With hydroxychloroquine a bust and vaccines not coming until after the election, President Donald Trump is touting a new silver bullet against COVID-19: monoclonal antibodies. “They call them therapeutic, but to me it wasn’t therapeutic,” he said in a video he tweeted on Wednesday, five days after receiving the experimental treatment from the biotech company Regeneron. He claimed that he felt better immediately. “I call that a cure,” he said. “It’s a cure,” he said again, defying whoever might have told him to please just say “therapeutic” instead.
Preliminary and still-unpublished data from small studies suggest that monoclonal antibodies, which are lab-grown versions of antibodies the immune system naturally makes to fight pathogens, are indeed promising. Although Trump claims to be on the mend from COVID-19, it’s impossible to conclude from his case alone that the treatment is a “cure,” especially given that he got a “kitchen sink” of treatments. “No one ever got the drugs he got before, in the sequence he got them,” says Myron Cohen, an infectious-disease researcher at the University of North Carolina who is studying monoclonal antibodies in clinical trials against COVID-19.
The president is only one data point. Clinical trials need thousands of data points to determine whether a treatment works, and his endorsement could ironically make it harder to recruit patients for the trials. In hyping a treatment without the data proving that it works and without the groundwork for deploying it “immediately,” as Trump said yesterday he wants to do, he is breezing right past the scientific and logistical challenges still ahead. Trump might have gotten antibodies immediately, but most Americans won’t.
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First, there simply are not yet enough doses in the world. Regeneron currently has enough doses for 50,000 patients. Eli Lilly, which makes a different COVID-19 monoclonal-antibody therapy that is also in clinical trials, says it will have 100,000 doses in October. To put that in context, the United States has 50,000 new cases of COVID-19 every day.
The manufacturing of monoclonal antibodies can’t just scale up on a dime to treat everyone, says Howard Levine, who leads a group of pharmaceutical manufacturing consultants at BioProcess Technology Group. The antibodies are made inside large stainless-steel tanks using genetically engineered ovary cells from hamsters. Like all living things, they can grow only so fast. The tanks are also sophisticated pieces of equipment that can take months to install, Levine says. Regeneron and Eli Lilly have already been increasing manufacturing capacity, and they expect to have 300,000 and 1 million doses, respectively, by the end of the year. The two companies have recently also filed for an emergency use authorization—a looser and faster process than formal approval by the Food and Drug Administration—-which Trump says will come soon.
The monoclonal antibodies will have to be reserved for patients who are at highest risk for eventually developing severe COVID-19. “To be able to treat thousands [of patients] is