Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases, has seen the photos of bars packed with mask-less patrons. He was not impressed.

He was similarly unenthused about a decision by the biotech company Moderna to issue snippets of early data from the vaccine trial his agency has been conducting — without waiting for fuller results.

That said, these days, Fauci sees reason for cautious optimism about Moderna’s vaccine, and others. The idea of having a vaccine by the end of the year is “aspirational, but it’s certainly doable,” he told STAT in a wide-ranging interview.

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One of the most visible faces of the U.S. response to the coronavirus pandemic, the NIAID director also acknowledged the world will have limited data on the new vaccines when they are deployed, and may have to balance the need to save lives with the possibility of some adverse events.

A transcript of the interview has been lightly edited for length and clarity.

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A lot of states are moving to open up really quickly, trying to get their economies back in gear. We’ve seeing pictures of crowds on beaches and in other settings; many people aren’t wearing masks. Are you worried that we’re setting ourselves up for a boomerang effect in the next few weeks?

I certainly have sensitivity for the need of the public to start getting to some form of normalization, given that we’ve been through more than three months of a very difficult time. But it’s a big country and the dynamics of the outbreak are different from one part of the country to another. If people want to get out, they’ve really got to gauge it with the level of the outbreak in their particular area.

When I see a situation where there is a region, a state, a city, a county where there’s a considerable amount of viral activity there, and you see people crowding around bars — and there were several pictures of that, that was quite striking over the last couple of days — or on boardwalks, where they’re very, very close to each other, I do get concerned.

Let’s talk about vaccines. In a recent interview with the Financial Times Merck CEO Ken Frazier effectively questioned the assertion — which you have made — that we could have Covid-19 vaccines within 12 to 18 months. Merck has a ton of experience developing vaccines. Are you at all worried that expectations for the timeline to vaccines have been set too high?

I am not really very concerned about the timetable of this for the following reasons.

The general trend on the part of the pharmaceutical companies, because of the enormous investment that goes into the development of a vaccine, is that you don’t go to the next step until you’re fairly certain that the step you’re in is going to be successful. The other thing is you don’t start manufacturing anything until you have a pretty good idea that you have a successful efficacy signal. That protracts out the time frame. But what we’re doing is something that’s called developing “at risk.”

What it means is that at the same time you’re finishing your Phase 1 trial, you’re preparing your Phase 3 trial sites, which is very expensive, and then you’re starting to manufacture the vaccine even before you know it works. All of that cuts months off.

We’re now completing the Phase 1 [with the Moderna vaccine]. The initial data look very promising from the neutralizing antibody standpoint. And so they’re planning to start the Phase 3 in the first week or so of July. Not only with the Moderna vaccine, but also very likely with the AstraZeneca vaccine. And then as we get later into the summer, we’ll get the Johnson & Johnson in clinical trials.

You need a few months at least of having vaccinated individuals getting exposed. So let’s say it’s July, August, September, October. By November, you should have an efficacy signal.

If you do and you’re already manufacturing doses, by December and January, if you’re lucky and if in fact it is effective, you can have a significant number of doses available by the end of the year, the beginning of 2021. So I think it’s aspirational, but it’s certainly doable.

The only thing that’s the big unknown to me is that, is it going to be effective? I think we could do it within the time frame that I’ve outlined. But there’s no guarantee that it’s going to be effective.

Let’s talk a bit about what you’ve seen so far in terms of data. When Moderna recently released some the information on the vaccine they are developing with NIAID, they showed neutralizing antibodies in eight people. Are there more data? And what are the antibody levels like? Because they didn’t give us any kind of scale against which we could assess what they were saying.

I know. I didn’t like that. What we would have preferred to do, quite frankly, is to wait until we had the data from the entire Phase 1 — which I hear is quite similar to the data that they showed — and publish it in a reputable journal and show all the data. But the company, when they looked at the data, as all companies do, they said, wow, this is exciting. Let’s put out a press release.

The thing that made everyone be cautiously optimistic is that we didn’t just see binding antibody. It was clearly antibody that was neutralizing live virus, at levels that you would predict would be protective — if in fact neutralizing antibody, which is a reasonable assumption, is going to be a correlate of immunity.

Have you been at all concerned about adverse events? They had some Grade 3s. [Grade 3 adverse events are serious, but not considered life-threatening.]

At the high dose. Of course, whenever you get adverse events at high doses, you’re hoping that you can get the protective effect that you want at a dose that’s considerably less than that. And it looks like we can. [Moderna has discontinued study of the highest dose.]

What about what you’re seeing about the other vaccines in the clinic already? Do you think things are looking good for multiple vaccines to come through? 

Well, the Oxford University vaccine [developed in partnership with AstraZeneca], the data in the animals, you know, some of the animals got infected. They didn’t get sick. I would have liked to have had protection against infection. But then again, it depends on what you’re looking for with the vaccine. That vaccine doesn’t look like it’s a knockout for protecting against infection, but it might be really very good at protecting against disease. So I withhold judgment on that.

You’re asking me an opinion of things, but there’s still little data. The Pfizer one is very similar to Moderna’s. It’s an mRNA vaccine. I’m sure that Pfizer is going to get results that are as good as the Moderna vaccine. There’s no reason to believe one is going to be any different than the other.

What I like about the whole thing is that there are multiple candidates that we’re involved with. It just feels good to be directly or indirectly involved in four or five candidates, to do it in a way that I refer to as sort of harmonized, where you come to an agreement, which we did, that we’re going to do things where the trial protocols will be quite similar, where the laboratory tests that we’re going to ask for are going to be quite similar, so that you can extrapolate results from one study to another.

Now, why is that important? If one vaccine proves efficacy in a clinical trial and another vaccine is behind it but it’s getting the same correlate of immunity you could bridge data and facilitate the approval of the second and the third one based on the efficacy of the first one.

You said vaccine could start to be administered in late December or January. Is that the time frame President Trump is looking for? It sounds like he’s hoping for something sooner.

I think that the president and the administration would be really very happy if we had a vaccine that we could deploy by the end of this year.

Does the president talk to you about the vaccine work often?

No.

We used to have task force meetings every single day, including Saturday and Sunday, and about 75% of the time after the task force meeting we’d meet with the president. So I was meeting with him four times a week back, a month or so ago.

But as you probably noticed, the task force meetings have not occurred as often lately. And certainly my meetings with the president have been dramatically decreased.

With such a compressed timeline for testing the vaccines, how much do you think we’re actually going to know about them before we start to deploy them? If you’re only getting a few months worth of data, we won’t know much, if anything, about the durability of the protection. And, you know, we may not have a ton of information about efficacy or safety.

So when you design a clinical trial, there are a certain number of events that will give you a definitive answer as to whether or not your vaccine is effective. That is set in stone. So we’re not going to declare efficacy or even begin to think about efficacy or not until we reach that predetermine statistically sound number of infections that either occurred and/or were prevented. I mean, whether we do the trial over 10 years, or we do it over four months, the endpoint is still the same. It’s certainly statistically significant difference. So I don’t worry about that.

On durability, you’re absolutely correct. We’re not going to know what the durability is. But we’re going to have to live with that. The first thing we’re interested in is: If we vaccinate you in the late summer, early fall, are you protected through that fall, that winter and then going into the spring? If the answer is yes, wonderful. Then we’ll worry about durability.

And in terms of safety, you are facing the same thing. I mean, obviously, the concern with a vaccine, with a virus like this, is what are you going to get enhancing effect, [where the vaccine actually makes some recipients develop worse illness if they contract the infection]. We’ve seen it with a couple of other viruses that we had reasonably good vaccines against, dengue and respiratory syncytial virus.

We’ve designed the Phase 3 trial, to very carefully look at safety, even more so than is done in a regular trial.

Is a trial of 30,000 people large enough to see that kind of a signal if it exists? 

Yeah, I think so. But then again, someone would say, appropriately, but what happens when you give it to 5 million people?

Or 5 billion?

And then if that’s the case, then you’ve got to balance — you balance the lives saved from the vaccine with the enhanced detrimental effect. So if for every one that has enhanced illness, you save a thousand lives, I’ll take that, right?

There’s a lot of interest in developing vaccine as quickly as possible, but there’s also a lot of concern about the speed at which this is being undertaken. Should there be major adverse events associated with use of these vaccines, it could really damage trust in vaccination in general. Is that something you are worrying about?

Yes, I am.

But I just realized that I have to phone into an Operation Warp Speed meeting. I’m already late. I’ll talk to you later.

    • Because your unfortunate delusional mindstate can’t create jails in the real world.

  • Great article. Fauci is human, and smarter and more honest than anyone.
    Antivaxers will continue to spread nonsense. Don’t listen to them.

    • There are numbers out now that are saying the Covid-19 pandemic is less deadly than the flu of two years ago. So how can you say Fauci is honest? He used tainted models from the same fake science that predicted global warming leading to the end of civilization and 2 foot sea change. Covid-19 is either a hoax or a false alarm that led to the destruction of the world’s economies, depending on what we can prove was the motivation of Fauci Bill Gates, and the other globalists who want to medically surveil and vaccinate the planet.

      Fauci has always been a talking puppet for whoever trots him out to give “scientific” cover. He changed his story every time he went before a microphone. He needs to be removed from the country and have his citizenship revoked along with Bill Gates. They are responsible for the destruction of millions of people’s livelihoods. If I were them I would hid my face and never show it in public again.

      And you either are a shill for the lying global (WHO, CDC)medical profession or have trouble using the rest of your brain.

  • Nobody cares Fauci.

    You are more of the same institutional ineffectiveness. You should never have a microphone in your face again.

  • This bug is killing only the sick and the aged. Why do those who are not at risk need a vacine? I have been living a normal life since this began. I am employed as an essential front line worker. I don’t wear a mask, I go out as normal. I haven’t gotten sick. This is all a big lie. My body comes with a imune system it’s working fine. Keep your poison. Not for me. Thanks.

    • So true. There is no way in the world I’d vaccinate my children or myself from COVID. It’s just not that deadly. The vast majority of people never know they have it. No ill effects at all. There seems to be more hype than anything around this virus.

  • How can Faucci be wrong? He’s covered every possible outcome; without apology for positions that totally opposite. It’s like the Delphic Oracle that if Croesus made war on the Persians, he would destroy a mighty empire

    • Because he is talking about odds and possibilities of an unknown vaccine. What do you expect him to say? Seems you just want a better oracle. He answered the questions based on what he knows.

  • I hope the vaccine and drugs can be developed soon so that I can go out as I want without any masks and worrying about deliver the virus to grandparents. We’ve bought some disposable masks from epidemiology.amotx.com and almost used them up. I think living with the senior, we have to pay more attention to protect ourselves from the coronavirus.

    • I think you should get back to your life and stop worrying about COVID unless you have some major health issues. It really is nothing to worry about.

    • The Wuhan Chinese Chinese Cold-Flu is n ow being shown to be less deadly than the seasonal flu of two years ago. But the political science experts have put everyone in a panic stating 2,000,000 Americans would die. And I see people like you are still in a hysterical uproar, because they are afraid to think rationally. The best thing for you is to stay inside without ever coming out, because you obviously only watch CNN. Others have reported that there may never be a vaccine because COVID-19 Fauc’s Flu is disappearing too quickly for them to create one. So it looks like all the naive people who will be waiting for a vaccine, before they go out without a mask, or government guidelines on how to walk and talk and travel and work and eat; (in other words, slaves) will never get one.

    • Over 1/2 of Americans over 40 have “underlying issues.” The disease doesn’t just kill insulin dependent diabetics with poorly controlled disease. Your odds of severe disease go way up even if you’re pre diabetic. Over 40% of middle aged Americans are hypertensive. Major risk factor. Obesity? LOL. So a vast % of the population has an “underlying condition”

  • What about the side effects that come with all drugs; may cause seizures, kidney failure, cancer, death? What are the ingedients, fetuses, mercury, the virus? Plus the majority of people will not get vaccine because we cant trust big Pharma. We don’t take any drugs and we won’t start now. The COVID-19 propaganda sounds like a big marketing plan to sell vaccines/poison.

    • Yes there are fetuses and human lung tissue. The ingredients are listed on CDC.gov website under Vaccine Excipient Summary. with other vaccine ingredients. Does this make is cannibals? “Vaccine. Date. Contains. MMR (MMR-II) 2/2020* vitamins, amino acids, fetal bovine serum, sucrose, glutamate, recombinant human. albumin, neomycin, sorbitol, hydrolyzed gelatin, sodium phosphate, sodium. …”

    • You are correct as I looked some up. Three month aborted female fetus in many. The vaccine industry relies on Planned Parenthood for supplies.

    • Good points, unfortunately the government slaves who believe if you don’t vaccine you are endangering them, will try to shame you, even though a poll came out stating more than half of Americans will not be getting the vaccine. And I’m one of them. Until they tell me exactly what is in there with independent lab study, they will not put their poison in me. And MEgaTron can leave if he doesn’t like it, or try and make me leave.

    • MEgaTron you said why don’t you just leave us, who do you mean by us? Most commenters are bringing up valid points against vaccines for a virus that has almost run its course. Next year there’ll be a different virus so no point in making a vaccine at this time.

  • I didn’t like the tone of this. Fauci seemed to be saying even if the vaccine injures certain people it’s still going to go ahead. I really don’t think that’s his choice to make, considering this disease has taken a mild course for the majority of those under 65+. If the risk of the vaccine is heaver than the risk from the virus, then maybe it should be specifically targeted towards those with the most a high risk of death.

    • Fauci should just go away, but he must be missing the attention. He hasn’t been right about much of anything so far, so I won’t be having any Vaccine, or Remdesivir either for that matter.
      How can you be in a job for 40 years & know so little?

    • Every drug or vaccine has risks. You have to balance them. If you have a 50% chance of being infected with SARS CoV 2 and if infected a 4% chance of having long term organ damage and a .001% chance of an adverse reaction from a vaccine that is 70% effective in preventing infection and 90% effective in preventing an infection progressing to severe disease, a rational person would take the vaccine.

  • A lot of information. How many people do you think will want to take a vaccine that is new and raced into production. There’s no way I’m getting it. I’m not an anti vaxxer, but I’m also not going to risk my health until it’s proven.

    • Depends on your risk factors. I’m in my mid 50s and will definitely take the vaccine. MRNA vaccines are highly specific and there is very little risk of immune enhancement with SARS CoV2. If I contract COVID-19 my age group alone puts me at a chance of death in the 0.5% – 1% range and well over a 5% chance of a case of serous illness as they are finding out that a lot of severe and even “moderate” cases “recover” with long term organ damage. So, an mRNA vaccine (where we have a huge amount of Phase I and II data from other mRNA vaccine candidates and know the mechanism is relatively quite safe)….no brainer.

  • Interesting information, but I find it disturbing that I haven’t read much at all about drug trials to treat the disease. Other than Remdesevir, there hasn’t been any information about what drug companies might be doing to find combinations of drugs that might make covid-19 less lethal.

    • Because there is no drug that will work on it. It is a virus, just like the yearly flu or a cold, they can work on the symptoms but only a vaccine will at some point offer protection

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