I am convinced that monoclonal antibodies saved my dad.
When he got sick last year around Thanksgiving, the Food and Drug Administration had just authorized monoclonal antibody therapy for emergency use, and we called everyone we knew in the medical community to get him on it. Before the treatment, he was weak and lethargic, with a high fever, chills and an endless cough. When I spoke to him 48 hours later, I broke down in tears: He sounded like he had just a common cold. Our family’s collective sense is that we dodged a bullet.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight harmful pathogens and have been safely used to treat diseases like cancer since 1986. My father’s experience has now been supported by numerous well-designed trials that consistently demonstrate impressive reductions in hospitalization and death for patients at risk of severe covid-19 if the treatment is administered within three days of a positive coronavirus test. The therapy has also been shown to reduce transmission of the virus. And it’s far easier to administer now than in the early days of its use. So why, nearly a year after my father’s successful treatment, is it so hard to come by in many places?
As of April, only 43 percent of doses paid for by the federal government had been delivered to patients, while thousands of doses sat unused. More recently, demand has soared during the delta variant surge, but access to this treatment remains highly variable, with seven states using 70 percent of the nation’s monoclonal antibody supply as of early September. This has led hospitals in some states to declare shortages, while the Biden administration has been moved to take over distribution and purchase additional doses.
Monoclonal antibody treatment is, in fact, one of the only areas of pandemic response that President Biden and Florida Gov. Ron DeSantis agree on. The president’s six-point coronavirus response plan calls for federal agencies to help health systems step up their use of the therapy. DeSantis, meanwhile, has set up 25 monoclonal antibody treatment sites, most of which are open seven days a week from 9 a.m. to 5 p.m. Florida is one of the states that has been using a large share of the national supply.
Until recently, administering this treatment was a logistical nightmare: Patients had to visit an infusion unit where they could receive the antibodies intravenously over a 20- to 50-minute period. They then had to remain for an hour of observation. These infusion centers are often the same places where cancer patients come for chemotherapy. Highly infectious covid patients and highly vulnerable cancer patients can’t receive therapy in the same unit. Many health-care systems had to make a stark choice: Give up chemotherapy chairs to open up covid therapy chairs? Or commandeer additional space and staff for covid infusion units when most models were predicting that the pandemic would wane as the vaccination rate grew?
But the landscape has now changed. In August, a covid prevention trial sponsored by the National Institutes of Health and Regeneron, one of the makers of this therapy, showed that monoclonal antibodies could be administered by simple injection. While intravenous infusion is preferable, the FDA’s emergency-use authorization specifies that injection may be used if infusion isn’t feasible or will delay treatment. In other words, monoclonal antibodies can now be administered to patients almost anywhere that trained clinicians are present.
And that is how my wife’s 84-year-old grandmother came to receive her own monoclonal antibody treatment in the gymnasium at West Gate Park in West Palm Beach, Fla. Grandma Ida was fully vaccinated in January, and she decided to resume her weekly card games, unmasked. Continuing to isolate and be without her vibrant social life, she concluded, was just not worth it at her stage of life.
We still don’t understand how frequently breakthrough cases in vaccinated elderly people become severe, so she really worried me when she tested positive for the virus earlier in September. She was feverish, wheezy, coughing and lethargic; she has a far longer list of high-risk medical conditions than my dad does, including emphysema, and is often hospitalized when she develops a respiratory illness.
It was 11 p.m. on the Friday before Labor Day, but we were able to go online and book her an appointment for monoclonal antibody therapy at 9:15 the next morning. Grandma Ida received four injections that took less than 15 minutes to administer, then sat in what looked like my old high school bleachers for an hour of observation. Two days later, she was feeling so much better that she wondered if the initial test had been inaccurate.
The sign-up process for monoclonal antibody therapy was as simple as signing her up for a vaccine shot and did not require a referral, making it easier for her to get the treatment early enough to be most effective. I hope that soon, my own patients in Massachusetts will get similarly quick access to monoclonal antibody therapy. Unfortunately, Massachusetts has only two treatment sites that publicize the ability for people to self-refer, and numerous health systems have had to limit access to treatment to the highest-risk patients because of capacity constraints.
In mid-September, the Biden administration took over distribution of monoclonal antibodies to help maintain equitable supply across the country in the face of the delta surge. States now receive a weekly allocation and are responsible for getting it to treatment sites. There may be near-term supply shortages, but the federal government recently purchased an additional 1.8 million doses of this treatment.
I hope to see easy-to-use scheduling websites and treatment sites at community centers around the country, as in Florida. We should administer monoclonal antibodies in tents and via mobile trucks — just as we see vaccination sites in a variety of places. Every urgent-care clinic should offer injections, and hospital systems should open their infusion units after hours and on weekends when they would otherwise be dormant. Monoclonal antibody therapy should be the standard of care. And we need a clear plan for how we will deploy it to protect our nursing home residents.
At $2,100 of taxpayer money per treatment, there is no doubt we must continue the search for more cost-effective, easier-to-deliver outpatient treatments for covid-19. Efforts to develop antiviral pills that work against the coronavirus have been accelerated by a $3.2 billion investment from the federal government; on Friday, drugmaker Merck announced that a pill it developed reduced the risk of hospitalization and death from covid-19 by nearly half in a clinical trial. Still, it makes no sense to wait for a pill when an effective treatment is already available.
Monoclonal antibodies are not a substitute for vaccination. Vaccination is a far simpler and more effective way to protect yourself and those around you from covid-19. Vaccines and monoclonal antibodies are complementary tools in our tool kit.
But as many as 80 million Americans remain unvaccinated, and the vaccinated elderly may experience severe breakthrough infections. That calls for outpatient covid treatment at scale. More than 2,000 people are dying every day in the United States. The vast majority of them did not have ready access to monoclonal antibody therapy. Unless we pivot quickly, most of the patients who would benefit never will.