When Trump administration officials leading the response to the coronavirus pandemic came to Capitol Hill last week, they were grilled for hours on everything from the reopening of schools to the efficacy of wearing masks.
But as the hearing wound down, Sen. Tina Smith (D-MN) posed an altogether different type of question to Dr. Stephen Hahn, the head of the Food and Drug Administration. Could he, Smith asked, promise that the administration wouldn’t rush a vaccine simply to help the president’s re-election chances?
A first-term Democrat, Smith hardly has a reputation as a congressional bomb-thrower—which was just one reason that her question stood out during an otherwise staid hearing. But she is not alone in wondering about a vaccine-related October surprise. Indeed, there is a growing anxiety among President Trump’s critics that he will sidestep the proper scientific processes in order to make a triumphant pre-election announcement that he’s delivered a cure for the pandemic that has roiled the country, left more than 130,000 people dead, and thrown his presidency into turmoil. They note, for starters, that he’s dubbed the effort “Operation Warp Speed.”
“I would not put it past this administration and this president to advance his personal political agenda ahead of our national interest,” said Rep. Raja Krishnamoorthi (D-IL), a member of the House Oversight Committee who has pushed the administration to provide regular briefings to lawmakers on the vaccine development process. “That’s why so many of us are so deeply disturbed by the prospect that… what’s going to happen is a bunch of emergency use authorizations are going to be handed out at ‘warp speed.’”
Smith told The Daily Beast that she asked the question because she believes Trump has given the public reason to worry, pointing to his touting of the unproven remedy hydroxychloroquine and his repeated suggestion that the virus will just disappear.
“It’s deeply concerning to me that the president and the administration would offer up some false hope in a hail-mary effort to rescue the election… to put pressure on scientists and epidemiologists to say, there’s a vaccine,” said Smith.
At the Senate Health panel’s hearing, Hahn responded by telling Smith she posed a “really good question,” before stressing that the government will hew closely to data and evidence-driven standards through rigorous trials. “We will,” said Hahn, “ensure that our high levels of safety and efficacy are met.”
Smith, for her part, did not find Hahn’s answer to her question about an “October surprise” persuasive. “Dr. Hahn has his talking points down on following the data and the evidence, and I appreciate he said that, but the proof is in the pudding,” she said.
As Smith noted, Democrats’ concerns are not based on mere speculation. Trump’s White House has sent several signals that they’re eyeing a pre-election rollout of some breakthrough COVID-19 remedy. At a roundtable at the White House on Tuesday, Department of Health and Human Services Secretary Alex Azar said that one of the leading vaccine candidates being developed “could deliver hundreds of millions of doses this fall and into early next year.”
Trump, sitting across from Azar, seemingly perked up.
“I know you’re getting close, very close,” said the president. “That would be incredible. What are your chances, like, early September?” Azar dodged, and instead began describing how one government-funded vaccine works. “It seems to be working,” Trump responded. “Do you have tests that say it does work?” Again, Azar didn’t address the question, and after the secretary thanked Trump for his leadership, the president offered a response: “We’ll hold you to it,” he said, to laughs. “September.”
Trump’s appetite for a quick vaccine has put him at odds with the nation’s most visible coronavirus expert, Dr. Anthony Fauci, who is on the record pushing back against any rushed process, saying last week “there is no chance in the world I’m going to be forced into agreeing to something that I don’t think is safe and scientifically sound.”
But with efforts to mitigate the spread of COVID-19 through social distancing and mask wearing having failed in many states, finding a viable vaccine has taken on more urgency. The administration has already poured substantial resources into speeding the process along, including billions for research and development as well as scaling up production capabilities for potential vaccine candidates.
In a statement to The Daily Beast, White House spokesperson Judd Deere described the development and eventual distribution of a COVID-19 vaccine as “emblematic of President Trump’s highest priority: the health and safety of the American people.” He also insisted that the process would have “nothing to do with politics” and that the president understood “that this vaccine cannot get bogged down in government bureaucracy, which is why he has cut through every piece of red tape to achieve the fastest-ever launch of a trial.”
But public health experts have remained wary that any vaccine candidate can realistically pass the approval process before the end of the year, much less Election Day.
“There is no way that a properly-tested vaccine could be ready before the election,” Dr. Vincent Racaniello, a professor of immunology at Columbia University, told The Daily Beast. But he said that Trump could plausibly claim victory for Operation Warp Speed—having hundreds of millions of doses of different vaccine candidates at the ready for use when one is shown to be safe and effective.
“It’s not technically correct,” said Racaniello. “He does this all the time and gets away with it.”
Were the president to do as much, it would fit a pattern of claiming COVID-related wins that weren’t quite fully baked. In the earlier stages of the outbreak, several testing methods received praise from the White House and emergency authorizations from the government allowing them to be sold and used by the public—only to then be shown to be less than fully effective.
Months after COVID-19 antibody tests, for example, flooded the market in the spring after getting the green light from the FDA, the Centers for Disease Control and Prevention found that the tests can register false results as often as half the time.
Those types of hiccups are what make Democrats concerned that the Trump administration may deliberately rush a vaccine as well. And with few, if any, levers to stop it from happening, they are putting their faith in government scientists and public health officials to serve as a bulwark on that possibility.
“Would the president in November declare victory and have a press conference?” asked Rep. Donna Shalala (D-FL), a former secretary of HHS under President Clinton. “Yes, but he’s not going to get the scientists to say what he’s gonna want.”
“The entire scientific community,” predicted Shalala, “is going to be watching this like a hawk.”
To date, observers say, the medical professionals do appear to be holding the line. The day Hahn testified in front of the Senate, the FDA released new guidelines to companies working on vaccines, which strongly encouraged the use of diverse populations in clinical trials and set the expectation that a vaccine would have to be at least 50 percent effective. And Lawrence Gostin, an American law professor who specializes in public health law at Georgetown, said that there were “safeguards” that could prevent Trump from rushing a vaccine out of political expediency.
“One safeguard is the Common Rule which requires researchers to follow ethical standards, including getting approval from Institutional Review Boards, participant consent, and privacy,” said Gostin. “There should also be a Data Safety Monitoring Board which is empowered to halt any research if early findings show the drug or vaccine is ineffective or unsafe. Finally the FDA must approve the product, finding it is safe and effective.”
But Gostin said there “is still good reason to worry that the Trump Administration will shortcut or undermine those safeguards,” noting that “there is enormous political pressure on government health agencies and pharmaceutical companies.” And others believe the administration must take additional actions to ensure public trust in the vaccination process through mechanisms like a totally independent scientific panel to review vaccine candidates, separate from the FDA and the White House.
“I think we are going to listen to the scientist on this,” said Rep. Dan Kildee (D-MI). “We have high faith in Dr. Fauci. When he says it we will believe it. I don’t have any doubt that Donald Trump will make up anything, say anything and direct anything that he thinks will help him, even if it puts people’s health at risk. He will say and do anything that will serve his purpose.”