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WASHINGTON — The Trump administration on Friday rolled out a hyper-ambitious plan to develop and manufacture hundreds of millions of Covid-19 vaccine doses by the end of 2020, outlining an aggressive process that, if successful, would shatter conventional wisdom about the typical process for developing vaccines for emerging infectious diseases.

At a Rose Garden press conference, the president and his deputies acknowledged their goal, dubbed “Operation Warp Speed,” was lofty. Trump said the project was “risky and expensive.” Gustave Perna, a four-star general who oversees logistics for the U.S. Army, called the task “Herculean.” Moncef Slaoui, the pharmaceutical executive Trump has appointed to lead the initiative, said the goal was “extremely challenging.”

But they allowed themselves little ambiguity. Mark Esper, the defense secretary, pledged to deliver a vaccine “at scale” to the U.S. and its foreign partners by the end of the year.

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The rollout highlights an overt shift in the White House’s messaging on vaccines. Anthony Fauci, the federal government’s top infectious disease researcher, has long warned Americans that, even optimistically, developing a Covid-19 vaccine would take between 12 and 18 months. Even that timeline, Fauci has said, would represent something of a biomedical miracle.

The Trump administration’s scientific muscle, however, was notably silent. During his remarks, the president was flanked by three physician-researchers: Fauci; Deborah Birx, the White House coronavirus response coordinator; and Francis Collins, the director of the National Institutes of Health.

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The three doctors were the only federal officials who appeared on stage wearing masks. None spoke at any point during the press conference.

Instead, it was Slaoui, the former GlaxoSmithKline executive who Trump has appointed to lead the vaccine initiative, who delivered yet another strikingly confident prediction.

“Mr. President, I have very recently seen early data from a clinical trial with a coronavirus vaccine,” he said to applause. “These data make me feel even more confident that we will be able to deliver a few hundred million doses of vaccine by the end of 2020.”

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Slaoui, who resigned his position on the board of the drug manufacturer Moderna to accept the government appointment, was likely referencing the company’s Covid-19 vaccine candidate, which was the first in the U.S. to enter a Phase 1 clinical trial.

According to federal financial disclosures, he still holds over 156,000 Moderna stock options, worth over $10 million at the company’s current stock price, creating a potential conflict of interest if the company’s vaccine is the first to be proven effective. Numerous progressive groups in Washington have already criticized Trump over Slaoui’s appointment.

The project will rely in part on allowing drug manufacturers to begin scaling up their manufacturing efforts prior to receiving approvals regarding a potential vaccine’s effectiveness, officials said.

Trump, separately, delivered a markedly optimistic message in terms of the vaccine’s price.

“The last thing anybody’s looking for is profit,” he said.

Nonetheless, the vaccine’s price has been a consistent topic of debate among Democratic lawmakers in Washington, some of whom have attempted to pass new laws that would include affordability requirements for any vaccine developed via taxpayer-funded research.

 

Trump also downplayed concerns about whether, as some public health experts have feared, the race to develop a vaccine could devolve into an international showdown that leaves foreign governments to compete to secure vaccine allotments for their populations.

He said that the U.S. would work with foreign governments to distribute a Covid-19 vaccine regardless of which companies, or which countries, are first across the finish line. The federal government, he said, has “no ego” regarding vaccine development.

“We want to get to the solution,” Trump said. “We know exactly where the other countries are, and we’ll be very happy if they are able to do it. We’ll help them with delivery, we’ll help them with it in every way we can.”

The pledge, he indicated, even applies to China, the country where Covid-19 was first identified. Trump has repeatedly expressed anger over China’s handling of the outbreak in early 2020, casting doubts on its reported death toll, blaming its government for not containing the virus within its borders, and even labeling Covid-19 the “Chinese virus.”

The new initiative is the latest sign of the federal government’s far-reaching efforts to accelerate research into coronavirus tests, treatments, and vaccines. Those initiatives, in some cases, have tested the practical boundaries of biomedical research. To date, the U.S. government has announced a “Shark Tank”-like competition to develop new Covid-19 diagnostics and a series of partnerships with drug companies on both therapeutics and vaccines.

Yet Trump also warned that his plans to reopen the U.S. economy are not contingent on the development of a vaccine.

At one point, he repeated the unscientific claim that the virus will “go away” even without a vaccine. Separately, he attempted to downplay the severity of the coronavirus, noting that despite nearly 90,000 recorded U.S. deaths to date, many Americans who contracted the virus displayed few symptoms and are likely now immune.

“We think we’re going to have a vaccine in the pretty near future,” Trump said. “If we do, we’re going to really be a big step ahead. If we don’t, we’re going to be like so many other cases where you had a problem come in. It’ll go away at some point. It’ll go away. It may flare up, and it may not flare up. We’ll have to see what happens.”

Damian Garde contributed reporting. 

    • ???? Even God knows better ! All health experts, a lot of Republicans, even prior presidents are clearly stating deep concerns about hap-hazard, impulsive, chaotic “leadership” – he is just dying for a quick fix, so he can get re-elected. Anyone who votes for the dude will see more blurting, denouncing, firing, bragging. It is a bit overdue to get your head out of the sand !

  • Bankrupt people might be able to recover their lives. Dead people never!!

  • Normandy was risky. There were other, more cautious plans to accomplish the same thing. They would have taken a long time and cost thousands of lives.

  • The point about doing vaccine testing in stages, is to weed out unknown side effects before committing to a remedy.
    Eg, DES worked very well for its purpose as an aid for pregnant women to prevent early miscarriages. But no one realized at that time that certain drugs could cross the placental barrier between the mother & the fetus. It was medical knowledge that the barrier was solid.
    Thay were looking for side effects in the mothers & found none!
    Yet years later the offspring had bad effects, after hardwon medical knowledge from the thalidomide tragedy alerted the world to this possibility. Iam one of those daughters myself.
    Are you willing to play medical Russian roulettewith the lives of millions, around the world, just because some Americans are impatient to get a haircut or something else to break quarantine??
    Such puny characters are NOT PATRIOTIC!!

    • You seem to live a very sheltered life, where not only are you not required to consider the realities of the disease, but you can also disregard the realities of the lockdown for millions of people. – “play medical Russian roulette with the lives of millions” – interesting phrase – for the record, no not for the record, for your personal edification, because most other people seem to get this without being explicitly told – I do not suggest putting one bullet in a revolver, spinning the – whatever you call it – putting it to your head and pulling the trigger.
      The virus is killing several thousand people per day now – that is the reality. No one needs to play Russian Roulette for that to happen – it is already happening and will continue, as best I can tell, until a vaccine is produced. Maybe it will somehow mysteriously die out, or a less lethal form will evolve and spread faster than the deadly one, and make us immune. I do not contend 1 – 3% of the world population will die from this without a vaccine. But it seems almost certain to be millions of deaths. Thalidomide was not used by any pregnant women from 100,000 BC until some time in the 60s, right? It looks nasty to have morning sickness, but it is rare that it kills anyone. This virus is on track to kill a couple million people worldwide.
      I also need to point out here, there are strong theoretical reasons a vaccine, particularly one based on a naturally occurring part of a virus, which is somethinng the immune system encounters all the time, will not be dangerous in the same ways a new drug can be. Many of the proposed vaccines are “natural” -not that natural makes it safe per se, but we’ve been studying immunity for a long time and the depth of our knowledge is quite incredible – I can not promise no unforeseen bad effects, but there is plenty of reason to think that risk is low – again, we are talking about a disease which will kill a couple million people over the next two years, not morning sickness.
      Finally, you blow off the people who lost their jobs, will soon lose their houses and be, possibly, homeless and starving, as “impatient to get a haircut” – clearly, you are not facing the financial ruin some of these people are. Try to realize the reasonable worst case scenarios for these people and the country before blowing them off.

    • Kathy, I feel for your plight – and you are right in seeing that a rush in order to get back to “normal” may very well do more damage than good. There are no fixes as quick as Trump wants them, he is putting far too many Americans at risk. I appreciate that people desperately want / need their lives back, but we will be beat by this killer virus if we are not smart. America needs to support its citizens-in-dire-straits better, and follow expert advice on drugs and vaccines. If the experts are continued to be ignored, there just might be another thalidomide disaster. We need smarter management at the top – even US doctors are writing in the Lancet that people better vote for someone else this fall ……
      That some men deem no meds are necessary in pregnancies speaks of grandiose ignorance (too bad they can’t get pregnant and feel for themselves). All the best to you, Kathy, please realise that many (women and men alike) know that you are right.

  • I am eager to hear someone tell me why, if we successfully promote vaccine challenge research on already identified candidates, we will not have preliminary safety and efficacy information by the end of the summer.

    I hear, again and again, “We can not do it, we need Phase 1, 2, 3 testing and those phases take a minimum of X months to do”, but that is not science, that is dogma.

    You do not need to do safety and efficacy research that way, you can do it by giving volunteers vaccines you know are likely to work, in very large numbers, and then, for those who seem to have the correct antibody response, infecting them with the virus.

    The standard claim this is impossible is nonsense. It is totally possible, it is just very risky – no one in power wants to do what is needed, because of course they will not be blamed for failing to get a vaccine in 18 months, everyone of their peers and colleagues will agree it was never possible – but they might be blamed if an experimental vaccine study goes terribly wrong.

    I do not blame them for being scared, but at some point, when the numbers so clearly demand super aggressive research, failing to do it is just cowardice.

    How am I wrong?

    • I am not a medical researcher. But it appears that all the renown researchers in the field are saying the same thing — that proper testing is absolutely necessary to ensure that we are not doing much more harm than good.
      It appears that the only ones not saying this are Trump and Slaoui, who will make billions on this whether the vaccine works or not.

    • Yes, I am aware you will see only a very few – not none, but very few – researchers advocating for challenge studies, and all of them repeating their own dogma that it will take at least 18 months, but please ask yourself, do you ever see any reporter demanding they justify that claim by comparing it to the harm done by not having a vaccine sooner?

      THEY NEVER EVEN TRY TO JUSTIFY IT, BECAUSE NO ONE DEMANDS IT.

      That is not science, that is dogma and no one willing to go out on a limb. If you put about 2,000 people in various challenge studies, and they all die – that is the same as the 1 day death toll – not worldwide, just the US.

      it should also be said, there is not really any great reason to fear the vaccine. A phenomenon called Antibody Dependent Enhancement seems to be what they are so scared of, where your own antibodies will make your infection worse. But, there is no clear evidence that has occurred with this virus at all, and no reason to think any vaccine candidate would cause it, and, more importantly, not reason at all to think EVERY vaccine candidate would cause it.

      In fact, if the reporters would ask them “Do you think ANY current vaccine candidate will work? Or will they all fail, some making things worse? “, then most scientists and doctors will say, “sure, I think one will work, I think people can develop immunity to this, and the right vaccine will induce that immunity” – Fauci himself seems certain people will gain immunity to the virus – but then if you ask the next question, “So, even if all the other candidates fail and make things worse, isn’t it worthwhile to find the good vaccine a year sooner?” they will not be able to answer, because the math is so clearly against the excess caution.

    • Walter Reed used human challenge studies 120 years ago. There are ethical taboos that don’t make sense when the alternatives cause economic damage of 10’s of billions per day to the US economy and kill large numbers of our oldest citizens. Everything we do involve tradeoffs between safety and money, and this catastrophe isn’t unique.

      I would like to see human challenge studies used to test the most promising treatments as well as vaccines. And finally, a plan to rapidly deploy a vaccine, when available is only common sense.

    • Anyone in favor of this mad rush pushing a vaccine without proper trials : you must volunteer. Practice what you preach. I’ll be patient, prudent, careful, isolate, and watch the results of the studies on you.

    • Richard O – not only did I sign up for the human challenge – which is not legally binding by itself – but I was sincere about it – IF, and this is very important, IF I was given a credible vaccine candidate, not placebo – giving people placebo, then infecting them, is not what I proposed, to be clear.
      I am happy to take an experimental vaccine with a good theoretical basis for working. Particularly one which seemed to work in the rhesus macaque studies = yes, there is risk, but, like most of the country, I can get infected with Covid anytime, and die from it. Obviously, if the vaccine they wanted to test on me scared me for some reason, I would decline it. I think it is kind of important to point out, even in a trial where everyone is scheduled for vaccine over the course of a couple months, most people will get it after someone else got it – if people start keeling over, one would stop the trial until there is some indication of what the problem is.

    • So I’m guessing you’ll be stepping up for the initial testing? Do you have any idea what it takes to get a safe drug to market? You can’t use humans as the initial “testers” as you have no idea the impact! There is efficacy and safety and long term impact to determine. And doing it for huge profits will only make it less safe in this greedy world! Let me know how your test goes! Smdh

    • Rhonda- I am eager to sign up for a vaccine trial with challenge. For the right vaccine, it means I would be protected a year or two before everyone else, and go about my business without much worry, back to work, etcetera. I think I said that already.
      People need to get some grasp of how much is known about virology and genetics now, compared to the recent past.
      I will go a bit further and point out, even the choice of treatment of choice, remdesivir, seems to have been made largely based on a very cautious federal bureaucracy, which did not look for the best drug, but rather looked for one which already had fairly favorable safety data.

      There is a lot of discussion of that in another StatNews article, with the author responding to comments extensively.

      Not only are we getting the vaccine late, we may not be getting the best treatment in the meantime, possibly due to the same reason, excess caution and bureaucracy.

  • Yeah, I wish he told us we were all going to die from the virus. I’m sure the left the culture of death misery and despair could get behind that message.

  • This is the same person who said we have 15 cases and it will be down to zero soon. Take it with a large chunk of salt.

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