US President Donald Trump announced on Sunday the emergency authorization of convalescent plasma for COVID-19 patients, in a move he called “a breakthrough”, reports The Associated Press.
Trump announced the authorization — which makes it easier for some patients to obtain the treatment — in a news conference Sunday evening.
The blood plasma, taken from patients who have recovered from the coronavirus and rich in antibodies, may provide benefits to those battling with the disease, though evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.
In a letter describing the emergency authorization, the chief scientist for the FDA, Denise Hinton, noted, “COVID-19 convalescent plasma should not be considered a new standard of care for the treatment of patients with COVID-19. Additional data will be forthcoming from other analyses and ongoing, well-controlled clinical trials in the coming months.”
Earlier this month, Mayo Clinic researchers reported a strong hint that blood plasma from COVID-19 survivors helps other infected patients recover, but it wasn’t considered proof.
More than 70,000 patients in the US have been given convalescent plasma, a century-old approach to fend off flu and measles before vaccines. It’s a go-to tactic when new diseases come along, and history suggests it works against some, but not all, infections.
Administration officials, in a call with reporters Sunday, discussed a benefit for patients who were within three days of admission to a hospital and were not on a respirator, and were given “high-titer” convalescent plasma containing higher concentrations of antibodies. They were then compared to similar patients who were given lower-titer plasma. The findings suggest deaths were 35% lower in the high-titer group.
The head of the FDA, Stephen Hahn, said Trump did not speak to him about the timing of the announcement and that “this has been in the works for several weeks” and came after a data validation for which the agency had been waiting.