President Donald Trump on Labor Day asserted that avaccine could be ready "during the month of October" — just weeks before the November 3 presidential election. Given that it typically takes several years to develop a vaccine, that shortened time frame is raising concerns that political pressure could override the normal regulatory process of vetting a vaccine.
Experts say the Food and Drug Administration, which is overseeing the process, is unlikely to bow to political pressure and push through a vaccine given the agency's reliance on scientists and career staffers, and not political appointees. Yet one loophole could allow the Trump administration to skirt the FDA's ordinary vetting process: Emergency Use Authorization (EUA).
Under an EUA, the FDA's commissioner can greenlight unapproved medical products for emergency use to diagnose, treat or prevent life-threatening diseases. Such approval must meet certain standards, with the potential benefits seen as outweighing the risks. But the FDA has already approved several treatments and tests for COVID-19, including and, for a time, the controversial hydroxychloroquine (The latter had its emergency usage authorization revoked in June after the FDA concluded it was "unlikely to be effective in treating COVID-19.")
An EUA "can be issued for drugs and vaccines," said Patricia Zettler, a law professor at Ohio State University and an expert in the regulation of medicine, drugs and other medical products. "The standards are much lower than for a full FDA approval."
She added, "It's useful to think about EUAs as providing temporary authorization for promising but unproven treatments."
Still, Zettler and other experts consulted by CBS MoneyWatch think FDA Commissioner Stephen Hahn is unlikely to circumvent the agency's normal vetting process by invoking that authority in pursuit of a vaccine. In part, that's because the product would be used on a massive scale to inoculate as many Americans as possible. Any perception that a vaccine had been expedited for political gain could hurt public confidence in its safety, undermining the goal of mass vaccinations, they said.
Hahn has sought to reassure the public that the FDA will stick to procedure in reviewing potential treatments. "We're not going to cut corners regarding decisions on potential vaccines. It will be based on science & data," he said in a Tweet on Friday.
How does a vaccine get approved?
Former FDA officials and other experts express confidence in the government agency's process for evaluating vaccines, describing it as rigorous and overseen by career professionals with expertise in their fields.
"You can't really bring political pressure to bear on career employees," said Peter Pitts, president of the Center for Medicine in the Public Interest and a former FDA associate commissioner. "You can't fire them."
First, drugmakers must put their vaccine candidate through a pre-clinical phase followed by three trials, with the final Phase 3 testing involving large-scale tests on people. While there are 170 potential vaccines in development, only seven are now in Phase 3. About a third of vaccine candidates typically make it through all three phases of testing, according to Deutsche Bank analysts.
One of those vaccines in a Phase 3 trial, developed by drugmaker AstraZeneca, paused its testing this month after one participant became ill. Dr. Anthony Fauci, the nation's top infectious disease expert,this week that the pause demonstrated "one of the safety valves that you have on clinical trials such as this."
Who reviews a potential vaccine?
After a drugmaker has concluded its Phase 3 trial, it submits a data package to the FDA, where the agency's Center for Biologics Evaluation and Research oversees the approval process. That division is headed by Peter Marks, who has said he will resign if the Trump administration approves a vaccine before it is proven to be safe and effective.
The FDA team includes doctors, microbiologists, chemists, biostatisticians and other experts, who then make a risk-benefit assessment and recommend either approving or rejecting a drugmaker's application for a vaccine license. The agency also studies the proposed facilities where the vaccine will be manufactured to ensure its safety.
"The career public health officials inside the FDA review the data and make a decision on their own, or can ask for an advisory committee to look at the data, and then express their views that the FDA will look at," Pitts said.
The FDA says the advisory committee typically has scientists, physicians, biostatisticians and a consumer representative who review the data. "The independence of these bodies is incredibly important," Pitts added, noting that he oversaw appointing experts to advisory committees while at the FDA. The agency almost always follows the panel's advice, he said.
Although it's unusual, the government can choose to ignore an advisory committee's recommendation. In 2011, for instance, the U.S. Health and Human Services secretary during the Obama administration overruled an FDA recommendation about making the so-calledavailable to patients of all ages.
"No margin for error"
Given the stakes, drugmakers are accelerating their efforts to develop a vaccine. More than 190,000 people in the U.S. have died from COVID-19, according to Johns Hopkins University. In 1976, the Ford administration took a similar "Operation Warp Speed" approach to developing a vaccine for the swine flu, leading to a debacle when some people developed Guillain-Barré syndrome after getting the shot, according to the CDC.
Consumers are also more wary of vaccines than in previous decades, thanks partly to the. But they're also concerned given misinformation from the Trump administration about the coronavirus, such as Mr. Trump's statements that COVID-19 was no worse than the flu and that it would " ."
More than 6 out of 10 Americans are concerned that political pressure will cause the FDA to rush its process for approving a coronavirus vaccine without ensuring its safety and efficacy, according to a poll released Thursday by the Kaiser Family Foundation. If the agency cleared public use of a free vaccine for use before the Nov. 3 election, only 4 in 10 adults said they would get the shot, the poll found.
"When it comes to vaccines, there is no margin for error," Pitts said. "There is no replacing lost public confidence."