Dr. Offit: be ready to wear masks and social distances even after receiving the COVID-19 vaccine



This interview is part of a series of conversations Marketwatch is conducting with some prominent voices in the US on the COVID-19 epidemic.

Dr. Paul Offit, a pediatrician at Children’s Hospital Philadelphia and co-inventor of the rotavirus vaccine, told friends not to worry about coronovirus. He went on CNN with journalist Christine Amanpour to talk about why a hard-hitting virus in Asia would not affect America more than the flu.

“I’m on record as being wrong about this,” Offit said.

His coming-Jesus moment?

When he realized that Americans were not prepared to wear masks and to close their lives in the same way as people in countries like China and South Korea. “I never thought it would be 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 felt that this virus was getting worse with the flu. There is no way. ” year.”


“People now see the vaccine as a magic dust that is going to be sprinkled on this country and removes it all. It does not work that way. ”


– Dr. Paul offit

As a vaccine specialist – he helped develop the rotavirus vaccine, which protects young children from virus-causing infections that can cause severe diarrhea, and the Food and Drug Administration’s Vaccine and Related Biological Products Advisory Committee Sits on – Officit is now keeping a close eye on clinical trials for COVID-19 vaccine candidates and the Trump administration’s potential impact on federal agencies closely involved in the epidemic response.

“The government has shown the ability to impose its will on science-based federal agencies,” he said. “There is reason to worry.”

Market Inspection: First of all I want to talk about AstraZeneca AZN has an adverse event,
+ 1.46%

AZN,
+ 1.24%
testing. What do you think of these types of incidents, especially for those who are making headlines about this, but cannot understand the ins and outs of the testing process?

Dr. Paul’s Office: If there is a temporary relationship between receiving a vaccine and having a serious adverse event, it is not uncommon to stop a clinical trial. Usually the data security monitoring board says, “This happened. This person received a vaccine. You need to take a look. “So they take a look, and they see if there is any other evidence of this among other people who have received the vaccine.” Regulators also look at those figures and say that they think the test should be stopped or that it is not a result of the vaccine.

There is so much attention on this particular vaccine. We are all talking about it. The problem is that we don’t really know anything about it. AstraZeneca has not inserted anything. It may be transverse to myelitis. Maybe it is not. You know when you look at a detailed clinical description, and until then you don’t really know. It is not an easy diagnosis to make, sometimes it is a diagnosis of exclusion.

Market Inspection: Are you concerned about the speed at which we are developing vaccines? Does it raise the red flag, or is it only a matter of moment and science?

Close this: Well, it costs a lot of money [the Biomedical Advanced Research and Development Authority]By the World Health Organization, by the Gates Foundation, which is basically taken out of risk for at least some small pharmaceutical companies. Modern Inc., MRNA
-1.38%
Usually they will not test a Phase 3 at the same time they will mass produce their vaccines. They would wait to see if it worked before it was mass-built and was safe. What the government has said, “Look, we will take this risk for you.” We will pay for Phase 3 testing. We will pay for mass production. “It’s really good. There is part of a vaccine that is going to get us out of this mess.

On the other hand, you cannot cut the phase 3 tests. This is evidence that cannot be summarized. I wrote something about what I worry about [American oncologist, bioethicist and senior fellow at the Center for American Progress] Zeke Emanuel in an op-ed from The New York Times in early June: an “October surprise” – that the government will find a way to trample that lawsuit, declare victory and get it out. Seeing what happened to hydroxychloroquine, seeing what happened to cramped plasma, seeing what happens with climate change and the EPA, the government has shown the ability to impose its will on science-based federal agencies. There is reason to worry.

But I think there is so much attention, and there are such clashes in the American public, that if the American public signs that things are being cut, academics stand up and say, “Well, I got this Won’t get the vaccine, “I don’t think it will work. Convulsant plasma has died to a large extent because it must have died because you had [National Institutes of Health], Tony Fauci said that there is no evidence that it works.

Market Inspection: How worried are you about people not getting vaccinated on apprehensions about vaccine safety?

Close this: Once we know the characteristics of these vaccines, we can explain what we know and what we do not know. Let’s say theoretically that a vaccine is active in preventing 75% of moderate-to-severe disease. It is in 20,000 people, which includes more than 65 people [years old], People who are African-American or Latino, people who have some co-morbidities, and have been shown to be safe.

First of all, you are not going to get enough vaccine even for those who were in first class 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 is going to end slowly. If there is problem, it will pop. This is the only way you want to know. You cannot rule out rare or adverse events of pre-approval. But there are systems like vaccine safety datalinks, [a safety monitoring project set up by the Centers for Disease Control and Prevention] And others, who will take up those rare events. The most concrete thing is when people see other people getting it, and there is no problem.

Market Inspection: CDC proposed to distribute COVID-19 vaccines. We have never seen mass vaccination like this. What do you think this process looks like? What are you worried about

Close this: A lot is going to be assembled. First, it is a two-dose vaccine. You need to vaccinate the person, and they need to come again after a month.

Secondly, it’s going to be on some levels [of people] To achieve this it is recommended: people who are over 65, people who work in health care, people who work in education. Now, there may be those who want to receive this vaccine, who do not fall into the first-class groups of anyone who will likely find a way to obtain it. If you are distributing this vaccine not only in physicians’ offices, but also in large chain pharmacies, are we asking those pharmacies to ensure that patients prove that they are one of those groups The And, if so, how would they do it? This is another problem.

Third problem [the storage and refrigeration needs] If one or more vaccines are released, they are messenger RNA vaccines. [The vaccines being developed by Moderna and BioNTech
BNTX,
+1.12%
 and Pfizer Inc.
PFE,
+0.10%
 are mRNA vaccines.] We have never done this before in this country. never. This means shipping and storage with dry ice, which we have never done. And so we have to make sure that people have boxes, storage facilities where they can do that. There is going to be a learning curve here.

Market Inspection: Some of these vaccines are about to form two doses. Do we know much about adherence to two-dose vaccination?

Close this: [GlaxoSmithKline’s
GSK,
+0.12%
 shingles vaccine] Shingrix is ​​a two-dose vaccine, which is separated by a month. People come and take another dose.

Market Inspection: FDA guidance in June suggested about 50% for COVID-19 vaccines. Do you think there is a need to give more education to the public that vaccine cannot be a surefire pill to protect against viruses?

Close this: Even if it is highly effective, it will not be a sure shot. If you get 75%, it means that one in every four people who receive it can still get moderate to severe illness, which may cause them to be hospitalized or die, which is why. Is that they are still required to wear masks. This will probably be a percentage greater than 25% that can still get mild infections or asymptomatic infections or they can still shed and become contagious.

This is what bothers me the most. People say, “Great. I have been vaccinated. I can engage in high-risk activity, and I’m going to throw off my mask. ” [Wearing a mask] The most powerful thing we can do.

Market Inspection: So, after vaccination, are we still going to wear masks?

Close this: Yes – the best we can do for a few years and for social distance. We can go back to school, as long as we do the kinds of things that have been done successfully in Denmark and other countries. We do not have this kind of federal leadership, sadly. People now see the vaccine as a magic dust that is being sprayed on this country and removes it all. It does not work that way.

Market Inspection: Do you want to see an authorization or approval for a vaccine?

Close this: I am not sure it matters, as long as we maintain this vaccine to the same standards that we have for every other vaccine for the past 70 years, whether it is called license or approval or authorization.

This Q&A has been edited for clarity and length.

Read a word more from the interview of experts:

Public Health Specialist Dr. Howard Koh says, ‘To defeat COVID-19,’ we need a unified national strategy

• A lung doctor on what he is learning about coronovirus ‘long healers’: shortness of breath, fatigue and depression but also ‘improvement over time’

• This Seattle man was to be injected with an experimental COVID-19 vaccine: ‘It was my duty as a healthy person to step up’

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