The FDA authorized a third cocktail—Eli Lilly’s bamlanivimab/etesevimab—in 2021, but the Department of Health and Human Services paused its distribution earlier this year after it appeared to be ineffective against certain new viral variants. After a two-month hiatus, the cocktail is back on the market in states where fewer than 5 percent of COVID infections are from strains that are resistant to the treatment (currently this applies to all 50 states).*In June the FDA authorized a fourth cocktail, Genentech’s tocilizumab, for people already hospitalized with COVID. Unlike the other therapies, which target SARS-CoV-2 itself, tocilizumab targets a signaling molecule that can cause the immune system to overreact and produce dangerous levels of inflammation. Back in 2010 the FDA approved tocilizumab for rheumatoid arthritis. It is only moderately effective against COVID, however: studies show that 12 percent of patients receiving the mAb required ventilation or died, compared with 19 percent of those receiving a placebo. Who can get mAbs?The antibodies from Eli Lilly, Regeneron, and GlaxoSmithKline and Vir are approved for children age 12 and older and adults who have not been hospitalized, whereas Genentech’s antibodies are for children and adults who are already on ventilators. But not everyone can get the treatments right now: the EUAs stipulate that patients must be at high risk of complications from COVID in order to receive them. That includes people age 65 and older and those with conditions such as obesity, diabetes and cardiovascular disease.In August the FDA authorized Regeneron’s mAb for people who meet these risk criteria and have been exposed to COVID but have not yet tested positive.What does the treatment entail?In a clinical setting, mAbs are administered as an intravenous infusion—similar to a chemotherapy treatment—that lasts about 20 minutes. The Regeneron cocktail can also be injected under the skin. That is the preferred method at pop-up sites and nonclinical settings where intravenous infusions are difficult, says Susanne Doblecki-Lewis, an infectious disease physician at the University of Miami. In the injection method, four shots are given simultaneously, typically two in the arms and two in the stomach.After administering the mAb treatment, clinics monitor patients for one hour for rare allergic reactions. Other side effects include hypersensitivity, rashes and diarrhea. While patients do not need to pay for the mAb cocktail itself, some clinics bill for the infusion, which requires skilled health care workers and specific equipment to administer. Are mAb treatments a substitute for vaccination?Both Webb and Doblecki-Lewis stress that mAb treatment is no substitute for vaccination. “Unfortunately, the vaccine has become so political that some people would prefer monoclonal antibodies because of the way they’re being promoted,” Doblecki-Lewis says. But the vaccines have fewer side effects, are cheaper and more widely available, and are much easier to administer. “The vaccine is just so clearly a better step one,” she says.Vaccinated people with breakthrough COVID infections can get mAb treatments if they meet the EUA criteria. That includes people who are immunocompromised and thus unlikely to have had a strong immune response to the vaccine. Conversely, though, some evidence suggests that getting mAb treatment before getting the vaccine lowers the latter’s ability to raise an immune response because the body already has high levels of antibodies against SARS-CoV-2. That is why the U.S. Centers for Disease Control and Prevention recommends that unvaccinated people who receive mAb treatment wait 90 days before receiving their first vaccine. But they should still get vaccinated, Webb says. “It’s unrealistic to think we could treat our way out of this pandemic,” he adds.*Editor’s Note (9/29/21): This paragraph was edited after posting to correct the descriptions of the FDA’s authorization of bamlanivimab/etesevimab.
ABOUT THE AUTHOR(S)
Sara Reardon is a freelance journalist based in Bozeman, Mont. She is a former staff reporter at Nature, New Scientist and Science and has a master’s degree in molecular biology.
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