A COVID-19 vaccine is just weeks away, President Donald Trump has repeatedly assured the public as the coronavirus continues its rampage across the United States. More than 200,000 lives have been lost since March, and models are predicting a potential doubling of that grim total by the end of the year.
The possibility that a prophylactic will pass the muster of rigorous testing is the only source of hope the world has in its attempts to control the virus, for which there exists no cure. In fact, a vaccine has never been successfully developed for any coronavirus, including the common cold, SARS, or MERS, and it is entirely plausible that COVID-19 will not be an exception, despite the efforts of the planet’s best immunologists.
Thus, Trump’s hapless guarantees that a safe and effective COVID-19 vaccine lies in wait for mass distribution just beyond the horizon (uncoincidentally, aligning with the upcoming election), are not predicated on any scientific data or precedent, and they pose a grave danger to public health and safety.
That is the opinion of seven former commissioners of the Food and Drug Administration, the federal agency that oversees development, clinical trials, and grants approvals of vaccines. They wrote in a Washington Post editorial on Tuesday that the public’s trust in the FDA is being perilously weathered by Trump’s flouting of sound scientific practices:
Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andy von Eschenbach are all former commissioners of the Food and Drug Administration. Kessler is an adviser for the Biden campaign. Gottlieb and McClellan serve on the boards of Pfizer and Johnson & Johnson, respectively, both of which are developing covid-19 vaccines.
The former overseers of the FDA forewarned of burgeoning anti-vaxxer-like resistance toward a coronavirus vaccine, but unlike fringe movements that illegitimately deny the efficacy of vaccines that prevent measles, mumps, and shingles, to cite a few examples, the current skepticism may not be as easy to refute or reverse.
“A safe and effective vaccine will not be enough; people will also have to choose to take it,” the former FDA chiefs wrote. “This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”
The phases of vaccine development “are matters of medicine over which political leaders have no expertise,” they stressed, “which is why our nation has long recognized the importance of having sound science drive public health and safety decisions.”
For over a century since its founding in 1906, the FDA has set the world’s standard for executing this process.
“When we and our predecessors spoke as FDA commissioners about issues of regulation and people’s health, the public knew we were speaking on behalf of experts whose judgments were grounded in science,” the former agency heads said. “That is changing in deeply troubling ways.”
Several recent actions by the Trump Administration have experts extremely worried:
The White House has said it might try to influence the scientific standards for vaccine approval put forward by the FDA or block the agency from issuing further written guidance on its criteria for judging the safety and benefits of a potential covid-19 vaccine. This pronouncement came just after key leaders at the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health all publicly supported that guidance.
The White House statements came on the heels of other concerning actions that could impact the FDA’s scientific standards. On Sept. 15, Health and Human Services Secretary Alex Azar revoked the FDA’s authority to establish rules for food and drug safety, instead claiming that sole authority for himself. This came in the wake of acknowledged acts of political influence on the FDA’s coronavirus communications, significant misstatements by the secretary and other political leaders about the benefits of hydroxychloroquine and convalescent plasma, and the overruling of FDA scientists on the regulation of covid-19 laboratory tests. At risk is the FDA’s ability to make the independent, science-based decisions that are key to combating the pandemic and so much more.
Therefore, public confidence on whom they can rely for accurate information – and when it comes to vaccines it should be scientists, not politicians, especially Trump – is steadily waning, and “the implications of the recent shift are potentially dire,” the commissioners warned.
Moreover, the consequences of this breach of trust could sow doubts that stretch beyond an uncertain vaccine for one virus:
When the FDA warns about a risk from contaminated food, will people heed it? When a new drug for cancer or heart disease is approved, will clinicians and families trust it to work? And most urgent for today: When the FDA approves a covid-19 vaccine, will Americans accept it?
Recent polling by the Pew Research Center has shown that an alarming “78 percent [of respondents] expressed concern that the approval process will be too hasty. Only 21 percent of respondents said they would definitely take the vaccine – half the percentage that said this only four months ago,” indicating that Americans are impulsively abandoning their faith in an institution once renowned for its successes. Failing to keep it intact would be disastrous.
“If the FDA makes available a safe and effective vaccine that people trust, we could expect to meaningfully reduce covid-19 risk as soon as next spring or summer,” the group said. “Without that trust, our health and economy could lag for years.”
Trump’s impetuous pledges notwithstanding, the former commissioners’ entrustment in the FDA’s capacity to adhere to the scientific method remain intact.
“We continue to have confidence in the integrity and high-quality scientific work of FDA staff. Following defined practice, each vaccine clinical trial will continue until independent oversight boards and the sponsoring manufacturers stop them. The FDA has already effectively communicated its strict standard for evidence from these trials to the manufacturers, despite comments from the White House,” the authors wrote. “The health professionals whom people still trust won’t recommend a vaccine that hasn’t met the FDA’s standards. Drug makers have also pledged to use the FDA’s scientific standards.”
Still, “perception of political influence matters,” the commissioners concluded. “With more than 750 Americans on average dying a day from covid-19, the FDA must be supported to play its unique and essential role. Scientists should make decisions based on data, unfettered by political pressure or the intrusions of ideology or vested interests. Political intrusion only prolongs the pandemic and erodes our public health institutions.”
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Brandon is a political writer for the Hill Reporter specializing in current events, breaking news, and scientific discovery. Brandon holds a Bachelor of Music degree from Indiana University. He lives in New York City.