months of age, because you want to make sure that they're fully immune against the diseases that are likely to cause harm in young children, like pneumococcal infection or Haemophilus influenza type B infection or Rotavirus infection. And then for some diseases, you're trying to really make sure that they're immune as they enter adolescence. So the human papillomavirus vaccine, the meningococcal vaccine are given as part of an adolescent platform. So I think that's really what operationally defines how we give vaccines, when we give vaccines.

JOHN WHYTE: You're a member of the FDA's Vaccines and Related Biological Products Advisory Committee that gives recommendations for approval. What's going to be different in your reasoning when it comes to vaccinating kids? The acting commissioner of the Food and Drug Administration, Janet Woodcock, often talks about that kids are not mini adults.

This is a new technology? Do we have to have different perceptions of safety data when you're balancing risk versus benefit? You talked early on about how we often don't see deaths and serious disease in children, although they do happen, and then we're weighing them against the risks of side effects, as well as a developing immune system. How does your calculation differ at all when you're evaluating this for children versus adults?

PAUL OFFIT: Right. If we're talking about SARS-CoV-2 vaccines, let me take a step back for a second. So normally when we, the FDA Vaccine Advisory Committee, looks at data, it's because the company has submitted a biologics license application, and they are asking the FDA to license the product. That's not true with SARS-CoV-2 vaccines. These vaccines are being approved through something called emergency use authorization, which is, frankly, not much different than allowing permission to use an investigational new drug.

JOHN WHYTE: But in fairness, part of the authorization was that both Pfizer and Moderna have announced they are going to apply for full licensure.

PAUL OFFIT: Right, but that may be a few years down the line. I mean, and let me just explain how it came to be that it's through emergency use authorization, I mean, what parents should-- or what people should focus on or not focus on. I think the reason that it's being done through emergency use authorization has nothing to do with the size of the trials. The size of the trials, Moderna's trial of 30,000 or Pfizer's trial of 44,000 or Johnson & Johnson's trial of 44,000 is a typical trial size for an adult or pediatric vaccine.

And it really has nothing to do with safety follow up. I mean, the follow up of safety for two months after the last dose is typical for any vaccine. And usually-- and not usually, but virtually always, if you look at the serious side effects of vaccines, and vaccines, like all medical products, can have serious side effects, they occur within six weeks of a dose. So I think by looking two months after the last dose, you were jumping with a net regarding safety.

The issue's efficacy. I mean, when Pfizer and Moderna's trials were approved through EUA, you could say that they were 95% effective for three or four months. You couldn't say beyond that. And that's the difference. So you didn't have one or two or three years of efficacy, nor were you going to, because when 400,000 people died last year, you're not going to do a three or four-year trial before you release those vaccines.

So that's the issue is one of efficacy. And I think we weren't jumping without a net there also. I mean, if it's highly effective for three or four months, I think you can assume it's going to be highly effective for at least a year, if not longer. And so that's what's going to happen. I think the companies, as we get two or three or four years' worth of effectiveness data in the real world, then they'll come back and try and get a license.

I do think in terms of children, you're not going to see those kinds of efficacy trials. You're not going to see studies of 30,000 or 44,000 children to see whether or not you have a vaccinated or unvaccinated group and then see whether the vaccinated group is more likely to be protected against disease than the unvaccinated group because disease is not that common in children. So you'd have to do a much bigger study than the 30,000 or 40,000 person study to do that. So that's not going to happen.

Rather, it's going to be a little more, I guess, closer to the influenza vaccine model, where you're going to do essentially phase I and phase II studies in children, which is to say you're going to make sure you have the right dose, and then you're going to give the vaccine to a few thousand children to make sure that it's consistently immunogenic and safe in a few thousand children. And with that, then I think you would go to vaccines, which is why it could be as early as the summer for children between 12 and 18 years of age.

JOHN WHYTE: And what about kids between 7 and 12?

PAUL OFFIT: Right. So I think that group, the six to 12-year-old, will follow this initial group, and quickly. And we could know then, I think, by September or October whether or not we have the right dose for dosing interval for that group as well. I would be surprised if we did children less than five years of age. It's very rare for children that young to get sick because for the simple reason that the virus, in order to enter cells, has to attach to cells. The receptor that it uses on the surface of cells to bind, the so-called ACE2 receptor, is not expressed as well on very young children. It's a maturational receptor.

JOHN WHYTE: It's an issue of efficacy, that's why we wouldn't do it for kids less than five as opposed to issues of safety, or we just don't know?

PAUL OFFIT: I think the main reason is that it's just extremely unlikely for them to get sick. Now, we may do this. I mean, if you look at Johnson & Johnson's vaccine, the so-called replication effect of adenovirus virus 26 vaccine, that vaccine actually has commercial experience, not for SARS-CoV-2, but for other agents like Ebola virus. And that vaccine strategy has been used down to four months of age. So at least you have commercial experience with that kind of vaccine.

We'll see how this plays out. I guess the thing about making predictions about this virus and this vaccine is always tricky because you're, like, always wrong. But I do think that as we move forward here, we're going to see us gradually move down in age to 12 and then down to six years of age. And then we'll see what's happening with the pandemic, see what the numbers are in very young children to see whether or not that is a disease worth preventing in very young children.

JOHN WHYTE: Do you think we'll see mandatory vaccination of kids 12 through 17 returning to school in the fall?

PAUL OFFIT: I certainly would be surprised if we had mandatory vaccination at the state level. I think it would not be surprising to see it at the private level. I think companies could do this. And I think privately owned schools could probably do that.

I would be surprised if you saw it in a public school, because then you're talking about more state mandates, and I don't see that happening with this vaccine, at least not initially. Although I do think, we struggle with this in our hospital, we're a private institution, there's a certain percentage of people who don't want to be vaccinated, which is true in all hospitals. Do we want to take that next step and mandate the vaccine? I think we're all struggling with this now.

JOHN WHYTE: Does it change your mind that it's authorized as opposed to fully licensed?

PAUL OFFIT: I'm not a lawyer. I think that's a legal question. Does it matter whether or not you can mandate something if it's under emergency authorization versus biologics versus a licensed product? At least the people who have weighed in on this so far, ethicists at NYU Langone like Art Caplan or lawyers at UCAL Hastings like Dorit Rubinstein Reiss have led me to believe that even though it is under EUA that you could still mandate this vaccine.

JOHN WHYTE: Well, Dr. Offit, I want to thank you for taking the time today to provide some insights and to tell us where the evidence is in terms of evaluating vaccination for kids. So thank you.

PAUL OFFIT: Thank you.

JOHN WHYTE: And thank you for watching. If you have questions about coronavirus, drop us a line, You can email them to [email protected], as well as post them on social media. Thank you.

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