Politico

How the FDA is trying to soothe coronavirus vaccine fears


FDA chief Stephen Hahn is stepping up efforts to convince Americans that his agency won’t sacrifice the safety or efficacy of a coronavirus vaccine for the sake of speed — even as President Donald Trump is urging the agency to move faster on Covid-19 cures.

Hahn, the nation’s top drug regulator, has been pumping out op-eds and popping up at scientific conferences in recent weeks to make the case for his agency’s independence. “FDA commissioner: No matter what, only a safe, effective vaccine will get our approval,” read the headline on a Washington Post piece Hahn wrote this month. “Unwavering regulatory safeguards for Covid-19 vaccines,” read another, published days later in the medical journal JAMA.

Within FDA, “the discussion has been: How do we communicate to the public and how do we push back on the misinformation — from all directions?” said one current health official. Asked about the president’s sometimes contradictory statements about the vaccines in development, the official said: “We just march forward.”

But it’s not clear whether Hahn’s efforts will persuade Americans who are hesitant about taking a coronavirus vaccine to do so.

Polls show that nearly a fifth of adults would refuse a coronavirus vaccine if one were available, in some cases over fears that any approval would be motivated by politics rather than science. Trump has repeatedly promised that a vaccine will be available by the end of the year — perhaps even before the November election, contradicting timetables laid out by top federal scientists. Just 14 percent of voters would be more likely to take a vaccine recommended by Trump, according to a POLITICO/Morning Consult poll this month.

The president has also taken direct aim at the FDA in recent days, accusing it of slow-walking its coronavirus response for political reasons. “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted Saturday. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”

POLITICO spoke to three current health officials familiar with discussions ongoing among Hahn and a small group of advisers — as well as three former FDA commissioners and several other health policy and vaccine experts, some of whom have advised the government during this pandemic.

Public fear that drugmakers are rushing vaccines or that the politics could instigate a so-called “October surprise” to greenlight an unproven shot before the election have fueled Hahn’s internal and public moves to champion science, not politics, in vaccine decisions, the current officials said. Convincing a majority of Americans to take a vaccine when one is available will be crucial to stopping the spread of the coronavirus, which has killed over 175,000 Americans.

“It’s a little bit challenging for the administration right now,” said Mark McClellan, who led FDA under President George W. Bush. “They are trying to say ‘we are going to follow the guidance, and follow the FDA gold standard process,’ but it hasn’t actually happened yet.” That’s because the agency is still waiting for data from the late-stage clinical trials that will reveal whether any of the shots in development are effective.

It’s a two-front battle for the agency: Rebuff any outside pressure, and convince the public that it has.

“It’s the job of the FDA commissioner, to make sure that the American people trust the agency,” said David Kessler, the longtime FDA commissioner who now advises the Joe Biden presidential campaign on the coronavirus response. “The other big job of the FDA commissioner is to put their body on the line in between all the forces that want to influence the agency.”

The FDA did not respond to questions about vaccine hesitancy among the general public, Hahn’s strategy to counteract fears about vaccine safety and the president’s promises. But a White House spokesperson rejected any suggestion that politics would influence a vaccine approval. “It has nothing to do with politics,” the spokesperson said. “This President understands that this vaccine cannot get bogged down in government bureaucracy.”

Public skepticism of vaccines has been steadily growing in the United States and worldwide. But polls indicate that confidence has plummeted in recent months amid discussion of bringing Covid-19 shots to market in record time and concern over the Trump administration’s coronavirus response.

“The national conscience has been traumatized over the past six months,” said one current senior health official. “People just don’t know what to believe. On top of that, it’s an election year.”

Trump has not always stuck to FDA’s new script on science and safety, instead doubling down on pledges during near-daily solo press briefings that a vaccine will be ready this year.

“We’re moving very rapidly towards that approval,” Trump said in an Aug. 11 briefing, hours after Russian President Vladmir Putin claimed that his country had the first working shot. Earlier in the month, the president had even suggested that a vaccine could be ready before the Nov. 6 election, months ahead of his administration’s already ambitious year-end target.

“This Covid vaccine is probably the most precious and prestigious medical resource in any of our lifetimes,” said Lawrence Gostin, a public health expert at Georgetown University. “The race to be first has enormous political, geopolitical overtones to it. It’s all wrapped up in international prestige and chest-thumping from populist leaders like Xi Jinping, Vladimir Putin and President Trump.”

At the center of the federal review of those vaccines is Hahn, a relative newcomer to D.C. who has little of the star power that has accumulated around infectious disease expert Anthony Fauci or White House coronavirus task force leader Deborah Birx.

The FDA chief is still virtually unknown to the greater public. He assumed the top post just a month before the pandemic hit U.S. shores and was originally left off of White House task force.

Hahn’s opinion pieces have largely been confined to medical journals that few average Americans read. He has rarely appeared on nightly news or morning shows in recent months. And he and other top health officials have been shut out of the president’s near-daily press briefings — at which Trump has touted the discredited coronavirus treatment hydroxychloroquine and has alleged political collusion by scientists over plasma therapy — until Sunday. Hahn appeared alongside Trump and HHS Secretary Alex Azar at a briefing on emergency use of plasma, where Hahn declined to contradict the president’s claim that the therapy was “very effective.”

FDA’s emergency use authorization for the infusion, issued Sunday after days of accusatory tweets and criticism by Trump, noted that more data was needed to determine whether it was effective. The agency’s top drug official, Janet Woodcock, told POLITCO on Friday that it had not yet been proven.

Meanwhile, the new FDA openness comes on its own terms. The agency initially told POLITICO that it would make Hahn available to discuss his transparency efforts. Four days later, it reversed course, citing his packed schedule. An HHS spokesperson later contradicted that explanation, saying that “nobody at the FDA” believed this story would be fair.

Former agency chiefs applauded current FDA officials’ efforts to reassure the public — but said there is still a long way to go.

“For FDA officials, the challenge with being in that position if you oftentimes speak in the echo chamber of Washington,” said former Commissioner Scott Gottlieb, who left the post last spring. “Ultimately the obligations of the job transcend that, and speaking directly to consumers and providers — people who are the end users of the FDA’s product — you need to reach those groups as well.”

Government trust is particularly low in communities of color: Just 54 percent of Black Americans say they would probably or definitely get a vaccine, according to Pew.

Other agency officials including longtime vaccine chief Peter Marks are echoing Hahn’s message. Marks oversees the Center for Biologics Evaluation and Research, the arm of FDA that will ultimately decide whether to approve any vaccines. He recused himself from his post for just a few days in May to join an administration effort, Operation Warp Speed, to accelerate vaccine development — but swiftly returned to the agency amid concerns about political pressure.

In June, FDA issued guidance saying that potential vaccines had to be at least 50 percent effective. That left the door open for a shot to receive an emergency use authorization, a speedy way for unapproved products to get to the broader public, even if evidence supporting their use is still thin.

“We don’t have any intention of using emergency use authorization to take a vaccine of suboptimal effect or an unproven vaccine to bring it forward — that would be doing such a disservice here, people need to feel confidence,” Marks said on a call with reporters this month.

Gottlieb, who sits on the board of Pfizer, which has received U.S. government funding for its coronavirus vaccine, said that if everything goes right in trials, it is possible for a shot to be ready for limited use at the end of this year. “I think a vaccine available for mass inoculation of the general population is a 2021 event,” he said.

Several drugmakers are optimistic that they could have data in 2020, even though none is finished enrolling the sweeping, 30,000-person trial needed for final results. The FDA is gearing up to discuss vaccine candidates in a late October advisory committee meeting, though it is not clear whether any conclusive data will be available then.

The October panel date raised questions among outside experts about whether the agency was getting ahead of its skis. But others including the former commissioners said it is a solid step towards transparency around the shots.

“I think they’re on notice. Be it the committee hearings, be it comments by scientists and public health officials: Everyone is looking to them to do the right thing,” said Paul Offit, a vaccine expert at University of Pennsylvania who co-developed the rotavirus shot and is part of the panel slated to meet in October.

“The only question is to what extent the administration would be able to put them in a position where they are being asked to not do the right thing, and would they be able to stand up to that,” Offit said. “That’s what worries people.”

David Lim contributed to this story.

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