The Confusion Over Johnson & Johnson

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S1: When I heard the news that Johnson and Johnson’s covid vaccine was getting pulled from distribution, I felt myself cringe. The FDA and the CDC called what they were doing, a temporary pause. But by the time the nightly news broadcasts were on the story, this pause, they felt like a screeching halt. Tonight, the major vaccine news. Why did the

S2: government pause the use of Johnson and Johnson’s covid shot

S3: appointments for the one shot vaccine canceled in all 50 states for six women develop blood clots, one of them dying.

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S1: The reporting was that six people, all of them women, had been diagnosed with a rare blood clot in their brains. I called up science writer Tara Haley because I wanted someone to reframe this news for me, help me see it in a way I couldn’t. I mean, when these vaccines got released for covid, I wonder if you were sort of expecting this day would come.

S2: Yes, I was. And I wasn’t the only one that I mean, you we’re giving out a vaccine to what’s ultimately going to end up being what, like, I don’t know, two hundred and eighty three hundred something million people just in the United States alone. The odds of something not happening are smaller than the odds of something happening. You could have all the time in the world and you could never produce a product that’s not going to have an adverse reaction in some people. It doesn’t matter whether you’re designing a food, a drug or a vaccine, anything that you’re going to put into your body. It’s basically I don’t even know if it’s possible. Water does water how we’re made of water so it doesn’t count.

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S1: So it’s like almost anything will hurt someone. Peanut butter to me is delicious to a bunch of other folks.

S2: It’s deadly. It’s deadly. Exactly.

S1: In some ways, listening to you talk, it sounds like what happened here makes you feel more safe.

S2: It does, actually. They stopped everything on a dime immediately to say let’s let’s investigate this. Let’s see what’s going on here. Let’s see what we can find out. That tells me they’re looking really closely. This is like finding a needle in a haystack and shutting down the whole farm as a result.

S1: Today on the show, if a pause like this is good, cautious science, something we should have expected, what should we expect to happen now? And will this vaccine be going back into American arms any time soon? I’m Mary Harris. You’re listening to what next? Stick around. Let’s start off by talking about exactly why the U.S. government is pausing distribution of this one particular covid vaccine than Johnson and Johnson vaccine is because of a rare condition called cerebral venous sinus thrombosis.

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S2: Yes, quite the mouthful.

S1: Can you tell me what that is?

S2: Yes, CVT is basically and it’s actually two different things together. It’s Kristie, and it’s a condition called here’s another mouthful for you thrombocytopenia so that five times fast, which means a drop in platelets level, it is probably connected.

S1: What’s weird is that one is a clotting disorder where you get clots and the other is a bleeding disorder. And it seems like you shouldn’t get both at the same time.

S2: Yes. So Christie is a it’s a blood clot in the brain, basically, and thrombocytopenia is a drop in the platelets. The platelets are the blood cells that encourage clotting. So how does this happen? How does it happen? Where at the same time you have less clotting and you have a blood clot? What’s going on? And I found out that this particular condition and what they think this is, is the same thing that’s happening with the AstraZeneca vaccine. And in order for it to make sense, we have to go and look at this other condition called heparin induced thrombocytopenia. Heparin is a blood thinner and heparin is the blood thinner that typically it’s what you see in the liquid that’s in the hospital when people have IVs on most of the time.

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S1: And it’s usually what you would give if someone has a blood clot.

S2: Yup, it’s exactly what you would give. In fact, I’ve been giving it for a blood clot myself. The thing is, apparently in some people who receive heparin, the heparin causes your body to make auto antibodies so antibodies against your own body. They grab on to this one thing called the platelet factor for so or PS4 and PS4 is a piece of a platelet and they make these antibodies against that piece of the platelet. So in addition to going after heparin, they go after platelets and they simultaneously destroy some platelets and activate the others.

S1: So is what’s happening here like exactly the same as what’s happening with the AstraZeneca vaccine or slightly different somehow?

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S2: That’s what we need to find out. That’s why they caused it. There are several reasons for doing the pause. One is just to investigate what’s going on. Is this what’s happening with the AstraZeneca vaccine? Does that mean this is how we should treat it? And they’ve already the reason I think that’s probably going to end up being the same thing is they’re making the same recommendation not to treat it with heparin. And that’s the exact same thing they’re saying with the AstraZeneca vaccine. So we don’t I can’t say right now for sure. Yes, this is exactly what’s happening with the AstraZeneca vaccine. But there are good indications that that’s likely because they’re saying don’t use heparin. And that means that they think this is something that’s going to lead heparin to create those same antibodies that were occurring.

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S1: And that’s the reason why it was so important for the FDA and CDC, I think, to kind of get out there, because if you’re seeing a patient and you’re a doctor, you might think like, oh, I know how to treat this. You just give this drug. But that may be the opposite of what you want to do.

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S2: Exactly. So the pause was a chance to say, hey, let’s investigate this. And by the way, doctors, if you see this, here’s what you should not do and here’s what you should do, because this is also treatable.

S1: Is it fair to say there’s a one in a million chance of developing this condition and kind of look at the odds that way?

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S2: So far, yes, it’s one in one point one million, if you want to be pedantic. But we still need to find out if there are other cases that we aren’t aware of. That’s yet another reason for the pause. Find out if there’s anyone else who’s experiencing this. Make sure that people know what the symptoms are so they can monitor themselves, because, again, this is diagnosable and it is treatable if you know what symptoms you’re looking for. And so they want to make sure that, you know, it’s good that this is getting everyone’s attention and everybody is paying attention to the fact that this has been paused because it’s going to lead them to say, oh, well, what do I have to watch for? And that’s what they need to happen. They need people on the watch. They need doctors to know how to treat it, and they need to investigate it and make sure they know what they’re dealing with.

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S1: So what does this pause mean for patients? This week? Plenty of people have tried to contextualize what we know about the risk of the Janjic shot. Many have pointed out that birth control pills and covid itself also come with the risk of blood clots, a much higher risk of blood clots, actually. And while those clots might not be in your brain, they’re definitely still dangerous. So I asked Tara whether she thought those comparisons were valid. She said they reveal a lot more about us than they do about this vaccine.

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S2: It’s really hard for humans to do risk evaluation. We are very we suck at it, too, frankly, which is not very good at assessing risk. It’s why we were afraid of flying, but not of driving most of the time. But like you said, hormonal birth control that contains estrogen, it’s about one to one out of a thousand, sometimes one of five hundred, depends on which one you’re in. And I was in that group. I was one of those ones myself. I developed of the serious blood. You got a blood clot? I got a blood clot and and it was misdiagnosed. It was misdiagnosed for five weeks. And they don’t really know why it didn’t kill me. But this was I was 18. This was way back in the 90s. They didn’t realize how common it could be. And I say common. It’s still rare, but one of the thousands more common than one in the million, which is what they thought it was back then. So that’s yet another reason for pausing. Make sure that this is the actual frequency that they think it is. But yeah, at the same time, pregnancy, which is what you’re trying to prevent with birth control pills, the risk of clots is one in three hundred. That’s three times more frequent. And as you mentioned, I mean, one of the big defining features of covid has been blood clots. The risk of it once you’re hospitalized is actually it leaps considerably. If you’re in ICU, it’s one in five people have blood clots.

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S1: After the break, we talk about why so far it seems like women are the most impacted by these clots. And we’re back when federal health officials met this week to discuss the future of the Johnson and Johnson vaccine, the company brought with them new data revealing a couple more patients who seem to have developed clots after getting a vaccination. We don’t know much about these people, just that they are, for the most part, women and terrace’s that part. It could be really important.

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S2: That was absolutely the first thing I thought of. And I think a lot of people have noticed that and thought, wait, with the on birth control pills, that’s kind of the front of the first thing a lot of people wonder because that already

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S1: boosts your risk

S2: of clots. Exactly. And so it’s a reasonable question. And that hasn’t they were of reproductive age. They were in the 18 to 48 age range. So they’re in the reproductive age. However, women in general have a higher risk of blood clots. And for this particular condition, like the quote unquote normal condition, if it’s the one that’s not necessarily related to vaccines, the women get it three times more than men. And the reason for that is that we have estrogen and estrogen encourages clotting anyway. So we have a naturally higher concentration of a hormone that is encouraging of it’s why we also have a higher risk of clots during pregnancy.

S1: So it sounds like in some ways it’s not surprising to you that these are women because it kind of makes sense biologically.

S2: Exactly. And I mean, that doesn’t mean it can’t happen in men. In fact, last night when I was looking through this, there was one man who had this condition, the CDC in the phase three trial of the Johnson and Johnson trials. It was determined at that time. Yeah, it was. He was a 25 year old man and he had a cerebral hemorrhage. And it was determined at that time that it was not connected to the vaccine. So I’m very curious if they’re going to go back and look at that case and determine whether it was related because it was a single event. And that’s that’s the thing. A lot of people. Why didn’t they catch this in the trials? Well, this is a one in a million event. You don’t have a million people in a clinical trial. You’re just not going to find a one in a million thing unless you’re testing millions of people.

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S1: Yeah, it’s funny. Before we had a vaccine, when it was still just an idea, a possibility. I remember being conversation with someone and saying we have to kind of get our heads around the fact that if and when a vaccine comes out, it’s going to be like a giant clinical trial because we will have just had these smaller clinical trials that aren’t built to really figure out what’s going on here. And I feel like that’s a hard thing for people like Dr. Anthony Fauci to say out loud, because there is so much hesitancy and there is so much worry already that this is getting out there too quickly. But I do wonder if you think we should have messaged it better or whether there’s just no good way to say that out loud.

S2: I don’t know if there is a good way to say that out loud. And I will say public health messaging has always been incredibly difficult and we’ve been getting better at it, but we certainly have a long way to go. And part of the challenge is it’s two pronged. One is that people don’t necessarily understand how science is an iterative process. It’s not a body of knowledge. It’s an ongoing sort of stumbling toward the light process of identifying knowledge, which means that when things change, it doesn’t mean that like the science changes in the sense that, like, facts change, it means new stuff has come to light. To paraphrase, am I allowed to curse on this? I was thinking of the dude. I was thinking of the dude in, you know, The Big Lebowski. New shit has come to light. That’s the history of science right there. New shit has come to light. And, you know, that also happens in public health. But layered on top of that is our complete inability to assess risks rationally. So I think no matter how they messaged it, it was going to be difficult to convey it because people don’t they don’t think about the fact that we face risks every day of our lives. No matter what we do, every single thing we do has a risk. Yeah.

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S1: Do you think about how what’s happening now with the JMJ vaccine is going to impact vaccine hesitancy like even globally, even even beyond this particular shot?

S2: I don’t know if it will be on this particular shot any more than any other thing has, but I definitely think it’s going to play a role in how people make decisions. We already are seeing that with the AstraZeneca vaccine. To be fair, with the AstraZeneca vaccine, even though it was not a it hasn’t been authorized in United States, but it’s been authorized in many other countries in the world and they are seeing some hesitancy around that. But that’s also a result of poor messaging. There hasn’t been good information coming from different governments and from AstraZeneca itself as to what’s going on. I think they’re doing a much better job with messaging with the Johnson Johnson vaccine and saying, OK, we’re going to halt this. We’re going to figure out what’s going on so that we can get you the information and so on and so forth. But there are still going to be people who say, whoa, blood clot, that’s scary. I don’t think I want to get that vaccine.

S1: I mean, if people do start shunning this vaccine for whatever reason. Is there enough of the other vaccines out there to get the U.S. to herd immunity?

S2: There will be eventually. Maybe not right away, but I mean, assuming the thing happens to the manufacturing facilities, there will eventually and I know that they’re ramping up production. So I think there’s going to be some people, but I don’t think it necessarily will be as big an impact as we think. I think there will still be people who want to get whatever shot they can. And if Johnson Johnson’s offer to them, that’s the shot they’ll take. I mean, if I were offered the Johnson and Johnson shot right now for my kids and I didn’t have the option of choosing a shot, I would still take that risk. To be a one in a million chance is not something that I’m going to worry about. In a way, I’ve already taken that chance with them by having them get certain other vaccines that might have caused an anaphylactic reaction.

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S1: Huh? Because I guess my concern is that the Johnson and Johnson vaccine becomes the vaccine of last resort, the vaccine that’s going to people in prisons, people who are on housed, people who don’t have choices. And I could see that happening so easily.

S2: I can, too. I’m not going to say it won’t happen. I mean, we’ve already seen huge inequities in how these vaccines are rolled out. So I don’t I’m not going to paint any kind of rosy picture about how all these might I. One thing I will say is if a particular community wants a particular vaccine as a community, I think they should have access to that vaccine, especially if they’re an oppressed community that has not often had a lot of choice in what kind of health care options they receive.

S1: It sounds like you’re pretty certain that distribution of the JMJ vaccine will resume pretty quickly? I think so, yes. I mean, the FDA and CDC have been implying that this pause will only last a little while, like a few days. And to me, I thought about that and I thought, what can you learn in just a few days? Like, what are you what are you going to get done in that time that will be comprehensive enough to make sure you’re not doing this all over again in two weeks?

S2: I think if this is in fact related to the same thing that was happening with the AstraZeneca vaccine, I think that is the more likely. I think that’s the reason because they already have a basis for understanding it. So I think there’s two things at work here. One is we think we might know what this is. And if it’s the same thing, then we already have a good handle on it because we’ve been learning about it for the past three weeks with AstraZeneca so we can transfer that knowledge. The second thing is it’s still one in one point one million. And if they find out in a couple of days that there aren’t I mean this people are going to be hyper vigilant about their symptoms right now. And that this is when we’re going to hear a bunch of people that may have experienced this come out and say something, and we’ll be able to get a pretty quick grasp on how, you know, if this is undercounted, if there are more than six people out there or not.

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S1: Satara, if if someone has had a Johnson and Johnson vaccine in the last week or two, what should they be doing right now to sort of make sure they’re OK? If they start to feel some kind of way, who do they call?

S2: Well, first, they should pay attention to their body and the symptoms and the symptoms to watch out for are a really severe headache. That is just it won’t go away. Just a persistent headache, shortness of breath, blurred vision or any kind of neurological effects like that, any kind of pain in the abdomen or the chest, swelling or redness or paleness or coldness in the arms or legs, a seizure or anything like that. And any of these things that might happen in the 21 days after getting the vaccine. Because if this is, in fact, the vaccine induced thrombocytopenia, then it is the thing that’s causing it is the antibodies and it takes up to three weeks for your body to make those antibodies. So these symptoms could start anywhere from a week to two and a half weeks after you get the vaccine. If you have these symptoms, you should contact your primary care provider. If you have one, if you don’t have one or if your primary care provider, you talk to them and they refer you out, then you may need to go to an urgent care clinic or to an emergency department.

S1: Tara Healy, thank you so much for joining me.

S2: Thank you very much for having me.

S1: Tara Hayley is a science journalist and author and that’s the show. Yesterday, I made a small error on this broadcast of House Minority Leader Kevin McCarthy, a promotion accidentally said he was a senator. If you heard that and you roll your eyes, you should really go follow me on Twitter, where you can just complain to me directly. The first person to catch that mistake I sent them. What next button? Anyway, go find me. I’m at Maria’s desk. What Next is produced by Kamal Dilshad, Alena Schwartz, Danielle Hewitt, Davis Land and Mary Wilson. We submit our end of your reviews to Allison Benedikt and Alicia Montgomery. And I’m Mary Harris. Thanks for listening. And one more thing before I go. If you’re wondering how substract newsletters became a thing. I’ve got a show for you. What next? TBD. Our Friday show. Lizzie O’Leary will be here to tell you all about it. If you just stay tuned to this feed and I will catch you back here on Monday.