Experts fear political pressure on COVID-19 vaccine

Public health experts are raising red flags that the Trump administration could exert political pressure on the Food and Drug Administration (FDA) to approve a COVID-19 vaccine before one is ready.

President Trump, searching for a political win just over three months from the election, has latched onto the push for developing a vaccine in record time and promoted it in a number of recent appearances.

Trump spoke optimistically of the prospects for a vaccine during a visit to a biotech facility in North Carolina on Monday, despite experts cautioning one may not be widely available for another year.

The president made similar comments Thursday, touting progress without dwelling on the fact that more than 150,000 Americans have died due to the pandemic, a massive toll higher than any other country’s.

“We are way ahead on vaccines, way ahead on therapeutics. And when we have it, we’re all set up with our platforms to deliver them very, very quickly,” Trump said during a White House press conference. “We’re all set to deliver them as soon as we have them, and that’s going to be very soon.”

The president has sought to take credit for “Operation Warp Speed,” the administration’s multibillion-dollar effort to fund the development and distribution of potential vaccines for COVID-19 and have them available as soon as they are found to be safe and effective.

The administration has been buoyed by some early success reports from top vaccine candidates, and political officials have confidently predicted a shot will be available before the end of the year.

Anthony Fauci, the country’s top infectious disease doctor, said Friday he is “cautiously optimistic” a vaccine will be ready by the end of 2020 and be widely distributed next year.

While there’s almost no chance a vaccine would be ready for widespread distribution before Election Day in early November, some of the companies with vaccine candidates entering the phase three clinical trial stages now might start to show initial results by then.

Researchers and experts said they are worried Trump could seize on those early results to pressure public health agencies into approving a vaccine before it is ready.

“You saw the issue of politicization around hydroxychloroquine and the pressure that was put on FDA then. There’s a legitimate concern that does not happen again,” said Jesse Goodman, a Georgetown University professor who was previously FDA’s chief scientific officer.

Many outside observers felt the FDA bowed to political pressure earlier this year when the agency issued an emergency authorization for hydroxychloroquine, an anti-malaria drug that Trump, his allies and members of his administration have continued to tout as a miracle cure for COVID-19 despite evidence.

Rick Bright, an agency whistleblower, made similar accusations and said he lost his job for objecting to the drug’s widespread promotion.

The FDA later revoked the authorization.

In another instance, the White House reportedly pressured the Centers for Disease Control and Prevention (CDC) to change its guidance on reopening schools in order to emphasize the importance of kids going to school while downplaying any potential risks.

Goodman said even if there is no political pressure on a COVID-19 vaccine, there’s still “a legitimate problem in public perception” because of the administration’s past actions in other areas of the crisis.

An ABC News/Washington Post poll released in July found that more than half the country distrusts Trump while six in 10 Americans disapprove of his handling of the virus outbreak overall.

A separate poll released this week found that 64 percent favor fully testing any potential vaccine, even if doing so delays its release and allows the disease to potentially spread further.

Health experts warn about the danger of a widespread portion of the population rejecting a vaccine once one is available.

Top administration officials are working hard to reassure the public that they will not be cutting any corners.

“Data and science. Those are what’s going to guide us,” FDA Commissioner Stephen Hahn said during a recent interview with the Journal of the American Medical Association. “We cannot have a situation where people lose trust in the FDA and the clinical trials process.”

Hahn said the FDA’s decisions have worldwide implications, beyond just a COVID-19 vaccine.

“America and the world’s public trust in FDA is really important. It’s worth a lot because people depend upon us every day in their lives, and we just cannot do anything that would break that trust, and that’s a solemn promise,” Hahn said.

FDA guidance requires any vaccine approved to be at least 50 percent more effective than a placebo in preventing the disease, among other criteria.

Drug executives have said they do not believe the FDA would lower its standards for approval.

Still, a potential workaround exists: the agency could issue an emergency use authorization, which requires less rigorous data than a full approval, as soon as officials are convinced a vaccine is safe and effective.

Goodman said all agencies involved in the decisionmaking need to be as transparent as possible.

“I don’t think emergency use authorization should be trivialized on very limited data, and I think the data need to be spelled out to people,” Goodman said.

Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said he thinks there are enough outside players involved that the Trump administration would be hard-pressed to push a vaccine based on limited evidence.

“My confidence is not in the White House managing this, but in the pharmaceutical companies that have delivered hundreds and millions of doses of vaccines for many different problems over time,” Adjala said.

Still, he said public skepticism will be hard to overcome. 

“If politicians get involved in vaccine decisionmaking, that is going to be tainted, because everything that politicians have touched so far in this pandemic has been compromised by their involvement in it,” Adjala said.

“This is not a place that politicians really need to insert themselves. This is a medical decision between doctors and patients.”