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.
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.
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.”
Support STAT: If you value our coronavirus coverage, please consider making a one-time contribution to support our journalism.
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.
About the Author Reprints
Roosevelt delivers audacious plan to deliver hundreds of millions of war supplies to Britain by the end of 1941.
Is the following path the way we want our government to function? “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.” That was Trump presenting his detailed plan for combatting Covid-19. We deserve better. Keep this in mind come 11/3
Thankyou.
The statement,
“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.”
does not seem particularly helpful. Drug companies can build manufacturing facilities, before they even have a drug candidate, if they want. There is no law against that now. But why would a company build a billion dollar manufacturing facility before knowing if they had a product? Bill Gates suggested he would fund such “at risk” construction about 2 months ago, but I have seen no further publicity on that point, nor did Project Warp Speed announce there would be government money to build such facilities at risk.
The Gates Foundations has spent $40 billion on global health and development programs, that have saved millions of lives.
Two manufacturing plants, where it’s gearing up to produce Covid-19 vaccines are Fujifilm Diosynth in Denmark and Richter-Helm BioLogics in Germany.
https://pipelinereview.com/index.php/2020043074501/Vaccines/INOVIO-expands-manufacturing-of-COVID-19-DNA-vaccine-INO-4800-with-new-funding-from-CEPI.html
https://www.fiercepharma.com/manufacturing/fujifilm-diosynth-sets-aside-manufacturing-space-for-a-possible-bill-gates-funded
Another point I think must be made – the basis for the “18 ot 24 months to a vaccine” claim is probably partly the normal endpoint for vaccines.
I am not defending Trump, or saying the scientists are “wrong” but there is good reason to hope we would have widespread vaccination in the US by the end of the year.
The scientists saying 18 to 24 months are basing that on the unchallenged assumption they must follow the normal safety/efficacy testing schedule, or if they speed it up, still follow the order typically used.
I do not doubt they know their business, generally, and their estimates are valid, if you follow the traditional schedule.
But we do not have to do that – and under these extreme conditions, should not do it
We can give large numbers of human volunteers vaccine prototypes within a few weeks – we can then test to see if they have produced neutralizing antibodies, and then inoculate those who appear to have immunity with the virus, as the ultimate test.
I understand this is dangerous in ways I do not even understand, but unbiased referees can review the candidates and give the go ahead for infection with the virus on a case by case basis. I think it is important to understand, some of the vaccines are highly conventional, they make a piece of the virus and inject you with it- your immune system reacts to new viruses and pieces of viruses all the time – though the risk can not be quantified, there is also no basis for assuming the worst – some candidates will cause serious problems, others will not- the fact people recover from this virus, and produce antibodies against it, is generally an indication some vaccine will work.
I really think the medical/science community is just too timid for this situation. They know better than anyone that great harm is being done by the virus, but they can not bring themselves to agree to take the risks we need to stop it.
I would point out here also – even if ALL vaccine candidates failed, all 100 of them, and killed every study participant, say 50,000 people – complete disaster – you would STILL get valuable information which we need – about how the virus makes people sick so you might get better treatment – but also, knowing there would never be a safe and effective vaccine – so we give that up, and put our efforts into other methods to combat this.
I know it sounds terrible but we are going to have about 2,000 people per day dying for the indefinite future, and a lot of them are not in bad health or very old.
This is doable but we need to break most of the old rules, but in an intelligent and carefully chosen way – not a “careful” way – that is the problem with the establishment in control of this – we need to take big risks – but we need to do it based on science.
This could be done. I am very fearful it will not be, but it is possible, but not under the old paradigms.
I wish to add in here – the normal endpoint for vaccine development should not be the aim of the crash program – we do not “need” a very safe, very effective, very affordable, permanent vaccine.
We just need something which will slow down the disease enough to prevent an epidemic.
If you are So confident why don’t you be one of the first to take it !
The previous fastest timeline for a vaccine is FOUR YEARS. It is likely a pipedream to think a safe vaccine can be found in less than a year.
Steve – under the conditions you propose, we would also need legislation prohibiting any litigation regarding any problems people encountered with the new vaccine.
While your proposal has – possibly – some evolutionary logic in it, telling the general population “some of you will be deliberately sacrificed so the rest of us can live”, is not going to work. That is essentially the draft, applied to the entire population with no restrictions of any type, including age.
If you want participation and compliance, then a very safe, very effective, very affordable vaccine is required. (It doesn’t have to be permanent.)
If “we just need something which will slow down the disease enough to prevent an epidemic”, quarantine and self-isolation are safe, affordable and effective.
David, I agree with everything you said, I have to admit I was not thinking about people being unwilling to take the vaccine, and you are right, many will not do so – as you probably saw, a survey found 20% of those asked are not willing to take a Covid 19 vaccine – and that was a theoretical vaccine which does not exist, therefore having no bad publicity at all.
I think your other points, the people involved can not be held liable for problems, and the point in your other post, that merely permitting vaccine makers to build factories, without a clear market for them, is not helpful, is a huge point.
I have not followed all of the details of this vaccine initiative. I hope it will do the funding right now for the production facilities, and give that money out without bias, but ???? If this thing is not run honestly, it could actually make things much worse I suspect. If many companies which could contribute see themselves shut out because those in charge pick another company or technology to favor, it might slow down or halt something which is better.
I am hoping the international market for vaccines will mean companies around the world invest in the research and development in the hope of proving the product and marketing it to foreign governments, WHO, private individuals in other countries, and so forth, but it seems like this is not reliable as a financial motivation.
Linda, I realize there is a lot to making a vaccine, and really I have no idea if it will happen, if it, or any vaccine, is even possible. My main point is, it is impossible without radically different paradigms, and we need to adopt those paradigms. The main point being, we have to put people who are research participants at much greater risk than we normally would.
You read up on these things – does it seem to you the doctors, professors, their IRBs and schools, and above that, the FDA, CDC, AMA and so on, are all living in the pall of the infamous research scandals?
Tuskegee? Milgram? Stanford Prison Experiment? American Indian remain abuses?
All this stuff is controlling what they do now, as best I can tell, but it might as well be 1,000 years ago, the culture of medical research is way too cautious. This predates this epidemic but that is to some extent another topic.
Steve – thanks for your reply.
Forcing people to undergo a medical procedure is something the world decided not to permit, following the Nuremberg Trials and the creation of the Nuremberg Code of 1947, and the subsequent Helsinki Protocols of 1963 in the wake of the excesses of Soviet psychiatric hospitals. Among other conditions, for clinical trials conducted today, there has to be “informed, voluntary consent”, and the prospect that the material being investigated has a reasonable chance of providing some benefit.
In a severe crisis, it is certainly possible that a level of desperation may be reached where the general population would be willing to literally roll up their sleeves and take a chance, even if it were a poor one. But at that point, all social and judicial structures would have ceased to function anyway.
But there still may be individuals who are willing to take a chance right now, today, under current conditions, and to do so for any number of personal reasons. Some kind of legal structure could be put in place that allows this, perhaps a “Phase X” (X for experimental) clinical trial in which untested therapeutics are given on a truly at-risk basis. Massive barriers to prevent coercion and litigation would have to be put in place – somehow – and such trials would have to be conducted using the same data collection standards that trials uses now – otherwise the data would be useless or even misleading. And obviously, total transparency and publication of all results would be essential.
That arrangement is something that could be constructively addressed at a social, ethical and legislative level right now. It might not happen fast enough to make much of a difference in the current race for a vaccine, but it would still be useful for letting individuals who are in a bad medical situation – such as terminally cancer patients – take some meaningful control of their own treatment when new and untested therapeutics might be available, and benefit society in a way that you had considered in your initial email.
I ‘ M IN WITH OUR PRESIDENT TRUMP!!! WE NEED TO GET ON WITH TRYING !!! NOT WAIT FOR OTHER COUNTRIES TO HELP!!! ALL TRUING IS BETTER THEN ONE!!!
“The last thing anybody’s looking for is profit,” he said.: Funniest and most ironic thing he has said. Plus – Trump said it is going to miraculously disappear after April with the warm weather or is it right after the November elections as per Eric?
There are many potential Covid-19 vaccines in development now. A NIH study showed that any specific vaccine has a only 6% chance of succeeding. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3603987/ The only realistic hope of a successfull vaccine is to invest in multiple developments efforts at the same time. That’s why Bill Gates is now funding production of the seven most promising vaccines, before any of them have been proven. Since leaving Microsoft, Bill Gates has devoted most of his life to developing vaccines.
But Trump & Slauci have decided that our country will only invest in the vaccine being developed by Slauci’s company.
Who else beside Slauci with his stock options will make a fortune on this decision?
A “normal” president would have made use of Bill Gates and his expertise, Reagan, Bush, Clinton, etc. But Trump can’t be upstaged especially by someone richer than himself
The author is incorrect in saying “ At one point, he repeated the unscientific claim that the virus will “go away” even without a vaccine.”
All pandemics do when heard immunity is reached.
“Herd”