Today, Explained - Johnson & Johnson & Problems

Episode Date: April 13, 2021

The US government is calling for an immediate pause in Johnson & Johnson vaccinations after six recipients (out of millions) developed blood clots. ProPublica’s Caroline Chen explains. Transcript at vox.com/todayexplained. Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit podcastchoices.com/adchoices

The all-new FanDuel Sportsbook and Casino is bringing you more action than ever. Want more ways to follow your faves? Check out our new player prop tracking with real-time notifications. Or how about more ways to customize your casino page with our new favorite and recently played games tabs. And to top it all off, quick and secure withdrawals. Get more everything with FanDuel Sportsbook and Casino. Gambling problem? Call 1-866-531-2600.

Visit connectsontario.ca. It's Today Explained. I'm Sean Ramos-Firman. We got big vaccine news from the federal government in the United States today. They're recommending states pause Johnson & Johnson vaccinations after finding out about some extremely rare cases of blood clots. One person's in critical condition and one person has died. To explain, I'm joined by Caroline Chen, healthcare reporter at ProPublica. Caroline, why recommend a pause here? Yeah, so the initial cause for the pause today is because of cases of a very rare type of blood clot, which is called cerebral venous sinus thrombosis, which was- Say it one more time. Yeah, cerebral venous sinus thrombosis, or CVST. And this was found in combination with low levels of blood platelets, which is called thrombocytopenia. And it's this combination together, which is a very rare event

that caught the attention of the CDC and FDA. Thank you all for joining us. This morning, the FDA and CDC announced that out of an abundance of caution, we're recommending a pause in the use of the Johnson & Johnson COVID-19 vaccine. Okay, and you mentioned rare twice. How rare is it? Very, very, very, very, very rare, which is so far they have data from six reported cases in the U.S. out of more than 6.8 million doses of the J&J vaccine that have been administered. So about one in a million. Okay. And though we know there's six cases out of like six, seven million, that doesn't necessarily mean there are only six cases to be fair, right? Yes. To be fair, part of the reason why the CDC and FDA are taking the action that they are today

and calling attention to this is because they want to make sure that they're aware of all the cases. And there might be providers who have seen clotting cases in the past few days, but not realized that it would be an order of magnitude off that we're missing because, you know, that would definitely show up much more evidently in ERs and in doctor's offices if this was happening at a much higher rate. What I'm saying is it might be just likely to get struck by lightning than to have these side effects. What's the justification for pausing the use of this vaccine entirely, which surely will raise hesitancy among people who are maybe scheduled to get the Johnson & Johnson vaccine later today? Yeah, I think this is an extremely good question. And one of the things that the FDA and the CDC said today in their press conference was that part of the reason why they decided to go for a pause, you know, instead of, say, continuing to investigate the cases while vaccinations go on, is so that there was time for the health care community to learn what they needed to learn about how to diagnose, treat, and report. So normally when you see a blood clot, you'd give anticoagulants. So the most common one is called heparin. But in fact, in this case, if you give those drugs to people, it could cause them to get worse or even be fatal. Again, this is super rare, but what they want to do is tell

the medical community, if you see a clotting event, you really have to think and ask about vaccine history, take a platelet count and know that what you would normally reach for might not be the right course of treatment here. So that's what they kept stressing, that they wanted to be able to have some time to tell the medical community how to diagnose, treat and report such cases if they come up. The other thing that I would point out is at this point in time, the J&J vaccine is a very small percentage of the supply. I think it's about 5% of the supply that's available in the US. So I'm sure it was part of their calculus that if they were to put a pause right now, it's not like all of a sudden most people cannot get their vaccines.

Right now, the large bulk of what's available is Moderna and Pfizer. And so I really don't think they're making this decision in a vacuum. You know, if this was February and we only had one vaccine available, maybe the FDA would have acted differently. But I think they are taking into context, you know, what the current situation is. So what does this mean practically for the states? I mean, the federal government is advising they pause this particular vaccine. Does this end up slowing down vaccination stateside and abroad? Yeah. So you had a number of questions in there.

And so the first thing I want to clarify is that this is a recommendation from the CDC and FDA. It's not a mandate. And so it is up to the states to decide what to do. Now, what we've heard so far is that a whole bunch of states I've seen already this morning have said that they are going to follow federal guidance. And I think it would be pretty surprising to me if a state would go against both FDA and CDC recommendation at this point in time.

The second thing is that the FDA did say today that they're hoping to resolve this issue in days. So they are aware of not taking away time from the vaccine rollout. They're gonna bring together their expert panel, which is called ACIP, tomorrow to discuss the cases. And then I think some of the options for what they could do is add a warning

on the provider fact sheet. do is add a warning on the provider fact sheet. This is like a drug label, but to give providers more guidance. One of the questions, I asked this question this morning at the press conferences. I was wondering if the FDA has any sense of any subpopulations or medical histories that may predispose a person to this rare side effect, or even if you have a hypothesis on that at this point. And they said... This is Jana Woodcock. I believe there are too few cases

for us to make that determination for this particular vaccine. We will look further into these. We'll have deliberations tomorrow, but we aren't prepared at this time to single out any particular subgroup. So I think when you ask how this is going to affect the vaccine rollout, if this is resolved in a couple of days and you just add some guidance for providers, I don't think it's going to be

a big impediment to the vaccine rollout. On the flip side, if they take much longer and there's continued confusion about who might be at high risk, I think it could have a greater impact just on overall vaccine hesitancy, specifically for the J&J. What if you already got the J&J shot? So let's start again with the numbers. So it's been six reported cases out of 6.8 million. So I think people tend to gravitate to fearing that they are the one in the million case. I'd like to remind you, everybody cannot be the one in the million case. So your chances are very, very low that you would be one of those cases. What the FDA has said to look out for is... If you've received the vaccine and developed severe headache, abdominal pain, leg pain, or shortness of breath, you should contact your health care provider and seek medical treatment.

However, if you're more than a month out from the J&J vaccine, nothing has happened, the chances become infinitesimally small that there's something for you to worry about. All six of the cases that the federal government is paying attention to here were women, women of a certain age, if I'm not mistaken. Is that right? Women under 50 is what I know. A writer at the New Republic said, I'm no public health expert, but from what I've seen, the clotting issue needs study. But since it only affected women, he wrote, the right move would have been for the FDA to declare the J&J the dudes only vaccine and then print t-shirts that say, it takes a real man to handle this Johnson. Should they just be giving J&J to dudes at this point? So again, I think that this is the sort of thing that ACIP will discuss tomorrow. Like, is there any data that actually points towards you being able

to say this is the subpopulation or subgroup that is more likely to be affected and therefore make recommendations? This is literally the job of ACIP. They make recommendations about vaccines, who should use them, what you should be careful about. Now, are they going to go and print t-shirts? I mean, that's one way to sell it if that's what they land on. But I don't think it makes sense for the FDA or CDC to come out and say, you know, this is going to be a dude's only vaccine today before they've even actually investigated the cases. And they have so little information because if it turns out that in fact, you know, it's safe and effective for 99% of women, which very well may be the case, and you come out today and say,

this is a dude's only vaccine, then you're shutting off the chance to use it for women in the future. And we know that the J&J vaccine is particularly useful in situations where you don't have the ability for cold storage or you have populations in whom it'd be much harder to get them two shots.

So there are specific benefits to the J&J vaccine, including the fact that they're selling it for not-for-profit, which makes it particularly appealing to certain countries, where I think it'd be premature to just be like, this is not for women, somehow get that message out, and then later have to scramble to retract and be like, actually, it's okay for almost every woman. Yeah. Yeah, I feel that. Sorry, New Republic writer. But I mean, talking about this vaccine and the bad press it's been getting, I mean, there was this thing at the Baltimore facility where 15 million doses had to be recalled and destroyed. I mean, is there coming back from this or is the Johnson and Johnson vaccine just going to be forever tainted as this lesser problematic thing?

I mean, you could ask the same question about the AstraZeneca vaccine right now, which has gone through a lot of stumbles. There is more information tonight about the Oxford AstraZeneca vaccine and those reports about rare cases of blood clots. We do start with news coming straight from Germany now, where several cities have suspended the use of the Oxford AstraZeneca COVID vaccine for people under the age of 60. The authorities in the Republic of Ireland have recommended temporarily suspending the use of the AstraZeneca vaccine while investigations are carried out. And I think that partly the reason why the FDA and CDC are moving in the way that they are is because this is a very similar type of rare side effect that was seen with the AstraZeneca vaccine. And they are both kind of in the same class of vaccines. They're both called adenovirus vector vaccines as opposed to the mRNA vaccines. And so I think that gives them more reason to feel like this is a real signal as opposed to something totally random.

And because it seems like there might be a similar mechanism. So you asked like, what is going to be the effect on J&J? I already think that there has been increased hesitancy and a bit of, you know, a taint on the AstraZeneca vaccine. But I think that this all comes down to communication. So I'll remind your listeners that back in summer, when we were running the trials and I was going around asking experts, what are you hoping for? What are you expecting to see from these vaccines? They all said it would be great if it was 70% effective. That would be ideal. That was where the bar was. And the FDA said, if it's over 50% effective and a safe vaccine, we're going to give it a green light and authorize it. So that's where the bar was. And then we opened up with Pfizer and Moderna that had 90% plus

efficacy in the trials. And that just set the bar so high for everything that followed. So if you kind of take that away and just go back to what scientists had hoped for, you know, the J&J vaccine and the AstraZeneca vaccine are really good vaccines and are going to make a huge difference to the pandemic. And I think it's that sort of communication explanation to people that you're not comparing, you know, your one in a million risk of getting a blood clot to nothing. You're comparing your one in a million risk of a blood clot to what would happen if you potentially had COVID, right? Transmission is still high in the U.S. right now.

So I think teaching people how to make those risk-benefit analyses and really clear communication about what the vaccines can and cannot do is what's going to shape the narrative around this shot. We're going to pause this show for a minute. And when we're back, we'll talk about the paths ahead on the road to normal. Support for Today Explained comes from Aura. Aura believes that sharing pictures is a great way to keep up with family, and Aura says it's never been easier thanks to their digital picture frames. They were named the number one digital photo frame by Wirecutter. Aura frames make it easy to share unlimited photos and videos directly from your phone to the frame. When you give an Aura frame as a gift, you can personalize it, you can preload it with a thoughtful message, maybe your favorite photos. Our colleague Andrew tried an Aura frame

for himself. So setup was super simple. In my case, we were celebrating my grandmother's birthday and she's very fortunate. She's got 10 grandkids. And so we wanted to surprise her with the AuraFrame. And because she's a little bit older, it was just easier for us to source all the images together and have them uploaded to the frame itself. And because we're all connected over text message, it was just so easy to send a link to everybody. You can save on the perfect gift by visiting AuraFrames.com to get $35 off Aura's best-selling Carvermat frames with promo code EXPLAINED at checkout. That's A-U-R-A-Frames.com, promo code EXPLAINED. This deal is exclusive to listeners and available just in time for the

holidays. Terms and conditions do apply. Bet MGM authorized gaming partner of the NBA has your back all season long from tip off to the final buzzer. You're always taken care of with a sports book born in Vegas. That's a feeling you can only get with BetMGM. And no matter your team, your favorite player, or your style, there's something every NBA fan will love about BetMGM.

Download the app today and discover why BetMGM is your basketball home for the season. Raise your game to the next level this year with BetMGM, a sportsbook worth a slam dunk and authorized gaming partner of the season. Raise your game to the next level this year with BetMGM, a sports book worth a slam dunk and authorized gaming partner of the NBA. BetMGM.com for terms and conditions. Must be 19 years of age or older to wager. Ontario only. Please play responsibly. If you have any questions or concerns about your gambling or someone close to you,

please contact Connex Ontario at 1-866-531-2600 to speak to an advisor free of charge betmgm operates pursuant to an operating agreement with iGaming Ontario herman lopez senior correspondent at vox tell us what is the future of the COVID-19 pandemic, at least in the United States? Yeah, I think I would summarize it as like three possibilities in the next month. One is we do see a fourth surge of COVID. The second is we see a rise in cases, but not necessarily hospitalizations and deaths because the vaccines are protecting people. And the third, hopefully the pathway I actually end up taking, is that there is no surge at all. People are cautious and the vaccines rollout continues and we don't see a forced surge. Okay, well, let's go through those three possible scenarios one by one,

starting with the worst. We'll end on the good one. Sure. The worst scenario is a forced surge of coronavirus. Basically outpaces the vaccine efforts we've seen so far. And I mean, we're already seeing hundreds of deaths a day. If there are more cases, if there are more hospitalizations, that could put us back in the situation we were closer to the winter or perhaps last summer where potentially thousands of people could be dying from COVID a day. And again, this would all be happening right as we're entering the finish line. So if we just hold out for like another month, we could avoid all this, but that's really the concern now if we see a rise in cases. Could there also just be

a fourth surge later in the year, like after summer, let's say, when people are heading back indoors? It's certainly possible, but we're getting to the point where that's going to be extremely unlikely just based on the amount of vaccine out there. By the end of the week, it's estimated that at least half of Americans will have at least one of their shots for the vaccine. I mean, it's going to be really hard to get sick from COVID because the vaccines are going to be doing the work. Okay, what about this other scenario, the sort of not great but not terrible scenario, the middle of the road?

Sure. So one possibility here is we see an increase in COVID cases. But because so much of the older population that's really susceptible to COVID is already vaccinated and they're going to continue getting vaccinated, maybe there isn't a big uptick in deaths and hospitalizations. Basically, the thinking here is like the most vulnerable population is protected. So we might see like an uptick in cases because there are more people getting sick. But these people who do get sick are going to get basically like the milder end of the symptoms.

Like it's not going to be pleasant for anyone going through this. But the risk of hospitalization and death, as we know, is much, much lower among younger populations. About 80% of the deaths are within older demographics in the U.S. So if you imagine that 20% is the only one getting sick, we're talking about a lot fewer people getting hospitalized and dying than was the case in the winter and last summer. Okay. And lastly, let's go with the best path. What's the best possible scenario here? So the best possible scenario, obviously, people do not get sick. We see COVID cases hopefully continue to decline. And we just kind of see this whole pandemic whimper out,

essentially. We cross the finish line, we get enough vaccines out. There's never a forced surge and we're good. As long as the variants obviously can throw a wrench in things, but as long as things continue as we hope they do with the vaccines, then we might not see this forced surge at all. And a lot of people will be saved by the vaccines as a result. And do we know if that best-case scenario involves, you know, vaccine boosters, the need for additional vaccinations down the road for people who've even already gotten it? Yeah, so there's a few possibilities here. One is, I think, that's worth emphasizing is the variant. So far, the vaccines we have seem to work against the variants. The question is if there are more variants developed,

especially if the vaccine rollouts are slow in other countries. And maybe these new variants will require a booster just because they'll evade the immunity we have already in some way. The other possibility is the vaccines don't last as long as we'd like. So far, some of the evidence suggests they last at least months.

So we'll be good for at least a few months, maybe even years. We frankly just do not know how long these vaccines and their immunity effects are going to last. But yeah, that's an important question. I mean, people are probably used to getting booster shots for the vaccines. It's just it's not out of the question that we'll have to do it for COVID too. Which one of these scenarios are we most likely heading to? Do we know? We don't really know.

The US has seen a sort of plateau in COVID cases in the past few weeks. And I mean, we've seen spikes in some states. We've seen continued decreases in others. And it's really just an open question. I think the big problem here is we're talking about probably the most unpredictable thing of all, which is human behavior. And if people loosen up their precautions, if they stop wearing masks, if they start going into risky indoor spaces again, then, yeah, we could see a forced surge before this vaccine rollout really finishes. And another big factor here is how quickly this vaccine rollout goes, depending on how long this Johnson & Johnson pause is, for example. Maybe we could see a slowdown in vaccination rates. Maybe other problems could come up in terms of logistics

and getting vaccines out. So we also need to, on top of people keeping up the precautions, the vaccine rollout has to continue going as well as it has and improve, hopefully. And while we are seeing a lot of good news across the country and vaccinations are ramping up in ways that, as you rightfully pointed out, we couldn't have really expected just a few months ago, things also look kind of sketchy in some places. Like, let's talk about Michigan for a second. Nowhere is the coronavirus roaring back more fiercely than Michigan. And tonight, an alarming number of cases in the state. Nearly as many now as there were during the worst of the pandemic.

Michigan's problems seem to be that people have eased up too quickly in terms of social distancing and masking. But also a lot of the problems stem from not getting vaccines out to like certain segments of the population quickly enough. And the reason that that might be like a little more hopeful than it was before is like these are fixable problems. For so much of the COVID pandemic, we've seen surges and it's like, I don't know, how do we get people to start following precautions again? Like, is that something policymakers can really do? Is that something that public health officials can actually do?

In this case, it's a matter of really just getting vaccines out to the populations that are now being hit quickly. And if you do that in other states, it might be too late to really, I mean, we're already seeing a surge in Michigan. So it might be too late to like really solve this there. But at least in other states, you can look and say like, yes, we need to improve our vaccine rollout. And if we do that, then maybe we can avoid the Michigan scenario. And if we avoid the Michigan scenario, and if today's news even isn't too great a setback, how close are we to some semblance of an end to this pandemic, at least in the United States? So the good news is the end is definitely in sight now. We have these three scenarios, but I want to emphasize that they really are short-term. Again, I'm talking maybe the next

month, maybe the next month or two. At the current vaccination rates, we're administering about 3 million doses a day. That's enough to vaccinate the entire adult population by July. July. If we do our part, if we do this together, by July the 4th, there's a good chance you, your families, and friends will be able to get together in your backyard or in your neighborhood and have a cookout and a barbecue and celebrate Independence Day. And like, look, there are still things that could go wrong there. Like maybe there will be vaccine hesitancy.

Maybe something will go off with the distribution process. But for once, we're saying like, look, in July, you can start planning your summer vacations. You can start celebrating with others. You might be gathering with people indoors before you know it again and feel safe. I don't want to tell people that they should get ready to throw away their masks because, I mean, it's like a still low-cost way to prevent any further surges. But we are really talking about a situation where life gets much closer back to normal by the end of the summer. And we can finally start, hopefully, moving past this pandemic. It sounds nice, Herman. Yeah, hopefully.

You can find Hermann's piece about the paths ahead over at Vox.com. The Force will be with you next time. Thank you.