- The Washington Times - Thursday, September 10, 2020

Most Americans worry that political pressure will force the Food and Drug Administration to approve a coronavirus vaccine before ensuring its safety, and more than half say they wouldn’t want a vaccine that is approved and available before Election Day, according to a poll underscoring fears that politics will override science in the scramble to end the COVID-19 pandemic.

Democrats are most likely to doubt the FDA, with 85% fearing reckless speed, though more than a third of Republicans (35%) and 6 in 10 independents espouse the same view. Overall, 62% worry about undue pressure.

“Public skepticism about the FDA and the process of approving a vaccine is eroding public confidence even before a vaccine gets to the starting gate,” said Drew Altman, president and CEO of the Kaiser Family Foundation, which conducted the poll released Thursday.

More than 8 in 10 Americans don’t believe a vaccine will be widely available by Election Day, Nov. 3, according to the poll. But if a vaccine is available and circulated widely, only about 4 in 10 Americans would want to try it.

President Trump is floating the prospect of an October “surprise” in the form of an approved vaccine from one of multiple candidates in late-stage trials. Yet members of his own party were more likely to say they would shirk a pre-Election Day vaccine. The poll showed 60% of Republicans, 56% of independents and 50% of Democrats saying they would decline the vaccine.

FDA and White House officials have repeatedly said they will not allow politics to taint the approval process, though U.S. Surgeon General Jerome M. Adams acknowledged there are “unprecedented levels of vaccine hesitancy” in general.

“We have a once-in-a-century global pandemic superimposed on a presidential election, and that’s made messaging even more difficult and concerning,” he told the Senate Health, Education, Labor and Pensions Committee on Wednesday. “Here’s what I can tell you: As a member of the coronavirus task force, there’s been no politicization of the vaccine process whatsoever.”

Once a vaccine is ready, Dr. Adams said, his own family will be in line to get it.

“There will be no shortcuts. This vaccine will be safe, it will be effective or it won’t get moved along,” he testified.

National Institutes of Health Director Francis Collins said the effort must be free of political interference.

“Otherwise, I’ll have no part of it,” Dr. Collins testified.

The scientific community is developing COVID-19 vaccines at a record pace, with multiple companies starting human trials with 30,000 enrollees each.

AstraZeneca, a British-Swedish company, said it had to pause its trial because of a suspected adverse reaction in one British participant.

The company said Wednesday that the voluntary pause will allow researchers to review safety data after “a single event of an unexplained illness.”

“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” the company said.

It’s not uncommon to investigate such hiccups, but the trial has been paused at a fraught time in the race for a proven shot to shield people from a disease that has killed more than 190,000 in the U.S.

“It’s really one of the safety valves that you have on clinical trials,” Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said on “CBS This Morning.” “It’s unfortunate that it happened. Hopefully, they’ll work it out and be able to proceed along with the remainder of the trial.”

In his testimony, Dr. Collins referred to a New York Times report that said the British participant was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and can be caused by viral infections.

It’s not clear whether the condition is linked to the vaccine candidate, so the company is investigating.

Dr. Collins said the pause “ought to be reassuring.”

When scientists say they are serious about ensuring safety, he said, “Here is Exhibit A about how that is happening.”

If the health condition “is a real consequence of the vaccine, then all of those currently being manufactured will be thrown away,” Dr. Collins said. “We do not want to issue something that is not safe.”

At least two other major vaccine candidates that have backing from the Trump administration are in Phase 3 or Phase 2/3 trials.

Pfizer and German-based BioNTech, as well as Moderna Inc., have partnered with the federal government as part of the administration’s Operation Warp Speed to develop a vaccine by next year.

As Mr. Trump looks to Election Day, Dr. Collins said it is impossible to determine whether a vaccine will be ready by a particular date.

“I have cautious optimism, by the end of 2020, one of these vaccines will have emerged and turn out to be safe and effective. That is a guess,” he testified. “To predict a particular date is well beyond anything any scientist could tell you and be confident they know what they are saying.”

Despite assurances, the Kaiser poll suggests public doubt about the government’s focus. Roughly 4 in 10 Americans said the FDA (39%) and the Centers for Disease Control and Prevention (42%) are paying too much attention to politics when it comes to issuing guidelines or recommendations.

Policymakers and medical experts hope the public’s misgivings don’t spoil a historic effort to stamp out the coronavirus, which has upended normal life around the globe.

Sen. Lamar Alexander, Tennessee Republican and chairman of the Health, Education, Labor and Pensions Committee, said it is important to remember that vaccines are a “true miracle of modern medicine.”

“Some people incorrectly believe ‘warp speed’ means cutting corners,” Mr. Alexander said. “But it refers to the extraordinary investment in research, development and manufacturing scale-up for a COVID-19 vaccine.”

• David Sherfinski contributed to this report.

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