The experimental novel coronavirus drug Donald Trump took last week is not, as the president claims, a cure for COVID-19.
The monoclonal antibody cocktail, under development by New York pharma Regeneron, seems promising, experts and health officials say. But it and a similar antibody cocktail from Indiana firm Eli Lilly—also touted by the president—are still in trials. It’s too soon to say exactly what they do and how well they do it, and the president’s bluster about them is just the latest in a pattern of pandemic braggadocio.
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Even if the U.S. Food and Drug Administration grants emergency-use authorizations and pushes the new monoclonal therapies out to the public, the drugs are in short supply. Ramping up production could take months.
That President Trump would be hyping a coronavirus regimen prematurely is not exactly shocking. The only difference this time around is that he has personal experience with the drug in question.
In the past, the president has touted ineffective (hydroxychloroquine) and downright unsafe (bleach) COVID remedies. In this case, he’s pushing an unproven one that, even if it is effective, wouldn’t be available to many Americans anytime soon.
“There are many questions that remain open such as dosage, adverse reactions, the duration of the treatment-created effects, and the production/distribution capacity,” Dmitry Korkin, a bioinformatics researcher at the Worcester Polytechnic Institute in Massachusetts, told The Daily Beast.
Trump announced he was positive for SARS-CoV-2 on Oct. 2. His embattled physician, Sean Conley, began treating the president before he checked into Walter Reed National Medical Center on Friday. The first major COVID-19-targeted treatment Trump received, according to Conley, was a standard, eight-gram dose of Regeneron’s antibody cocktail.
The FDA apparently granted the president a “compassionate use” waiver for the unapproved drug—an exception the agency usually reserves for patients who have exhausted all other treatment options. Doctors also treated Trump with supplemental oxygen, the antiviral drug Remdesivir, and the powerful anti-inflammatory steroid dexamethasone.
Trump infamously checked out of Walter Reed on Monday and has since made some dubious claims about the therapies he received. In a rambling, five-minute video Trump posted on Twitter on Wednesday, he called the Regeneron drug cocktail a “cure.” On Friday he repeated the claim in a phone call to right-wing radio host Rush Limbaugh.
But monoclonal antibodies aren’t a cure.
A monoclonal antibody is a lab-grown copy of a human immune cell. Combine several different cell clones and you’ve got a drug cocktail that can, in theory, duplicate the functioning of a healthy immune system—and do it nearly instantaneously. Instead of your body learning to produce antibodies after exposure to a pathogen, you get lab-made antibodies directly via transfusion.
Monoclonal antibodies aren’t a new concept. The basic science has its roots in the 1970s, and monoclonals have been available for a number of diseases since at least the early 2000s. When the novel coronavirus pandemic took hold early this year, scientists scrambled to produce monoclonal therapies specifically for COVID-19.
Regeneron and Eli Lilly’s antibody cocktails are the most sophisticated examples. But they’re still being tested.
Regenerson began so-called “seamless” trials—which, unlike vaccine trials, involve just one continuous phase—with 2,000 test subjects over the summer. The New York firm teased some initial trial findings in a note to investors on Sept. 29. Regeneron’s cocktail “rapidly reduced viral load and associated symptoms in infected COVID-19 patients," George Yancopoulos, president of Regeneron, stated in the note.
Eli Lilly’s initial findings, which the company released on Wednesday, also indicated a reduction in viral load in test subjects. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, described both companies’ drug cocktails as “very promising” in a call with reporters on Friday.
Monoclonal antibodies are probably most effective at preventing an infection, not treating it, Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, told The Daily Beast. But the reduction in viral load in the Regeneron and Eli Lilly trials could indicate the cocktails might also help treat COVID post-infection.
That hunch is apparently the justification for Trump receiving monoclonal antibodies after testing positive for the coronavirus. The White House did not respond to a request for comment.
The cocktails’ potential to reduce viral loads does have broader implications. In theory, a dose of monoclonal antibodies could suppress the virus in even infected yet asymptomatic people, making them less infectious and slow the virus’s spread, Stephen Jameson, a professor in the University of Minnesota Medical School, told The Daily Beast.
“If this was a way to decrease spread in the community—especially relevant for asymptomatically infected subjects—this and similar treatments could be very valuable, I think,” he said.
But “valuable” isn’t the same as a cure. And even as a means of limiting transmission of the virus, the antibody cocktails could have their limits. Specifically, there isn’t very much of the therapy available. And producing more could take a while.
Both Regeneron and Eli Lilly have asked the FDA to go ahead and grant their respective monoclonal drugs authorization for emergency use. While the agency considers granting the requests, it has urged both companies to produce doses of their antibody cocktails.
So far, Regeneron and Eli Lilly have manufactured a “couple hundred thousand doses” of their monoclonal drugs, combined, Paul Mango the deputy chief of staff for policy at the U.S. Department of Health and Human Services, told reporters on Friday. Citing securities regulations, Mango declined to say exactly how many doses each company has produced.
In the event the FDA gives both companies emergency-use approval, the firms could grow their stockpiles to a combined million doses by the end of 2020, Mango said. “That would be enough to take care of all Americans who need them, from a clinical perspective,” he told reporters.
But that would leave out asymptomatic carriers of the coronavirus, who are highly unlikely to be under clinical care. And depriving asymptomatic patients of the monoclonal antibodies renders moot one of the main potential benefits of this type of drug—its possible ability to decrease viral loads in large numbers of people and help limit the spread of the disease.
Monoclonal antibodies may have benefited Trump, and could help countless everyday Americans, too. But they’re no cure, and it’s going to take more time and testing to know for sure what they can do—and a major ramp-up in production to make the drugs widely available.
