Fauci on Vaccines, Virus Mutations, and 2021

John Whyte, MD, MPH; Anthony Fauci, MD

Disclosures

December 23, 2020

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  • There is some degree of immunity after the first dose of the COVID-19 vaccines, but it's not optimal and we don't know how long it will last. We do know definitively that immunity increases dramatically after the second dose and lasts considerably longer.

  • A "bridging study" in children will probably begin in mid-January to make sure that the COVID-19 vaccines' efficacy and safety data are comparable to those of the successful adult vaccine trials. It's not necessary to vaccinate children before we reopen schools.

  • April could be "open season" for the general public to start receiving COVID-19 vaccines, as long as the current rollout to priority groups goes smoothly. We could have "umbrella protection" across the country — establishing herd immunity — by the end of summer 2021.

  • People who are hesitant to get a COVID-19 vaccine should be reassured that the approval process has been independent and transparent, made by people who have no allegiance to the federal government or to pharmaceutical companies.

  • Like all RNA viruses, this coronavirus has been mutating, and a new variant that has shown up in the United Kingdom may be more contagious. However, there is no evidence that it is more virulent or that current vaccines will not be effective against it.

This transcript has been edited for clarity.

John Whyte, MD, MPH: Welcome, everyone. You're watching Coronavirus in Context. I'm Dr John White, chief medical officer at WebMD. Today I have a very special guest, Dr Anthony Fauci, the world's leading authority on infectious diseases. Dr Fauci, thanks for joining us.

Anthony Fauci, MD: Thank you. It's good to be with you.

Whyte: Dr Fauci, I heard that you got the vaccine today, so I wanted to ask you about your experience. How are you feeling?

Fauci: I'm feeling perfectly fine, normal. Nothing so far. I have no pain in my arm. I had nothing to even indicate that I had been vaccinated. That was about 3-4 hours ago. I'm doing great.

Whyte: People ask, "Does it feel cold?" They know the vaccines are kept at these super-frozen temperatures. Was there any tingling?

Fauci: No, you really don't feel it at all. I got it with a group of healthcare providers (and I'm also a healthcare provider), and all of us agreed that it was even less of a feeling than with the flu shot. Flu shots sometimes hurt a little. Didn't hurt at all. It was perfectly fine.

Whyte: I want to ask you about the vaccines because you've talked about how impressed you have been with the safety and efficacy data — both Pfizer and Moderna vaccines are 94%-95% effective. If the data are so compelling, why have the vaccines been authorized under emergency use authority (EUA) as opposed to full approval?

Fauci: That's a very good question. The reason is that you want to get it out as quickly as possible — do the full dotting of the i's and crossing of the t's of a biologics license application, the BLA. That would take several more months to do. When you do an EUA, particularly an EUA that's granted on the strength of these data, which is really quite impressive — both of these vaccines not only were safe, but they were 94%-95% efficacious in preventing any clinically recognizable disease, and even better in preventing severe disease.

So, we felt that we wanted to get it out quickly while in the process of putting in for the full license approval. We didn't want to have months go by without people having the advantage of the vaccine. Given the extraordinary situation in our country — as you well know, we're in a very difficult situation. We're having 200,000 and more cases per day and anywhere between 2000 and 3000 deaths per day. Hospitalizations have reached a record of 118,000. Places like California are being stressed to the point that they may run out of beds. So you don't want to be delaying vaccine merely because bureaucratically you have to go through a bunch of hoops to get the official approval. The data are quite strong to grant an EUA.

Whyte: Given the number of infections and deaths and the scarcity of the vaccine right now, some people have been saying, "Let's not focus on two doses. There's some significant efficacy after the first dose." Why not just start giving more people the first dose (one is better than none)? What are your thoughts about that approach?

Fauci: That has been discussed a fair amount, and what people don't appreciate, even though there is some degree of efficacy after a single dose, is that it is really not optimal at all and we don't know how long it lasts. We do know definitively that even though you do get some degree of immunity after the prime single dose, after the second dose it's dramatically higher and it lasts considerably longer.

Whyte: What about data and children, particularly those less than 12 years old? We know the journey of the disease in children; should we be worrying about vaccinating them vs teachers, essential workers, and other adults?

Fauci: Well, you want to do both. When we make and test the vaccine, we don't want to test it on children because children are vulnerable. They do not have the capability of giving informed consent, which is important. It's their life. Though they're very young, it's still their life. So you've got to take extra special care in safety.

The standard traditional thing we do is a vaccine study that's a phase 3 large study in adults. When you get good safety and data on efficacy, then you can feel justified in taking the risk of trying it in a child. You can do a phase 1, phase 2 in a child after you complete the vaccine trial in the adult, and then quickly get the children to get vaccinated by what's called a "bridging study."

A bridging study means you don't have to spend the entire time with tens of thousands of children the way we did with the adults. You can do a couple of thousand — 2000-4000 kids — show that it's safe, and show that it induces the kind of response that's comparable to the response that protected the adult. Then you can make the assumption that it will protect children, and then you license it because you've proven safety and you have a very good indication that it likely will protect children. We're going to start that probably in the middle to the end of January.

Whyte: Do we need to vaccinate kids before we can reopen schools?

Fauci: No, I don't think that that's necessary. I think that the default position should be, as best as possible, to keep the children in school or get them back to school if they're not in school. We know now that, all other things being equal, children in school get infected less than the adults in the community. If you have the capability of dealing with kids when they get infected, you have reasonably good surveillance — like maybe vaccinate the teachers to protect them in the school and prevent them from infecting the children.

Whyte: Those are on the next prioritization list as well. I want to ask you about vaccine confidence. You might have seen the data from a USA Today survey that just came out, which talks about Democrats being nearly twice as willing as Republicans to receive the vaccine. Even more concerning is that 36% of Republicans say they'll never take the vaccine. How do we get to 70%-80% herd immunity if we have these issues with confidence in the vaccine? What are the one or two things that we need to be doing now to inspire confidence?

Fauci: Well, I think we need outreach to the communities of all people — Republican and Democrat, minorities, and people in the general population. The way we have approached it is to not confront people who are hesitant or who have skepticism, but try to reason with them and say, "What are the reasons why you have skepticism?" And there are a couple of well-defined reasons.

If the reason is "Boy, this went really quickly. Was it careless and quick?", then you show that the fact that we went from a brand-new virus in January to a vaccine that we're putting into people in December is not compromising safety, nor is it compromising scientific integrity. It is a reflection of the extraordinary scientific advances that have been made in vaccine platform technology, which have allowed us to do things in months that normally would have taken years. There's no compromise in safety.

The next question people ask, understandably, is " You're saying that it's safe and you're saying that it's effective. Is that true or is this the government putting pressure on you? Is it the pharmaceutical companies wanting to make a lot of money?"

Whyte: So tell us: What's the answer?

Fauci: The answer is — and this is important —the decision of whether something is safe and effective. The data get examined by a totally independent data and safety monitoring board made up of vaccinologists, virologists, immunologists, statisticians, and others. They have no allegiance, don't answer to the federal government, don't answer to the pharmaceutical company. They're an independent group. When they decide that the vaccine data look really good and it's safe and effective, they then give the data to the company that presents it to the FDA. Then the career scientists at the FDA — not political appointees, but the career scientists — work with their own independent advisory committee; they have an established committee called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC. They then say, "Okay, it's cleared. Let's give it."

So in reality, the entire process is independent and transparent, and that's what people need to know. And when they do, I believe they will be much more amenable to getting vaccinated.

Whyte: Everyone's talking about the variant and the concern about whether the vaccine will be effective. What are the countermeasures that we need to be taking now? You've been saying we don't want to overreact, and others are saying, "Now is the time that we need to be overly cautious in a way." What's your response to assuage people's concerns about what they might be hearing on the news or reading online about the impact of these potential variants?

Fauci: I think they need to understand something broadly at 40,000 feet: that this is an RNA virus, and RNA viruses mutate all the time. Their occupation is mutating. The more they replicate, the more they mutate. Most of the mutations do not have any functional significance or functional relevance. The one that's being looked at now, the one that's dominant in the United Kingdom, is one that appears — we don't know for sure — but it looks like it has a better capability of transmitting, of going from person to person. There's no evidence that it has any effect on its virulence or, namely, that it makes people more sick. It doesn't.

The other important issue is whether it's evading the protection of a vaccine, and it doesn't appear that that's the case at all. So, what we need to do is watch it very carefully, and we need to do surveillance in this country. Then there is discussion about: If it isn't already here — which it might well be and we don't know it yet — what do you do? I know the European Union is banning travel from the UK. I think that may be an overreaction now. I would not be against at least making sure that people who fly here, or come to the United States from the UK, be required to be tested before they get on the plane so that you know they're negative when they get here. That, I think, is something that might be considered. I'm not saying we should do it, but we should consider it.

Whyte: Those are all good points. You know, I always ask my colleagues, "What should we ask Dr Fauci?" So I want to give them an opportunity. The question was: "Many people have postponed their weddings from 2020 to March or April of 2021. Do they need to postpone it again?"

Fauci: You know, they should have postponed it until June or July.

Whyte: I don't think they'll be happy to hear that.

Fauci: I'm sorry, John. We don't know. I think it's going to work out that way if we do it efficiently. It depends on how efficient we are. If we get the priority people vaccinated, the ones that the ACIP (Advisory Committee on Immunization Practices) is recommending, by March or beginning of April, we could then start in April doing what I call "open season" on vaccinations — namely, anybody in the general population who wants to get vaccinated will get vaccinated. If that's the case (when we go through April, May, June, July), by the time we get into the middle or end of the summer, I believe we can have 70%-85% of the population vaccinated if we do it correctly. When that occurs, there will be an umbrella of protection over the entire country. The level of virus will be so low that you have essentially been able to establish herd immunity. So I'm looking forward to it as we finish the second quarter and go into the third quarter of 2021.

Whyte: And finally, I want to ask you about the "Fauci effect" — the impact that you're having on young students who are saying, "I want to go into medicine; I want to go into science." When you heard about the Fauci effect, how did you feel?

Fauci: Well, I felt good that young people want to go into a profession that I love and that I have been in for so many years. It goes beyond me. They're calling it the Fauci effect, and I'm very flattered that that's the case. But I think it also relates to the courage of the healthcare providers in the emergency rooms and in the intensive care units. People are seeing a face of medicine that they may not have seen before, of people who are really stepping up to the plate and doing their job. I'm doing it by trying to speak truth to the country and trying to be clear in the explanation of what is going on in a way that they understand. The healthcare providers are risking themselves, their health, and their lives every day to take care of people. So I think that the face of medicine is a much more attractive face now than it may have been in the past.

Whyte: My colleagues have also wanted me to ask you, "In terms of your professional career, you've dealt with HIV, Ebola, other pandemics around the world. Why has COVID-19 been so difficult? Is it the politics around this issue? Is it the impact of social media that didn't exist before? Why is it so hard now?"

Fauci: Whenever you have a public health outbreak — a really transforming outbreak, the likes of which we haven't seen in 102 years — everyone has got to pull together to get a maximum impact on addressing it. Unfortunately, we are living in a very divisive society. I think anybody that looks at what's going on in the United States has to realize that there is a lot of divisiveness. That makes it much more difficult because simple public health measures take on a political connotation.

You said it yourself when you gave the numbers. Why should there be any difference between a Republican and a Democrat as to whether they want to take a vaccine or not? There's no reason why there should be because it's a public health issue. I think it's just a reflection of the kind of divisiveness we see. So, you're right, that it has made it difficult, because it has led to mixed messaging. And when you get mixed messaging, people get confused as to what the best thing to do is. You've really got to be uniform and consistent when you're fighting something as serious as a pandemic.

Whyte: Dr Fauci, I want to thank you for all the work that you've been doing for 40-plus years, running the National Institute of Allergy and Infectious Diseases, as well as for all you are doing to keep us safe during a type of pandemic that occurs once a century.

Fauci: Thank you, John. It's good to be with you.

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