The Food and Drug Administration suddenly decided to withdraw its emergency use authorization of two COVID-19 antibody treatments this week, leaving hundreds of patients who depend on them in the lurch.
The monoclonal antibody treatments made by Regeneron Pharmaceuticals and Eli Lilly have proven invaluable in fighting off hospitalization and death from the virus, especially against the delta variant. I would know: My grandmother was one of the patients in Florida who benefited from this treatment. Fully vaccinated and boosted, she tested positive for COVID-19 last month and was able to receive an antibody infusion within a few days. It improved her condition dramatically, and she has since recovered. But she might not have if she did not have access to this treatment.
The FDA is arguing monoclonal antibody treatments are no longer necessary because delta is no longer the dominant variant. Omicron is now dominant, and the treatments aren’t nearly as effective against omicron as they were against delta.
There are two problems with this. First, there are still cases of delta out there that must be treated. Second, the FDA is basing its decision on lab results rather than peer-reviewed clinical data, as Florida Gov. Ron DeSantis pointed out on Tuesday. This distinction is important, according to Jeremy Redfern, press secretary for the Florida Department of Health, because although the FDA’s results appear to be accurate, “things that happen in the lab don’t always translate to the real world.”
“We’re not trying to say that this does or does not work against omicron. We want clinical data inside of a controlled environment, so we know for certain that it doesn’t work,” Redfern told me.
Moreover, Redfern said Florida’s health officials have heard directly from physicians who believe antibody treatments still work in some cases.
“We’ve heard from physicians who feel like their ability to practice medicine is being hampered by a federal bureaucracy. So, we want to solve that disconnect between what we’re seeing in the lab and what doctors are seeing with patients,” he said. “That’s why we need clinical data in a clinical setting.”
The White House has dismissed these criticisms by discounting the importance of COVID-19 treatments altogether. When asked about the FDA’s decision, press secretary Jen Psaki claimed it is “crazy” to want to keep antibody treatments on the market because “we know what works: vaccines and boosters.”
To be sure, many studies prove vaccination is highly effective at preventing hospitalization and death among at-risk groups. But studies also show vaccines are not as effective at preventing infection and transmission as we originally thought — which means fully vaccinated people, such as my grandmother, will still catch COVID-19 and need to be treated. In fact, the “vast majority” of Floridians who have sought monoclonal antibody treatments have been fully vaccinated, and many have been boosted, Redfern said.
“The people seeking treatment are at high risk for developing symptoms regardless of vaccination status,” he said.
At the very least, the FDA should have kept its emergency use authorization in place and left the decision to doctors and their patients. Not everyone will need an antibody transfusion, but individual practitioners familiar with their patients’ particular needs are much better equipped to make that call than the federal bureaucracy.
