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Tanzina Vega: This is The Takeaway. I'm Tanzina Vega and I'm thrilled to be back with you in the host chair today. We start with a look at the latest on the Johnson & Johnson vaccine. US health agencies have called for a pause on the distribution of the single shot Johnson & Johnson vaccine as they investigate its potential link to an extremely rare blood clotting disorder. The decision comes after six reported cases of women developed blood clots after receiving the J&J vaccine.

One of those women has died. The CDC and the FDA recommended the pause on the J&J vaccine "out of an abundance of caution". We should be clear that nearly 7 million people have received the J&J vaccine in the US so far, with the overwhelming majority reporting zero or mild side effects. So far there are no concerns about blood clots with either the Moderna or Pfizer vaccine. Here to answer our questions and yours is Dr. Megan Ranney, an emergency physician and director of the Brown-Lifespan Center for Digital Health. Dr. Ranney, welcome to the show.

Dr. Megan Ranney: Thank you Tanzina. It's a joy to join you.

Tanzina: Let's start with the details. There were six cases of clotting. What do we know about, are these directly related to the J&J vaccine?

Dr. Ranney: We don't know for sure yet. I think the thing that gives us suspicion that they're related is that the type of clot that we're seeing, that's a combination of clotting in the veins or arteries and low platelets, is first of all very unusual, and second of all is the same type of clotting that was observed with the AstraZeneca vaccine which is made in a similar way to the Johnson & Johnson vaccine. So out of an abundance of caution, the CDC and FDA are asking for a pause until we figure out a little bit more

Tanzina: I want to ask you a little bit more about the comparison to the AstraZeneca vaccine in just a minute. But what struck me Dr. Ranney, is that the cases that we're talking about were all women. What more do we know about these women? Are they in the same age group? Do we know anything else about the women particularly that were affected here?

Dr. Ranney: We know that all the women in the United States that had these clots were of childbearing age, and we know women in that age group are a little higher risk for blood clots in general. Sometimes because we get pregnant, sometimes because we're on oral contraceptives, sometimes for reasons that we don't really know. Beyond that, we're waiting on data. I know that the council on immunization practices is going to be reviewing more extensive data this afternoon.

I think by mid-afternoon we're going to know a lot more about the characteristics of these women, if they have any similar factors that may have predisposed them to having this unusual type of clotting disorder.

Tanzina: Dr. Ranney, do we know anything else about, we mentioned the Pfizer and Moderna vaccines so far have not had any issues when it comes to blood clotting, but I'm wondering if women in particular who've taken either of those vaccines also experienced similar types of side effects?

Dr. Ranney: A great question. A really important point is that the Pfizer and Moderna vaccines are made with a totally different technology from the Johnson & Johnson or AstraZeneca vaccines. Pfizer and Moderna are made with mRNA. Johnson & Johnson and AstraZeneca are made with an adenovirus

or cold virus vector. It's basically the shell of a cold virus that's used to introduce this little teeny bit of the COVID spike protein into your body so that you can create an immune reaction.

Because of that, we don't suspect that there's going to be any overlap and there really haven't been any reports of blood clotting disorders among folks receiving those mRNA vaccines. I think of them as being a totally separate category of vaccine, despite the fact, of course, that they're both vaccinating for the same disease.

Tanzina: Dr. Ranney, I'm wondering, and again, I'm not sure how much we know about this because this is such a process that's been so fast in terms of creating these vaccines, but as we know, the medical establishment tends to test women less frequently than they do men. I'm not sure if that also happened with the development of these vaccines for corona virus. Were women part of trials in the way that perhaps men may have dominated the trial process?

Dr. Ranney: They actually did a pretty good job of matching on gender in these trials. But remember, this unusual side effect is only being seen in about one in a million cases. Even if their trials have been entirely women, it's really unlikely that they would have picked this up, because the trials were 20,000, 30,000, 40,000 people. They're not going to see this one in a million case. Even if they saw one case it wouldn't have been enough to make them concerned that it was linked to the vaccine.

Tanzina: What kind of calculus was behind the decision, in your expert opinion, that the CDC and the FDA took to pause the distribution of the J&J vaccine?

Dr. Ranney: Obviously, I'm not part of the CDC or the FDA, but knowing what I know about public health, I think they most likely paused J&J vaccine distribution for a couple of reasons. The first is there was evidence from Europe that the vaccine there, the AstraZeneca vaccine, is linked biologically to this unusual type of clot, so they have a reason to then think that J&J is linked to this unusual type of clot being seen in the US.

The second is that they need to let doctors and other healthcare practitioners know that this happens, because it is so unusual, because you do treat it differently from regular blood clots, it's important to get that information out. Then the third thing is that they want to get a little more information.

They want to stimulate some reporting and they wanted a little bit of time to assess risks of the vaccine versus benefits. The FDA's primary job to the American people is safety and protecting us, and so from their perspective they don't want to hide anything. They'd rather err on the side of caution

Tanzina: I was just going to say transparency feels like it's a really big part of this and we're going to be talking more about the messaging around these vaccines and the virus later in the show today. In terms of just regulatory steps that are taken with any vaccine or medication, this is pretty typical, isn't it?

Dr. Ranney: Yes. It is utterly typical to monitor new medications, new medical devices, after they go on the market. There's a whole system for that and medicines and devices actually have to submit reports and guarantee that they're going to do post-approval marketing, so it's not uncommon to find problems after something is released. They're usually really, really rare problems like this one, and they rarely ultimately change the FDA's decisions about whether or not to keep a drug on the market.

This is not an unusual thing. The difference is, of course, the vaccines are so caught up right now both in politics and in this horrible moment that we're in where we all have been hoping that the vaccines are going to be the way out of this past year and a half, which is, I think, part of the reason that we're all paying so much attention to this news.

Tanzina: Now, we should be clear that pausing is not the same thing as stopping the distribution of the vaccine and that this pause is a recommendation not a mandate. Am I right there?

Dr. Ranney: That is exactly right. It is a temporary pause until the FDA and CDC can do a little more information gathering, and again, until their council on immunization practices can- which is an independent body of scientists. Until they can meet and look at the data, it in no way shape or form is the same as withdrawing authorization. In fact, very few of us in the public health world expect to see authorization withdrawn. What we may see is recommendations to limit the use of the J&J vaccine to folks who are lower risk for, again, this very, very rare complication.

Tanzina: This recommendation comes, as we were talking about this yesterday with my team I thought, the worst timing for something like this is right now. As you mentioned earlier, we're trying to get past this. We're trying to get vaccines in arms and distributed. How long, doctor, do we expect this pause to be in effect? I know that's a hard question to assess and it's okay if we don't have a timeline, but I'm just curious because I think the timing of this could hurt folks' perception of the vaccines.

Dr. Ranney: I don't have an answer for how long the pause will be in effect. It may go away as early as this afternoon or it may last for another week or two, but I worry that the damage on people's perceptions may already be done. We saw a dramatic decrease in the number of Europeans who were willing to be vaccinated after a similar pause on the AstraZeneca vaccine.

I'm quite worried about that here in the US, which is one of the reasons that I try to keep emphasizing, first, that the Moderna and Pfizer vaccines have not changed in their risk assessment, and second, for the Johnson & Johnson vaccine, even if these side effects, these unusual rare blood clots, do end up being linked to the J&J vaccine, they are still so much less common than the risk of catching COVID, or being hospitalized from COVID, or the risk of any of a thousand other everyday things that we all decide to take on the risk of. It may not ultimately change our risk calculus. It just is a thing to be aware of, just like we're aware of side effects from aspirin or oral contraceptives or blood pressure pills or anything else that we do want to take into our body on a daily basis.

Tanzina: It's interesting you mentioned the brief list of side effects, because so many of us who, I guess maybe I'm one among the rare that still watch network television, but the ads that come on about medications list side effects so quickly, you can barely process them these days. I'm wondering, we've had people who have reached out to us and are worried about what they should do if they received the vaccine, if a loved one received the vaccine. There's someone who reached out to us who said they had heart issues, someone who's already predisposed to blood clotting. What do they do? Should they be okay, or should they be monitoring themselves for any changes?

Dr. Ranney: The first thing is, and it's a one in a million chance, so you could go win the lottery, hopefully, before you're going to get this unusual but very horrible rare side effect. So take a deep breath, the chance of this happening to you is quite small. Your point Tanzina, about the side effects for so many of those medicines whose ads we see on TV. Side effects are so much more common. As an ER doc, I can tell you, I frequently see people with side effects from other medications that occur at a much higher rate than this one.

That said, if you have gotten the Johnson & Johnson vaccine, know that this problem has shown up in general, somewhere between one and two weeks after you get the vaccine, so it doesn't happen the same day. If you're a month out, it's unlikely to show up then. The things to watch out for are a severe headache, something different from what you normally get. Changes in your vision, or your ability to move your arms or legs, or to feel your arms and legs. Stroke-like symptoms, or severe trouble breathing, or severe belly pain. Basically, anything that would make you consider calling the doctor or going to the ER anyhow, would be something for you to go to the ER or call your doctor and let them know that you got the J&J vaccine a couple weeks ago.

Tanzina: As a provider yourself, are you expecting to address these concerns and patients?

Dr. Ranney: I am. I'm already hearing from my colleagues across the country that we're seeing an increasing number of folks come into our ERs and doctor's offices concerned.

Tanzina: Dr. Ranney, I want to pivot for a minute here, because we've talked a lot about the vaccine hesitancy narrative, which is something we'll get into more in a minute, but what about vaccinating children? I know Pfizer said that they are going to start vaccines, at least trials, on younger people, 12 and up. Vaccines have been now been available in certain cities across the country for those 16 and older. Where do we stand with those under 18?

Dr. Ranney: Pfizer is already approved for age 16 and up. They now have data showing that their vaccine is 100% effective in age 12 to 15. I expect that we'll be seeing FDA emergency use authorization for that age group within a month or two. I am so excited about that. I'll say I'm a mom of two kids, one of them fits in that 12 to 15 age group, and I can't wait to get that child vaccinated. It is just going to transform her ability to be able to be with friends without a mask on, and it's going to make her so much safer at school.

I expect that the younger age groups, my other kid probably won't be eligible for a vaccine until the winter or so, unless I manage to get him into a trial. For parents across the country, I would say to expect that your 12 and up should get vaccinated hopefully this summer, and the younger kids, midwinter to the beginning of next year.

Tanzina: So we can expect younger children to potentially be on the list for vaccines?

Dr. Ranney: I would expect so. They've already started doing trials. There's no reason to think that these vaccines won't work in the younger age groups. I think it's important to get them vaccinated, although the younger kids are not at high risk of the severe side effects of COVID, they certainly can catch it. Just like with the side effects of the J&J vaccine, when kids do get sick, there's the potential for them to get quite sick. As a parent, if you can avoid that, it's always a good thing to protect your kid.

Tanzina: There is lots of talk about opening schools in the fall and vaccines becoming a part of that conversation. We know particularly when it comes to colleges, college students, some colleges are mandating students get vaccines. That feels like a very traditional thing to do. When you go to school, you have to provide your measles and mumps and other types of vaccine proof. Without getting into a debate about vaccine passports, this feels very standard, I would imagine, for places like universities.

Dr. Ranney: That's exactly right. My own university, Brown, is going to be requiring vaccinations for students coming back in the fall semester, and it's exactly what we do around other typical vaccines like meningitis or measles, mumps, and rubella. It's a way to protect the community. I hate to see it politicized because it's something we've been doing for quite a long time. This is standard practice for schools and even for businesses and hospitals across the country.

Tanzina: Let's talk a little bit, we're going to be talking about this later in the program, but I'm curious about the messaging about vaccines. Going back to the beginning of the pandemic, the messaging that we've gotten from everyone from public health officials on down, has been confusing. I remember a year ago, we were being told don't wear masks, and then it was wear masks. There's a lot of confusion about the messaging around this. I'm wondering from your perspective whether you think, particularly around vaccines and vaccine hesitancy, there has been the narrative of hesitancy overplayed in communities of color, and perhaps underplayed among say, Republicans, 40% of whom have so far in a poll that we mentioned earlier, said that they're not interested in getting the vaccine.

Dr. Ranney: Absolutely. I actually prefer to use the term vaccine confidence, because I think based on the studies that I and others have done, what we actually see is that folks just don't really understand or don't yet trust the vaccine. They worry it was developed so quickly, or it hasn't been followed for long enough.

Now, both the mRNA and the adenovirus vectors are new technologies for vaccines in humans, but not actually all that new. They've both been in development for decades. This is just the first time there's been enough federal funds to get them over the finish line into something that's been fully approved.

I think there's a lack of information, and as you say, the confusion of the messaging can hurt that confidence and this latest pause is only going to make that tougher. I think the big takeaway, first of all, we need to teach public communication in public health schools. Secondly, we need to work with communities to recognize that the same message doesn't necessarily resonate for everyone, whether it's communities of color or rural communities, they need folks that make sense and speak in the language that makes sense to them.

Tanzina: Of course, we ourselves here in the media "can't leave ourselves off the hook." How would you assess how the media has taken the information from public health officials and others and communicated it to the general public? That's what we're supposed to do, right?

Dr. Ranney: It is, but I think it's tough because the information is changing so quickly and the media wants a story. It's tough to communicate nuance sometimes, particularly in short TV segments or social media.

Tanzina: Is there something that you suggest the media or public health officials can do better at communicating this, so we can reach that line between getting the headline or getting the story and not frightening the population, but also being transparent? It's a really tricky balance.

Dr. Ranney: It is a tricky balance. I think part of it is having medical or public health folks on staff to help translate the latest news, to make sense of it, to provide storylines that are nuanced and accurate, and also to not over-present or over-promise. Very little in a pandemic is a clear yes or clear no. There are these shades of grey in between. We've seen it with a 15-minute rule, with the six feet versus three feet, with droplets versus aerosols.

The science is evolving and it's a place where we need to be able to-- it's a challenge to explain those small gradations that can make a difference. To me, for the media, it would be having those of us with public health backgrounds to help inform you, so I appreciate the chance to be on today with you.

Tanzina: That's why we talk to you. Dr. Megan Ranney is an emergency physician and director of the Brown-Lifespan Center for Digital Health. Dr. Ranney, thank you so much for being with us.

Dr. Ranney: Thank you.

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