Was ever an October surprise so publicly plotted? President Donald Trump has repeatedly said, despite nearly all evidence to the contrary, that a vaccine for SARS-CoV-2 will be available before Election Day. When the heads of U.S. health agencies contradicted him in public hearings, he said they were wrong. When the U.S. Food and Drug Administration planned to release more stringent requirements for approving the emergency use of a vaccine, Trump immediately threatened to overrule the agency. Now, as Election Day approaches, health experts worry there may not be enough safeguards in place to prevent Trump from rushing an insufficiently tested vaccine to the public. The damage from such a move could resonate for years, undermining public trust in vaccines and medical authorities. And so, in a bizarre and frightening turn, pharmaceutical companies with ethically patchy pasts could become one of the last ethical lines of defense against their own drugs being marketed before they’re ready.
Eleven vaccines for the coronavirus, five of which have received a financial commitment or support from the U.S. government, are now in phase 3 clinical trials to test their safety and efficacy. Earlier this month, states were told by the U.S. Centers for Disease Control and Prevention to prepare for vaccine distribution by November 1. A few days later, on September 7, Trump said at a press conference that the vaccine “will be delivered very soon. You could—you could have a very big surprise coming up.… It could be during the month of October, actually.” His top medical advisers contradicted him: Dr. Moncef Slaoui, the chief adviser for the U.S. vaccine development program known as Operation Warp Speed, said it is “very unlikely” that a vaccine will be delivered so soon, and Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, agreed. In a Senate hearing on September 16, Dr. Robert Redfield, the director of the CDC, said he expects vaccinations to begin before the end of the year—perhaps November or December—but only among very high-risk populations.
A week after Trump’s unexpected announcement, FDA Commissioner Dr. Stephen Hahn said in another hearing that the “FDA will not authorize or approve any Covid-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness.” Last week, the FDA reportedly planned to release more stringent rules for a coronavirus vaccine, intended to make sure it is properly tested: Drug manufacturers seeking an emergency use authorization, which would allow the vaccine to be put into widespread use before official FDA approval, would need to follow participants in phase 3 clinical trials for at least two months, making a preelection vaccine all but impossible.
But as of yet, those stricter guidelines have not materialized. And hours after Dr. Hahn’s testimony, Trump told reporters at the White House that such a requirement “has to be approved by the White House. We may or may not approve it,” he said. An FDA official agreed that guidelines are usually reviewed by the White House Office of Management and Budget, and the FDA plan appears to have stalled after those comments. It is unclear, from the most recent developments, whether there is any fail-safe impediment to the president pushing out a vaccine entirely on his own, unscientific schedule.
“What I’m very keen to emphasize,” Dr. Ruth Faden, founder of the Johns Hopkins Berman Institute of Bioethics, told me, “is just how terrifyingly awful it is that the president’s even raising this as a prospect. It is such a bad idea.” There are two challenges to curbing the pandemic with a vaccine, she said: developing safe and effective vaccines very quickly, and getting people to take them.
“Having a safe and effective vaccine that large numbers of Americans do not want to take, because they don’t trust that the vaccine is indeed either safe or effective, is a big problem,” Faden said. When a public official—like, for instance, the president—stakes out a path that undermines the public’s already shaky confidence in a safe and effective vaccine, both challenges are exacerbated, with potentially disastrous results.
“We’re not going to get a do-over here, right? If the vaccine rollout does not go well, it’s going to be very, very difficult to right it.” Even if vaccine makers wait until they are certain they have a safe and effective vaccine, she said, it doesn’t matter much, if no one trusts the regulatory process anymore. “If people’s confidence is eroded, it’s not just going to be with respect to this vaccine, it’s going to be potentially with respect to vaccines in general,” Faden said. “The authoritative voices that the public could count on are now, in terms of their legitimacy, threatened, if not already viewed as illegitimate by big chunks of the American public.”
Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and a member of the FDA’s advisory board on vaccines, told me an emergency use authorization for a vaccine that has yet to be formally approved is very likely. The official FDA approval process can take years to complete, and a vaccine proven in clinical trials to work well and safely could be put into emergency use very quickly. The only question, Offit said, is how soon an EUA would be approved. He believes the vaccine companies will wait until they have enough data—ideally, after two months of following participants, as the FDA planned on requiring—before they seek or receive an EUA.
“As long as we let those trials go to completion—that we don’t try to interfere with those trials—then I think the American public will have a lot of good data to look at to see whether or not these vaccines work and whether they’re safe,” Offit said. Trump isn’t on the FDA board reviewing data from phase 3 trials, Offit pointed out, so he wouldn’t be able to rush that process forward.
However, there’s a chance Trump wouldn’t even wait for that phase 3 data. He could simply point to earlier clinical trials among a few participants—as, for instance, Russia has done—to claim the vaccine is safe and effective enough. These trials, in a few dozen people, look at how humans tolerate the dose; they don’t confirm whether it actually works.
Americans have grown increasingly skeptical of fast-tracked vaccines. About half of U.S. adults say they would get a SARS-CoV-2 vaccine if it were available today—a sharp decline from 72 percent who said the same in May. In another poll, most adults did not believe a vaccine would actually be available by Election Day, but 62 percent worry that politics will rush vaccines to market before they’re ready.
Several companies, responding to Trump’s claims of an early vaccine, released their protocols for conducting trials—usually kept under wraps until the trials have been completed. Moderna, with one of the more well-publicized vaccines, will not begin analyzing data from the trial until late 2020, making an early 2021 timetable for a vaccine likely. Pfizer, on the other hand, could begin conducting its first preliminary review of the trial as soon as October, which means a fall vaccine could still be a possibility.
By overriding U.S. regulatory agencies, Trump puts the burden on pharmaceutical companies to act ethically. While nine vaccine developers have vowed not to distribute a vaccine before they’re confident it is safe and effective, pharmaceutical companies have a checkered safety record, Offit said. “When the Trump administration says that they trust the pharmaceutical companies—that these are great scientists, and they care, and they really work hard, and I think we can trust them—what he’s saying is, we don’t need the FDA. That goes against everything we know about the history of drugs in this country. Because the fact is, you can’t trust pharmaceutical companies.”
“The history of drug regulation is built on tombstones,” Offit quoted—a line ubiquitously attributed to Smithsonian historian Michael R. Harris. The FDA was created to oversee treatments and vaccines that, left unregulated, caused more harm than good. “We need the FDA. That’s what upsets me the most,” Offit said. “You look at any of the major advances in terms of FDA regulation, and it’s all because there was a disaster that happened.”
Offit worries about the long-term damage this could cause to public trust in future vaccines and in regulatory agencies like the FDA. The degree of political interference is “unprecedented,” he said, “and so, as a consequence, people have lost faith in the FDA. They have. And it’s a sad thing when we get to that point in this country.”
There’s another way Trump might be able to push a vaccine forward. The administration has already pledged millions to vaccine developers, essentially advance-ordering quantities of vaccines as they were being developed. Could they compel a pharma company to distribute a vaccine once initial phase 3 trial data is in?
“What if the president moves ahead? Can he legally do this? Can [he] do it on his own without a pharmaceutical partner?” Faden wondered.
Offit asked the same thing. “Would he be able to say, ‘I am going to just put these vaccines out there,’ because he owns them?” Offit asked. The legality of such an action could depend on the contract each pharma company has with the U.S. government. “Does the contract say a company ultimately has the right to say no? In other words, if Donald Trump says, ‘I think that this is good enough,’ but the company doesn’t think it’s good enough—can the company say, ‘No, I’m not going to allow you to put it out there?’” Experts I talked to didn’t know the answer to this question.
As Faden pointed out, pharmaceutical companies are “not the only brake.” High-level officials in the Trump administration—from Dr. Hahn to Dr. Fauci—have stated that a vaccine will not be rushed, she said. And other officials may also halt the early rollout of a questionable vaccine. New York Governor Andrew Cuomo announced last week that the state would conduct its own independent review of vaccines. And the National Medical Association, a group of Black physicians, also plans to vet Covid-19 drugs and treatments.
If Trump were to circumvent the process—either by moving ahead with data from earlier trials or by somehow moving the process forward in phase 3 trials—the outcry would be swift and fierce, Offit said. “You would have every researcher and clinician who was associated with vaccines, who knows anything about this, stand up and say, ‘Wait, you can’t do that. We don’t know enough yet.’ And if they said that to what is already a skittish American public, I think that his attempts to vaccinate Americans would fall flat, because people are already skeptical. All you’re going to do is make them all the more skeptical.”
There’s a downside to relying on public outcry, though. Once the public has learned it can’t rely on the testing process for a vaccine, its trust may be difficult to win back.