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Twenty-eight million American children ages 5 to 11 are now eligible for a COVID-19 vaccine. Within hours of the emergency use authorization, vaccine distribution mechanisms kicked into high gear, allowing for kids to roll up their sleeves without having to go too far.

Vaccines are now being distributed in pediatrician offices, pharmacies, and schools, as a strategy to eliminate any logistical barriers that kids may face in getting vaccinated. But many parents, who are the key decision makers, remain skeptical that kids need the shot. After all, COVID cases among children have been more mild, with fewer hospitalizations and deaths compared with adults.

An October poll by the Kaiser Family Foundation found that 30% of parents of kids in this newly authorized age group will “definitely not” vaccinate them. So what does this mean for classrooms and masking? And what does the science say when it comes to the need to vaccinate kids?

On this week’s episode, Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, joins us to discuss how vaccinating kids may be the key to returning to a “new normal.”

The following is an abridged transcript of his interview with “Track the Vax” host, Serena Marshall:

Marshall: The last time we spoke to you, we were anticipating the rollout for kids, when it would be kids’ turns. Now that time has finally arrived.

Offit: Yes, and I think it’s a great day for children, but I agree with you. I think that you’re going to find resistance among parents. I mean, parents of kids in this age group, 5- to 11-year-old children, see those children as vulnerable, and the notion of inoculating them with a biological agent is a little scary.

What they need to understand is that a choice not to get a vaccine is not a risk-free choice. It’s just a choice to take a different risk. And I would argue, given the statistics that you just went through, a much more serious risk. Children can get infected with this virus and can get infected severely.

Marshall: Let’s dive into some of the data. Let’s look at the clinical trial that was underway, wrapped up perhaps a little bit sooner than we anticipated it would — 1,500 children. We had this discussion previously with the last group of children. Is it a big enough cohort?

Offit: It’s always a little nerve-wracking when you’re on the FDA Vaccine Advisory Committee that you’re asked to make a decision for millions of children based on data that were generated in thousands of children. Is that predictive? So, I mean, what this study showed was that roughly 2,400 children were in the study. It was a 2:1 vaccine to placebo study, where roughly 1,600 children got the vaccine, 800 got placebo. There were 19 total cases of COVID in that study, 16 in the placebo group, for a vaccine efficacy of 91%. Is that enough? Is that enough to make you feel comfortable that it is an effective vaccine?

I think it is. I mean, it mimics almost exactly the study that was done in the 12- to 15-year-olds where, again, it was about 2,400 children and there was a 1:1 vaccine to placebo. There were 18 cases of COVID in that group. Some of those children, you know, suffered significantly … all in the placebo group.

So, again, I mean, there’s also just hundreds of millions of adults now who have gotten this vaccine, including those over 16 years of age. So I think that in terms of efficacy, I feel comfortable with that. We all did. The issue of safety then is tougher, for the fact that mRNA vaccines can cause myocarditis, inflammation of the heart muscle. It’s rare, but it’s real.

Marshall: And that occurs more in men, right? Younger men?

Offit: That’s right. And you knew that it occurred primarily for the second dose. Primarily in males, primarily in those between 16 and 25 years of age. So you worry, as you get to younger and younger age groups, that that may be a problem. I mean, what you are reassured by here is that the incidence of myocarditis, which was rare — sort of roughly one in 20,000 in those younger age groups, was even less common in the 12- to 15-year-old age groups, both in the United States and in Israel.

And the dose that’s given to the 5- to 11-year-olds is one third of the dose that was given to those older adolescents and adults. So, I think that’s all reassuring. And remember a choice not to get a vaccine is a choice to risk a disease, a disease, COVID, which also causes myocarditis far more commonly than does this vaccine.

Marshall: Interesting that you just said that. So the risk that you get from the vaccine is essentially the same risk you get from contracting COVID?

Offit: Oh no, it’s much greater with the virus. So, there was a study done that was reported in JAMA Cardiology, a journal of the American Medical Association, where they looked at about 1,600 athletes in the Big Ten Conference who had COVID, and they did just a heart MRI on all of those patients, independent of whether they had heart symptoms. And what they found was that 2.5%, so roughly one in 45, who had COVID had evidence of myocarditis. So compare that to the risk of the vaccine, which is more like one in 20,000. The risk is much greater with the virus than the vaccine.

And if you look at multisystem inflammatory [syndrome in children, or MIS-C], which is a disease of this age group, I mean, it’s typically diseases of the 5- to 13-year-olds, peaks at roughly 9 years of age, I mean, their incidence of myocarditis is as high as one and two people who get that phenomenon.

Marshall: And does that happen with the vaccine as well?

Offit: So, the vaccine is a rare cause of myocarditis, about one in 20,000. But, again, far less commonly than occurs with the disease.

Marshall: With MIS-C though …

Offit: Oh, I see. You’re asking, does the vaccine cause MIS-C?

Marshall: Yeah.

Offit: Not that I know. No.

Marshall: Okay. So if a parent chooses to go, you said, it’s a choice between two risks, right? The risk of getting COVID and the risk of the vaccine. And with COVID, it sounds like the risk for all of those adverse events is much greater than the risk of getting any of those adverse events with the vaccine?

Offit: Exactly right.

Marshall: Okay. So what are the side effects that parents should be on the lookout for?

Offit: So within the first couple of days, children can get fever, including low-grade fever, headache, muscle ache, joint aches, sometimes chills.

Marshall: That sounds like everything the adults experienced, too.

Offit: Right. And then like the adults, those symptoms go away in a couple days.

Marshall: Okay. Anything that we’ve seen long-term?

Offit: No, no, not at all. And remember, just historically, if you look at the last 200 years of vaccine development, starting with the smallpox vaccine, there are no long-term consequences, meaning something that is not observed within 2 months of getting the vaccine. That hasn’t happened.

Now, sometimes these events are extremely rare. Like, so, for example, you know, thrombosis with thrombocytopenia syndrome associated with J&J’s [Johnson & Johnson’s] vaccine. That was like a one in 500,000 person phenomenon. So that’s not going to be picked up in a pre-licensure or pre-approval study. But it will be picked up when it’s given to tens of millions of people. But, again, that phenomenon all occurred within a month of getting it.

Marshall: So, it’s interesting though, Dr. Offit, because a recent Kaiser Family Foundation poll found the biggest concern for parents when it comes to vaccinating their children are fears about long-term effects — 76% said they were concerned about those long-term effects. So is this just a messaging issue with parents and between them and their doctors?

Offit: Yes. Now, I think when you inoculate a child, especially with a genetic vaccine, I mean, this is really the first of the genetic vaccines. People think somehow that may alter your DNA and cause problems down the line, but that’s just not possible. These vaccines can’t possibly alter your DNA. So just wrong.

Marshall: So why do you think that that myth, or that false information of the impacting things like fertility — 66% in that poll was worried about fertility — continue to percolate, especially among parents who are going to be the decision makers for this age group?

Offit: Because “falsehood flies and the truth comes limping after,” as Jonathan Swift said. It was a false concern. It was raised by two researchers who wrote a letter to the European Medicines Agency, claiming that the SARS-CoV-2 spike protein mimicked syncytin-1, which is a protein on the surface of placental cells. So that while you were making an immune response to this spike protein, you were also inadvertently making an immune response to your own placenta. That’s wrong. Those are two immunologically distinct proteins.

And frankly, you know, if you look at that as a premise, you know, more than a hundred million people in the United States have been infected with this virus, during which time they’ve made antibodies to the SARS-CoV-2 spike protein. So if that was true, if that affected fertility, then what’s happened to the birth rate over the past year? And the answer is it stayed the same. So it was just all nonsense. But once you put that in people’s heads, it’s hard to unring the bell.

Marshall: So we know parents have a tendency, even with general childhood immunizations, to try and space them out. We’ve seen it happen time and time again that differs from the American Academy of Pediatrics recommendations. And now there’s a movement to do that with this vaccine as well. What impact would that have on inoculation rates? Is it better to space them out and get the vaccine, or to mandate the … you have to do it within the 3 weeks.

Offit: Well, no, I don’t think it has to be mandated that it has to be done within 3 weeks. If you get dose one and then you get dose two 4 weeks later, 5 weeks later, 6 weeks later, I don’t think that’s a problem. Regarding, say, the flu vaccine … the CDC has come out and said that you can get those two vaccines at the same time. If someone wants to wait 2 weeks between, you know, getting one vaccine and another, I don’t think that’s a big deal. But, there’s no real reason to do that right now.

Marshall: Do you think parents are going to be going to the pharmacy for their kids’ shots? We know pediatricians are where the vast majority of kids get their vaccinations. But historically with COVID it’s been more in the pharmacy. Is that going to work against hitting those vaccination targets?

Offit: I think the whole point of the 5- to 11-year-olds’ vaccine was to make it more convenient for the pediatrician. So the formulation has changed. No longer is the Pfizer vaccine buffered with something called phosphate buffered saline, rather it’s buffered with a Tris buffer, which then makes it very stable at refrigerator temperature, meaning stable for 10 weeks of refrigerator temperature, where, previously, it was much shorter than that.

So that, and the fact that it doesn’t have to be shipped and stored on dry ice also makes it much easier for the pediatrician to do this. So, I think that the 5- to 11-year-olds are probably best served in the pediatrician’s office because that’s who the child trusts, that’s who the parent trusts. And that the pediatrician then can explain what the parent needs to know or the older child needs to know about this vaccine.

Marshall: Within those formula changes — you mentioned earlier that this dosage is only one-third of the adult dosage. We talked earlier about the efficacy. It doesn’t sound like it changes the efficacy at all, but is it something the parents should be concerned about in any way?

Offit: No, it’s something they should be happy about. The dose-ranging studies: the phase I study showed that if you looked at 10 mcg, 20 mcg, 30 mcg, at least in that younger age group, 10 mcg was good enough to induce an immune response. It was likely to be protective. In addition, the company did studies looking at the 5- to 6-year-olds and compared to the 7- to 8-year-olds and 9- to 10-year-olds, the 11-year-olds, to see if there was any difference in that dose’s capacity to induce an immune response based on whether you were littler or bigger.

And, not surprisingly, there was no difference. The geometric mean titers of neutralizing antibodies was the same across the age range of 5 to 11 years of age. So, that should also be reassuring.

Marshall: What if somebody has a child that’s 11, should they wait then, and get the higher dosage? If their kid’s almost 12? Or go with the one-third dose?

Offit: No, I mean, get vaccinated now. And then if they, their birthday, for example, happens to straddle that 3-week interval where they’re 11 [at] dose one and they’re 12 [at] dose two … You can get the higher dose when you’re 12. But, again, if they got the 10 mcg dose when they were 11, and then when they just happened to turn 12, also got a 10 mcg dose, they still can consider themselves to be fully vaccinated.

Marshall: Do parents need to worry about the size of their child? Is that something that the pediatrician would determine?

Offit: No. See, vaccines don’t really work like that. I mean, if you take a drug like amoxicillin, an antibiotic, you have to have a certain amount of that drug in your bloodstream in order to effectively fight a bacterial infection. Vaccines don’t work that way. It’s not a matter of how big you are or your bloodstream. So often the doses that are given to children are the same doses that are given to adults of different vaccines. Because what you do is you inoculate the arm with that particular vaccine, the vaccine then is taken up in a local draining lymph node where it’s processed and presented to the immune system. So size really doesn’t matter.

Marshall: Okay. Do we expect then this vaccine to be added to the list of mandatory vaccines given to children to enter schools?

Offit: I guess we’ll see how things move as we move forward. In a better world, we wouldn’t need mandates. And, first of all, I wish we had a better word. Maybe we could call it, like, good health requirements.

I mean, if you look at the data on this, I think any reasonable person would get these vaccines. You shouldn’t have to feel compelled to essentially coerce people to get a vaccine through mandates. But, we’ll see.

I noticed that there were some governors who have said that. In a better world, again, people … and as children enter schools and as teachers enter schools, because it’s so important to have an onsite education. I mean, we learned that lesson the hard way last year. That we would do everything we could to preserve onsite education, which means getting vaccinated. So, hopefully it really shouldn’t come to that.

Marshall: But we’ve already seen exemptions for things like the measles vaccinations run rampant through different sections of the U.S., through different sections of the world, Italy, for example. So, you see those exemptions for those vaccines, and so you could anticipate perhaps the same school exemptions for COVID.

Offit: We’ll see … I mean, in the 1970s they were put in place in all 50 states, vaccine mandates for school entry. And then, you know, about 10 years into that, you started to see exemptions. Like, initially, the religious exemption, then a philosophical exemption. And so all but two states had some sort of exemption, either philosophical or religious, or both. Every state except Mississippi and West Virginia.

But what’s happened is because there’s been outbreaks of measles, you’re starting to see states fight back. So there were initially only two states that had only medical exemptions. Now there are six states that only have medical exemptions. So people are getting a little tired of the fact that we can prevent these diseases, and a critical percentage of parents are still choosing not to prevent them. And so they’re starting to eliminate the option to choose not to vaccinate your children.

Marshall: Are there concerns for parents with this vaccine, with children who have pre-existing conditions of any kind?

Offit: No, there’s really not a contraindication to getting this vaccine. Other than a child who has, for example, severe allergic reaction to the first dose. That’s the only current contraindication.

Marshall: A friend shared with me, Dr. Offit, you might find this as interesting as I did. How their kids were comparing when they were getting our “shot days.” That excitement over a child getting a vaccine. And that doesn’t happen very often. So is this a signal to children that, “hey, you’re going to get your life back?”

Offit: I hope so. I mean, I think a child who’s well versed on what’s going on out there will know that vaccines are our ticket out of this pandemic. They’ll know that when they walk into school with a group of children, many of who have not have gotten vaccinated or aren’t wearing masks, that they can be protected.

I’ll tell you a story. There was a fellow who worked in our division who had a nephew that was between 4 and 6 years of age that was about to go get the four or five shots that you get at that age group, in that age range. And so she explained to him how vaccines worked and what he could expect. And then she goes with him to the doctor’s office to watch this happen. So she’s sitting outside in the waiting room and she’s a little nervous about how her nephew is going to handle this. And then the door swings open and he walks out and he puts his hands up in the air and says, “I’m immune.” That’s his attitude.

Marshall: That is the attitude we’re kind of seeing in some of these groups. So does that mean the second semester of school will look different for kids in the spring? Masks could come off?

Offit: Well, yes, I think that’s right. I think that if you can get to at least 90% vaccination rate in a school, in a classroom, that you can take your masks off. But, again, maybe that can serve as an incentive, although I don’t think children seem to mind wearing masks much, as much as their parents seem to mind them wearing masks.

But, I like to think you have 28 million children between 5 and 11 years of age, that all of them will get vaccinated. But I think that’s not going to be the way this is going to play out. I mean, if you look, we’ve had a vaccine available for now for many months, for the 12- to 15-year-olds, but only about 45% have been vaccinated. Which means more than half haven’t.

And, you know, in our hospital, Children’s Hospital of Philadelphia, we see occasionally children over 12 years of age, who come into the hospital, who come into the ICU, and invariably it’s because they’re not vaccinated. And their parents aren’t vaccinated. It’s really hard to watch. This was hard enough last year to watch when we didn’t have a vaccine, it’s even harder this year.

Marshall: So that decision on masks coming off is really going to be on a case-by-case basis, because, I mean, getting 90%, that’s a huge metric. Considering the statistics you just laid out.

Offit: Right. But you know, considering how clearly these vaccines work and how safe they are and how a choice not to get a vaccine is a choice to take a more serious risk, it shouldn’t be hard at all. In a better world. It shouldn’t be hard at all. We seem to have more problems in this country than in other countries, because in some ways, somehow this has become a political statement.

Marshall: We talked about the risks that are associated with COVID right from the get … but parents might still say that risk isn’t that big of a deal. One of the things they’re worried about is the long-term impact of the vaccine, but one of the things we haven’t really talked about is the long-term impacts of COVID — long-haul COVID in kids. What are you seeing when it comes to that?

Offit: That’s right. About 8% of children who suffer this disease can go on to develop longer-term symptoms that last for weeks. And, again, you know, parents have a view often, and, I think, among them, you just never can imagine that something bad would happen to your child. I mean, my children, not surprisingly, are fully vaccinated. But I never could imagine something bad would happen to them. And people tend to think of their children as invulnerable in that sense. And so they choose not to vaccinate them.

And if you look at these parent activist groups, like Families Fighting Flu, Meningitis Angels, National Meningitis Association, these are parents whose children either suffered or died from a vaccine-preventable disease. And they all tell the same story. They say, I can’t believe this happened to me. Until it happened to them. And so, don’t take the chance. I mean, you’re playing a game of Russian roulette. And although it doesn’t have one bullet and five empty chambers, it probably has 10,000 empty chambers, why take that risk?

Marshall: What does long COVID look like in kids?

Offit: It looks like persistent fever, sometimes it’s low-grade fever, brain fog, muscle ache, you know, confusion. It’s a little frightening.

Marshall: Yeah. And so younger kids, you know, that’s the next group, under 5. When do we expect a vaccine for that age group? And do parents who have kids that are under 5 and in this newly vaccinated cohort need to still worry about protecting the unvaccinated child?

Offit: Sure. Certainly children can get disease, even in the first couple of years of life. And there are studies being done now looking at children between 6 months and 5 years of age. Those data hopefully will be generated by early next year. I know that the studies are being done at least for Pfizer’s vaccine, where they’re not using the 30 mcg dose that was used in adults or the 10 mcg dose that is being used in the 5- to 11-year-olds, but rather a 3 mcg dose, so one-tenth of the adult dose is being used in that age group.

Marshall: When do you think that vaccine will become available?

Offit: I don’t know, hopefully by early next year. We’ll see … it’s hard to read the tea leaves.

Marshall: Yeah, definitely. I’m asking you to predict the future. Will that come out for just under 5, or will that be staggered to like 2 to 5, and then zero to 2?

Offit: No, I think it’s going to be … it’s a guess, but 6 months to 5 years of age. We’ll see.

Marshall: Okay. And then under 6 months, probably not getting it because you don’t get your flu shot until 6 months, correct?

Offit: That’s right.

Marshall: All right, now do we expect this vaccine to have a booster or will this be something that parents are going to have to get their kid inoculated against every year, like the flu?

Offit: It depends on what we want from this vaccine. If what we want from this vaccine is for children to be protected against serious illness, meaning the kind of illness that causes them to seek medical attention or go to the hospital or go to the ICU, I’m not sure we really are going to need boosters. If, on the other hand, we’re trying to constantly keep up the level of virus, specific neutralizing antibodies, which will protect against asymptomatic or mildly symptomatic infection, then we may need boosters, but we’ll see how things get defined over time.

Marshall: Thank you, Dr. Offit, such an interesting conversation and something we’re going to be continuing to watch as the vaccine rolls out across the nation.

Offit: Thank you. It was my pleasure.