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- [00:00]
Jonathan Cohn
Hello, everybody. It's Jonathan Cohn, senior writer at the Bulwark. Today we are going to talk about vaccines and vaccine safety, and we're going to do it with a bonafide expert in the field. So we are recording this in the middle of what is shaping up as the worst measles outbreak in decades in Texas, which is the epicenter of the outbreak. At last count, they had recorded 702 cases, which is probably an undercount. 92 of them ended up in the hospital and two have died, both of them children. The first known child deaths from measles since 2003. Nearly every case of the measles we're seeing is from somebody who was not vaccinated, which is something that is happening we're seeing increasingly in the United States. One reason for that is high profile figures in the media and politics who have been saying that vaccines are not safe. And as you may have heard, one of them, Robert F. Kennedy Jr. Is now the Secretary of Health and Human Services. As someone who's spent a career interviewing people about healthcare and as a dad, you know, I know that every parent wants what's best for their children. And when you're hearing lots of confusing information, you're hearing leaders question vaccines, it's hard to know what to do. And that's why I'm so pleased to have here today. With us today, our guest, Joshua Sharfstein Northland. If the name or face is familiar, that's because he's on TV a lot. He also hosts a podcast that launched during the COVID epidemic called Public Health on Call. He has a lengthy resume in government, having served as public health Director for the City of Baltimore, Secretary of Health for Maryland. He was Deputy Director at the Food and Drug Administration. He is now a Distinguished professor of Practice in health Policy and Management at Johns Hopkins. Although just to be clear, he's here speaking on his own behalf, not for any of the institutions or employers which he's been affiliated in the past. I mentioned his resume in government, but there's two other qualifications that I think are most important for this conversation. One is that Josh is a board. Board certified pediatrician. And two, he's the father of two. And actually, that's where I want to start. Josh, you're a doctor, you're a dad. Let's start with the basic question every parent wants to know. Are vaccines safe? Would you recommend them to your patients? Would you, you know, do you give them to your kids?
- [02:35]
Joshua Sharfstein
Well, I absolutely recommend vaccines for kids, and I certainly have had my kids vaccinated. In fact, back when our older child was born, I was still working in the hospital and I had seen cases of pneumococcal meningitis, which is a devastating disease. And that was before the pneumococcal vaccine became available for kids. And I went out and got that vaccine before it was even covered by insurance. I paid out of pocket for it because I had seen the devastation that that kind of meningitis can cause. And, and some of the other parents were wondering, you know, hey, why are you doing that? And I said, this will be recommended soon, but I really want to get this in to him while he's in daycare. And then there was a case in the daycare and then everyone went out and got it, by my recollection. So, you know, I think that vaccines are incredible scientific accomplishments. It's very important that they are studied very carefully for safety. It's very important that the products that are available have benefits that far exceed the risks. And I think that's what we have in this country.
- [03:43]
Jonathan Cohn
Yeah. And I think one thing, I mean this has come up in other conversations, but people forget there was a time when childhood deaths from a lot of these diseases were far more common than they are now. And it was sort of a fact of life. You don't have to go even that far back. Right. Just a few decades for some of these vaccines. Well, I think part of the confusion and you know, people hear different messages out there, they have questions, they stem from the fact people don't really understand, you know, what is the process? How does a vaccine go from, you know, being discovered and being reviewed to kind of being put out there for patients. And that's a process you understand. I know you helped to oversee when you were at fda, kind of talk us through the process. So walk us through what are the stages that a vaccine goes to check, you know, from development to check its safety so that people can be confident when the vaccine is available.
- [04:32]
Joshua Sharfstein
Sure. Well, there's a whole pre clinical process which is where you're designing the vaccine, trying to figure out whether it is going to produce the kind of immunity that will actually protect you against the illness that you're worried about, against the pathogen. And then at a certain point, so.
- [04:53]
Jonathan Cohn
Preclinical just for our listeners. When you say pre clinical, I mean this is like in a lab, like they're like you're looking at like what's happening with interactions. Yeah, exactly.
- [05:00]
Joshua Sharfstein
Could be in cell culture, could be all kinds of different laboratory studies. It's not that people dream up an idea and they're injecting it the next day. There's a lot of work that goes in to develop it. And there's a lot of science into figuring out what part of the virus or bacteria to target in a vaccine. Because what you're trying to do with the vaccine is essentially get your immune system to be ready for the real thing, so that when you actually get exposed to a virus or bacteria, whether it's haemophilus influenza, which used to cause an awful meningitis, or it could be polio, that your immune system's ready and it kills it before it gets you. So by. By not having to be exposed to the actual disease to get immunity, you're ready so you don't run the risk of getting very sick or even dying. And it works really well. And so there are all kinds of lab tests that are done before it goes into clinical studies. And then there are different types of clinical studies. The ones that are done are called phase one, for just pure safety. And there. And, you know, making sure that the dose that people think works is going to be safe. There's phase two, which are generally for vaccines to demonstrate that you can produce the right kind of antibody response that looks like it's going to be effective. And the phase three studies for new vaccines are very large, and those involve controls, and some people get the vaccine, some people don't. And you see whether the people who are vaccinated are actually protected or not. And those often involve tens of thousands of patients.
- [06:33]
Jonathan Cohn
So that's really interesting because it was. I think it was a week ago, Secretary Kennedy made a big deal. He said, look, from now on, you know, one of his things has been, we're going to, you know, we're going to really. We haven't, you know, we're going to check for the safety of vaccines, and we're going to require better testing. The implication being that there hasn't been sort of rigorous testing in the past. And one of the. One of the things, one of the changes he said he was going to make is that, okay, from now on, we're going to have placebo testing for vaccines, meaning that, you know, what you were just describing. So, you know, you have a group, two groups of people. One group gets the vaccine, one does not get the vaccine. They get, I guess, a saline solution, and then you compare the two. So his implication is that there isn't. That we're not subjecting vaccines to placebo testing. You just said we were. So what's going on here.
- [07:22]
Joshua Sharfstein
Right. So it's always hard to kind of parse through some of these statements. But vaccines are tested against placebos when they come onto the market. You know, if you go way back to some of the earliest studies, they're not conducted according to modern standards. But the good news is we have years of experience with these vaccines across millions and millions of patients. And there's a whole safety process to assess vaccines after they get approved. And this is a really important point because when Secretary Kennedy talks about placebo controlled studies, let's just set aside the fact that he's wrong about whether there have been placebo controlled, controlled studies. He's really talking about safety. And there are two ways to think of safety. One is whether they're common side effects. Those are generally like, you know, your sore arm or a little fever. And you'll see that in a clinical study even of tens of thousands of patients. But when we're talking about giving a vaccine, we're talking about giving it to hundreds of thousands or millions of patients. There's no clinical study that you can do to spot something that's relatively rare. That's why you need big safety databases to be able to assess and characterize very rare risks. Those will never be done by placebo controlled studies. And so when we actually want to make vaccines safer, we're talking about strengthening the safety systems that involve these large data sets.
- [08:42]
Jonathan Cohn
Because.
- [08:43]
Joshua Sharfstein
Because it allows us to ask questions that you can ask even in that initial study for licensure.
- [08:49]
Jonathan Cohn
Now, there are some cases where, when you're dealing with vaccines that have been around for a while, where isn't it unethical to do certain kind. And there are certain circumstances where it's actually unethical to do a new placebo study.
- [09:01]
Joshua Sharfstein
Sure. I mean, take measles. You know, if you were to say, well, we have a new measles vaccine, let's study it. This is a situation where you've already got a safe and effective vaccine. What do you this, the new one may have some advantages. I don't know, it could be, maybe you only need one or something like that. You wouldn't have a group that's totally unexposed to the measles vaccine. You wouldn't leave a group vulnerable to measles. That would be unethical. So it's true that for new vaccines, I probably should have said for new types of organisms, you're going to do a placebo controlled study. But if what you're doing is making a better vaccine, you're probably going to test it against the existing one because it would be dangerous to allow people to be vulnerable to the pathogen.
- [09:47]
Jonathan Cohn
Now, we don't do placebo testing on the flu vaccine. Right?
- [09:50]
Joshua Sharfstein
Well, that would be a good example. We have a flu vaccine, we have a flu vaccine process. And there are studies though that can be quite rigorous, called non inferiority studies, where you have a lot of people and you're making sure that at a minimum, a new vaccine is as good as an older vaccine for flu. The virus changes every year, so you're catching up. That's why you're getting a new shot every year. And that is based on essentially the knowledge that when you design that new vaccine correctly, you should see a certain kind of immune response because that immune response predicts actually being protected from illness. And so that's how we get a new flu vaccine every year based on those lab tests that show that immunity. And it's. There just isn't time to do a whole clinical study because then the flu season's over.
- [10:42]
Jonathan Cohn
So, you know, I think about like, why, you know, vaccine hesitancy is sort of seems to be growing. It's kind of a hard thing to test. But it does seem like we've seen an uptick. And certainly I think some of that feels like it came out of the pandemic. And I think there are some people out there who look at the COVID vaccine, right, and they say, wait a minute, you know, we didn't even have, we didn't even know what Covid was till January of 2020. And you know, before the end of the year, we had a vaccine that we're putting into people's arms. How could you possibly know that vaccine was safe in such a short time?
- [11:12]
Joshua Sharfstein
Right. Well, I should say, John, that for as long as there have been vaccines, there has been vaccine hesitancy. You know, there were supreme court cases over 100 years ago about this. It's really important for public health to explain the value of vaccines, to study the safety really carefully. If there are problems, to take action on them. And I think the system does that pretty. What happened with the COVID vaccine was that there was such an imperative to get a vaccine that the process happened in the usual stages, but those stages were all funded at the same time. So they could happen one after another. Typically what happens is you have an idea for a vaccine, you design it in the lab and you see, well, let's do that phase one study. Did it work out okay? Now let's raise money for that phase two. Study. Let's plan that phase two study. Did that one work out okay? How many patients do we need for the phase three study? And there's just these long gaps in between. It's not, you know, it's just the time to raise money, basically, and figure out what you're going to do. What they did with COVID is they designed it all up front, and so they did the phase one. If that didn't work, they were going to stop the development. But when it did work, then, boom, they had phase two already planned and funded and ready to go, and they had a huge, huge phase three study. Tens of thousands of patients against placebo for those Covid shots. And all that evidence was disclosed as part of the advisory committee meetings. And it was a very, very rigorous vaccine development process, and particularly in the United States, because the United States, they insisted on all kinds of extra parts of those studies that other countries didn't do. And for that reason, we wound up with some very effective vaccines that were extraordinarily safe.
- [13:01]
Jonathan Cohn
And is there anything, I think people get caught up on, you know, the MRNA vaccine, this is like this new technology. It seems scary. Is there any reason to be more skeptical of that than other, you know, more, you know, older forms of vaccination?
- [13:14]
Joshua Sharfstein
Well, this is a platform that hadn't been used in a widely marketed vaccine before, but it had been used for other things. So there was a lot of, of understanding of how MRNA works. Basically, it is instructing the cells in your body to make the antigen that becomes the trigger for the immune response that protects you. And so I think there was a lot of science that had been done for decades on this technology, and then that science fed into this opportunity to protect people. And, you know, the proof is in the pudding that those vaccines saved many, many lives. And, um, in randomized controlled trials, you could see the value. And then when you look across again, in those big data sets, across all the people who are vaccinated, they were far less likely to develop severe disease and to die.
- [14:02]
Jonathan Cohn
Yeah, yeah. You know, and I think we've seen some studies afterwards looking at comparing vaccinated, unvaccinated, and, you know, you look at the sort of number of people who lives that could have been saved if more people had been vaccinated, I think, you know, into the hundreds of thousands in this country potentially. So that, that, that, you know, is just something to keep in mind.
- [14:23]
Joshua Sharfstein
I mean, you, you may remember, Jonathan, there was almost like a, a story a week about somebody who was saying they would never get vaccinated they would never get vaccinated. And then they wound up dying. Yeah, you know, happened all the time. Yeah, those were. Those were tough stories to read because you could see, you know, the. The tragedy. And some of those people, as they were getting sicker and sicker, really realized that they had been focusing their fire in the wrong place.
- [14:48]
Jonathan Cohn
Yeah. Yeah. So, I mean, there's the autism questions that's been around, and that's something. Secretary Kennedy has certainly done a lot to promote. This idea that somehow the MMR vaccine causes autism. Has that been studied? You know, what. What's. What. What do we know about that?
- [15:04]
Joshua Sharfstein
Sure. Well, that allegation stems back to a 1998 paper that was published in the Lancet, where there was a. A British doctor who published a case series. It was just, I think, somewhere between 10 and 15 patients who he thought had evidence of getting autism after being vaccinated against measles, mumps, and rubella. That paper has since been retracted. There were all kinds of challenges with it, including some pretty severe conflicts of interest, but it caused a huge panic about that vaccine. And, you know, parents are obviously very protective of their kids. And if they're reading in news reports about an esteemed medical journal publishing a paper like this, you could understand why they might change their. Their practices. And in Europe, the vaccination rates plunged. There were huge measles outbreaks, and that story has kind of cast a big shadow over vaccines, even after there was study after study so much better designed than that original, just, like, listing of a few patients. Studies involving thousands of patients that have reported repeatedly failed to find any association. And there was also the case that at one point, the Institute of Medicine in the United States pulled together a blue ribbon panel. People who had no financial connections to the pharmaceutical industry. They looked at all the evidence, and they also said the evidence favors disproving any connection between vaccines and autism. This has been studied and studied without anything to back up that original accusation, which, again, was based on a paper that was retracted.
- [16:38]
Jonathan Cohn
Last question, because I've already kept you here too long. You know, during the confirmation hearings, Secretary Kennedy got a lot of questions about, you know, his position on vaccines. And he certainly gave the impression he wasn't gonna use his position to undermine faith in vaccines. He wasn't going to change vaccine policy. We're almost three months into his tenure now. You've been watching him. I know. What signs are you seeing? Is he being true to those pledges, or do you see him working to undermine vaccine? Faith in vaccines, programs, et Cetera, Jonathan.
- [17:10]
Joshua Sharfstein
I don't think you need a microscope to see the signs about what's happening on vaccines right now. Start with the measles outbreak. Secretary Kennedy has said all sorts of untrue things about the measles vaccine. As part of that, in fact, the lead vaccine regulator was pushed out at FDA and said he was being ordered to find problems with the measles vaccine that did not exist. That was part of his resignation letter. But beyond that, we see that there have been enormous cuts to the vaccination efforts of states and localities, loss of staff at CDC related to vaccination. So the infrastructure is getting weaker. There have been changes, or at least the suggestion of changes to vaccine policy at fda. Now, look, I'm open to any change in policy, but the way I would think it should be done is you would have a very clearly written guidance document that explains the change, explains the logic, maybe gets public comment on it, and then you tweet, hey, check out our policy document. You know. But instead we're seeing the tweets and the press statements, but no policy. So what's actually happening is a little bit unclear right now. Secretary Kennedy has apparently brought in a vaccine researcher who's been quite disgraced. He was cited by the Maryland Board of Physicians for practicing Medicine without a license and had his testimony disregarded in a number of court cases to do some kind of project ostensibly or reportedly related to vaccines and autism that is most likely not going to end well. And then you have a couple other things that I would say are, are head scratchers, like the fact that there reports that $500 million have been moved from funding a next generation set of vaccines, including for Covid, over to two political appointees for an older technology called whole virus technology. And something that was a little strange to me is when HHS announced it, they said, hey, this technology could be used for rsv, Respiratory syncytial virus. This technology was tried for respiratory syncytial virus. It is one of the most iconic failures of vaccine development because the kids who got the vaccine, when they actually got the disease got worse and some of them died. And so, you know, it is really a head scratcher that they would be investing so much without any apparent scientific or peer review in an effort led by two of their appointees. $500 million, you know, what's going to happen with that is definitely worth understanding more.
- [19:52]
Jonathan Cohn
Joshua Sharfstein, thank you so much for your time and your expertise. Thanks for coming on the Bulwark.