For researchers working on possible coronavirus treatments, time is short.
More than 100 clinical trials of dozens of potential coronavirus treatments are already underway around the world, a mobilization of global medical resources rarely seen before in human history.
But science can be slow and indirect. And despite the sheer number of scientists involved in these efforts, the scientific method requires a rigor that can only be sped up so much.
Experts have said that it could take at least 12 to 18 months before a vaccine is commercially available to administer widely — a timeline already seen as aggressive. And with international attention focused on coronavirus efforts, some researchers are warning about the potential pitfalls of accelerating scientific research and the risks of overpromising what science can deliver in a short time.
In an essay published Monday in the journal Science, the publication’s editor-in-chief H. Holden Thorp, a chemist and a former provost at Washington University in St. Louis, voiced concerns about the unusual nature of relying on science to find a swift solution to a problem with still many unknowns that is unfolding in real time.
The scientific method, Thorp wrote, inherently takes time, and involves basic research to first identify the problem and subsequently applying that research to test and build on scientists’ understanding.
“Now, scientists are trying to do both at the same time,” he wrote. “This is not just fixing a plane while it’s flying — it’s fixing a plane that’s flying while its blueprints are still being drawn.”
As new coronavirus cases multiply in many countries and fatalities rise, the scientific community is under enormous scrutiny and pressure to identify potential treatments.
The proposed timeline of 12-18 months for a vaccine is already exceptionally fast given the normal pace of vaccine development and trials, according to Walter Orenstein, a professor at the Emory University School of Medicine and the former director of the United States’ National Immunization Program at the Centers for Disease Control and Prevention.
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“It often takes 10 years for a new vaccine to make it through all the steps and all the tests necessary,” Orenstein said. “The public health urgency of this is definitely moving things faster than would generally be done.”
Part of the challenge of working at such an accelerated pace is ensuring that safety is not compromised.
Typically, clinical trials are made up of three main stages. Most of the trials currently underway are in the first phase, which is designed to test whether the experimental drug of a vaccine candidate is safe to give to humans.
“Phase one is about basic safety — does it make people get violently ill, or are there other extreme consequences?” said Jeremy Block, a biochemist and co-founder of Medaptive Health, a New York-based company that develops tools to help scientists conduct clinical studies and trials. “This step is not necessarily to see if the drug even does what you want it to do.”
Once safety is established, the drug moves into phase two, which is designed to test its effectiveness and the specificity of the treatment.
“If you give somebody a drug and it does a good job of killing the invading cells, but it also kills three of your main organs, it may be effective but it doesn’t work specifically on what you want it to work on,” said Block, who is part of Northwell Health’s Institutional Review Board, which approves and monitors biomedical research on humans at the organization’s hospitals.
The last step, and sometimes the most involved, requires demonstrating that the drug is effective in different populations, and thus would be safe and ready to administer widely.
But over the course of a clinical trial, there are few, if any, opportunities to speed up the process, Block said, particularly because scientists need to monitor the long-term effects of these new drugs.
“All these things take time, and if we cut corners, bad things can happen,” he said.
In 1982, for instance, research emerged that benzyl alcohol — which is used as an anti-bacterial agent in some medical solutions and was approved for use in adults but had not been studied in children and infants — was associated with 16 neonatal deaths at two medical centers in the U.S. And in the 1970s, pressure to rapidly develop and issue a new flu vaccine was later associated with hundreds of cases of a type of paralysis known as Guillain-Barré syndrome.
Avoiding these types of dangers is even more important during a pandemic, because researchers will likely have to weigh potential risks and benefits that are magnified by the urgency of the situation, according to Orenstein.
“Ideally you want a vaccine that is more than 90 percent effective,” he said. “But we would have to look at: Even with a less-than-ideal effectiveness, are there greater benefits if we can reduce the pressure on the health system? So it may be that under certain circumstances, a 50 percent effective vaccine is better than nothing.”
Regulators will most likely also have to weigh these same risks in deciding whether a potential vaccine is safe for the general public, he said. In some cases, this may involve accepting the results of smaller trials that may carry more uncertainty than normal.
Orenstein said that over the course of his career, which includes 26 years working at the CDC, he can’t recall a situation comparable to the one unfolding now.
“Nothing comes to mind of this kind of setting, where we’re talking about a massive pandemic occurring and the longer we wait, the more we have potential for really adverse outcomes,” he said.
But Thorp cautioned that putting pressure on the meticulous and sometimes deliberately lengthy scientific process could have negative impacts for both members of the public looking for hope and answers, and the scientists who are trying to deliver them.
“I worry that engendering false hope will cause complacency that will deprive us of the time needed to find a lasting solution. And I worry about lasting damage if science overpromises,” he wrote in Science. “Let’s underpromise. Let’s overdeliver.”
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