A Vaccine Won’t Be the End

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S1: Since the genetic sequence for the coronavirus was first made public in January, scientists worldwide have been working on developing a vaccine. Never before in history has it taken less than several years for a new vaccine to be produced. Dr. Anthony Fauci says a covid inoculation could be available to the public as soon as next January. And this emphasis on speed has some people worried that politicians are pressuring scientists to cut corners. But other people just want to know how soon they can get in line. So where do you stand?

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S2: People are being asked, would you get a covid-19 vaccine or said another way, would you get a theoretical covid-19 vaccine because there is no covid-19 vaccine.

S1: That’s Dr. Paul Offit Offit is the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. He was also co inventor of a rotavirus vaccine and serves on the vaccine advisory committee for the FDA.

S3: If you ask me that question. If you said, would I get a covid-19 vaccine? My answer to that would be not until I see the data. Let me see whether or not my group is represented there or whatever it is, whether it’s African-American or Latino or obese or health care worker or someone over 65. You want to see that your group is represented in the safety data and the efficacy data.

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S1: But Paul says that data may not come for months. And when it does start to trickle in, don’t expect certainty. Instead, assume that you’ll have to make educated guesses.

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S2: The question when you launch a medical product is not do I know everything? The question is, do you know enough to say that the benefits of this particular product outweigh its theoretical risks?

S4: I mean, do you know enough to say that sometimes there’s unpleasant surprises, but that’s the nature of medical breakthroughs. There’s always a learning curve. Today on the show, selling the vaccine. When we finally get an FDA approved inoculation, will some refuse to get the shot? I’m Celeste Headlee, filling in for Lizzie O’Leary. And you’re listening to What Next TBD, a show about technology, power and how the future will be determined. Stay with us.

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S1: Forty covid vaccines are currently being tested on humans, at least 92 others are not yet in human trials. If one of those vaccines proves to be effective before phase three testing is complete, the manufacturer may pursue an EU a. That’s an emergency use authorization issued by the FDA. And Paul has a role in all this. He’s part of a select group of vaccine experts who sit on the FDA’s vaccines and related Biological Products Advisory Committee. And in just a few weeks, they’ll meet to discuss the development and authorization of the leading covid-19 vaccines. Now you’re meeting with the FDA Advisory Committee on October 22nd. What kind of data do you expect to receive by then?

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S2: Well, to be honest, I expect to see no data. I can’t imagine with the most recent emergency use authorization guidelines, which recommend that we have at least two months of follow up after the final dose would allow us to see, frankly, any data before December. We just don’t have the information. We will have information about how good these vaccines are after phase three trials are done. And until that happens, we really don’t know everything that we need to know.

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S1: Well, with that in mind, can you walk me through how a phase three goes? What happens for the beginning, middle and end of a phase three?

S2: So you recruit people roughly or 30000 people, about either half or two thirds will receive a vaccine and half or one third will receive placebo. The person who gets either vaccine or placebo won’t know which one they’ve gotten. The people who give the vaccine won’t know which one the person has gotten. The people who evaluate these participants to see who got sick and who didn’t won’t know who’s gotten the vaccine, who has. And it’s a blinded prospective study.

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S1: Now, I know Dr. Fauci talked about possibly getting an emergency use authorization on EOA for a vaccine before the Phase three trial has been completed. I wonder what your thoughts are on that?

S3: Well, that does happen. I mean, occasionally what can happen is that a vaccine is so clearly effective in the safe thousands that you’ve tested it on so far. Let’s say there’s one hundred and fifty cases in the placebo group of people who are moderately or severely ill. And there’s only two in the vaccine group. I think that is a statistically significant observation. And you you may not have finished the trial at that point. And you can say, look, I think that we can now submit this for approval through emergency authorization. That does happen.

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S1: However, if the broader American public knows what an easy way an emergency use authorization is, it’s because of two very significant failures in recent months. Right. There was an easy way for hydroxy chloroquine. There was an easy way for convalescent plasma. That’s the therapy in which they use blood from people who recovered from covid-19 that was supposed to help others recover. And then it turned out to not really be effective. So in this particular case, there could be mistrust of the issuing of an Ebola.

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S3: I think you can only imagine there would be mistrust. I mean, you have the job of the FDA, the Food and Drug Administration, just to stand between the pharmaceutical companies and the American public to make sure that the American public doesn’t receive products that are either ineffective or unsafe. In this case, they received both. I mean, Hydroxycut Raquin didn’t work. And it was it had a so-called heart toxicity arrhythmias associated with 10 percent of people. There clearly was evidence that the convalescent plasma had not been shown to work. I mean, so much so that the NIH felt that after it was approved for use that they issued statements showing that there’s no evidence that it worked. And certainly, I mean, theoretically, it could cause a problem. Plasma, because plasma contains clotting factors and excess clotting is one of the features of this particular infection. So you’re giving clotting factors to people who have a clotting disorder. So the FDA did fail us twice.

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S1: So the FDA issued two emergency use authorizations. Both treatments failed. It would be understandable if some lost faith in the FDA’s process after two very public missteps. But Paul says we shouldn’t make a connection between these blunders and the vaccine approval process. He says we can trust the systems that are in place to ensure a safe and effective vaccine.

S3: I think there are two things that stand in defense of that. One is the data safety monitoring board. Vaccines are not treatments that are preventive, and you’re giving them mostly to healthy people. So it’s different than giving Hydroxycut chloroquine or convalescent plasma to people who are in hospital. And secondly, the FDA is vaccine advisory committee. Stephen Hahn, who’s the FDA commissioner, has said that he will rely on the FDA as vaccine advisory committee. Both the Data Safety Marketing Board and the FDA Vaccine Advisory Committee are composed primarily people who don’t have government affiliations and don’t have any associations with the pharmaceutical industry. They typically have historically always given unvarnished, honest thoughts about how they see these vaccines. So I think as long as those two systems are in place, I think we will have what has. Happened for us for the last 70 years with vaccines, which is, you know, clear evidence of safety and efficacy data, that this vaccine is going to be a value.

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S1: Paul, office experience with vaccines began before he was a world renowned expert in immunology and virology. He has strong memories of his childhood years when the U.S. was terrified of another virus.

S3: If you look back in the mid 1950s with the polio vaccine, polio terrorized parents. I mean, I am a child of the 50s. I wasn’t allowed to go swimming, you know, in any sort of public swimming pool. It was just me and my two cousins in the backyard in one of those little plastic pools because my parents were scared to death of polio because polio paralyzed thirty thousand children a year, killed fifteen hundred. And like this virus, you didn’t know who you were going to get it from because most people who had polio never had any symptoms, just like this virus. Yet we waited to do a prospective placebo controlled trial for a year after the vaccine had been shown to be at least safe and highly immunogenic by Jonas Salk in Pittsburgh. But we still waited to do a big Phase three trial. And so if we can wait, then we can wait.

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S1: Now, I’m glad that you took us back in history a little bit, though, because I’ve wondered about nibbling away at the edges of public trust. And if you look at some of the measles or the RSV vaccine from the 60s, it actually made people worse, right? It made them sicker when they got the inactivated RSV vaccine. And are we past that distrust, do you think? Is that far enough? Back in history?

S3: Any time you make a vaccine, you may have an unpleasant surprise. I mean, what happened with measles and RSV vaccines in the 60s was those vaccines were inactivated with formaldehyde. And then because of the nature of the protein on the surface of that virus, actually made an aberrant or unusual immune response. That hasn’t happened since. We’ve gotten much better at knowing what to look for. So I don’t think that’s going to be a problem.

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S1: How much better are we at making vaccines even within just the past 25 to 30 years? Would you say we’ve we head and shoulders above where we were?

S3: Yes, we make purer, safer vaccines. I mean, the advent of recombinant DNA technology, protein purification has allowed us to make very safe vaccines. The Hepatitis B vaccine, hepatitis A vaccine. Human papillomavirus vaccines are safe, effective vaccines. So, yeah, we’re definitely better than we were 50 years ago.

S1: And yet, while vaccines have gotten safer and more effective, public trust has fallen in the U.S. confidence in the safety of vaccines fell eight percentage points between 2008 and 2018.

S3: I’m sure that those who are sort of the formal anti vaccine people will be all over this and claim that these vaccines cause a variety of problems that they don’t cause. But that’s our job, is to separate out causal from coincidental associations. And we’ll do it. We do it well. I mean, it’s the same thing with vaccines causing autism. Vaccines don’t cause autism. I mean, study after study has shown that yet there’s still a certain percentage of the population who believes that to be true. You know, all you can do is, is use reason and logic. That’s all you have on your side. And when people come to a certain opinion that’s not based on reason and logic, it’s very hard to use reason and logic to get them out of that opinion.

S1: But I think that’s all we have nonwhite communities especially having to have a lot of skepticism around not just medical opinions. And some of that is for very credible reasons, but of this administration in particular. What do you think about the idea that non-white communities might be even less likely to take a vaccine than a white community?

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S3: Well, historically, they have been less likely to take vaccines. I think, though, that we need to get this pandemic under control. And so so if we have clear data that vaccine one or more vaccines are safe and effective, then I think we have to figure out what is the best way to convince various communities. I mean, if you’re talking about, for example, an African-American or black community, there is the National Medical Association, which is an association of African-American doctors. They have already talked about how they would go out there to try and calm fears associated with with this vaccine or these vaccines because, you know, a choice not to get a vaccine is not a risk free choice. So I think that’s incumbent upon us to figure out who the influencers are among these various communities and recruit them to get the word about good science out there. And this all assumes that we’re going to have vaccines that are safe and effective. We don’t know that yet.

S1: You famously said you were dead wrong about the coronavirus in that you initially didn’t think it would impact the United States that badly, but it ended up obviously causing now over 200000 deaths. But as I understand it, the reason you didn’t think it would hit us so badly is because you didn’t think Americans would refuse to wear masks or shut down the economy, as people did in South Korea and in China. And I wonder how that informs your view of vaccine deployment.

S2: When I looked at what happened in China or South Korea, Japan or Singapore, I sort of thought, OK, these countries are, you know, X percentage of our country in terms of size. Here’s the number of cases and deaths they’ve had. I tried to extrapolate it to what I thought would happen in our country and came to the conclusion that the sars-cov-2 would not cause more hospitalizations and deaths and influenza, which last year caused 780000 hospitalizations and 60000 deaths. But I was wrong. I was dead wrong. I mean, we did much worse than those other countries. We have roughly four percent of the world’s population and 25 percent of the world’s deaths. It’s unconscionable how badly we’ve done and we’ve done badly because we just have not taken hygienic measures and testing and contact tracing seriously, not as seriously as the other countries have. We don’t have any sort of federal policy on this, as other countries did. And so we suffer this and it’s been hard to watch, actually. And so I do worry with vaccines will be oversold as something magical as we’ve been trying to sell magical things like oleander flower extracts or bleach or UV light. And I think, you know, this is a real scientific product and it will be a value it’ll be a tremendous value, but it’s not magical. And, you know, you can’t abandon the hygienic measures, which is the far more powerful of the two prongs that we have to try and defeat this virus.

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S1: So most likely when people get a vaccine, they’re going to need two doses, is that correct?

S3: Yeah. For the first vaccines are coming out. Looks like they’re all going to be two dose vaccines. Yes.

S1: So it’s kind of a long process, right? It’s you get a dose, you wait a month to get your second dose, but you don’t have your full immune response until weeks later. How much risk is it that people might get that second dose and immediately take off their masks?

S3: I think it’s the thing that keeps me up at night. I mean, that’s I mean, I think the administration has sort of been selling vaccines as as this magic powder that we’re going to distribute over the United States. And this is all going to go away. You know, if you think about it, the smartest thing you can do, if you if I was given the choice of I can wear a mask and trying to do the best I can to social distance or get a vaccine, and I had only I could only do one or the other, I would pick the mask. I mean, the mask is, you know, fits well over my face and will protect small droplets from entering my nose and mouth. It should do a very good job of preventing me from ever coming in contact with the virus.

S1: I want to I want to interrupt you just for a second, because you’ve just said something incredibly important to your mind. A face mask is more effective at this point than a vaccine.

S3: Yes, I think a face mask and social distancing means that you are very, very unlikely to come in contact with the small droplets that contain the virus. Therefore, you’re not going to be infected. If you choose not to wear a mask, then you might be infected. If you’re thinking, well, it’s OK because I’m vaccinated. You know, I think the best of vaccines will be, let’s say seventy five percent effective against moderate to severe disease. I think Dr. Fouchier would be happy with that. I think every all the researchers would be happy with that. Well. Seventy five percent effective against moderate to severe disease means that one out of every four people who is vaccinated could still get moderate to severe disease, the kind of disease that caused you to go to the hospital or go to the morgue. So no vaccine is 100 percent effective.

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S1: And I think when you wear a mask and you stand apart from somebody that’s much closer to one hundred percent effective than a vaccine will be, that’s why Paul doesn’t think it’s a good idea to talk about the race to produce a vaccine or to refer to the effort as warp speed. On the other hand, he takes some comfort in the fact that the president is so supportive of the effort. Paul says there was a lot of cause for concern about Trump’s views of vaccines when he was first running for president in the run up to the election in 2016.

S2: Donald Trump, during one of the debates said, quote, We all know vaccines cause autism and that children get way too many vaccines at too high of a dose. He invited Andrew Wakefield and Mark Blackwell to anti vaccine activists to his one of his inaugural balls. And he then flirted with RFQ Jr. to head a commission on vaccine safety and scientific integrity. RFQ Junior is also a major anti vaccine activist. So I think when Donald Trump was elected, the anti vaccine movement thought, great, we’ve got our guy in the White House certainly hasn’t worked out that way. None of those things that he had sort of alluded to or hinted at ever happened. So now he’s a he’s a vaccine advocate. Great. I fear that he may oversell a vaccine and lead people to believe that now they can throw away their masks and forget social distancing ET, which would be a mistake in the long run.

S1: Do you do you feel that the medical community is having an. A relatively easy time getting its message out, unspun untwisted without any political spin on it.

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S2: Well, no, and, you know, it’s hard it’s hard to watch science get politicized. It’s hard to watch the phrase climate change get taken off. The EPA’s website is hard to watch. The National Oceanographic and Atmospheric Administration lean on the National Weather Service to change the path of Hurricane Dorian, to sort of fit what had been said by the administration. It’s hard to watch science be politicized like this. I’ve never seen anything like it. I never imagined it would be possible. But it has been. And I think people have had their confidence in the FDA shaken. And that is sad because if we don’t trust the FDA in this country, we’re in trouble. I mean, we need the FDA and the CDC and the CDC and the NIH. I mean, that’s probably the saddest. I mean, you know, I was NIH funded investigator for more than 25 years. I certainly was on the advisory committee for Immunization Practices at the CDC. I’m now on the FDA’s Vaccine Advisory Committee. I know these groups. And, you know, they are composed of the people who are exactly who you want them to be. They’re great. They care about what they do. They’re brilliant, they’re hardworking, and they’ve been sidelined largely. And it’s just hard to watch. We certainly suffer that. We have a lot of talent in this country, a lot of hard working talent in this country who have been sidelined. And it’s just hard to watch.

S5: Paul describes himself as generally optimistic, but seeing his talented colleagues silenced has been painful, and he knows the stakes are high when the vaccine is produced.

S3: He says it needs to be safe and it needs to work because if it’s not, if it’s if it’s 20 percent effective and it does have a safety problem, you have just lost the trust of the American public and they’re not going to trust you. Then on the second or third, try. Vaccines are in large part our way out of this, we can’t afford to make that mistake.

S5: Dr. Offit, thank you so much. Sure. Thank you. Dr. Paul Offit is a professor of pediatrics at the Children’s Hospital of Philadelphia, and that’s it for the show today. TBD is produced by Ethan Brooks and edited by Allison Benedikt and Torie Bosch. TBD as part of the larger What Next family TBD is also part of Future Tense, a partnership of Slate, Arizona State University and New America. I’m Celeste Headlee. Thanks for listening and have a great weekend. Mary Harris will be back in your feed on Monday.