Americans are growing more concerned that the U.S. Food and Drug Administration is being pressured to rush a COVID-19 vaccine to the market, and the nation is increasingly losing trust in other public health institutions, such as the U.S. Centers for Disease Control and Prevention, a new poll found.

Even the top U.S. infectious disease expert, Anthony Fauci, took a hit in the public's trust for his advice about COVID-19, the Kaiser Family Foundation reported Sept. 10 in a new poll.

President Donald Trump has exerted political pressure on both the FDA and the CDC.

Trump made an unsubstantiated claim Aug. 22 that FDA scientists are "deep state" operatives who are slowing down the regulatory process to harm him politically. He said he wants the FDA to approve a COVID-19 vaccine by the Nov. 3 election.

White House Chief of Staff Mark Meadows said Aug. 23 that the administration was willing to put "heat" on regulators if they "don't see the light."

"There can be no doubt that Trump's attacks aim to influence decision-making at the agency," Joshua Sharfstein, vice-dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health and a former principal deputy FDA commissioner, wrote in a Sept. 9 op-ed in Nature magazine.

But the FDA has also disclosed little about how it is making decisions, "squandering the chance to build up understanding and support," Sharfstein said.

The Sept. 10 Kaiser poll came on the same day FDA Commissioner Stephen Hahn and Peter Marks, director of the agency's Center for Biologics Evaluation and Research, suggested at two separate events that an emergency use authorization, or EUA, was highly likely to be the path used for at least one if not more COVID-19 vaccines.

In August, a group of more than 50 legal and policy experts called on Congress to consider banning the FDA from using the EUA mechanism to put COVID-19 vaccines on the market.

At the online event hosted by Duke University's Margolis Center for Health Policy, Marks also suggested the FDA may issue new guidelines clarifying the agency's standards on granting EUAs for COVID-19 vaccines. Those guidelines would be in addition to a set of COVID-19 vaccine standards the agency issued July 1.

Marks suggested the EUA for COVID-19 vaccines may be stricter than for other products the emergency use mechanism has been used.

Both Hahn and Marks said the FDA may convene the agency's outside expert advisers to review specific COVID-19 vaccine applications prior to any EUA or license being granted. However, the FDA has repeatedly declined to put that commitment in writing. So far, the FDA has only scheduled an Oct. 22 advisory committee meeting to discuss general topics about COVID-19 vaccines.

Speaking at The Economic Club's Sept. 10 online event, Hahn said the FDA has not yet seen any phase 3 COVID-19 vaccine data.

The commissioner also pledged he would not overrule any decisions made by the FDA's scientists and regulators involving COVID-19 vaccines. A group of COVID-19 vaccine-makers pledged Sept. 8 they would not seek an EUA or licensure unless there was sufficient data to support those actions.

Losing trust

In the Kaiser poll, a majority of U.S. adults (62%) said they are worried the FDA will rush to put a COVID-19 vaccine on the U.S. market without making sure it is safe and effective.

About four in 10 U.S. adults surveyed said the FDA and the CDC are paying too much attention to politics, 39% and 42%, respectively. And about 46% said those agencies are not paying enough attention to science, versus 43% who said it was about the right amount of attention.

While Fauci remains the most trusted U.S. official on providing reliable information about the COVID-19 pandemic, Americans' confidence in the U.S. National Institute of Allergy and Infectious Diseases director has dropped by 10 percentage points since April, falling from 78% to 68%, the poll showed.

Trust in the CDC also dropped by 16 percentage points from 83% in April to 67% in the September survey.

Credibility

In a Sept. 10 op-ed in USA Today, Marks and the other heads of FDA's centers pleaded with Americans to trust the agency's decisions for COVID-19 products.

"If the agency's credibility is lost because of real or perceived interference, people will not rely on the agency's safety warnings," the FDA center directors wrote.

"Erosion of public trust will leave consumers and patients doubting our recommendations, less likely to enroll in clinical studies or to use FDA-regulated products when they should to maintain or improve their health," they said. "This is problematic under normal circumstances but especially if we are to ultimately overcome COVID-19. Protecting the FDA's independence is essential if we are to do the best possible job of protecting public health and saving lives."

The op-ed ended with a disclaimer that the views expressed in the column were exclusively those of the co-authors "and do not represent the position of the FDA, the Department of Health and Human Services or the U.S. government."

While the disclaimer may be boilerplate, in the context "it totally undercuts the message," tweeted Steve Joffe, a pediatric oncologist and bioethicist at the University of Pennsylvania.