Experts in medicine and public health are expressing growing concerns, in some cases even alarm, at the possibility that the FDA will bend to political pressure and grant early approval to coronavirus vaccines that haven’t been thoroughly vetted.
If a prematurely released vaccine proves ineffective or, worse, harmful, the result could set back the fight against COVID-19 and also diminish the public’s already shrinking faith in all vaccines, these doctors and researchers say.
“Any hint of political pressure would feed into the vaccine skeptic and antivaccine groups,” said Dr. William Schaffner, professor of preventive medicine and infectious diseases at the Vanderbilt University School of Medicine.
And even if the Food and Drug Administration does everything right, many people may reject the vaccine anyway if they have lost trust in the agency.
The FDA already may have created a “damned-if-you-do, damned-if-you-don’t” situation, said Dr. Jerry Avorn, codirector of the Program on Regulation, Therapeutics, and Law at Harvard Medical School. “If you end up with a good vaccine but people mistrust it,” Avorn said, “then you’ve won the first battle but you’re losing the war.”
Worries deepened last week when the FDA and the CDC — another federal health agency once considered inviolable — made widely criticized decisions, apparently in response to pressure from the White House.
After President Trump accused the FDA of delaying approvals of coronavirus drugs and vaccines for political reasons, the agency allowed treatment with plasma from recovered COVID-19 patients despite what federal scientists considered weak evidence that it works. And the Centers for Disease Control and Prevention, without providing a scientific rationale, changed its guidelines to discourage testing of healthy people, even though people without symptoms frequently catch and spread the coronavirus.
The FDA had previously faced criticism for initially allowing unproven COVID-19 tests to go on the market and for giving emergency approval to hydroxychloroquine, an antimalarial drug touted by Trump as a treatment for the virus. The FDA later withdrew that approval when the drug was shown to be ineffective and sometimes harmful.
“We have a trust and credibility crisis that is enormous,” said Dr. Irwin Redlener, founding director of the National Center for Disaster Preparedness at Columbia University. “The more that we erode public trust in the FDA and the CDC, the more difficult it’s going to be to get anything done.”
In early August, even before the plasma decision, a group of nearly 400 public health experts called on the FDA to conduct a “transparent and rigorous” approval process for any coronavirus vaccines.
Last week, the American Medical Association wrote to Dr. Stephen Hahn, the FDA commissioner, asking him to keep physicians and the public informed about the licensure process and standards.
“They’ve got to do a better job providing clarity and transparency,” Dr. Susan R. Bailey, AMA president, told the Globe on Wednesday. But she said the AMA is “working closely” with the FDA and she was “hopeful” the agency will be open about its processes.
Hahn has repeatedly offered assurances that his agency will not cut corners on vaccine safety and will follow the science. But he also recently said he would consider an “early use authorization,” or EUA, for a coronavirus vaccine, which would allow the vaccine’s use before completing the usual FDA approval process.
Even in the best of times, the coronavirus vaccine would pose thorny challenges. The virus, new to humanity, remains poorly understood. Many of the vaccines in development are using technologies never before tried in any medication. And the vaccines are being produced at a record pace in response to the emergency.
Worldwide, 33 potential vaccines are being studied in people, and eight have entered the late-stage trials involving tens of thousands of people. Those trials are critical, because only when the vaccine has been tested in a large number of people will uncommon side effects emerge. Typically scientists wait years for all the data to come in.
A deadly pandemic creates a need to act faster. But how fast? “There are obviously complications and dangers from waiting too long because we’ve got to get the epidemic under control,” Redlener said. “But if we act too soon, there could be pretty dangerous complications from the vaccine.”
Circumstances need to play a role in the decision, Redlener said. “If the second wave is as bad as the first wave, or worse, that would be a compelling reason to try and fast-track release of a new vaccine or vaccines,” he said.
The New York Times reported that the CDC has alerted state and city health authorities to get ready to distribute a vaccine to high-risk groups as soon as late October or early November.
Talk of an October rollout raises concerns about the timing, a month before the November election, said Ali Nouri, president of the Federation of American Scientists.
“Is anyone going to think this is a science-based process rather than a political one?” Nouri said. “I don’t know how you issue an EUA in October and at the same time convince the American people that it was not a political decision.”
The solution, for a confused and anxious public, is to rely on independent experts, said Schaffner, of Vanderbilt. An independent advisory committee typically makes recommendations to the FDA before it approves any drug.
“A lot of us would be reassured if the advisory committee had given the green light,” Schaffner said. “They examine it very thoroughly. That is an external group of experts that has functioned over 50 years and has provided a remarkable safeguard for vaccines.”
If the advisory committee is bypassed or overruled, there would be “a howl of protest” from experts around the country, Schaffner said.
Avorn, of Harvard, agreed that the public now has to rely on independent researchers and medical professionals, who have shared their expertise with the media.
But providing objective answers to scientific questions used to be the FDA’s role. “It’s a strange way for a country to run a drug regulatory system,” he said, “where the average doctor and average citizen has to turn on CNN to find out what the truth is.”