Keeping Kids Under 12 Safe From COVID-19

John Whyte, MD, MPH; Paul Offit, MD

Disclosures

August 03, 2021

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JOHN WHYTE: Welcome, everyone. I'm Dr. John Whyte, the chief medical officer at WebMD. What do we do about our kids when it comes to COVID? Does it matter if they're a 14-year-old versus a 6-year-old? Joining me today is Dr. Paul Offit, he's professor of pediatrics and director of the Vaccine Education Center at the Children's Hospital of Philadelphia. Dr. Offit, thanks for joining me.

PAUL OFFIT: Thank you.

JOHN WHYTE: I want to start off with helping our audience understand: What's the difference, if any, when COVID infects a 14-year-old versus a 6-year-old? Is there a difference? Does it matter based on age?

PAUL OFFIT: Well, to some extent. There is a -- it's a general rule, children get infected, meaning people less than 18 years of age get infected, less frequently. And when they're infected, they're infected less severely as compared to adults. And that's consistent with the data where you have 93% of the deaths from this virus are in people over 65 years of age.

There is one disease called multisystem inflammatory disease in children, which occurs in about 1 out of every 1,000 people who is infected. That occurs primarily in the 6- to 14-year-old with an average of about the 10-year-old. So the younger adolescents -- the 14-year-olds, 13-year-old -- is more likely to get this multisystem inflammatory disease than would be a 6-year-old. But nonetheless, I mean, about 400 children have died from this infection. And because that's true, because the virus can cause suffering and hospitalization and occasionally death, and if we can prevent this virus safely, then we should prevent it.

JOHN WHYTE: What's the latest in understanding whether children are spreaders? Particularly, I'm interested in elementary school, because some folks have argued, “Well, their respiratory tracts aren't fully developed to expel virus.” Others talk about their immunity systems aren't as developed. What's our latest thinking?

PAUL OFFIT: Well, they certainly can spread the virus. There was a study done by the -- it was presented by the CDC, where they looked at spread in the home to find that the children could spread to adults and adults could spread to children. The general adults bring the virus into the home. But I mean, children certainly can spread the virus. That's true. Yet all the more reason to vaccinate.

JOHN WHYTE: I want to talk about masking. And I want to talk about the AAP has recently announced that they feel all children, irrespective of vaccination status, should wear a mask in the fall. Do you agree with that? And if you do, what's the science that says kids that are vaccinated should still wear a mask?

PAUL OFFIT: Right. This is certainly going to be controversial heading into the fall. I mean, you do have -- as we head into the fall you have a confluence of three unfortunate events. You are going to have a population of children who are unvaccinated. It's very unlikely that when school starts that there is going to be a vaccine that is available for the 6- to 12-year-olds.

You have a Delta variant that is clearly more contagious than the ancestral strand, the first strand that came in to this country, the so-called V614G strand. The CDC just released data showing that the so-called R-naught, the contagiousness index, is somewhere between 5 and 9, which is really high. I mean, that's --

JOHN WHYTE: That’s measles. That's chickenpox, yeah.

PAUL OFFIT: It’s certainly chickenpox; measles is more like 18. Measles is like in its own league of contagiousness. You're absolutely right. I mean, it's chickenpox. So it should scare people that it's highly contagious. Plus our behavior is not as good as it was last summer or last fall. We were much more scared of this virus and we were better at not having weddings, not having birthday parties, not having groups of people together. We're not as good this year. That's why you can see over the last couple of days, you had -- I mean, today is July 30, but 2 days ago, we had about 85,000 cases and almost 500 deaths. Yesterday we had 90,000 cases and almost 400 deaths. That's remarkable because those are the numbers we had last summer. And last summer, we had a fully susceptible population, we didn't have a vaccine. Why is that? And I think it's because of the Delta variant. It's because our behavior has changed.

JOHN WHYTE: The deaths, in fairness, are lower, given the proportion of cases than they were 6 months ago. But I want to push on the masks because what a lot of parents are saying, Dr. Offit, is, if they're vaccinated, they wear a mask; if they're not vaccinated, they wear a mask. What are the metrics to actually not have to wear masks anymore? Is it number of cases? It doesn't seem like it's vaccination. I know vaccination and cases are tied together. But parents want to know, OK, if we're going to start the year with masks, what does that mean, masks all year long? It doesn't seem like the schools and the CDC are providing any metrics to help understand when you change mitigation strategies.

PAUL OFFIT: Well, so the CDC has at least at one point said that if there is a high level of disease in the community, i.e., if 10 cases or greater in a population of 100,000, that that is a metric whereby one could say with a greater number you could reasonably wear a mask. David Rubin, who's our head of PolicyLab at Children's Hospital, feels that number is far too conservative and then a more reasonable number would be 100 cases per 100,000. Because the schools invariably reflect the community. You can reasonably argue that if you're in a highly vaccinated community and spread is low, that you don't need to wear a mask. So I think that's true.

JOHN WHYTE: I want to talk about vaccination for kids under 12. So Pfizer is talking about they plan to submit data, perhaps September or October, in a recent conversation we have. Dr. Fauci says we're not going to have anything before mid-winter. In terms of safety and efficacy standards for kids under 12, we know as you pointed out there aren't as many cases, they're often not severe. How do we demonstrate safety and efficacy in this population? Is it a measure of neutralizing antibodies? Is it exactly the same as we've done for teens? Help us think through the criteria for approval.

PAUL OFFIT: So you had, for example Pfizer did a study of 12- to 15-year-olds. That was a 23 -- roughly 2,300-child study. Half got vaccine, half got placebo. There were 18 cases of COVID, most symptomatic cases all in the placebo group. So that was enough to answer the question about efficacy. So now if you drop down to the 6- to 12-year-old group, will you be able to have the number of cases of disease that will be able to answer that question.

Now if you don't, you could reasonably say you could use immuno-bridging studies and say, well, we know that when you had this certain of neutralizing antibodies in this 12- to 15-year-old study, then you have to have had a certain level of protection. And we've just mimicked that, therefore we're going to assume that you're going to have the same level of protection. Would the FDA accept immuno-bridging studies? I think they would. But we'll see.

There's so much disease out there right now. You have like 80,000 cases, 90,000 cases a day. And that's just those people who've been tested and found to be infected. We'll see how this plays out. It's interesting to me that when that study was put forward as a way to then approve vaccines for 12- to 15-year-olds, we got a lot of pointed emails from people saying, “Why don't you do a bigger study. I mean, here you did a 30,000 study for Moderna, 44,000 studied in adults. Why not do also a similarly sized trial in children?”

So if you did, instead of a 2,300-child, probably 23,000-child trial, then you have 180 cases of disease in that trial. And most presumably if not on the placebo group. The question is always at what price knowledge. I mean, how much do you need to see children in this case suffer this disease before you can say comfortably that you have enough information to say you can give this vaccine?

JOHN WHYTE: While recognizing in fairness safety that a 6-year-old is not the same developmentally as a 12-year-old. I ask you, some people have been raising that in kids under 12, would vaccination meet the criteria for emergency use authorization.

PAUL OFFIT: Right. And that was discussed at a vaccine advisory committee meeting about a month ago. There was ambivalence among committee as to whether they wanted this to be emergency use authorization or full licensure. But really, the big difference between emergency use authorization and full licensure mostly has to do with how the FDA licenses not just the product, but also the process and manufacturing. They submit that to validation of every single aspect of the manufacturing process. They have to be strictly protocolled, et cetera. So it really doesn't have as much to do with what you care about, which is safety and efficacy and size of the trials.

So we'll see how this plays out. I mean, I think the bottom line for me is that we know that at least 4 million children have been infected with this virus. We know that at least 40,000 been hospitalized. We know that around 400 have died. We know that MIS-C is not uncommon. I was once service a week in January, we saw five cases of MIS-C in the one week I was on service. And we also know that those children can go on to develop longer-term symptoms.

JOHN WHYTE: So the FDA has announced previously that it will go to an advisory panel in this age group. Given that, assuming they still do that, what do you think is the realistic timeline for when we might see shots in arms for elementary school students?

PAUL OFFIT: Well, so I'm on the vaccine advisory committee.

JOHN WHYTE: I know you are.

PAUL OFFIT: I don't know. I mean, I know that our next scheduled meeting is in -- the meeting date that we've reserved is late September. So whether that will be presented with these data, I don't know. I know as much as you know.

JOHN WHYTE: OK. But some people get frustrated when they hear Dr. Fauci say, “Well, it's going to be mid-winter.” Is it helpful to say those things when we haven't even seen any data and we really don't know yet? I mean, that could be the best-case scenario. But it may not go as planned.

PAUL OFFIT: Maybe he does know, in his defense. It's not unrealistic to set a certain expectation, especially if you're right. It is disconcerting that we won't have a vaccine for children when they head back to school. And in winter, this virus is far more capable of spreading than it is typically in the summer months. It spreads, as is true of all winter respiratory viruses, under cooler, more drier conditions. So that in an unvaccinated population, it’s a bad combination going back to school.

JOHN WHYTE: Well, given that. What's your advice to parents that are listening? What do they need to know to protect their kids?

PAUL OFFIT: I think that obviously, we need to go back to school. Children have suffered isolation arguably more than any other group. I think it depends on what's happening in your community. If you're in a highly vaccinated community and transmission is low in that community, then I think you can reasonably argue that you don't necessarily need to mask going back to schools. But if you're in a relatively under-vaccinated community and you see the transmissions happening -- and transmission will start to happen presumably greater in the winter months -- then it's reasonable to wear a mask. I think that if I was the father of a 10-year-old and I was in a community that had a fair amount of spread, I certainly would hope that there was a mask mandate for my school.

JOHN WHYTE: And parents themselves need to get vaccinated to help protect their kids.

PAUL OFFIT: That's the easy one. I mean, everyone over 12 should get vaccinated. We call this a pandemic of the unvaccinated. That's not true, it's always been a pandemic of unvaccinated. Now it's a pandemic of the willfully unvaccinated and we really need to get those people vaccinated. There is no excuse for this. And I think what's happening now is going to be what we're going to be talking about for the next 6 months, which is mandates. Because if people are unwilling to take this vaccine for free, which is going to keep them out of the hospital, keep them out of and most importantly, protect those with whom they come in contact. If they're just saying to you, I don't want to get this vaccine, then I think you frankly have to compel them to do it. And that's where we are now.

JOHN WHYTE: There's no better way to end with that advice. Dr. Offit, thanks for taking the time today.

PAUL OFFIT: Thank you.

This interview originally appeared on WebMD on August 2, 2021.

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