The FDA's Decision on COVID Booster Shots

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Brian Lehrer: It's the Brian Lehrer Show on WNYC. Good morning again, everyone. On Friday, as most of you heard, a panel of experts from the FDA voted to recommend COVID vaccine boosters for people 65 and up, and others at higher risk of serious disease if they get COVID, but they voted against recommending a third dose for most other people. We'll try to clear up confusion about who's in and who's out and how that will work and we'll also talk about booster shot ethics from a global perspective. Some of the ethical concerns across the continent of Africa for example, less than 4% of people are vaccinated. Even in Vietnam, which had such a robust initial response to the pandemic, the number of people vaccinated sits below 6%.

How much additional protection for already vaccinated people here in the US is ethically acceptable under those circumstances. With us now to talk all things boosters is Dr. Eric Topol, physician, founder and director of the Scripps Research Translational Institute, Professor of Molecular Medicine and Executive Vice President at Scripps Research. Good morning, Dr. Topol. Thanks very much for doing this.

Dr. Eric Topol: Good morning, Brian, great to be with you again.

Brian Lehrer: Can you summarize last week's recommendations from the FDA advisory panel on booster shots. If the full FDA and CDC accepted, who is in and who's out?

Dr. Eric Topol: Sure. Well, it's a little complicated because Pfizer put in for a very aggressive approval, that is for everyone over age 16. There were no data, really, to support that. The first thing the panel did was to review that and ultimately vote and say no, which of course made sense. Then they had to come up with the criteria that were of unanimous consensus, which turned out to be 65, we'll talk about that a bit, age 65 and over, as well as people at high risk for coexisting medical conditions, as well as people at risk because of environmental exposures such as healthcare workers, teachers, essential workers.

The criteria for the booster for people who've already had two doses of Pfizer are fairly broad. The only real issue was the data from Israel, which was driving this for Pfizer's application, really was for age 60 and older. So the 65 was a little bit peculiar.

Brian Lehrer: Why that distinction? There are bigger questions to ask then about this particular five year age group, but it's a big one in and of itself. I saw you quoted a month ago, saying, I guess you were discussing the Israeli data and you were saying it's probably a good idea for those 60 plus in the United States, plus those with underlying conditions that could leave them vulnerable to really serious COVID if they get COVID, plus people exposed a lot like healthcare workers and that's exactly how it came down from the FDA Advisory Committee, except 60 turned into 65. Do you know why?

Dr. Eric Topol: Well, I think it's a little bit of the US, the FDA panel believing in their own data from different sources, a couple from CDC reports from a week ago, that was the risk of people over 65. That's how the data were broken down, was considerably higher for these breakthrough infections that resulted in hospitalizations. That was, I think, driving it because there's this unwillingness to accept the data from Israel, which I think is quite exceptional. In fact, it was published last week in the New England Journal. The fact that people over age 60 had their full protection restored after the booster dose, but otherwise, they were at a 20 fold risk.

I think the data really cut well at 60, but the other thing was, Brian, because they had this high risk, there's a matter of interpretation so your doctor could say, "Well, you're 60. I consider you at higher risk." So there's a lot of discretion here.

Brian Lehrer: Sounds like there's a lot of, well, you said it, discretion. There's a lot of wiggle room, a doctor could say, "Oh, because of whatever, you're 61 years old, and I consider you at high risk." There's no precise list of conditions that the doctor might have to say is in or out. If this is accepted by the whole FDA and the CDC, a doctor could basically write a prescription for anybody at any age, it sounds like.

Dr. Eric Topol: That's right. The matter of interpretation is at the discretion of a physician, but there's a couple of things that you just alluded to. Firstly, the FDA has to come out with their recommendation, which of course, can be different, as we've seen from the Advisory Committee. We haven't seen that yet. That could change age, or could stipulate what is a higher risk. Then on Wednesday and Thursday this week, it goes to the so-called ACIP panel, the advisory panel for the CDC, and then they add their annotation. The final wording for what this booster for Pfizer is going to be like is still a little bit fuzzy.

Brian Lehrer: The Biden administration, I think, is saying, at least for Pfizer, and we'll talk about Moderna and Johnson & Johnson in a minute, but at least for the Pfizer, with all these backs and forths that we're discussing, including some others that we'll get to, that they could be ready for distribution, people can go get them next week at the earliest. Do you think that's too optimistic?

Dr. Eric Topol: No, I think that's very reasonable. Millions have already gotten a booster for one reason or another, so that, I think, is not an issue. I think the problem really is that we've been overdue to get to this, because some people are, well, eight months, healthcare workers, some of my colleagues who've had COVID now after vaccination, eight or nine months out. So the risk starts to crop up around five months and so we need to get on this. A lot of people are many months past when they got their full vaccination, two doses, and they're at risk, particularly those who are advanced aged.

Brian Lehrer: Listeners, we can take some vaccine booster questions for Dr. Eric Topol at 646-435-7280, or tweet a question @BrianLehrer, we'll watch our Twitter go by as we do @BrianLehrer or on the phone at 646-435-7280, 646-435-7280. We've talked about this on the show before, the Israeli data indicated that protection in many people starts to wane after about five months so they let people get boosters after that. President Biden originally talked about six months, then it was eight months. What actually came down from the FDA advisory panel?

Dr. Eric Topol: Well, that's interesting. They didn't really give the time boundary. I suspect that will be part of the final wording. Six months, it's what's being used not only in Israel, but many other countries throughout the world, actually, UK and Singapore and Germany, France. This is now-- the booster thing, we're late at the table here to get this resolved, but six months has been pretty much the consensus. In Israel, they've already given boosters to over three million people now, well over a million over age 60 that they published on. They actually use a five month cut off, but six months, in that zone, is certainly reasonable.

Brian Lehrer: What about countries that we haven't mentioned yet, except I mentioned a couple briefly in the introduction, Vietnam and the continent of Africa, so many countries, so much of the world doesn't have access to even a first dose of a COVID vaccine. Why shouldn't the United States and these other advanced industrial countries in Europe, plus Israel and others, put off booster shots until somehow global distribution can get more, many more to places like Africa where the vaccination rate for the continent or in particular countries such as Nigeria sits around 1%?

Dr. Eric Topol: Well, that's a really important issue. As you mentioned at the top of this segment about this ethics and global vaccine equity, we all want that, we need the whole planet of people, as many as we can, get vaccinated, or if they've had prior COVID that provides some immune protection. The issue here is that if you're giving two shots and basically the protection is lost in certain individuals, then you haven't really vaccinated them. That's the problem.

Last week on Monday, there was a paper from The Lancet written by two FDA scientists and the WHO. The World Health Organization has been pushing very hard that we don't have boosters, but look at all the countries that are going ahead with boosters. Over 20 countries are doing boosters now. This is a tension, but the problem is that we never envisioned for the vaccinations to be a two-dose program.

There were always to be three doses. The only question was when was the third dose going to be needed? We found out now, at least for Pfizer, we're going to learn more about the other vaccines. This is really an issue of, do you want to leave a lot of people unprotected, at least to some extent, or do you do the best you can to preserve that protection while you also, it is not an either-or, also get vaccination across the entire planet? I think both can be done but part of this relies on the manufacturers revving up their production, markedly, and we haven't seen enough of that.

Brian Lehrer: It is a zero-sum game. It isn't either-or outside of the manufacturers revving up production markedly. There is a real ethical dilemma here, but who has to make that decision? Is it president Biden? Is it the heads of state of these other industrialized countries? How does that decision actually get made that leaves a country like Nigeria, one of the major countries in the world per population with 1% vaccination?

Dr. Eric Topol: Right. I think there's no easy answer. One thing to note is that we have about 70 million vaccines distributed through this country already that have not yet been used and we're not vaccinating new people or getting the second doses in at any appreciable numbers, less than a million even often less than 700,000 a day. The point is those vaccines are not going to get brought back to the government and then sent out to other countries. We have enough vaccines to get this booster program for people over age 60 and the criteria that we discussed done without compromising, exporting vaccines or as was announced Friday, the administration, Biden's administration has bought a huge number of vaccines to distribute throughout the world.

I think there are some factors here that have to be considered such that we already have a glut that's out there that's gonna take care of the boosted program, which would not in any way interfere with the US interest of trying to get everyone on the planet to be vaccinated or protected in some way or another.

Brian Lehrer: Jane in Chelsea, you're on WNYC with Dr. Eric Topol. Hi, Jane.

Jane: Good morning. Thank you for taking my call. I am an 85-year-old woman, relatively healthy and cogent and mobile. I received my last Moderna shot eight months ago, and it's going to be a while before Moderna boosters will be approved. I want to know whether I should get the Pfizer booster shot.

Dr. Eric Topol: Right. There aren't any data, of course, that tell us about people who get one mRNA vaccine and then another-- it's happened, but no data has been collected, which has been a failing, really, in this country about many aspects about the pandemic and especially vaccines. We don't know how long it's going to take, weeks, before this Moderna goes through the FDA, just like Pfizer did on Friday and still, there's many days left before that gets to be practically available.

My recommendation for you to consider would be, you can go to a drugstore like cvs.com and you can actually get a Moderna booster through that mechanism now. That's something for you to consider at age 85 because you are in a very high-risk group, and it's many weeks in the waiting, that's just because we're not moving fast enough to get on top of this. That's something to consider.

Brian Lehrer: Wait, can Jane or other 85-year-olds or anyone else go to CVS? For some reason I think CVS offers Pfizer, not Moderna.

Dr. Eric Topol: No, both. You have to just go to the CVS.

Brian Lehrer: Oh, you do? Okay.

Dr. Eric Topol: [unintelligible 00:14:47] Moderna and you schedule it and they have very loose criteria as it turns out. Their wording about getting a third shot is vague.

Brian Lehrer: You do have to lie a little bit and say you have some immunocompromised condition, don't you?

Dr. Eric Topol: At age 85, Yes. It's not really a lie the way they-- Do you have anything, including these things? It isn't a lie, Brian, and I have to say of the millions of people that have gotten their boosters, a lot of them have used this mechanism, but one other thing I would just add to this, the dose of the Moderna booster, the official one, will likely be 50 instead of 100 dose. Anybody that gets a moderna booster now is getting the full, original, high dose that was used in the vaccines.

Brian Lehrer: Interesting, and I also know people who've done it just to let people know for what it's worth, but there are people out there doing it and you check the box and nobody asks you questions. I know of one elderly person, somebody was telling me the other day, they know somebody who's elderly, probably around the caller's age, and went in and was like, "Oh, well, I don't technically qualify." Then the pharmacist actually helped them fill out the form and then gave them the shot.

Dr. Eric Topol: Right. No, that's happening all throughout the country. The pharmacies have the interest of getting the vaccines in people because that's the way they make money and people who are getting in line to get boosters already because they don't wanna wait extra time for this to get settled. I would just say about the Moderna, we don't have nearly as much data about the time of waning. We know it occurs, but it may be a couple of months later than Pfizer, just because as you'll recall, the dose of the mRNA in the Moderna vaccine of 100 as opposed to 30 in Pfizer, that's more than threefold increased dose. Plus it was an extra week of spacing.

Remember the Pfizer was three weeks between the two doses, whereas Moderna was four weeks. The waning, it occurs, we know that, but it isn't as fast as what is occurring with Pfizer, probably an extra month or two, but more data is needed to make that determination.

Brian Lehrer: Interesting. What you were just saying about the 50, what's the measure? Is it milligram?

Dr. Eric Topol: 50 MICs versus the 100. Moderna did a randomized trial, unlike Pfizer. They had a much higher dose with Moderna, but they did a randomized trial of half dose, 50 MICs versus 100 MICs of the mRNA. They showed that you got excellent antibodies from the 50, so that's why they're applying for the booster to be half dose, which will stretch the vaccine supply markedly and Brian, to the earlier point we were discussing, that's really good for global vaccine equity too.

Brian Lehrer: It sounds like you were headed toward an opinion in your professional medical opinion that the 100 dose booster that people could go out and get now of the Moderna is more protective and they should consider that.

Dr. Eric Topol: No, what I'm saying is it may be weeks before we get that booster approved. For somebody aged 85, they have to weigh, that person has to weigh waiting X number of weeks getting probably the lower dose, versus getting 100, the higher dose in the imminent time. It's a tough call because if you've had a lot of side effects from Moderna because of the high dose, you might not want to get that flu-like illness again. Right. The 50, going to half dose will be associated with less side effects. That's another part of the consideration of whether you want to try to jump the process from getting this higher dose right now.

Brian Lehrer: Got it. How good are those antibody tests that you referred to, by the way? Because I know people who are getting them and then the number comes back and they're, "Oh, my antibody was only a--" whatever number they say, or, "Oh, my antibodies still look pretty good," but my understanding, which might be wrong, about your protection is that it can't be measured by a single antibody test because there are also T-cells that aren't tested by that blood test and other things like that. What would you say about that?

Dr. Eric Topol: I wouldn't recommend people getting these antibody tests. They're not normalized or standardized, so you can't compare one versus the other. They're not really measuring neutralizing antibodies, which is what we're interested. People make lots of different types of IgG antibodies after a vaccine. I think they're unhelpful at this point. It's possible that we would have an assay that would be useful in the future, but right now I would not recommend these commercial tests. They're very hard to interpret. As you say, there are other ways that people-- There's redundancies in our immune response and the cellular response of B and T cells is not something that can be measured commercially at all. I wouldn't recommend that at all.

Brian Lehrer: Peter in Katonah, a paramedic with the FDNY, you're on WNYC with Dr. Eric Topol. Hi, Peter.

Peter: Hi, Brian. Thank you. Thanks for taking my call. I was very interested in what the doctor would say about the fact that I contracted COVID in September of last year, then I got over it for the most part. It was a slow ride, but I got through it. Then I was vaccinated with Moderna in December and January. What do you think my antibody status might be at this point?

Dr. Eric Topol: You're not lucky to have gotten COVID, but you are lucky that you had it and have been vaccinated. In fact, even one dose would be great. You have the best protection known to mankind against COVID right now, that is so-called hybrid immunity. Remember that when you get an infection with COVID, it's the real deal so that you make antibodies. Your cellular response is not just to the spike protein, which is just one part of the virus, it's to the entire virus.

Your immune response to the infection is different than when you get a vaccine. The two together are, frankly, awesome. What I recommend for people who've had prior COVID confirmed is they only need to get one dose of the vaccine, and you had two. You're in really good shape. Very few people could have better protection than you do against COVID right now.

Brian Lehrer: Peter, you told our screener that you're particularly concerned because of your line of work as a paramedic, and you come in contact with a lot of people who in many cases are sick. You're concerned about your individual exposure on the job.

Peter: Absolutely.

Brian Lehrer: How would you explain the rate of your colleagues in that profession? Which is shocking to some vaccinated outsiders who look in and see that even a lot of paramedics, like other healthcare professionals, are declining the vaccine.

Peter: In the beginning, last March and April was an unbelievable time for us, because let's say I would have five to six cardiac arrests that I would attend to in an entire month. During that time, I was dealing with four to five cardiac arrests a day, and because of the way COVID acts, it was completely fruitless. There was nobody we could save, really, because of the way that the disease breaks down the blood and then it leaves all these clots. It was a mess. When we were working on them, we intubate and we do a lot of things that put us in direct exposure with their airway and with their breathing. We had a lot of people get sick and we had some very-- We lost people. People died. It was bad.

Brian Lehrer: Why wouldn't healthcare workers want the vaccine?

Peter: Oh God. If that's the question, I don't have an answer for it. I have talked with people, especially my colleagues, I said, "Why is it that you wouldn't take it?" They're like, "Well, because I don't think I need it. I could get it." I have a good friend in my station, I'm an older medic, so good friend. He never wanted to have the vaccine. He was, "Oh, no, you build your own antibodies. I'm healthy as a horse." All this stuff. He got it, and he got it very badly. It was horrible. He's still in intensive care, actually in one of our hospitals. It's a lesson learned. Thank God he's still alive. It hit his pulmonary system very hard. That was the end of that for a while.

Brian Lehrer: Peter, thank you for your call. We were really appreciate it. Stay safe out there. Good luck. Dr. Topol, I guess what would count as a follow-up to the advice you were just giving, or your reaction to Peter that you're super immune if you've had COVID and then the vaccine. Here's a question from a listener via Twitter asking, what about those of us who were vacced and then had a breakthrough case? Is our immune system stronger than those who haven't had a breakthrough and are on the other side? In other words, it came in the opposite order for this listener. Instead of COVID then vaccine, this is vaccine then breakthrough COVID.

Dr. Eric Topol: No, it's just as good. It's the same hybrid immunity. You develop an immune response to the full virus, and you also have this super spike protein protection. No matter how you get it, in whatever order, we don't want anyone getting COVID. It's a bit of roll the dice, what could happen. If you do have it, plus you have a vaccine in either order, you're in really great shape.

Brian Lehrer: By the way, I saw you quote it, obviously you’re a big proponent of everybody getting vaccinated, except those relatively few people for whom there would be a health risk from it. I also saw you quoted in a couple of articles, being very conservative more than a lot of people might be about how vaccinated people should behave or view the pandemic. I saw you quoted in the Santa Monica Daily Press, in their article called Questioning a catchphrase: 'Pandemic of the unvaccinated.' You don't like the phrase pandemic of the unvaccinated.

I saw you in another article saying, I'm going to read your quote, "Even if you're fully vaccinated, you need to have a mask on, a high-quality mask, tightly fitted if you're indoors. You need to be distancing and staying outdoors as much as possible. When you're meeting people, you need to be maintaining ventilation when you’re indoors. What is your position on why we shouldn't look at this as a pandemic of the unvaccinated, and why that should not dissuade people from getting vaccinated?

Dr. Eric Topol: Brian, firstly, I think you would easily recognize the pandemic is affecting everyone. So to segment it to just the unvaccinated is just not accurate. Moreover, there's a false sense of security of people who are vaccinated. They think, "I'm good to go." It turns out this is not true. That's why the whole booster campaign is getting going. Many weeks ago, I was getting fed up with all the happy talk by many people who are public health experts saying, "Not to worry. You’re vaccinated. Go on with your life like a pre-COVID world."

It turns out that's a very bad advice, because particularly if you're at high-risk because of your age or you have some immunocompromised issues, or you’ve got coexisting conditions, you can get these breakthrough infections, and they can be serious. They can be short of hospitalization. I've had many colleagues who they could have wound up in the hospital, they got monoclonal antibodies, or they could have, of course, actually get to the hospitalization point.

The vaccine does provide protection, and it probably will reduce the hit, if you will, of a COVID breakthrough infection. We shouldn't count on that. That's why it's important to do all the things that we were doing before vaccination until people who need boosters get them. That criteria for the boosters may get dropped down to age 50 and possibly lower in the weeks ahead, because the Israeli data is trending in that direction. Don’t feel totally protected. Still do the things you know that can help beyond the vaccine to keep you from getting a breakthrough infection.

Brian Lehrer: Question from a listener via Twitter. Is there any downside immune exhaustion to the higher dose Moderna booster? I will generalize that question even further and ask you, is there any such thing as immune exhaustion if people need to keep getting booster shots every six, eight months for a period of time? I think in Israel, they're talking about fourth doses already.

Dr. Eric Topol: These are the unknowns. The hope is that with the booster, a three-dose program that was envisioned before this whole vaccination thing started may be good for years, that's the hope. We're only going find out about the answer about four shots and about this whole concern that's being raised here over the next several months. There are good reasons to think that this will really help the B and T-cell memory respond to such a degree that we won't be vulnerable, and we won't rely on these neutralizing antibodies so much, which is what this booster is intending to primarily get at. That is still unknown but sometime by early next year, we'll have the answer.

Brian Lehrer: Before you go, you wrote an opinion piece, I see, for STAT news the other day calling on president Biden to consider issuing an executive order that would break the FDA log jam and immediately make available in the US suitable rapid tests developed here and around the world. We've been having a rapid tests dialogue on this show. We had Dr. Michael Mina from Harvard recently, who's a big proponent of using rapid tests instead of 10 day quarantines.

when kids have been exposed to someone with COVID in school, with the rapid test, you could test all the kids every day and see if they're safe and they could get back to school much more quickly. Mayor de Blasio on the show on Friday, when I played that clip for him, said, "Oh, that's interesting. They're going looking into that." Today they didn't implement that but they changed the rules to make quarantine a little shorter in New York City depending on how people test with the PCR tests, but talk about rapid tests from your vantage point and what's important here because this is still a new area to a lot of listeners.

Dr. Eric Topol: This is something that we are so way behind here in the US as opposed to so many other countries around the world that have made these routine. These countries largely either give them out for free like in the UK and other countries in Europe or they make them available at very low cost like in Germany, less than equivalent to a dollar and so you need to use these frequently. The whole idea of schools would be instead of the quarantine, instead of closing schools and all that sort of thing, you would just get rapid tests on a daily basis and keep kids in school.

In fact, there was a very nice article in The New York Times just yesterday. Many US schools are doing that and there was a randomized trial published in The Lancet last week but it's not just about schools, it's about getting back to a pre COVID life. The whole idea is the rapid test tells us, are you infectious? Not whether you've ever had COVID in recent days or have some remnants of the virus or such low copy numbers that you could never infect somebody, but this test tells whether you are infectious.

Here, they're very expensive, you can't get them. They're not given out for free by any means. They haven't been made production to do that. There's over 160 of these tests approved by the European Union. We have about three or four and only one, Binax, that's out there, but you you can't even get. We are way behind, it would help us immensely, there has been some interest only recently expressed by the Biden administration to get on this, but it's long overdue.

Biden: Last thing. We've been talking about booster shots as if we know they're safe and effective. There's some pushback from two FDA regulators who I think resigned as well as signing an opinion piece in The Lancet, which brought up a lot of questions on the data behind the recommendation for widespread booster shots at all, including a lack of data on safety and dosages. Sounds like you're in favor of widespread boosters. What was your reaction to those objections which come from mainstream scientists not from anti-vaxxers.

Dr. Eric Topol: Well, the two FDA scientists, doctors Gruber and Krause, have really taken this to an extreme and it's led to lots of infighting within the FDA and then across the leaders in the administration. They basically are trying to support the WHO Global Vaccine Equity but they're denying the data, and that's a real problem. The data from Israel is powerful as is replicated in the UK and other places. I think you may know, Brian, that last week the UK started giving boosters irrespective of whatever vaccine, Pfizer, AstraZeneca, Moderna, age 50 and above.

They've made many good decisions along the way such as the spacing decision between the two doses, 8 to 12 weeks, which gets a better immune response than the three or four weeks. We just are ignoring what's out there and those two FDA scientists and other co-authors of the Lance paper you're asking about, were in denial of incontrovertible data of boosters being beneficial. Do we want to get everybody vaccinated around the world? Absolutely, but let's not leave people at high risk stranded.

Brian Lehrer: Data debates, policy debates and Dr. Eric Topol, physician, founder and director of the Scripps Research Translational Institute, professor of molecular medicine and executive vice president at Scripps Research, thank you so much for your time this morning and all your thoughts.

Dr. Eric Topol: Thank you, Brian. Great to be with you.

Brian Lehrer: We'll have more on this tomorrow with another vaccine expert, Dr. Paul Offit.

 

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