Source: WSJ
By Thomas M. Burton and Amy Dockser Marcus
The Food and Drug Administration authorized use of convalescent plasma, the antibody-rich blood component taken from recovered Covid-19 patients, for the treatment of serious coronavirus cases.
The agency’s action Sunday, called an emergency-use authorization, permits use of the treatment on hospitalized Covid-19 patients. The Wall Street Journal reported last month the move was coming.
For Covid-19 patients and the doctors who treat them, the designation opens up the possibility for faster and easier access to a promising treatment, while studies and clinical trials continue to explore who is helped and how much.
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In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.
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However, scientists and health officials say more data from randomized controlled trials, which are considered the “gold standard” in science, is still needed to know whether it is safe and effective. Results of a study by the Mayo Clinic that the FDA cited in its authorization suggested the plasma may reduce mortality in some hospitalized patients. The study had no placebo group to compare the results, making it hard to determine whether the treatment actually worked.
“The EUA was granted without a published peer review study and rolled out with political fanfare,” said Lawrence Gostin, a professor and faculty director of the O’Neill Institute for National and Global Health Law at Georgetown University. —Berkeley Lovelace Jr.
https://www.cnbc.com/2020/08/24/coronavirus-live-updates.html