FDA Chief's Take on Child Vaccines, Boosters, and Antivirals

[MUSIC PLAYING] Welcome, everyone. I'm Dr. John Whyte, chief medical officer at WebMD. And you're watching Coronavirus in Context. Today, we're joined by the acting commissioner of the US Food and Drug Administration, Dr. Janet Woodcock. Dr. Woodcock, thanks for taking time this afternoon.

Great to be here.

Let's start off with the issue that everyone is talking about, vaccination for kids ages 5 to 11. So I want to just put it out there what people are talking about, and give you a chance to respond. So some of the criticism is there weren't enough kids in the trial, roughly 2,200. Even though it was not a 1 to 1 ratio, that's still not a lot of kids to make this type of decision.

Well, you know, this vaccine has gone into over 100 million people, including adolescents down to the age of 12. So with the younger kids, we're looking for what is the right dose because they're smaller, and also do they have any different side effects. No matter how large a trial we had, a very rare side effect might not go detected in a trial. But the kind of trial that was done would let us know if there was anything unusual or different about this vaccine in the younger kids than in the teenagers or the very large number of adults that have received this vaccine.

What about the criticism that people say, we really don't know the risk of myocarditis? That's often what people are talking about. If it's 1 in 50,000, we're not going to see it in this trial. The panel discussed this, and found that the benefits far exceed any risks. What's your response to parents who say, well, we're really not sure what the side effects are, we should wait a while?

I understand the hesitancy. I'm a parent. But this vaccine has really gone into a large number of people, if you look at everyone. And although children don't get severe COVID as often, we've had many, many cases, thousands of cases of multisystem inflammatory syndrome. Kids have to actually be hospitalized, and often get into the ICU. Also, kids can get long COVID. And there have been deaths in this age group. And of course, any death of a child is a terrible tragedy.

What do you say to parents who say, well, it's only two months, and we need a longer time period? I thought it would be interesting for you to compare it to other trials that we do on vaccinations. Isn't two months, in general, the time frame that we look at for any other vaccine?

Well, any of these trials may have extensions, where you do a longer-term follow-up because you're looking both at does the immunity wane over time and do you see anything late. But with vaccines, we know that most of the side effects you're going to see are in the first few weeks after vaccination, particularly the kind of side effects that are immune-related and so forth, because that's when the immune response actually happens. So I think we have followed both the government and other countries' governments, and the companies have followed recipients of this vaccine for quite a long time. And we pretty much know what-- we don't see anything unusual later on.

I'm going to ask this question, so I'm going to give it to you. What do you do if your child is 11 and 1/2?

Yeah.

Do you give them the third dose, or do you give them the full dose?

Sure. Well, we've talked about this internally. And I think either one. If you've ever looked at a class of 11-year-olds, they're all different sizes. Some of them are taller than me, right, and some of them still look like really little kids. So I think talk to pediatrician or the health care provider, and you can decide what's appropriate for that child.

Let's talk about boosters. That's the other thing everyone is talking about, who should get a booster and when. So I want to pose that to you, Dr. Woodcock. Who should get a booster and when, and does it matter which one you get?

Well, you know, what we have put out there and CDC has agreed with is you can get whatever vaccine that is authorized or approved in United States as a booster. You don't have to take the one that you got originally for the first two, or one or two injections. People who got the J&J, they got a single injection, they should go ahead, if they're more than two months out, and get a booster. People who have had the other two mRNA vaccines should go ahead and get a booster after a longer period of time. As far as who, you know, everyone over 65 and then people with co-morbidities or people who are working in occupations where they are exposed frequently are all recommended to get a booster.

What about for the general population? There's been talk and Pfizer has announced that they're going to seek authorization for everyone to be able to receive a booster, independent of age, for the mRNA vaccine for them. Other people have been talking about it's going to be age 40 and above, irrespective of other health conditions. What can you help tell us in terms of where we are in boosters for a broader population?

Sure. Well, you know, right now, the recommendations really would apply to a very large amount of the US population because many of the adult population have certain co-morbidities. However, it doesn't apply to everyone. And what you're thinking about here and what the health authorities are thinking about is, OK, in those younger age groups, is immunity waning significantly versus what is their risk of experiencing, say, myocarditis or a side effect, particularly in younger age groups. And so you're balancing those two things and making sure that everybody has a positive benefit from getting a booster shot.

So we'll look at the data when it's submitted. And we're watching waning immunity in the United States. And that will help us determine whether or not everyone should get a booster at some point.

Do you expect that decision to be made before the end of the year?

It depends on what data we see, how the data come out. It's quite possible that the age could be extended lower if you see that younger people are getting breakthrough infections that are making them sick.

JOHN WHYTE: But the advisory panel even on the last recommendation around boosters for the mRNA vaccine was by no way unanimous about broadening it too much. A lot of debate back and forth. Would you expect that to again be the issue, as we're talking about a broader population that doesn't have underlying health conditions? It really allows us to discuss what are our measurements for waning immunity, what does that mean about breakthrough infections, what's the role of vaccination in general. We can't be boosting ourselves every six months, can we?

Right. Well, we have some natural experiments where other countries are boosting their entire population. And we're going to be getting data from there, both on the side effects and what that did to the pandemic in those countries. We're also going to get more-- this is a dynamic situation, and we're watching the people who are vaccinated in the United States who are younger and seeing, like, are they becoming more vulnerable to more severe COVID breakthrough infections. And if so, obviously then they should probably get another vaccination.

Now, to your other point about will we have to get boosted all the time, we don't know yet. It may be that you get a boost like this, and you've had enough to have really durable immunity, or it may not be. Or we may get a variant that escapes some of the response to this vaccine, and then people might, like influenza, have to get a slightly different vaccination.

Well, it has been an argument that the boosters should be reformulated, and not simply be the same one that someone got at the beginning of the year. Is there some validity to that?

Well, these immunogens in the vaccine seem to be slightly less potent against the Delta variant than they were against the original variant, where they were constructed. But it's not that much of a difference. Most people, most scientists are looking at this belief that the breakthrough infections we're seeing are from waning immunity, not from the fact that we have a slightly different variant.

Let's turn to treatment, therapeutics. And there's been some encouraging data from both Merck and Pfizer about the use of various antivirals. Some are old drugs that are being repackaged that were used for HIV. Some are new. Where are we in terms of the FDA review of some of these potentially new therapies to treat COVID?

All right. Well, the first one, molnupiravir, the FDA is going to have an advisory committee at the end of this month to discuss that agent. That is polymerase inhibitor, yet was repurposed from its original development, I think for influenza. The other drug that's been in the news lately is simply that Pfizer announced that their protease inhibitor had a significant impact on hospitalizations when it was given to outpatients early in infection.

So of course, everyone has hoped that we could have a small molecule antiviral that would be oral. It could be used in outpatients. That would be a tremendous advance because, as you said, there are going to be breakthroughs even if people are vaccinated. Some people don't respond to vaccination and so forth. So we need a variety of tools in the toolbox.

And then finally, Dr. Woodcock, you and I have been talking through a series of interviews over the past 18 months. How much longer are we going to be talking about COVID? How do we decide when the pandemic is over? No one's suggesting that we're saying that it's over right now, but what metrics do we use to decide that it's over?

Yes. Well, I mean, there are multiple scenarios. One is the pandemic becomes endemic, that enough people have been exposed or resistant that it just is circulating around at lower levels, and is not completely interfering with the process of society. Another scenario of concern is the fact that many areas of the world, people are not vaccinated, have very low vaccination rate. And the fear is that we may see variants arise that are resistant or more virulent or more transmissible or both.

Another scenario might be we find a more transmissible variant that is very transmissible and not very virulent. That would be terrific, right? Then we just have another respiratory infection that people would have to deal with that wouldn't be so devastating.

So I don't think we know how we're going to come out of this. And there are various paths that could be followed. And what we need to do, at least what FDA needs to do, is make sure we develop and help develop all the tools that can be brought to bear.

Well, the FDA processes have never been so public as they have over these past 18 months. What impact do you think that has had, in terms of the FDA and its interaction with the public, in terms of people are kind of seeing how decisions are made? Is that helping? Is it hurting? Is it promoting political discussion? How would you say the impact has been?

I've always been a big fan of transparency, and I think it's very helpful. However, I think there's an overlay here both of political opinions and misinformation that is very difficult for everyone to deal with. And so the transparency of the FDA is alongside of other information channels that are putting out a lot of misinformation. And believe me, I hear it. I hear a lot of it, because transparency works both ways. I hear from the public a lot. And there is a tremendous amount of misinformation out there that's being very diligently disseminated. And so in that regard, although we're trying to be extremely open, we aren't always believed. And same with many other public health institutions and experts.

Is it getting worse?

I believe so. That's hard for me to say, John. You have your finger on the pulse of the media probably better than I do, but it certainly isn't very good that two years ago, say, the hope was, OK, we'll get vaccines and we'll get this all under control and so forth, and yet instead we find ourselves in a state where a large number of people, adults do not wish to get vaccinated because of what they've heard. And so we continue to have this epidemic flourishing, with people in hospitals. We have a lot of deaths every day. And that's not a good situation.

What keeps you up at night?

Well, I mean, I think the worst-case scenarios the biggest concern, that we'll get a resistant variant that'll still be virulent and arising in some population that is not vaccinated. And then the pandemic can start another wave across the world.

But we're more prepared now than we were before?

I think everyone has learned a lot. We're prepared, but we're also very tired. And I think the health care workers, public health apparatus, and the supply chains are all very strained right now. And so although we may have a better understanding of how to deal with this, we've exhausted a lot of human and other resources as we've gone through the last 18 months.

Dr. Woodcock, I want to thank you again for taking the time to help explain the science behind the decisions that you all are making, and to inspire confidence in terms of the regulatory process.

Thanks very much. Great talking to you.