A study, published in the medical journal JAMA, analyzed data from nearly two million medicare beneficiaries who tested positive for COVID-19 between November 2021 and August 2021 , and compared rates of receiving monoclonal antibody treatments by age, sex, region, chronic conditions and other factors.
The results: Researchers found that just over 7% of medicare beneficiaries who did not die within seven days of diagnosis received an infusion, with higher rates of treatment seen among groups with fewer chronic conditions.
"Monoclonal antibodies should first go to patients at the highest risk of death from COVID-19, but the opposite happened — the healthiest patients were the most likely to get treatment," Michael Barnett , assistant professor of health policy and management at Harvard Chan School and lead author of the study, said in a release. "Unfortunately, our federal and state system for distributing these drugs has failed our most vulnerable patients."
Monoclonal antibody treatment, which was initially given an emergency use authorization by the Food and Drug Administration (FDA) in November of 2020, before additional infusion treatment authorizations followed, is designed to lower the risk of patients with mild to moderate COVID-19 symptoms from progressing to more serious outcomes.
The antibodies are manufactured in a laboratory to specifically target the coronavirus spike protein — the mechanism used to enter human cells — and coat the spikes to disable the virus from attaching to other healthy cells and multiplying.
In the first months of its use on Staten Island , more than 1,000 borough residents received infusions, the Advance/SILive.com reported, with overwhelmingly positive results observed by the borough's two hospital systems.
However, as the pandemic progressed, borough officials noted that the treatment was not being used in as high a frequency as was hoped. While the FDA expanded the groups eligible for the treatment, use of the antibodies was limited.
Then, new variants that emerged throughout 2021 led some monoclonal antibody therapies previously granted emergency use authorization to be revoked, underscoring the ability of different strains to skirt the protection offered by current treatments.
The emergence of the virulent omicron variant then fundamentally changed the effectiveness of nearly all monoclonal antibody treatments. The variant, which fueled a record-setting wave of infections on Staten Island , has dozens of mutations on the spike protein — rendering most antibody treatments essentially useless.
During that surge, Rep. Nicole Malliotakis ( Staten Island / South Brooklyn ) penned a letter to President Joe Biden , urging him to bolster production of therapeutic treatments to defend against rising infection rates.
Sotrovimab, an antibody treatment that has shown effectiveness against the latest strain of the virus, faced severe shortages nationally due to its lone-effectiveness against omicron. Nationally, Malliotakis said at the time, the country only distributed around 55,000 doses of the therapy in December 2021 , causing widespread inability to use the antibodies.
Richmond University Medical Center in West Brighton, centered in the borough's North Shore, said it was experiencing shortages of Sotrovimab late last year. The New York Times previously reported the Biden administration is in talks with GlaxoSmithKline , the maker of the treatment, about securing more doses to be delivered in early 2022.
Harvard researchers said the disparity in the disbursement of the antibody treatments underscores the need to better reach at-risk populations. Scientists said it is possible that navigating the steps needed to receive treatment after a timely diagnosis could have caused some of the observed hurdles.
"We need new approaches to prevent these inequities from happening again with newer treatments on the horizon," said Barnett.
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