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Lizzie O'Leary: It's The Takeaway. I'm Lizzie O'Leary, host of the podcast, What Next TBD from Slate, in for Tanzina Vega this week. With around 32% of the population in the US fully vaccinated and 44% partially vaccinated, demand for the COVID-19 vaccine has begun to wane, but there's a huge chunk of the population for which no vaccine has been approved, at least not yet, and that's children.

Currently, in the US, anyone over the age of 16 is eligible to receive a COVID-19 vaccine. The Pfizer-BioNTech vaccine has been approved for use in people as young as 16, while both the Moderna and Johnson & Johnson vaccines are approved for ages 18 and up, but what about the youngest people among us?

Dr. Zinaida Good: Although the kids are at low risk of severe COVID-19, they're not at no risk.

Lizzie O'Leary: That is--

Dr. Zinaida Good: Dr. Zinaida Good and I'm a research fellow at Stanford University. We have two kids, Andel and Soren. Soren is just eight months and Andel is three years old. We love them very much.

Lizzie O'Leary: Thousands of children, some as young as six months are currently participating in vaccine trials. Dr. Good's two children are participating in the phase one trial of the Pfizer vaccine at Stanford.

Dr. Zinaida Good: This is an open-label trial where you know what you get, where all kids get the vaccine at one-tenth, one-third, two-thirds, or a full-adult dose. Both kids did great after the first dose of the Pfizer vaccine and had no notable side effects. My three-year-old will have the second vaccine tomorrow and the baby will get the second one next week. It'll likely prevent them from spreading the virus as fully vaccinated adults spread the disease about 90% less according to a recent study by CDC.

Lizzie O'Leary: Last night, the Associated Press reported that the FDA is expected to grant fast track approval to Pfizer for kids age 12 and up in the next week. For more on these trials and when we can expect to see vaccines more widely available for younger Americans, I'm joined by Dr. Miriam Laufer, pediatric infectious disease specialist at the University of Maryland School of Medicine Center for Vaccine Development and Global Health. Dr. Laufer, thanks for being here.

Dr. Miriam Laufer: Great to be here. Thank you.

Lizzie O'Leary: The FDA is soon likely going to authorize the Pfizer vaccine for kids ages 12 to 15. How significant will that authorization be?

Dr. Miriam Laufer: It's a very good question. This is a much-awaited authorization for those of us with school-aged children who we are trying very hard to get back to some sort of regular school life. The truth is this will increase the availability of vaccines for a small segment of the population, right about a four-year age range. I think it's important for a number of reasons.

One, it will show further confidence in the safety and efficacy of these vaccines. What we see in this pandemic is there is just a limit to how much our behavioral interventions have been able to stop the spread of COVID-19, and it's really with widespread vaccination that we'll be able to get rid of the, at least the pandemic nature of this infection and allow us to return to regular life.

Certainly, school-aged children, or at least in this age group, are a population that don't have a huge burden of severe disease and death but we do know that they have a lot of infections. They're certainly responsible for transmission of COVID-19 to their older adult family members. In addition, I think this could represent a great opportunity for schools to reopen with more confidence and being able to resume activities that seem to be much more a normal part of school life.

Lizzie O'Leary: Do you think that most States are going to be able to make this available to kids who are 12 and up or is the supply not there yet?

Dr. Miriam Laufer: That's a great question. If you had asked me this a few months ago, I would have said states will not open up vaccine to children under 16 years of age because there'll be too busy vaccinating adults. What we're seeing now is that there is adequate supply and we've created these massive infrastructure systems to vaccinate huge numbers of people, stadiums, convention centers. Given the ability to vaccinate large numbers of people and the unfortunate case where the supply is adequate if not exceeding the demand, I do think it will be, let's just say an easy lift for states to expand the age range of people that are available for vaccination. That's my guess at this point.

Lizzie O'Leary: Schools obviously require proof of vaccination in most cases for kids to come to school for a whole bunch of different diseases. Do you expect that there will be a similar requirement for these more novel vaccines?

Dr. Miriam Laufer: I have two opinions. There's two ways of looking at this. One is that we're in extraordinary times with a pandemic that is essentially raging out of control with the one intervention that we think will be the key to getting it under control and to safe reopening of our regular life and that's vaccination. If you look at it that way, I do think schools will require vaccination in order for children to come back to school, the 12 years old and up. Just like other vaccines, there will be ways to get exemptions from that requirement.

I suspect, assuming the ACIP that makes the recommendation for vaccines does recommend the vaccine for this age group, that it will be if not either encouraged or a requirement. We're seeing this in universities as more and more universities are requiring vaccination for students and faculty to come back onto campus.

On the other hand, this is not yet a fully FDA-approved vaccine and so it's not in the same category as, for example, our measles vaccine which has already gone through the complete review process that COVID-19 vaccines are under emergency-use authorization. They had a very thorough but more sped-up review because of the emergency need of the vaccination.

Lizzie O'Leary: What about younger kids? I know there are trials underway right now. What do you think the timeline is for children who are under the age of 12?

Dr. Miriam Laufer: We have a few different trials that are going on now. One is to include other vaccines that would want to expand their age group. The Novavax vaccine and the Moderna vaccine both are looking to expand their age group to the 12 and up age group. In addition, there's now vaccination, there are now vaccination trials for the under 12-year-old group.

The way that we safely do vaccine trials in children is always what we call age de-escalation. We start with the teenagers and then we move down because presumably, as children get younger, they're more susceptible to adverse events, and then the other thing we'd need to find out is what the correct dose is of the vaccine. Obviously, a 15-pound one-year-old will not require the same dose as a 160-pound adult. We use the lowest possible dose we can think of and then increase as we need to see how much of the dose is needed to get a good immune response and to make sure it's safe in that population.

Because there's a lot less disease in younger children instead of having an endpoint of COVID illness, which has been the endpoint for adult trials, it was looked at in these adolescent trials. The endpoint for the vaccine trials will be just looking at the antibody response, how well your body responds to the vaccine and makes antibodies to fight the virus. That makes it a little bit easier because we don't have to wait and see if anybody gets COVID-19 illness. On the other hand, we're very careful with pediatric vaccines, and the march down from let's say the 10 and 11-year-old, getting us all the way down to the six-month-old will take some time because we're monitoring the safety so carefully.

Lizzie O'Leary: I'm thinking about vaccine hesitancy in parents and children. My mom was a polio pioneer. She marched into her second-grade classroom and got the shot and her parents were completely fine with that. We are obviously in a very different scenario now. Do you expect that we may see some vaccine hesitancy among parents of younger kids, even parents who are completely fine for their children to get the standard battery of vaccines?

Dr. Miriam Laufer: I think it's possible. We're in a time that is just generally, I think, panicked about public health and while some of us respond to that by saying we're going to do everything we can to stem this pandemic, I think there's just a lot of concern and worry that maybe we're wrong. I think there's that level of concern. I do want to just re-emphasize that these vaccine trials, although done amazingly quickly, were done with exactly the same rigor as all other vaccine trials for FDA-approved vaccines. I do feel that the science does support the fact that the vaccines work extraordinarily well and that they are safe.

Lizzie O'Leary: Given that children have generally seen less severe disease and we are thinking about the global burden of vaccine, does it make sense to be vaccinating otherwise quite healthy preteens and teens, when there is a real crisis in other parts of the world and vaccine rates of 2% and 3% in countries where there are a lot of vulnerable adults?

Dr. Miriam Laufer: I think that's-- [chuckles] If I said it was a $100 million question, that wouldn't even be enough to capture it. There's two elements to that question. One is should we be vaccinating in this country younger children. It's true that they are less likely to have severe disease or die from COVID-19 infection.

There is this phenomenon of multi-organ system failure in children as a result of COVID-19 but they don't see nearly as much severe disease and death as older adults do, so then why should we vaccinate them? The answer is for us to stop COVID-19 transmission. To make it so that COVID-19 is no longer spreading rapidly in this country, we will need to have everybody vaccinated and not have anybody carrying the infection even if they're well.

In fact, the people who carry infection when they're well are, we don't know how effectively they spread COVID-19 but we know that they are spreading COVID-19 because they're not sick and so they're not staying home and they're going out there in the community.

Lizzie O'Leary: Dr. Miriam Laufer is a pediatric infectious disease specialist at the University of Maryland School of Medicine. Dr. Laufer, thank you so much.

Dr. Miriam Laufer: Great to be here. Thank you.

Lizzie O'Leary: Now it's your turn to weigh in.

Susanna: This is Susanna in Aiken, South Carolina. I'm planning to get my kids vaccinated because they want to go to camp this summer and I'll feel a lot better about sending them if they're vaccinated.

Heidi: Hi, my name is Heidi Williams, and I live in Hillsboro, Oregon. I will absolutely be getting my two children vaccinated as soon as it's available to us because I believe in science. Our children have always been vaccinated. I see no reason why we should not continue. There's really no controversy around the vaccine except for things that have been drum up with politics in mind. Let's send our kids out there with every opportunity they have. I think the opportunity to resist a deadly virus is a no-brainer.

Lou: This is Lou from Northern Wisconsin. As a former medical professional, I believe in science and I will wait until proper time that would have been given for a proper trial for these vaccinations. I'm surprised at the medical professionals who are going ahead and getting the vaccines. I understand the fear behind it but I also respect the science behind a proper trial.

James: James calling from Dover, Ohio. Would I get my children vaccinated for COVID-19? Absolutely not. I don't want my children being test subjects for a vaccine that we do not know the long-term effects of. Also, one of my children have already had a mild case of COVID-19 and it didn't seem to affect her very much. Getting a vaccine that we know little about is not worth the risk of them actually getting COVID-19.

Ryan: This is Ryan from Ogden, Utah, and we will be getting our children vaccinated as soon as possible except for our 11-year-old daughter who has type one diabetes. We will wait just a little longer to get her vaccinated just to see if there are any potential side effects.

David: Hi, this is David from Cleveland Heights, Ohio. I am calling about getting my child vaccinated. She's 10 years old and I am very much looking forward to opportunities to get her vaccinated. She is too because she wants to be protected enough and be able to protect the rest of the family who are vaccinated. She plays with other kids who are also not vaccinated, some of whose parents are not vaccinated. I have not been able to find a way to get her vaccinated yet. I hope to have that opportunity soon.

Carol: Hi, this is Carol, I'm in Vancouver, Washington. My answer is yes, I'm looking forward to getting both my nine and 13-year-old vaccinated when they're eligible for a safe and reliable vaccine option. Until then, they are still remote learning and not participating in team sports.

Pat: For us, it's the grandchildren that need vaccination. The 17-year-old got vaccinated on the first day of availability and we're anxiously awaiting the emergency use authorization for 12 to 15-year-olds. Why is it taking the FDA so long? This is Pat from San Jose.

Lizzie O'Leary: Thank you so much for the honesty. We appreciate you being a part of our show every day. If you want to talk with us, remember you can call us at 877-869-8252. That's 877-8-MY-TAKE or record a voice memo and email it to us at takeawaycallers@gmail.com

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