President Donald Trump’s blunt demands that the Food and Drug Administration speed the approval of coronavirus vaccines — before it's clear whether any now in development are effective — threaten to undermine the country’s best hope for ending the pandemic.
Rushing out a vaccine without solid proof it works could lead many people to refuse to take it, public health experts warn. Worse still would be cutting corners to distribute a shot that then turns out not to work, leaving people unknowingly vulnerable to the deadly virus.
Either scenario could lead to large numbers of Americans losing faith in vaccines at a crucial moment. Most public health experts see mass immunization as the most powerful tool to defeat the coronavirus. But many also predict that the first vaccines to win approval won’t be perfect — they might provide only partial or short-lived protection. In that case, several rounds of vaccination could be needed to end the pandemic.
That could only happen if the public trusts scientists and health officials.
“If a vaccine isn’t trusted, it’s not going to be used. And if it’s not used, it’s not effective,” said John P. Moore, a vaccine expert at Weill Cornell Medicine who has worked for years on developing an HIV shot. “[Trump is] completely missing the point — the point is that the FDA exists to give the public confidence that the product they are being asked to take is safe and effective.”
The president has made vaccine development the center of his coronavirus response, repeatedly promising a vaccine by the end of the year. His administration has spent billions to help companies test and manufacture their shots, even as it brushed aside calls for a national approach to testing, contact tracing and other time-honored public health tools.
Concerns about a so-called October Surprise, or Trump declaring vaccine victory weeks ahead of the upcoming presidential election, have percolated for months as he alternately downplays the pandemic and assures the public it will soon be resolved. But his recent attacks on the agency — accusing scientists of slow-walking coronavirus vaccines and drugs to harm his reelection campaign — and open calls to authorize emergency use of convalescent plasma despite thin evidence have kicked those fears into overdrive.
“Any time the president says things that are saying that the FDA is not doing things correctly, that is going to hurt the whole process, that is going to hurt confidence in a vaccine,” said Melanie Kornides, a vaccine hesitancy expert at University of Pennsylvania who specifically studies social medial conversations around shots. “Even if he is saying they are doing it too slowly, it is implying that they are doing things wrong.”
It’s affecting people on both ends of the political spectrum, says Kornides. “The common thread is that people will say in these comments that they are not anti-vax, they would normally get vaccinated, but given these political maneuverings, they don’t feel comfortable with this particular vaccine.”
Polls show that a significant chunk of Americans are already wary of any future vaccine. POLITICO/Morning Consult surveys this month found that nearly a fifth of American were hesitant to take a Covid-19 shot and just 14 percent would be more likely to take one that Trump recommended. Vaccine confidence is even lower among communities of color: A little over half Black Americans say they would probably or definitely get a vaccine, according to Pew.
That sobering poll data motivated more than 400 scientists — Moore among them — who wrote to Hahn this month calling on the agency to be transparent in vaccine reviews and keep politics out.
The White House and Health and Human Services have denied that politics will play any role in a vaccine approval.
“Data is driving the development of all COVID-19 countermeasures. Careless talk about career F.D.A. experts somehow approving an unsafe and ineffective vaccine just for politics only undermines confidence in the public health system,” HHS spokesperson Michael Caputo said in a statement. The push to develop a vaccine quickly “has nothing to do with politics,” a White House spokesperson told POLITICO last week.
The nuance of working vaccines is lost on the press briefing stage, where Trump appeared without administration scientists for weeks before Hahn accompanied him Sunday to tout convalescent plasma. While the therapy is considered safe, plasma has not yet been proven effective against the coronavirus. The president said otherwise; Hahn did not correct him. The authorization was based on anecdotal data from a 70,000-person program run by the Mayo Clinic.
In that press briefing, Hahn also overstated the benefits of plasma, saying it would result in far more lives saved than the data indicated. The comments, which drew wide rebuke from the medical community, were also amplified on Twitter by numerous administration officials, including spokespeople for the FDA, HHS and Vice President Mike Pence.
More than 24 hours later, Hahn on late Monday night issued a mea culpa on Twitter, saying criticism of his statements on plasma’s benefits "is entirely justified."
"I thought it was really important for the American people and the agency, the FDA, to correct that record," Hahn told POLITICO. “We’re going to make our decisions based on data and science ... As we get more data, if we have to change the EUA, we will change it."
Accurately communicating the flaws, as well as the benefits, of any vaccine will be crucial — especially since the first shot to market isn’t likely to be a silver bullet.
Realistically, “the first ones are going to be helpful but not slam dunks,” said Mark McClellan, who led FDA under President George W. Bush. “We could be in a situation where people are considering — which has never happened before — ‘Should I take this vaccine now or should I wait two months [for another one]?’”
There is the distinct possibility that the first batch of vaccines will lessen the chance of severe illness but not eliminate the risk entirely, much like the annual flu shot. That will not become clear until drugmakers conclude the mass phase 3 trials currently underway — studies that enroll 30,000 people apiece and determine how effective a shot can be.
“It’s not only important to show what we know, it’s important to show what we don’t know,” said Syra Madad, a fellow at Harvard and expert on the Federation of American Scientists’ Covid-19 task force.
It is equally important, health experts agree, to communicate progress and health advisories through non-political channels.
“Trust is so important,” said Madad. “Something as simple as a behavioral change — like [having] everyone wear a mask — if you politicize something that is coming out from a politician versus someone with a science background, … that makes a huge difference.”
Companies themselves are looking to quell unrealistic expectations. British drugmaker AstraZeneca, which is working on a candidate with Oxford University, refuted reports Monday that the Trump administration is considering fast-tracking the vaccine before the election.
“It would be premature to speculate on that possibility,” the pharmaceutical company said in a statement. Like others, AstraZeneca’s shot is in the sweeping last stage of trials known as phase 3. But the company is still enrolling the 30,000 people needed for those studies, which only began in June.
The availability of a vaccine also does not mean a quick return to normalcy, said McClellan. “But if enough people like you take the vaccine and we see cases really start going away, then we can really think about more changes in what you are doing day-to-day.”
The availability of a Covid-19 vaccine this year is one bullet point on a short list of goals for the Trump reelection campaign. As the president’s campaign heads into the Republican National Convention this week, experts are raising alarms that the political rhetoric will only increase.
“You just can’t get the politics out of this, and once you get the politics into this, you are turning off a substantial fraction of the American public over lack of trust,” Moore said.
Dan Diamond contributed to this report.
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