A Covid-19 vaccine could be approved in record time, thanks to an unprecedented mobilization by the federal government and private sector — but it almost certainly isn’t coming before Election Day, as President Donald Trump has suggested throughout the year that it could.
Instead, drug makers and public health experts think early 2021 is a more likely timeframe for the rollout of a vaccination campaign.
Trump had clung to the speedy development of a vaccine as the best hope for ending the coronavirus pandemic and for boosting his reelection chances — and his administration’s Operation Warp Speed can claim some credit for the rapid scientific advancements that we have seen over the last eight months.
“What we’re seeing with Operation Warp Speed is unprecedented speed and public-private collaboration in a way that we’ve not seen before,” Kim Monk, founding partner at Capital Alpha, an investment advisory firm, told me. “It could set a model for these types of public-private partnerships that move science and regulation along to achieve great things.”
And yet, there has been little sign of Trump receiving a political boost from that progress. That likely reflects the consensus among experts and insiders close to the project that it will succeed in spite of, not because of, the president himself.
Rather than let the vaccine science run its course, irrespective of electoral deadlines, Trump has meddled. This week, the president’s aides reportedly wanted to stop the FDA from releasing its criteria for evaluating a Covid-19 vaccine that would all but assure there is no approved option before November 3. The FDA released the guidance anyway, with support from the drug industry. Trump has also reportedly been calling the CEOs of drug companies, pressing them for more progress on the vaccine front.
Those are merely the latest examples of the White House appearing to intrude on what is supposed to be a sacrosanct process driven by science.
The problem is Trump has a much bigger microphone than his subordinates. The public hears what Trump says about a vaccine — and it seems to be creating more distrust, based on polls that show many Americans are skeptical of getting vaccinated. If people won’t get the Covid-19 vaccine because they don’t trust it, all of the project’s accomplishments will be moot.
“The president who is in charge of all these various efforts being out there saying we will probably have a vaccine soon is hugely problematic,” Rachel Sachs, a health law professor at Washington University in St. Louis who follows pharmaceutical policy, told me. “I don’t know how much [Operation Warp Speed] even matters if the president’s comments drive the media narrative nearly every day.”
Vice President Mike Pence could decide to tout Warp Speed’s accomplishments at his debate with Democratic vice presidential nominee Kamala Harris. As the head of the White House’s coronavirus task force, he’s been close to the project.
“What you’re witnessing today is the extraordinary talent and ingenuity of American scientists, of American pharmaceutical industries, and of the American people,” Pence said in July at an event promoting Warp Speed’s progress. “What you’re also witnessing though is what’s possible when we’re able to come together and provide the resources to support those efforts.”
There will be some truth to his version of the story. But the vice president will likely leave unmentioned one of the biggest obstacles to the project’s eventual success: his boss.
What Operation Warp Speed has done
There are many parts to Operation Warp Speed. One of its goals was to help ramp up production of Covid-19 therapeutics and diagnostics, to tide the US over until a vaccine is widely available.
A STAT review concluded the program had had a modest impact on production, with just one $450 million contract signed for Regeneron to produce doses of the antibody treatment Trump received during his own Covid-19 hospitalization. The same was true for testing, with Warp Speed largely sidelined while NIH took the lead, STAT found.
But it’s gained the most attention as a hub for vaccine development and distribution. And there’s a reason for that: Vaccines have been the operation’s focus.
The Trump administration has spent $10 billion through the project already, paying companies to conduct their clinical research and also to pre-manufacture doses of their vaccine candidates so that, if the vaccine should win FDA approval, they can start distributing it as quickly as possible. There is some variation in how much the drugmakers are participating — for example, Pfizer is not getting any money for its clinical trials but signed a contract for manufacturing — but most of the companies with vaccines in phase 3 trials are participating: AstraZeneca, Johnson & Johnson, Moderna, Novavax, Pfizer.
The quick progress on a Covid-19 vaccine has been partly the result of good fortune (coronaviruses, the family SARS-Cov-2 is part of, are a pathogen very familiar to modern science so vaccine work on some of its relatives had already been underway) and partly by the investment made by the federal government.
But the biggest payoff for Operation Warp Speed could be the rapid deployment of a vaccine once one is approved. The upfront investment for drug companies to produce vaccine doses without knowing whether they will ever be used is the kind of thing the federal government is best positioned to do. Risk-averse pharmaceutical companies wouldn’t ordinarily spend hundreds of millions of dollars in that way otherwise.
“We want to make it worthwhile for these companies to do that under these conditions of uncertainty,” Sachs said.
Warp Speed has become in effect a military operation, with a STAT report on its organizational structure revealing that the military personnel working on the project actually outnumber the civilians. The military has flown equipment and raw materials around the world to manufacturing centers, and it will likely play a central role in vaccine distribution. Even Joe Biden has compared that process to a large-scale military operation.
The project has also inked a contract with McKesson, which was responsible for pushing out H1N1 vaccines during the 2009 outbreak. More detailed plans are forthcoming, but the Trump administration has released a general strategy for vaccine distribution, with a more limited initial phase focused on public health protection before moving into the population-level vaccination campaign.
Taken together, some right-leaning policy experts see the prospect of a Covid-19 vaccine being approved within a year or so — the previous record had been four years, to develop a mumps vaccine — as validation of the Trump administration’s approach.
“I think some people are learning a great lesson in the power of the private sector. When all is said and done, the development of these vaccines will be an enormous scientific and commercial accomplishment,” Doug Holtz-Eakin, president of the American Action Forum, told me. “They put money on the table, and they let them go. The money matters. You don’t run stage 1, 2, and 3 trials or make vaccine in advance without the money.”
Others were more tepid in their praise, acknowledging the benefits of public funding to incentivize pharma companies but pointing out that most of this work likely would have been done under any administration. As one drug executive, who requested anonymity to speak candidly, put it: “It feels like marketing.”
“While I think the effort has shown good results, I don’t know how much of it is ‘Warp Speed specific,’” Derek Lowe, who writes about drug development for Science, said in an email. “And of course it could all be undone by political interference, or even the appearance of such, which we’re in the process of getting right now, thanks to Trump.”
How President Trump has undermined Operation Warp Speed
The problem for Operation Warp Speed is even if it succeeds in facilitating the quick development of a vaccine and the large-scale production of enough doses to vaccinate most of the US population, those successes aren’t going to matter if the American people are skeptical of the vaccine. And polling indicates trust is falling.
A Pew Research Center survey found that the percentage of Americans who said they would definitely or probably get a Covid-19 vaccine fell from 72 percent in May to just 51 percent in September. Most people said they were more concerned about the approval process moving too fast (as opposed to too slow) and most thought it was likely a vaccine would be used before it was fully understood whether it was safe or effective. Other polls have found most Americans don’t trust what Trump says about a vaccine and they worry the vaccine approval process is being driven by politics.
And yet, Trump continues to undermine trust in the approval process. The New York Times reported this week that the White House had initially blocked the FDA from releasing more stringent criteria for approving the emergency use of a Covid-19 vaccine. After the FDA did finally release those guidelines, Trump accused his own agency of being part of a political conspiracy against him.
New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA— Donald J. Trump (@realDonaldTrump) October 7, 2020
Trump’s agitations have put him at odds with the drug industry, which issued a statement supporting the FDA’s decision that read like a brushback of Trump even if it did not mention him directly.
“PhRMA [Pharmaceutical Research and Manufacturers of America] supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines,” the industry’s top lobbying group said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.
There is a frustration within the industry that Trump has sown doubts during this delicate time for public health. In this view, the existence of Warp Speed itself is a problem because it puts a political cast on what should be an apolitical, science-driven process.
“I think it undermines the FDA every day, undermines the NIH ... FDA should be the clear arbiter of the regulatory process and how things become prioritized,” the pharma executive said. “It’s created a lot of confusion and complexity, and I’m not sure what it’s achieved.”
Then there are the complaints I heard that Warp Speed simply hasn’t been well run. The recent reports that Moderna had failed to enroll enough minorities for its phase 3 vaccine trial, forcing that research to be slowed down, is a telling example.
It’s a problem that should have been preventable. Earlier this year, around the same time Warp Speed was getting off the ground, the NIH convened a large network of vaccine experts to work on Covid-19. These were people with years of experience running clinical trials.
But for months, Warp Speed and the companies it’s working with, including Moderna, didn’t rely upon that group’s expertise in developing its plans for clinical trials, according to one source familiar with its workings. When news broke about the Moderna clinical trial failing to achieve enough diversity among its participants, it was not a surprise to the people who work with the NIH group.
“We could have told you that months ago,” the source, a non-government vaccine expert who refused to be quoted by name, said.
Not only have Trump’s public comments and this lack of coordination hindered the project, but the administration’s singular focus on Warp Speed has arguably led to other parts of the US pandemic response being undermined.
As Bloomberg reported in late September, the Trump administration has redirected about $6 billion in federal funding meant for the National Strategic Stockpile to Operation Warp Speed, even though protective equipment shortages persist. And about $1 billion in CDC funding, which otherwise would have been sent to state and local health agencies, was also steered to the project, according to Bloomberg.
Operation Warp Speed could still set a precedent for future crises
Warp Speed’s problems are more in its execution than its conception. And in spite of its struggles, the project could still help deliver a Covid-19 vaccine on a timeline that nobody had previously thought possible.
Even people I spoke with who had specific criticisms of Operation Warp Speed thought the model could be effective if it were better implemented.
“In concept, this idea that you can marshal a variety of resources across the federal government to deal with a national emergency, like Warp Speed, is actually a really good idea,” said the vaccine expert.
It’s an idea that’s been acted upon before, but never in a public health emergency like this. After 9/11, Congress and the George W. Bush administration established Project Bioshield, a $6 billion program to encourage drug makers to develop vaccines that would be used in the event of a bioterrorist attack. During World War II, the government offered funding for companies that figured out a way to mass-produce penicillin.
Covid-19 has tested the proposition of these public-private partnerships like never before. The funding from Warp Speed will be undeniably well-spent, but it’s also clear that such a program could be better run next time. For one, there could be even more money made available; given the scale of the coronavirus threat, $10 billion or so arguably isn’t enough. We could also have a president who doesn’t undermine faith in the effort. There could be better coordination from the start among the federal agencies and outside experts who are advising clinical trials.
In the end, the US will likely be better off because the Trump administration threw money at this problem. As Sachs put it. “These are the kinds of policy tools that should be used in this situation.”
But it could have gone better if the president had gotten out of his own way.