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Evidence conflicts over efficacy of monoclonal antibodies in severe COVID


The
New England Journal of Medicine yesterday published two studies on the effectiveness of the interleukin-6 receptor antagonists tocilizumab and sarilumab in severely ill adult COVID-19 patients, one finding a benefit to a combination of the two drugs and the other showing no benefit with tocilizumab alone.
Early treatment with combo may be key
The first study, led by researchers at Imperial College London as part of an ongoing international platform trial, involved randomly assigning 803 patients in 113 intensive care units (ICUs) in six countries to receive tocilizumab, sarilumab, or usual care from April (tocilizumab) and June (sarilumab) through November 2020.
Median number of organ support–free days was 10 in the group receiving tocilizumab (353 patients), 11 in the sarilumab group (48 patients), and 0 in the control group (402 patients). Both monoclonal antibodies showed effectiveness in improving 90-day survival, time to ICU and hospital release, and Wo ....

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Pfizer Vaccine Gets FDA Panel Review as Clearance Decis...


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A Food and Drug Administration advisory panel gathered Thursday to consider issues including the safety of the shot from Pfizer Inc. and BioNTech SE, which employs a technology called messenger RNA that’s never before been used in human vaccines.
The government is prepared with a safety monitoring system that will go into place the first day of the immunization campaign, said Nancy Messonnier, director of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
“Vaccine safety and effective monitoring are a top priority for the U.S. government,” she told the panel in the online meeting. The CDC is considering working with the National Academy of Sciences, Engineering and Medicine to evaluate safety issues that may arise when the vaccine is in use in the general population, she said. ....

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