Brian Lehrer: It's the Brian Lehrer Show on WNYC. Good morning, everyone. What should be done about the Johnson & Johnson vaccine? Many people were shocked by the news yesterday of these few cases of blood clots, including one death and the temporary suspension of using it in this country. Some people actually think that the CDC went too far, but they want to send a signal very clearly that they are being transparent, that they are being as cautious as possible to keep trust in the whole vaccination system as high as possible, as well as, of course, to protect people as much as possible for its own sake.

What should they do next? Should they bring it back for selected populations, but not for women under 50? Do we need it at all to have enough doses overall in the US or in the world? Do we really know for sure that it caused these serious blood clots, including the one that was fatal that has not been conclusively determined? What counts as proof in a case like this? What should you be looking for today if you recently had a J & J shot, especially if you're in that risk group? Today the CDC is reviewing the rare blood clot cases that led to this pause.

The one in a million possible side effect is similar to the issue that Europe has found with the AstraZeneca vaccine, although even less common than that one. Let's review what we know about the J & J vaccine and the other vaccines being offered in the US and how to assess any potential risk versus the known danger of illness, disability, and death from COVID-19. For this, we will be joined once again by Krutika Kuppalli, an infectious disease physician and global health specialist, and an Assistant Professor of Medicine in the Division of Infectious Diseases at The Medical University of South Carolina. Dr. Kuppalli, welcome back to WNYC. Thank you so much for doing this today.

Dr. Krutika Kuppalli: Sure. Thanks for having me.

Brian: Let me actually start with a clip of the US surgeon general. I was struck by what surgeon general Vivek Murthy said about the pause that it's not just to review the data, but to have time to get the word out to doctors. Listen.

Vivek Murthy: Even though this wasn't an easy decision, it was the right decision to put a pause on administration of the vaccine and to give us a chance to do two things. One is investigate whether there is in fact a link between the vaccine and the six cases, the dangerous blood clots. Second, to give us a chance to talk to the medical community and to help them understand what we're looking for and to also help understand how to treat these blood clots if they do in fact arise.

Brian: Let me start on that. The very practical that he brought up at the end because we have many listeners who would have recently gotten their Johnson & Johnson vaccine so are understandably concerned right now. He said there that this disorder is treatable, but it has a specific treatment that physicians have to be looking for. Is that why the surgeon general brought that up in that way?

Dr. Kuppalli: Yes, absolutely. This is not treated like a typical blood clot. What they have found is that people who develop a blood clot related to getting the Johnson &

Johnson vaccine, they have a low platelet count and they can't be treated with the typical anticoagulant that we give for people who get blood clots. That's one of the reasons they are wanting to make sure that they get the information out to physicians and they are recommending consultation with specialists hematology doctors or doctors who specialize in the treatment of blood disorders. They want to have that ability to get that information out to physicians who might be seeing these complications.

Brian: I gather that one of the big things here is that other kinds of blood clots are often treated with a blood thinner called heparin, but that heparin might make this kind of blood clot worse. Is that something that doctors would likely be aware of if the surgeon general and others weren't out there saying it a lot right now?

Dr. Kuppalli: No, people would not be aware of that. So you're absolutely right. Typically, we treat blood clots with a medication called heparin. However, the concern is that people who get blood clots that might be related to the Johnson & Johnson vaccine might have this thing called a platelet-activating antibody against platelet factor four. If you give them heparin it can cause more problems.

You don't want to give them heparin and physicians may not be aware of that, which is why, again, we want to have time to educate the medical community about that. If you are suspicious that somebody has a blood clot related to getting the Johnson & Johnson vaccine, you would not want to give them heparin, you would want to consult with a hematologist about the best way to treat this person.

Brian: Listeners, doctors welcome to call in, anybody who's had the J & J shot, especially if you're a woman under 50 and had it in the last two weeks, but anybody may call, if you have a question about the J & J or for that matter the mRNA vaccines, the Pfizer and Moderna ones for Dr. Kuppalli, 646-435-7280, 646-435-7280 for Dr. Krutika Kuppalli, who is an infectious disease, physician and global health specialist and Assistant Professor of Medicine in the Division of Infectious Diseases at The Medical University of South Carolina. What should women who've received the J & J vaccine in the last two weeks be alert to in terms of potential early warning signs?

Dr. Kuppalli: I want to step back for a second. Yes, these cases so far have been described in women. However, we don't know that it's only in women, so I want to make sure that we are reaching out to women and men to be aware of these particular warning signs. I think that right now we don't know. I think to recap the data that we have thus far individuals who presented with these clots they occurred up to 13 days after they received their vaccine. I want to reiterate that these events have been found to be extraordinarily rare.

Six patients out of over 6.8 million individuals who've received the vaccine, so extraordinarily rare. Patients presented with abdominal pain, nausea, vomiting. Four people developed neurological symptoms, so weakness, visual disturbances. Those are the things that you would want to look for. I think particularly if you develop very, very bad headache that's something to be concerned about and to have further assessed. Again, I'm making the point here that we're not just targeting women we

want everyone to be aware of these symptoms.

Brian: I saw Dr. Fauci on television last night answering the question, "Why wasn't this revealed in the clinical trials if this is a problem?" His answer in statistical terms was very interesting. If this is a one in a million reaction, and we're talking about six cases out of six million doses, so it is literally one in a million, there are tens of thousands of people in a typical clinical trial. There were 30,000, 40,000 people I believe in this clinical trial. This reaction is so rare that it didn't even show up in the clinical trial of 30,000 or 40,000 people. Can you comment on how the public should understand that?

Dr. Kuppalli: I think just like you said this is an extremely, extremely rare side effect. I think as one of my colleagues put it yesterday, your chance of being struck by lightning is higher than having this side effect. I think that maybe puts a little bit more into context for how people could think about this. This is an extremely, extremely rare side effect. In fact, we know people who have COVID also develop this type of side effect and people who have COVID and develop this side effect are more likely to develop it from having COVID than you would if you were to get this vaccine.

Again, this is basically an example of our regulatory systems working. These adverse events were reported through the vaccine adverse event reporting system. They saw a signal, they are investigating it, and they want to put a pause on the vaccine. Again, as Dr. Murthy said, to further understand what's going on to inform the medical professionals so they know how to best manage the symptoms if they do see it.

Also, to have a transparent discussion about what is going on later today during the ACIP meeting. We want to make sure people feel safe about the vaccines and feel confident about the vaccines and that's exactly what they're doing. I think that the public should feel reassured about this information and how it's being handled. This is exactly the system working as it should be.

Brian: They can at least make the point that this is not China bottling up the information about COVID and its spread in the early days. This is not the Trump administration downplaying the risks of the virus for its own political purposes in the early days. They came out with this right away so they can figure out what is the actual best interest of public health in general. What's in the actual public interest in terms of public health in terms of whether and how to bring this vaccination back, right?

Dr. Kuppalli: Yes, absolutely. Again, the administration is committed to being transparent in all of this. We want to follow the science, we want to make sure the public is safe. That's the ultimate goal, is patient safety, and we want people to feel comfortable moving forward. Again, that's why the pause is there to understand what is going forward and I feel confident that we will be moving forward with readministering the J & J vaccine.

I'm not sure exactly in what population and who and maybe there won't be any

amendment into which populations we are giving the vaccine to. I think it's important again, to understand what the mechanism is of this reaction and to have the appropriate information out there so people feel comfortable.

Brian: What is the mechanism? Meaning do we know why or how the Johnson & Johnson vaccine may have caused these blood clots?

Dr. Kuppalli: I don't think we know just yet. I think that's one of the things they're investigating. One of the hypotheses out there is that the J & J vaccine and the AstraZeneca vaccine, which has also had reports of this similar problem are both the same type of vaccine. They're both what we call viral vector vaccines. The question is, "Could that have a reason as to why that's happening?"

Just to refresh people's memories, the viral vector vaccine is when we have inserted the gene for the spike protein that's approaching [unintelligible 00:13:03] on the surface of the coronavirus and is responsible for entry into human cells is then inserted into a harmless virus so, in this case, the adenovirus and it delivers the gene to the human cells where the spike protein is produced and then stimulates the immune response to produce antibodies.

One of the thoughts out there is there's something about using the viral vector vaccine that stimulates a robust immune response, is that leading to some sort of hypercoagulable state? Again, we don't know. There are other adenovirus vaccines out there that this doesn't happen with. So is it something specific about this type of viral vector vaccine and the spike protein that could be doing this? We just don't know yet.

Brian: For context, my understanding is the only vaccines that are not viral vector vaccines are the Pfizer and the Moderna. Of course, they are the most commonly used ones in this country, but there are several other ones in use or in the pipeline. The Russian Sputnik vaccine, I believe is like the Johnson & Johnson in terms of being a viral vector and AstraZeneca as well.

That's an important distinction if that really was the risk factor here to make in terms at least of this country, that the Moderna and Pfizer vaccines do not seem susceptible to this risk, but that the various other vaccines in the world right now need to be looked at for it. Let's take a phone call. Gina, did you want to say something about that? Go ahead if so.

Dr. Kuppalli: I think the only thing I was going to say is to reiterate the point that the Pfizer-BioNTech and Moderna vaccines there have not been any problems related to them that have been noted. As you pointed out, those are the majority of the vaccines being given here in the United States. I've gotten a lot of questions about that over the last 24 hours. I just want it to be clear for any of your listeners that might be out there that this blood clot problem has not been seen with either the Pfizer and Moderna vaccines.

Brian: Gina in Manhattan, you're on WNYC with Dr. Krutika Kuppalli. Hi.

Gina: Hi. Thanks so much for taking my call. Dr. Kuppalli, I was on birth control for

decades, and my risk of blood clots was hundreds of times greater than the Johnson & Johnson, which I did receive and I am a woman under 50. I wonder the risk-benefit analysis when just on WNYC this morning they're talking about tens of thousands of SUNY students who will not be vaccinated before they are released back into the general population. I'm very confused as to how this decision was made when we think about the toll that COVID has taken on our communities when this is such a low percentage of cases. Thanks so much.

Brian: Thank you for that question. Doctor.

Dr. Kuppalli: Sure. I think if I understand your question correctly is the decision about to put a pause on the vaccine? Is that the question?

Brian: Yes, I think that's what she's asking. Frankly, I've seen some commentary to this effect. I think you can find commentary on various points on the spectrum, but I saw at least one article that posed the question, was this pause an overreaction considering the statistical risk that's going to do more to scare people away from getting vaccines that will statistically save more lives than if they had not paused it?

Dr. Kuppalli: Sure. I think that it is a valid point. Again, I look at this as, again, the system working and then being transparent about them seeing a signal. I think, again, given what's happened with AstraZeneca in Europe and then being the same type of vaccine vector, they're doing this out of an abundance of caution. They want to be transparent about what's going on. I think the flip side of this is let's say they hadn't been anything and then we see more and more cases, the question would be, "Why did you guys not do anything?" I think they're doing this out of an abundance of caution.

I think it's the right thing to do and I think it should actually make the public feel reassured that they are being so transparent. They are being so careful and it shouldn't actually increase vaccine hesitancy. It should make people feel safe that the vaccines that we're using are safe and we're doing everything we can to make sure that they are safe for the public.

That's the way I look at it because they say, "Hey, our regulatory agencies are keeping such a close eye on what is going on, but they want to make sure that our public is safe. They're also doing a good job of trying to make sure that our health care professionals are well-informed as to the potential side effects to make sure that if we see them that we know how to take care of patients."

Brian: The other thing that the caller raised was the risk of blood clots on birth control. We had a caller who referenced that yesterday too in the context of describing-- Well, let me leave that aside so as not to confuse people, but that's a thing that this is being compared to, to some degree. Yet another commentary I saw this morning said, "Do not compare this clotting risk from J & J in women under 50 to the clotting risk from birth control pills." How do you think we should talk about the birth control pills risk in the context of this story at all?

Dr. Kuppalli: Well, again, I think this is a very different situation. We know that in

women who are on birth control there are various things that can increase or decrease their risk for getting blood clots. Secondly, the type of blood clot women get on birth control pills is different than the one that we're seeing here. If a woman gets a blood clot on birth control pills, you can give them heparin. You can give them the typical type of anticoagulant we would give them. Also, the blood clots we see in them is not this cerebral venous sinus thrombosis that we're worried about, that we're seeing in people who are getting the vaccine.

There's differences. Then, finally, again, as I pointed out earlier, we are not sure that this blood clot that we're seeing is only confined to women. Yes, the cases that have been reported thus far have been only in women, but we're not sure that it's a gender-related issue thus far. I understand why people want to make the comparison, but there's definitely a lot of differences in the situation.

Brian: Many more questions to answer. We'll continue in a minute. Brian Lehrer on WNYC.

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Brian Lehrer on WNYC. As we assess the situation with the Johnson & Johnson vaccines with Dr. Krutika Kuppalli, an infectious disease physician and global health specialist, and Professor of Medicine in the Division of Infectious Diseases At The Medical University of South Carolina. Alex in Manhattan, you're on WNYC. Thank you for calling in.

Alex: Hi, good morning. I'm just looking at a headline that says, "The WHO says no link between AstraZeneca vaccine and blood clots." They had reported 230 cases, the 237 cases of blood clots, but I just noticed that in my actual question was if you had aspirin every day would that be potentially good or could that could potentially increase the clots?

Brian: Thank you. People take aspirin as a blood thinner for those of you who don't know Dr. Kuppalli.

Dr. Kuppalli: Yes, that's a really good question. I think that at this point we still don't know about that. I'm not sure if it would help prevent the blood clots. I don't think it would hurt, but I'm not sure if it would help. I honestly can't answer that question just yet based on the information we have.

Brian: What do you think the CDC and the FDA are looking for right now in order to make a determination on whether to recommend restarting use of the J & J vaccine and in whom?

Dr. Kuppalli: I think there's probably a number of different things that they're looking at. They're probably trying to understand the circumstances around each of the cases that occurred. I think that they would want to understand any medical co-morbidities that any of the patients had. I think that they would want to understand if there's other cases out there which is also-- One of the things they're trying to get people to do is they have this system called-- There's a vaccine adverse event reporting system.

If there are other cases out there, trying to get them reported so can understand if there are others out there and try to understand if there's any commonality between the cases that have been reported so far. I think they're trying to understand the mechanism of what's causing this as well. Then, other things where any of these patients potentially positive for COVID when they got vaccinated because that then a mediating factor. I think those are some of the things that they're looking at.

Brian: How convinced are they, and how convinced are you that the Johnson & Johnson vaccine was even a cause of these blood clots?

Dr. Kuppalli: Well, again, I think that's one of the things that we're going to want to look at in these patients. I think that the fact that we have six reported events so far of what is a very rare event, but happening close in proximity to when these people had their vaccine, I think it does seem like it is probably a very rare event that may have happened with this vaccine.

Again, I want to keep saying that it is a very rare event. It's a one-million event. That's why we didn't see it on the clinical trials. It does sound like that it was possibly related to the vaccine. I think I want some more information before I could say it is related to the vaccine. That's why I'll be interested to see some of the information that is presented when they have their meeting today.

Brian: I guess for the general public that doesn't deal in risk calculations and risk perceptions and risk regulations. Maybe we should take a minute and talk about how to think about one in a million odds. We usually think of one in a million as a very, very low risk of something, but because the consequences could be so dire for that one in a million, one of the people died in this case, we still have to take one in a million very seriously.

If there were no other option and we knew that many more than one in a million people would be harmed by banning the shots that would argue for continuing to use it broadly. What if one in a million people get blood clots, but with no vaccine, a thousand people in a million would otherwise die. There are medical treatments in the real world, even just nonmedical commercial products where one in a million risks are allowed under the law.

The caller brought up birth control pills. For example, the National Safety Council estimates your lifetime risk of dying, and those weren't fatal complications in the birth control pill to be clear, they were blood clots that the caller was referencing, but the national safety council estimates your lifetime risk of dying in a car crash is one in 107, but we don't ban cars. In this case, we do also have an alternative.

We have the Pfizer and Moderna vaccines as alternatives. We also have the apparent math that it's not one in a million randomly getting the blood clots, at least from the data so far, and I know you said we should be cautious about this, but so far it's all among women ages 18 to 48. If they are, let's say 20% of the people who've gotten the shots, the risk in that group is actually one in 200,000. Women in that group rarely die from COVID.

That affects the decision too for people in that group. I'm doing a little back and forth on back of the envelope risk-benefit calculation on how to begin deciding what to do, and in a case like this and compare it to other risks in the world that we allow people to take. Let me zoom in on one of the things that I brought up there. We do have the Pfizer and Moderna vaccines as alternatives. The Biden administration has already emphasized that even without the Johnson & Johnson for now, we can meet the national goal that the administration has set of 200 million vaccinations by June. Given that we have those alternatives, how does that inform the decision of when and how much to bring back Johnson & Johnson?

Dr. Kuppalli: I think we need to think about two things. First off, our vaccination here in the United States, and then also at the global vaccine situation. You're right, the Moderna and Pfizer vaccines are predominantly what's used in the United States. However, there's definitely a subset of the population where the Johnson & Johnson vaccine is definitely seen to be more advantageous.

I'm thinking of patients we discharged from the hospital, certain difficult to reach populations, where it definitely is going to be advantageous to have a single shot vaccine and we do need to think about that. More than anything, I think it is important to understand what is going on. I think you made a very good point and at least right now it looks like this is a one in a million type of reaction and it is, again, extremely rare.

When you think about your risks with other medications, your you're driving and having to think it'll happen, or your risk of even when you think about the risk of having this reaction potentially happening versus if you were to get COVID and what could happen, I would take my risk of getting the vaccine. I think there are a lot of things you need to think about. I think that, again, the reason in my opinion is to just understand, are there going to be certain populations we don't give this vaccine to?

Are there going to be other things that we can understand by further understanding why you get these blood clots so that we can potentially mediate in people to make sure that they don't get them? Then, I think we also need to think about the global population. This is a vaccine that really we were hoping for, for the global population. It's a one-shot vaccine, the storage requirements are much easier than the Moderna and Pfizer vaccine. To really get out of this pandemic, we are going to need a vaccine like this. I think that's another really important thing for us to think about here.

Brian: To clarify the car crash stat that I got from the National Safety Council website, it doesn't mean every time you get in a car you have a one in 107 chance of dying. As I understand that stat of all the deaths in the United States in a year, one in 107 of them were caused by car crashes. In 2016, for example, according to the National Highway Traffic Safety Administration, 37,000 people were killed in motor vehicle crashes, an average of 102 deaths a day.

Again, this is not to say don't get behind the wheel of a car or to be overly fearful when you get behind the wheel of a car. It was just to give an example of the kinds of risks that we allow people to take for all kinds of reasons in this country and risk

decisions and regulation decisions are made based on all of those relative risks and benefits. So just saying. How about Anna in Hunterdon County. Ann, you're on WNYC. Hello?

Anna: Hi, Brian. Hi, Dr. Kuppalli. Thank you so much for taking my call. My question is I had read something in The Lily, which is published by the Washington Post aimed at millennial women, that anecdotally some women are having much heavier periods and those kinds of effects after having the Moderna vaccine. I'm post-menopausal, so that wouldn't affect me, but the reason I'm bringing it up is as I'm sure you know, lots of medical trials and things don't seem to take into account, not just women, but let's say how things may interact with women's hormones. I'm wondering if you know any more about that?

Dr. Kuppalli: I think that's a really great point that you bring up about how the trials don't take into account how some of these medicines and vaccines don't interact with women. I had not heard that piece of information that you're reporting about how women are having heavier menstrual periods after the vaccine. That's something I'm happy to look more into. I guess that's pretty much all I can say about that at this point.

Brian: Sorry, we can't give you more on that, Ann. Jim in the South Bronx you're on WNYC. Hi, Jim.

Jim: Hi. How are you? Thank you for taking my call. I was scheduled to take the Johnson & Johnson vaccine today. Again, a message said that it was suspended two days ago. My issue is this. I think the CDC overreacted in this and I think it's for this reason, there's a vast infrastructure out there of anti-vax people of conspiracy theorist types. This predates COVID by many, many years.

There's actually a radio program here in New York and another station where this guy is deeply committed to spreading this anti-vax ideology for years now. I understand that the CDC wants to reassure people and to inform them. I really don't think there's very much you're going to do to successfully fight this way of thinking, this sort of a spiritual thinking, this anti-vax thinking, this poor understanding of science. As Brian says, a hundred people die a day from automobile accidents.

That doesn't stop people from getting into cars and going out there. I think trying to essentially cater to that way of thinking, this conspiratorial, or anti-vax thinking is really productive. You do have to inform people, keep people informed, but I think it's really capitulating to a very, very uninformed, very dangerous way of thinking. Again, there's a good chance that more people will die because of this distinction that otherwise might live. I wonder what the doctor might think about that.

Brian: Dr. Kuppalli. Jim, thank you.

Dr. Kuppalli: Sure. You make an excellent point. The anti-vaccine movement has been out in strong force even before COVID and they are a very loud and vocal segment of the population, unfortunately. They have been spreading misinformation for quite a long time. I think it's always easy to, unfortunately, second-guess a

decision made by our regulatory agencies. My personal opinion is that I really do think that they did the right decision here. Again, we don't know what information they're going to uncover.

We don't know how many more cases there could have been and or could be. If they waited longer, people would be criticizing them for not being upfront sooner. They're in a difficult spot and I think that it's always better to come out earlier and be transparent rather than wait and then have other things happen. That being said we're also in a difficult situation here in the country because we are trying to get people vaccinated and people have questions about vaccines.

What I see in the work that I do is two different situations. Yes, you have the anti-vax people who no matter how much work you're going to do, you're probably not going to convince them to get the vaccine, but then you have the people who are on the fence who want more information and have a lot of questions about the vaccine. I think by having open transparency about what's going on, they will feel more confident about the vaccine.

They will feel more confident that it's safe. My hope is that by having these types of conversations and showing that we are being transparent, we will be able to convince them to get vaccinated. To the last point about maybe by pausing the vaccine, more people are going to die. I don't agree with that simply because I do think we have enough from the Moderna and Pfizer vaccine. I think that this pause is not going to last weeks and weeks. I think it'll last maybe hopefully just a few days and then we'll get our answers and then be able to move forward.

Brian: Dr. Krutika Kuppalli, an infectious disease physician and global health specialist, and Professor of Medicine in the Division of Infectious Diseases at The Medical University of South Carolina. Thank you for all your information and context. We always appreciate it when you come on.

Dr. Kuppalli: Thanks for having me.

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