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This interview is part of a series of conversations MarketWatch is conducting with some of the leading voices in the U.S. on the COVID-19 pandemic.
Dr. Paul Offit, a pediatrician at Children’s Hospital of Philadelphia and a co-inventor of the rotavirus vaccine, told friends not to worry about the coronavirus. He went on CNN with the journalist Christine Amanpour to talk about why the virus that was hitting Asia hard would not impact the U.S. any more than the flu.
“I am on the record as being dead wrong about this,” Offit said.
His come-to-Jesus moment?
When he realized that Americans were not prepared to wear masks and lock down their lives in the same way that the people did in countries like China and South Korea. “I never imagined it would be this bad,” he said. “Looking at what happened in China, Singapore, Japan, South Korea, I was looking at the size of those countries compared with the size of our country, and I thought there is no way this virus is going to be worse than the flu this year.”
“ “People now see vaccines as a magic dust that’s about to be sprinkled over this country and make this all go away. It doesn’t work that way.” ”
As a vaccine expert — he helped develop the rotavirus vaccine, which protects young children against infections with the virus that can cause severe diarrhea, and sits on the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee — Offit is now keeping a close eye on the clinical trials under way for COVID-19 vaccine candidates and the Trump administration’s potential influence on federal agencies closely involved in the pandemic response.
“The government has shown its capacity to impose its will on science-based federal agencies,” he said. “There is a reason to worry.”
MarketWatch: The first thing I want to talk about is the adverse event in the AstraZeneca AZN, +0.99% AZN, +1.24% trial. What’s your thinking on these types of events, especially for people who are seeing headlines about this but may not understand the ins and outs of the trial process?
Dr. Paul Offit: It’s not unusual to have a clinical trial be put on hold, if there’s a temporal association between receiving a vaccine and having a severe adverse event. Usually the data safety monitoring board says, “This happened. This person got a vaccine. You need to take a look.” So they take a look, and they see whether there’s any other evidence of it in other people who’ve gotten the vaccine. The regulators also look at those data and say that they think that the trial should stop or that they think that this is not a consequence of the vaccine.
There’s so much attention on this particular vaccine. We’re all talking about it. The problem is we don’t really know anything about it. AstraZeneca hasn’t put out anything. Maybe it’s transverse myelitis. Maybe it’s not. You know when you see a detailed clinical description, and until then you really don’t know. It’s not an easy diagnosis to make, sometimes it’s a diagnosis of exclusion.
MarketWatch: Are you concerned about the speed at which we’re developing vaccines? Does this raise red flags, or is this just a matter of the moment and the science?
Offit: Well, there’s been a lot of money put into this by [the Biomedical Advanced Research and Development Authority], by the World Health Organization, by the Gates Foundation, that has basically taken the risk out of it for at least for some of the smaller pharmaceutical companies. Moderna Inc. MRNA, -2.46% would not normally do a Phase 3 trial at the same time they would be mass-producing their vaccine. They would wait to see whether it works and was safe before they mass-produced it. What the government said is, “Look, we’ll take the risk out of it for you. We’ll pay for the Phase 3 trial. We’ll pay for mass production.” That’s good, actually. A vaccine is part of what’s going to get us out of this mess.
On the other hand, you cannot truncate the Phase 3 trials. That is the proof that cannot be short-circuited. What I worry about is something I wrote about with [American oncologist, bioethicist and senior fellow at the Center for American Progress] Zeke Emanuel in an op-ed in The New York Times at the beginning of June: an “October surprise” — that the government would find a way to truncate that trial, declare victory, and put it out there. Watching what happened with hydroxychloroquine, watching what happened with convalescent plasma, watching what happens with climate change and the EPA, the government has shown its capacity to impose its will on science-based federal agencies. There is a reason to worry.
But I think there’s so much attention on this, and there’s such skittishness in the American public, that if the American public got a hint that things were being truncated, that academics were standing up and saying, “Well, I wouldn’t get this vaccine,” I don’t think it would work. Convalescent plasma has largely died the death it should have died because you had the [National Institutes of Health], Tony Fauci, saying there’s no evidence that this works.
MarketWatch: How worried are you about people choosing not to vaccinate over fears about the safety of vaccines?
Offit: Once we know the characteristics of these vaccines, then we can explain what we know and what we don’t know. Let’s say theoretically that a vaccine’s 75% active at preventing moderate-to-severe disease. It’s been in 20,000 people, including people over 65 [years old], people who are African-American or Latino, people who have certain co-morbidities, and it’s been shown to be safe.
First of all, you’re not going to have enough vaccine, even for the people who were in the first-tier groups [who are designated by the U.S. to be at high risk of contracting the virus and so would have the first opportunity to be vaccinated]. It’s going to slowly roll out. If there’s problems, it’ll pop up. That’s the only way you’re going to know. You can’t rule out rare or adverse events pre-approval. But there are systems in place like the Vaccine Safety Datalink, [a safety monitoring project set up by the Centers for Disease Control and Prevention] and others, that will pick up those rare events. The most convincing thing is when people see other people getting it, and there’s not a problem.
MarketWatch: The CDC just put out its proposal for distribution of COVID-19 vaccines. We’ve never seen a mass vaccination like this. What do you think this process is going look like? What are you worried about?
Offit: There’s going to be a lot of assembling. First of all, it’s a two-dose vaccine. You need to vaccinate the person, and they need to come back again a month later.
Secondly, it’s going to be certain tiers [of people] that are recommended to get it: people who are over 65, people who work in health care, people who work in education. Now, there may be people who want to get this vaccine who don’t fall into any individual first-tier groups who will probably find a way to get it. If you’re distributing this vaccine not only in physicians’ offices, but in large chain pharmacies, are we asking those pharmacies to make sure that the patient proves that they’re in one of those groups? And, if so, how would they do that? That’s another problem.
The third problem is [the storage and refrigeration needs] if one or more of the vaccines that come out are these messenger RNA vaccines. [The vaccines being developed by Moderna and BioNTech BNTX, +0.81% and Pfizer Inc. PFE, -0.30% are mRNA vaccines.] We’ve never done that before in this country. Never. It means shipping and storing, with dry ice, which we’ve never done. And so we would have to make sure that people have the boxes, the storage facilities, where they could do that. There’s going to be a learning curve here.
MarketWatch: Some of these vaccines are going to be two doses. Do we know much about adherence to a two-dose vaccination regimen?
Offit: [GlaxoSmithKline’s GSK, -0.29% shingles vaccine] Shingrix is a two-dose vaccine, separated by a month. People come and get a second dose.
MarketWatch: The FDA guidance in June suggested around 50% for the COVID-19 vaccines. Do you think there needs to be more education to the public that the vaccine may not be a sure shot in protecting against the virus?
Offit: Even if it’s highly effective, it’s still not going to be a sure shot. If you get 75%, that means one out of every four people who get it could still get moderate to severe disease, which can cause them to be hospitalized or die, which is why they’re still going to need to wear a mask. It will probably be a greater percentage more than 25% who could still get either mild infections or asymptomatic infections or they could still shed and be contagious.
That’s what worries me the most. People say, “Great. I’m vaccinated. I can engage in high-risk activity, and I’m going to throw away my mask.” [Wearing a mask] is the most powerful thing we can do.
MarketWatch: So, post-vaccination, are we still going to be wearing masks?
Offit: Yes — for a couple of years and doing the best we can to social distance. We can go back to school, as long as we do the kinds of things they’ve done in Denmark and other countries that have been able to do this successfully. We just don’t have that kind of federal leadership, sadly. People now see vaccines as a magic dust that’s about to be sprinkled over this country and make this all go away. It doesn’t work that way.
MarketWatch: Do you want to see an authorization or an approval for the vaccine?
Offit: I’m not sure it matters, as long as we hold this vaccine to the same standards we do to every other vaccine for the last 70 years, whether it’s called a licensure or an approval or authorization.
This Q&A has been edited for clarity and length.
Read more A Word from the Experts interviews:
• To defeat COVID-19, ‘we need a unified national strategy,’ says public health expert Dr. Howard Koh
