FDA on COVID-19 Vaccines for Kids, Boosters, and Treatments

John Whyte, MD, MPH; Janet Woodcock, MD

Disclosures

September 02, 2021

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JOHN WHYTE: Welcome, everyone. I'm Dr. John Whyte, the chief medical officer at WebMD, and you're watching Coronavirus in Context. Are we going to need boosters for sure, when are we going to see vaccination for kids under 12, and what is everyone talking about in terms of ivermectin?

To help answer some of these questions, I've gone straight to the source. My guest today is Dr. Janet Woodcock. She's the acting commissioner of the US Food and Drug Administration. Dr. Woodcock, thanks for joining me. It's nice to see you again.

JANET WOODCOCK: Great seeing you.

JOHN WHYTE: Dr. Woodcock, let's start off with the biological licensing application for Pfizer. It's now fully approved their vaccine for people 16 years of age and older. You mentioned, in a media conference call, that this was a game changer. Really a big deal. Why does full approval matter?

JANET WOODCOCK: Well, I think this is a milestone in our fight against COVID-19 we have now a vaccine that's fully approved by the FDA. There are groups of folks out there, polls have shown, that were holding out, waiting for a full approval before they would get vaccinated. And we know the most important weapon we have against this virus and the way to control the pandemic is to get as many people vaccinated as possible. So this is yet one additional step in making that fight be effective.

JOHN WHYTE: What do you say to critics that say what took so long, what's different? Because, let's be honest, many people don't understand the FDA process. So what did the FDA have several months ago when they authorized the vaccine that they got to enable them to give full approval?

JANET WOODCOCK: Well, that's a great question, John, because so many other people are asking how did it happen so fast? And the answer to both is this: When we did the emergency use authorization, the trial was still ongoing. We had very good data on a large number of people that we knew the vaccine was effective based on the reduction of cases of a virus, and we had a good safety information. But the trial was still ongoing. We didn't have a lot of long-term safety data, and we didn't have many of the other things that you have for approval of a biologics license application.

That trial gathered more data, we have more people vaccinated, we got more safety data, follow-up data, and we also got a tremendous amount of real-world evidence, from hundreds of millions of people being vaccinated, and CDC, FDA, and regulatory agencies around the world are watching the adverse events and monitoring that administration. So all of that information and including additional manufacturing information, additional inspections, so forth, were done so that the vaccine approval for scientific standards that the FDA has for all vaccine products.

And so some people are saying they can't understand how it happened so fast, other people are saying they felt it took too long. And in fact, we work with all due speed. We make no shortcuts. We didn't cut any corners. We did everything according to our standards. However, it did take a while to get through hundreds of thousands of pages of data and make sure that all those requirements were met.

JOHN WHYTE: Let's talk about kids. Three hundred kids are hospitalized today. That's not something that we saw even at the height of the pandemic. Everyone wants to know about where are we in terms of timing for vaccination for kids under 12. Previously, FDA officials had said that vaccination for kids under 12 would go to an advisory committee. Has there been any final decision made about the role the Advisory Committee in terms of reviewing the data for kids under 12?

JANET WOODCOCK: Well, I think whoever said that said it because it may be likely that we would need to have a public discussion with our advisors about children under 12. I can't speak to when such a review might take place and be finalized. Obviously, we are going to move with all haste for the younger children when we get applications, and we will get them in the lives as quickly as possible. But children raise additional questions they're not small adults, as we've learned over the years. They have to be studied separately. They will need different dosage forms, lower doses, and they might have reactions and safety issues that could be different than adults. And so all these questions are going to depend on the data and what is actually found in the trials.

But as soon as we get that information from the companies, we will jump on it. I've been hearing from parents around the country every day how important it is to them to get their children vaccinated as soon as possible as they get back to school.

JOHN WHYTE: Now, because Pfizer is fully licensed, there are some advocates who are saying that Pfizer should be used off label for kids under 12. What's your message to those parents who are thinking that's a good idea or those pediatricians and there are some out there and they're saying it's legal to do so that are considering vaccinating kids under 12 off label?

JANET WOODCOCK: Yes. Well, there are two separate kinds of considerations. The first is, it's really not appropriate because, as I just said, you may need different doses that is extremely likely and we don't have the safety information on the younger age groups. And until we get those squared away and we understand both proper dosing for younger children and the safety profile of the vaccine, as well as its efficacy profile, it would not really be appropriate to expose children to the vaccine.

The second issue is, unlike most drugs that can be used freely off label by clinicians, this vaccine is being distributed by the U.S. government through the CDC and there's a provider agreement in place. And under the provider agreement, there are certain protections, liability, and so forth that adhere to that. If you deviate from that, then these things may not be the case, even compensation potentially for someone who suffers an adverse event. So I would refer people to the CDC for further information on that. But those are additional considerations. This isn't just like a drug that's available for use in the public.

JOHN WHYTE: But, Dr. Woodcock, I'm going to go back to it. Everybody wants to know. Parents want to know, school districts want to know, Dr. Fauci has said he expects there to be vaccination of kids under 12 perhaps by the end of the year, or early winter, do you think that's realistic?

JANET WOODCOCK: I would certainly hope so. But it depends on trials getting done, that the results are favorable, that we feel comfortable, everyone feels comfortable, that the new safety questions do not arise, that the companies are able to manufacture the dosage forms and have them available, and so forth. But everyone is trying their best because we understand the urgency of getting children under 12 vaccinated, if that actually is feasible.

JOHN WHYTE: And it's been publicly announced by the manufacturers and you referenced it in a media call on the BLA that the trials are still being conducted. It is not correct, as you just point out. So we still need to get those trials done in time.

JANET WOODCOCK: Correct. That trials have to be done. There is some safety follow-up and some trials are still inoculating children, so they're in different phases and they need to be completed. And we really need that information before we start exposing children to these vaccines.

JOHN WHYTE: I want to talk a little bit about treatment. You headed up Operation Warp Speed, great success on vaccines. In terms of therapeutics, it's been a little bit mixed. In terms of convalescent plasma and severe monoclonal antibodies has been a success story, hasn't it? Are there other success stories in terms of therapeutics treatments for those persons who still get COVID?

JANET WOODCOCK: The early treatment with monoclonal antibodies is very protective of progression of disease. And the vast majority of people you could prevent progression to hospitalization and even death by getting early treatment with a monoclonal. The problem is, of course, the administration of that is difficult and it isn't always a standard practice everywhere. Utilization of them has picked up quite a bit though, and I think that's decreasing hospitalization. And when we develop the monoclonals, we specifically had in mind the idea that even once that effective vaccine was available, certain immunocompromised people may not respond to the vaccine, and we will still have people getting sick into the monoclonal antibody treatments if used early or effective.

JOHN WHYTE: Let's acknowledge the elephant in the room, ivermectin. You know this data, but I want to share with our audience. Eighty-eight thousand prescriptions a week, normal is 3,600 a week, at 2,400 increase and five times the number of calls to poison centers. We'll put up on screen, the FDA put out a creative social media post, not typical, reminding people that they're not a horse, not something we typically see with FDA.

Here's your opportunity to talk to the public, to talk to doctors. Because, let's be honest, some doctors, many doctors are prescribing ivermectin to their patients. What about people that say, what's the harm, Dr. Woodcock? Why can't they just try it? What's your message to them?

JANET WOODCOCK: That there are not data that show that ivermectin is effective, and there are data --there is a rather large trial done in South America that really doesn't show an effective ivermectin or the progression of the disease.

JOHN WHYTE: In terms of physicians, do you have a message specifically to those prescribers who are thinking, well, what's the harm? There's the opportunity cost as well, correct?

JANET WOODCOCK: That's right.

JOHN WHYTE: If that doesn't work, where they could have been taking something that actually is effective?

JANET WOODCOCK: So I simply believe that ivermectin should not be prescribed either to outpatient or inpatient outside use in a trial setting, period.

JOHN WHYTE: Dr. Woodcock, one of the questions that we're getting asked a lot is around boosters. Let's talk about boosters for the general population, not those folks that are immunocompromised that we've already talked about the data that supports its use in boosters. Now, some people are suggesting that the FDA is getting ahead of the science. And the White House had announced that we're going to be giving boosters in late September. You and Dr. Walensky were part of this press release. And then there is the line that it still has to go through the FDA and the CDC, ACIP, etc., but you all are the chiefs of those agencies.

So what's your message to those folks that are saying, although it might be well-intentioned, people are getting ahead of the science. We haven't looked clearly enough at the data, and there is confusion, is it 8 months, is it 6 months, where you write it 8 months or you write it at 6 months. I want to ask, can you see that frustration? But even some scientific experts are having, how do you address that in terms of, it's a few weeks away from when the White House has said, we're going to start boosters for the general population?

JANET WOODCOCK: Yes. Well, I think a crisis is very difficult and everyone needs to calm down and look at the facts. The facts are, it looks as if there is immunity from the current regimen of vaccines that we have in the United States, immunity is waning over time. And we are seeing breakthrough infections, that's not a secret, we don't need data. We need data, but for the general public, it's obvious that there are people acquiring infections who have been fully vaccinated and there are a few people who are getting to need hospitalization who have been fully vaccinated. Now, even right after vaccination, the vaccine doesn't work in everyone, and some people don't respond and still get ill. It's not 100% effective.

So why would you announce this? Well, we need to have a plan. And the plan would involve the vaccination of very large numbers of people in the United States with a booster dose. And we have to make a plan somewhat before we have all the data. And I think that, John, is what's confusing people.

JOHN WHYTE: It does, but to be fair, Dr. Woodcock, it sounds like it's a done deal. And some experts will argue, well, what's the purpose of vaccination, which is a great conversation, the story is a success story. It's preventing people from dying and getting into the hospital, that's the goal of the vaccines. These aren't sterilizing vaccines that are going to eliminate every type of infection. And if we allow the fact that people are going to get mild to moderate and be OK.

JANET WOODCOCK: The trends that we're seeing in resistance to the virus and fully immunized people lend us to believe that at some point we're going to cross that threshold and we're going to see hospitalizations and more serious disease. And when that happens, we want to be ready. If it doesn't happen, fine. But when it happens, we don't want to have a couple more months where we have to get ready and make a plan and then execute against the plan.

So it is true we don't have all the data, we have a lot of data from both this country and other countries in the effects of waning. But we don't have all the data on the most all the safety data and so forth. Those studies have been completed and should be available to the FDA soon. But I will say to you, you can talk to me in two months, and if a plan hadn't been made, you would be saying, well, why was there no contingency plan if in fact, the vaccine efficacy waned to the point where we were seeing a lot of hospitalizations and yet we were not ready?

JOHN WHYTE: Well, I might call you in 2 months, but I want to ask you, what do you think things are going to look like in 6 months? And you and I have been talking throughout the pandemic, and I appreciate you giving us the time to help educate the public and there has been some brighter spots than may look like right now. And most folks are curious, what do you think the spring is going to look like, or late winter? And I know you don't have a magic crystal ball, what's your best guess, Dr. Woodcock?

JANET WOODCOCK: We don't know what's going to happen. Our best case that we hope is that we will get more of our population vaccinated. We will reduce the spread of this virus. We can move back to an ordinary way of managing it, which would be contact tracing, isolation of infected people, and so forth. And we could get back to normal in our society.

But it's also possible we may see additional resistant variants that have other characteristics. We hope we won't see any that really elude protection from the vaccines, but we have to think that could happen and plan for it. And there are other possibilities in between those scenarios. So I think with a pandemic, you have to think about scenario planning, not this is what's going to happen in 6 months, because we don't know.

JOHN WHYTE: Dr. Woodcock, I want to thank you for taking the time. Again today, I want to thank you for all that you and your colleagues have been doing around the clock for more than 18 months to protect the American public.

JANET WOODCOCK: Well, we will continue doing everything we can to get both vaccines and therapeutics and diagnostics out there to help combat this threat to our very society, so thank you very much.

This interview originally appeared on WebMD on September 2, 2021

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