Future Tense

What Keeps an Immunization Expert Up at Night

In the race to get a coronavirus vaccine to market, there’s a danger of losing Americans’ trust.

Man in a mask receiving an injection.
A volunteer participates in a coronavirus vaccination study in Hollywood, Florida, on Thursday. Marco Bello/Reuters

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For months, scientists worldwide have been scrambling to develop a vaccine for COVID-19. Never before in history has it taken less than several years for a new vaccine to be produced. Forty novel coronavirus vaccines are currently being tested on humans, and at least 92 others are not yet in human trials. Dr. Anthony Fauci says a COVID inoculation could be available to the public as soon as next January. But this emphasis on speed has some people worried that politicians are pressuring scientists to cut corners. Others want to know how soon they can get in line.

Dr. Paul Offit has a role in the race to get a vaccine to market. Offit is the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and serves on the vaccine advisory committee for the Food and Drug Administration. On What Next TBD, I spoke with him about the vaccine development process, how to restore Americans’ trust in science, and why the vaccine won’t be a miracle cure. Our conversation has been edited and condensed for clarity.

Celeste Headlee: Would you get a coronavirus vaccine?

Paul Offit: Not until I see the data. Let me see whether or not my group is represented there—whether it’s African American or Latinx 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.

You’re meeting with the FDA advisory committee on Oct. 22. What kind of data do you expect to receive by then?

To be honest, I expect to see no data. I can’t imagine with the most recent emergency use authorization guidelines, which recommend that that we have at least two months of follow-up after the final dose, would allow us to see 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.

Can you walk me through how a phase three goes?

You recruit roughly 30,000 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 and who hasn’t.

I know Dr. Fauci talked about possibly getting an emergency use authorization for a vaccine before the phase three trial has been completed. What are your thoughts are on that?

Occasionally what can happen is that a vaccine is so clearly effective in, say, thousands that you’ve tested it on so far. Let’s say there’s 150 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 may not have finished the trial at that point, but you can say, “Look, I think that we can now submit this for approval through emergency use authorization.”

If the American public knows what an EUA is, it’s because of two very significant failures in recent months. There was an EUA for hydroxychloroquine and for convalescent plasma—the therapy in which they use blood from people who recovered from COVID-19. And they turned out to not really be effective. In this particular case, there could be mistrust of the issuing of an EUA.

I think you can only imagine there would be mistrust. The job of the FDA is to stand between 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. So the FDA did fail us, twice.

But I think there are two things that stand in defense of a vaccine. One is the Data and Safety Monitoring Board. Vaccines are not treatments—they’re preventives. And you’re giving them mostly to healthy people. That’s different than giving hydroxychloroquine or convalescent plasma to people who were in hospital. And secondly, Stephen Hahn, who’s the FDA commissioner, has said that he will rely on the FDA vaccine advisory committee. Both the Data and Safety Monitoring Board and the vaccine advisory committee are composed primarily of 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 we will have what has happened for us for the last 70 years with vaccines: clear evidence of safety and efficacy data that this vaccine is going to be a value.

But if you look back at the measles or the RSV vaccine from the 1960s, those vaccines actually made people worse, right?

Anytime you make a vaccine, you may have an unpleasant surprise. What happened with measles and RSV vaccines in the ’60s was those vaccines were inactivated with formaldehyde. Then because of the nature of the protein on the surface of that virus, it made an 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.

But although vaccines have gotten safer and more effective, public trust has fallen. In the U.S., confidence in the safety of vaccines fell 8 percentage points between 2008 and 2018.

I’m sure that the anti-vaccine people will be all over this and claim that these that these vaccines cause a variety of problems that they don’t cause. But that’s our job, to separate our causal from coincidental associations. And we’ll do it.

All you can do 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 or logic, it’s very hard to use reason and logic to get them out of that opinion. But I think that’s all we have.

Nonwhite communities especially have a have a lot of skepticism around not just medical opinions (and some of that for very credible reasons), but of this administration in particular. What do you think about the idea that nonwhite communities might be even less likely to take a vaccine than a white community?

Historically, they have been less likely to take vaccines. I think, though, that we need to get this pandemic under control. So if we have clear data that 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? If you’re talking about, for example, a 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 to calm fears associated with this vaccine because 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. And this all assumes that we’re going to have vaccines that are safe and effective. We don’t know that yet.

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 as I understand it, you didn’t think Americans would refuse to wear masks or shut down the economy. How does that inform your view of vaccine deployment?

I when I looked at what happened in China, South Korea, Japan, or Singapore, I sort of thought, OK, these countries are 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. But I was dead wrong. We did much worse than those other countries. We have roughly 4 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. 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.

I do worry that vaccines will be oversold as something magical, as we’ve been trying to sell magical things like bleach or UVB light. This is a real scientific product. It’ll be of tremendous value, but it’s not magical. And you can’t abandon the hygienic measures, which is the far more powerful of the two prongs that we have to try to defeat this virus.

Most likely, when people get a vaccine, they’re going to need two doses, correct?

Yes.

So it’s kind of a long process: You get a dose, then 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?

It’s the thing that keeps me up at night. I think the administration has been selling vaccines as this magic powder that we’re going to distribute over the United States, and this is all going to go away. But if I was given the choice of wearing a mask and doing my best to social distance or getting a vaccine, and I could only do one or the other, I would pick the mask. The mask, if it fits well, should do a very good job of preventing me from ever coming in contact with the virus.

So to your mind, a face mask is more effective at this point than a vaccine?

Yes. I think a face mask and social distancing mean 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. Maybe you’re thinking, It’s OK because I’m vaccinated, but I think the best of vaccines will be, let’s say, 75 percent effective against moderate to severe disease. I think Dr. Fauci would be happy with that. But that means that one out of every four people who is vaccinated could still get moderate to severe disease, the kind of disease that causes you go to the hospital or go to the morgue.

No vaccine is 100 percent effective And I think when you wear a mask and you stand apart from somebody, that’s much closer to 100 percent effective than a vaccine will be.

Do you feel that the medical community is having a relatively easy time getting its message out unspun, without any political spin?

No. 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 is website. It’s hard to watch the National Oceanographic and Atmospheric Administration lean on the National Weather Service to change the path of Hurricane Dorian to fit what had been said by the administration. 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. We need the FDA.

And the CDC.

And the CDC and the NIH. That’s probably the saddest. I was an NIH-funded investigator for more than 25 years. I 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. 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.

If this vaccine is 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 that on the second or third try. Vaccines are in large part our way out of this, and we can’t we can’t afford to make that mistake.

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