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For months, outside researchers have been closely monitoring the development of antibody treatments. And senior White House officials fought for faster progress. At one point during the summer, Dr. Deborah L. Birx, White House Coronavirus Response Coordinator, slammed drug officials on Operation Warp Speed, the vaccine and therapy development program. administration, for what she considered to be slowness in setting up clinical trials. for antibody treatments, according to a senior administration official.
The president and two of his top advisers – Mark Meadows, the White House chief of staff, and Jared Kushner, Mr Trump’s son-in-law – called on Dr Stephen M. Hahn, the FDA commissioner, to lobby to speed up agency reviews, said two other senior officials.
Although neither Regeneron nor Eli Lilly have completed their antibody trials, evidence so far suggests that these treatments work best early in the course of the disease, before the virus takes hold in the body. .
The FDA’s emergency clearance only covers one antibody treatment developed by Eli Lilly, but the company is also developing a combination of two antibodies that has been shown to be more effective at lowering viral load in patients. patients. In an early analysis, the combination of two antibodies reduced the hospitalization of newly infected patients by about 5 percent. Eli Lilly said he plans to seek emergency clearance for the combination treatment this month, but will only receive around 50,000 doses of the therapy before the end of the year.
Early evidence shows that antibody treatments don’t work well once people are sick enough to be hospitalized. Eli Lilly has stopped giving his treatment to inpatients in a government-led trial because the company has said it doesn’t appear to be helping them. And Regeneron has suspended the recruitment of the sickest hospital patients in one of its trials.
Upon issuing the emergency clearance, the FDA said the treatment has not been shown to benefit hospital patients and that monoclonal antibodies like bamlanivimab may be associated with worse outcomes when given. to Covid-19 hospital patients who require high flow oxygen or mechanical ventilation.
This creates a problem for the distribution of the treatment, as it is only for people who are not hospitalized, but these people have to be infused intravenously by a health care provider. Getting it to the right people will require quick turnaround times in testing, as well as coordination between federal, state and hospital authorities – many of the same challenges that have complicated the US response to the pandemic.
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