michael barbaro

From The New York Times, I’m Michael Barbaro. This is “The Daily.”

Today: To end the pandemic in the U.S., the White House is trying to defy the timelines that have governed the development of a vaccine for decades. Is it working? My colleague, Katie Thomas, on Operation Warp Speed. It’s Monday, August 17.

So, Katie, when does the hunt for a coronavirus vaccine begin in the United States?

katie thomas

Well, the vaccine companies started working on something back in January when the genetic sequence for the virus was first published. But it wasn’t until later in February, as it was spreading around the world and as cases were growing in the United States, that the broader conversation about when can we have a vaccine really began.

archived recording (president donald trump)

Well, thank you very much. Today we are meeting with the pharmaceutical and biotechnology companies, the biggest in the world —

katie thomas

So then an early March —

archived recording (president donald trump)

— to discuss how the federal government can accelerate the development of vaccines and therapeutic treatments for the coronavirus.

katie thomas

President Trump met with several executives from drug companies, big vaccine manufacturers —

archived recording (president donald trump)

When do you think you could have the vaccine? When do you think you’d be able to have it — start producing it?

archived recording

We’re producing it now, an experimental lot.

katie thomas

And so these executives told him that they were moving on it at a really accelerated timetable.

archived recording

So we’re hoping to get the phase one stuff very soon now. And then it’s going to be a few months to get the human data that would allow us to pick a corrective dose to start a phase two [INAUDIBLE].

katie thomas

But even with that timetable, it would take a couple of months to get into clinical trials.

archived recording (president donald trump)

And how long would that take?

archived recording

Phase two would take a few months before then going to phase three.

archived recording (president donald trump)

All right, so you’re talking within a year.

archarchived recording (dr. anthony fauci)

Like I’ve been telling you, a year to a year in a half.

archived recording (president donald trump)

But Lenny is talking about two months.

katie thomas

And then it could be a year to a year and a half before we would have a vaccine.

michael barbaro

Hm, and by my count, a year to a year and a half from then would mean we would have a vaccine maybe next summer.

katie thomas

Right, at some point in 2021.

archived recording (president donald trump)

I mean, I like the sound of a couple of months better.

katie thomas

And it was clear that President Trump wanted to see it move more quickly.

archived recording

We have to be very careful here if you vaccinate several hundred million —

archived recording (president donald trump)

You got to make sure it works.

archived recording

Works and safe.

archived recording (president donald trump)

Doesn’t hurt you — right. I agree, I agree. Thank you very much.

archived recording

Thank you.

archived recording (president donald trump)

Great company, thank you.

katie thomas

It’s worth noting that that year to a year-and-a-half timeline is already extremely fast. The current record for developing a vaccine is actually four years for the mumps vaccine.

michael barbaro

And, Katie, can you walk me through why exactly it takes so long?

katie thomas

Well, it’s a huge process. I mean, first it starts out in the lab. And you have scientists who are basically testing out different candidates for a vaccine. And that in and of itself can take years.

michael barbaro

Right.

katie thomas

And if they do get lucky and they do come out with something that could work, then they need to start testing it on animals. And we see if they survive and if there’s any big problems. That can take months. If it passes that test, then we start human clinical trials.

So there’s three phases of that. There’s phase one, which is the early safety trial. And that can take months. And then they have to evaluate the data. And then only if they feel like it’s safe can they move on to the next phase, which is phase two — you know, with a larger group of people to test mainly safety. And they have to analyze those results again.

michael barbaro

Which I’m guessing could take months.

katie thomas

That’s right. And then, only then, do they start the biggest, riskiest phase, which is phase three, the large-scale trials to really test out whether a vaccine works. And in order to do this, they have to test it out in tens of thousands of people. And then they wait months, sometimes years.

michael barbaro

Wow.

katie thomas

And so if a vaccine makes it through all of these phases and goes through lengthy analysis of the results to make sure that they didn’t miss anything, then they submit their application to the Food and Drug Administration, which itself goes through a very long review process. And then the agency decides whether it will get approved. So you’re looking at a process that can really take a decade.

michael barbaro

I mean, just listening to you, this is an exhausting process. You have to follow each and every one of these steps in order, no matter how long it takes.

katie thomas

That’s right. And one thing that stops a lot of companies from bringing their products to the finish line is something that people call “the valley of death.”

michael barbaro

Hm, what’s that?

katie thomas

So the valley of death is the period between when a company has figured out a good candidate for a vaccine or even a drug, and then they have to put it through clinical trials. And clinical trials —

michael barbaro

Those three phases you just described?

katie thomas

Yeah, three phases. And those trials — they’re expensive, they’re risky, they take a lot of coordination with hospitals and doctors around the world. And if you fail at any step in the process, you kind of had to go back to the drawing board. So that’s a lot of times where products that were very promising basically die.

michael barbaro

And none of this timeline that you’re describing would seem ideal for developing a vaccine in the middle of an urgent deadly pandemic?

katie thomas

No. So after that March meeting when Trump was pushing for the companies to go even faster than what would have already been a record timeline, a top regulator at the F.D.A. was also thinking about how to make this process go faster. And what emerges becomes known as Operation Warp Speed.

archived recording (“star trek” clip 1)

Warp drive, Mr. Scott.

archived recording (“star trek” clip 2)

Accelerating to warp one, sir.

katie thomas

Which is a reference to “Star Trek,” because the regulator was a fan of the show.

michael barbaro

Right, because as everyone who is at least 40 years old knows, the ship at the center of Star Trek travels at warp speed.

katie thomas

Yeah, that’s right.

I was really skeptical when Operation Warp Speed first came out, because I thought it was Trump just repackaging stuff that was already being done.

michael barbaro

What do you mean?

katie thomas

Well, there’s already a unit within the Department of Health and Human Services whose whole job is to give money to companies that are developing vaccines or other treatments and to help them get through that valley of death. But what Operation Warp Speed did was they took that idea and they just ran with it. The idea was to get more companies involved at a much bigger scale. So Congress at that point had appropriated almost $10 billion in funding for both vaccines and for treatments. And the hope was that that would allow the companies to shift their resources to these clinical trials and to data analysis and development. That they would give them a lot of cash and that could basically speed up the whole process. But what was really new under the Operation Warp Speed plan was how they were approaching manufacturing. Because normally, a drug company isn’t going to start mass producing their vaccine until they know that their vaccine works, until it’s gone through all of these clinical trials and they have a pretty good idea that it’s actually going to come onto the market. And so the federal government had the idea to pay these companies a lot of money to start making millions of doses of their vaccine before they even knew that it would work. But if one of them does, then you know, as soon as we know that it’s safe and effective we will have millions of doses that are ready to go.

michael barbaro

But of course, on the flip side of that is the reality that the government will be paying companies to make millions of doses of vaccines that will very likely — many of them — never get used and probably have to get tossed into the garbage.

katie thomas

Yeah, so they’re basically taking on a financial risk that the companies would never want to do on their own. And the final piece of Operation Warp Speed is they brought in the military. Operation Warp Speed is actually being led by two agencies, the Department of Health and Human Services, which is overseeing the science and the development of the vaccines, and then the Department of Defense, which has a lot of experience in logistics. And the thought here was that the military can supply a vast amount of materials quickly to different locations, whether that’s for clinical trials or for manufacturing, or ultimately, to distribute it to millions of Americans.

michael barbaro

So, Katie, just to summarize this, under Operation Warp Speed, the government is incentivizing companies to try to make vaccines by giving them billions of dollars. On top of that, it is paying for these companies to manufacture those vaccines even before we know whether they’re safe and effective so that they will be ready at a moment’s notice. And finally, behind the scenes and surrounding all of this, the United States military is basically on call to keep this process moving.

katie thomas

Yeah, that’s right.

michael barbaro

OK, so how does it all go? I mean, what happens once all this stuff is in place and Operation Warp Speed is unleashed?

katie thomas

They start giving just vast sums of money to a lot of different companies.

archived recording 1

Well, U.S. government is pledging about $1.2 billion to AstraZeneca in its fight —

archived recording 2

And Moderna, they got a lot of money, about a half a billion dollars in federal funding —

archived recording 3

Johnson & Johnson has been given a boost, nearly half a billion dollars to develop a Covid vaccine and treatments.

katie thomas

And then in July, the government gave the biggest amount it had given out to date.

archived recording

This is a $1.6 billion — that’s billion with a B — contract to Novavax vaccines. It’s the largest —

katie thomas

Up to $1.6 billion to a company called Novavax.

archived recording

This is a huge award for Novavax, which is a smaller company —

katie thomas

Which was notable, because this is a company that had been around for more than 30 years. And yet, it had never in that history successfully brought a vaccine to market.

archived recording

Yeah, Novavax is unproven. They have been trying for decades. And so far, have not succeeded.

michael barbaro

We’ll be right back.

So, Katie, why would Operation Warp Speed give up to $1.6 billion to Novavax, this company that has never brought a vaccine to market?

katie thomas

Well, it was surprising because you know, only a year ago they were basically on the brink of collapse. Their stock was trading so low that it risked getting delisted from the NASDAQ. They had to sell their manufacturing facility to try and raise cash. And they had to lay off a number of their employees. And so you know, they were really struggling heading into 2020. But that’s kind of the way things work in the pharmaceutical industry. Failures are a part of the business. And so when 2020 came around and the coronavirus arrived, they got started working on a vaccine. And they ultimately came up with something that they felt was pretty promising. And so that’s when the government decided to give Novavax this $1.6 billion award.

michael barbaro

So this seems to be working exactly as Operation Warp Speed was designed to do, which is to give companies a big government assist so that we have as many potential vaccines arriving when we need them.

katie thomas

Yeah, that’s right. But it also is potentially problematic. Anytime you have billions of dollars just kind of sloshing around, there’s going to be questions and scrutiny and people who want to know, you know, how are these decisions being made and why. And the contracts that have come out have been heavily redacted. There hasn’t been a lot of transparency around the process. And that always raises fears about whether there are conflicts of interest. So in the case of Novavax that question immediately came up, because two of their former executives used to be the directors of the unit at the Department of Health and Human Services that gives money to companies. Before Operation Warp Speed, Novavax had applied to that unit for vaccine funding and had actually reached out to one of those directors about the application in a way that director said crossed ethical lines. He felt discussing the application while the company’s vaccine was being considered could violate federal law, given that it could influence what was supposed to be a purely scientific review. The company has said that it did nothing wrong and it had gone through the proper channels. And when things weren’t moving quickly enough, they reached out to see how they could be moved more quickly.

And questions like this around conflicts of interest have come up more broadly with Operation Warp Speed, because the person overseeing the program is a pharmaceutical industry veteran.

archived recording (president donald trump)

Operation Warp Speed’s chief scientist will be Dr. Moncef Slaoui, a world —

katie thomas

His name is Dr. Moncef Slaoui, and he was a former board number of one of the companies that received funding, Moderna. And he also holds millions of dollars in stock in another company that got government funding, GlaxoSmithKline, where he worked for 30 years.

archived recording (dr. moncef slaoui)

I have never been about the money, ever.

katie thomas

He has said that he won’t allow his ties to interfere with his work on Operation Warp Speed.

archived recording (dr. moncef slaoui)

It’s been extremely painful for me that anybody would even think that I took this job to enrich myself or my former colleagues —

katie thomas

And a government agency has reviewed the information and said that he can continue in his position.

archived recording (dr. moncef slaoui)

That’s all I have to say. I have a personal compass in ethics. And people who know me personally know that.

katie thomas

But another reason why there’s so much scrutiny around these billion dollar deals is because once companies get that label of being Operation Warp Speed, it can be very financially lucrative for them and their investors. In fact, in the case of Novavax, their stock since May has jumped nearly 800 percent.

michael barbaro

Wow.

katie thomas

Yeah, and that’s true of many of the companies that have gotten this label. They have seen their stocks surge on this vaccine news.

michael barbaro

Katie, listening to you tell the story of Novavax and its experience with Operation Warp Speed, I feel like I’m struck by two competing impulses. The first is that it feels admirable that the government is trying to throw caution to the wind, toss aside those old timelines when it comes to a vaccine, and just spend billions of dollars to save lives in the middle of this pandemic. But on the other hand, the idea of giving billions of dollars of our money — taxpayer money — to a bunch of private companies, some without much of a track record, some with complicated connections to the people granting them the money — that also feels kind of hairy.

katie thomas

Yeah, I mean, it’s very much being sorted out as we speak. You know, everyone wants a vaccine. People are desperate for it, and the federal government has kind of wagered in a way that this is really what it takes in order to get that.

michael barbaro

So, Katie, at this point, companies are getting all this money to cross that valley of death you described. So tell me how warp speedy is all this? I mean, how fast is it moving?

katie thomas

Well, things are moving pretty quickly. You know, with the help of Operation Warp Speed, the federal government has given money to seven different vaccine companies. And that’s a promise of nearly $11 billion.

michael barbaro

Wow.

katie thomas

And three of those companies — Moderna, AstraZeneca and Pfizer — are in those late-stage trials to test whether the vaccine works.

michael barbaro

So that’s pretty impressive in a way?

katie thomas

Yeah, I mean, so far, things have gone more or less according to the most aggressive schedules that have been laid out. And one thing that federal officials have said repeatedly is that when they talk about warp speed, the speed that they’re talking about is not the clinical trials themselves. They say the clinical trials themselves are not being rushed. What is being rushed is kind of everything on the outside — you know, these manufacturing deals, and analyzing the data, and kind of moving those gears of bureaucracy and making them go as quickly as they possibly can. That being said, there’s fears among scientists that there’s this X factor of President Trump —

archived recording (president donald trump)

We have a lot of vaccines under study, by the way —

katie thomas

— and his urgency to approve a vaccine.

archived recording

So what’s the earliest we could see that — a vaccine?

archived recording (president donald trump)

Sooner than the end of the year, could be much sooner.

archived recording

Soon than November 3?

archived recording (president donald trump)

Oh, I think in some cases, yeah, it’s possible before, but right around that time.

katie thomas

Their fear is that he wants to approve one before his election, and that he could push his F.D.A. to approve a vaccine before it’s truly ready.

archived recording

Will that help you in the election?

archived recording (president donald trump)

It wouldn’t hurt. It wouldn’t hurt. But I’m not doing it — I’m doing it not for the election. I want it fast, because I want to save a lot of lives.

michael barbaro

And, Katie, is that a legitimate fear? My sense is that the Food and Drug Administration, which approves drugs in the U.S. does answer to the health and human services secretary who does answer to the president. But is it reasonable to think that the president can actually stick his finger into the approval process for a vaccine?

katie thomas

Well, everyone from the F.D.A. commissioner to others in the federal government have publicly said —

archived recording (dr. anthony fauci)

The F.D.A. will look at that data. And on a science-based decision will make a determination as to the safety and efficacy and whether or not it will be approved.

katie thomas

— they will be guided by the science, and they will follow the guidelines that they’ve set out for whether they will approve a vaccine or not.

archived recording (dr. anthony fauci)

Historically, the F.D.A. has based their decisions on science. They will do it this time also, I’m certain.

archived recording

I appreciate it. Thanks for your assurances that we’ll have a safe —

katie thomas

But the concern is whether there could be a little bit of a middle ground. Rather than a full-blown approval, could there be an emergency use authorization where a vaccine could be approved, maybe for a limited group of people — say frontline health care workers — prematurely or early, before it’s made widely available to the public.

michael barbaro

And of course, that has already happened in the case of hydroxychloroquine. Because just a few months ago the F.D.A. authorized the emergency use of that as a treatment for the coronavirus, and it was a drug that President Trump himself constantly promoted and talked about and said we should all be using. And it turned out it didn’t work well — correct me if I’m wrong, Katie. It even presented safety risks and the F.D.A. ended up rescinding that emergency authorization.

katie thomas

That’s right. And so there are fears that could happen again — that the F.D.A. could be influenced by politics. You can also see the flip side though too, which is that perhaps the agency could see how it didn’t go so well, and could be newly determined to not make that mistake again.

michael barbaro

So, Katie, a quick gut check here. Just how close are we to getting a vaccine from Operation Warp Speed, something that we could start distributing across the United States?

katie thomas

Well, first of all, it’s important to remember that a vaccine is a crucial step. But it won’t mean the immediate end of the epidemic. It takes time to get the vaccine to people. Not everyone will want to get vaccinated. And it could be more effective for some people than for others. That being said, the best estimates that people inside the federal government have given is that something could be available, if all goes as planned, by the end of the year or the beginning of next year.

You know, already there are some promising candidates. And one of the companies that has released some of the most promising results is actually Novavax.

michael barbaro

Huh, this company that had never really developed a vaccine before?

katie thomas

That’s right. They recently released some results from their early trials. And they tested the blood of the people who had been given their vaccine. And they found pretty high levels of antibodies against the coronavirus. That doesn’t really prove yet whether it works. We’ll need those late-stage clinical trials to really know for sure. But it’s a really promising hint that it could work. And that’s gotten the scientists that we spoke to fairly optimistic about it.

michael barbaro

Katie, thank you very much. We appreciate it.

katie thomas

Thanks for having me.

michael barbaro

On Sunday, The Times reported that the Trump administration is working with four states — California, Florida, Minnesota and North Dakota — as well as the city of Philadelphia to develop plans for distributing an eventual coronavirus vaccine. The government is not prioritizing those communities to receive the vaccine. But instead, chose them because they represent different population densities and infection rates. Among the questions that the government is trying to answer is where to store the vaccine, and what kinds of clinics should distribute it.

We’ll be right back.

Here’s what else you need to know today.

archived recording (bernie sanders)

What you are witnessing is a president of the United States who is doing everything he can to suppress the vote, make it harder for people to engage in mail-in balloting at a time when people will be putting their lives on the line by having to go out to a polling station and vote.

michael barbaro

On Sunday, congressional Democrats acted to block President Trump from trying to undermine the United States Postal Service and mail-in voting, something that the president has suggested in interviews that he may seek to do.

archived recording (bernie sanders)

So what Trump is saying is we’re going to do everything we can — and this is not me talking. This is what Trump himself said. Look —

michael barbaro

House Speaker Nancy Pelosi said that she would call members back from their annual summer recess to vote on legislation that would prevent the president from making changes to the postal service. At the same time, House Democrats said that they would hold an emergency hearing about the postal service and would demand to hear from the postmaster general, a Trump ally and donor. Democrats said that the urgency stems from a warning from the postal service sent to states recently that it may not be able to meet deadlines for delivering mail-in ballots.

That’s it for “The Daily.” I’m Michael Barbaro. See you tomorrow.



Source link