New COVID-19 Treatment Using Blood Plasma From Recovered Coronavirus Patients Authorized

The plasma from former patients is hoped to be rich in the antibodies that develop as a person recovers from an illness. When someone recovers from a virus their plasma contains antibodies against that specific disease.

The concern is that this could be a waste of time and resources which could be expended more usefully and safely.

"This product may be effective in treating Covid-19 and. the known and potential benefits of the product outweigh the known and potential risks of the product", FDA said in a statement.

Providing more details, the USA president said, "We provided $48 million to fund the studies that tested the efficacy of the convalescent plasma treatment".

AstraZeneca, like many other COVID-19 vaccine developers, is enrolling 30,000 subjects to assess the safety and efficacy of its candidate, AZD1222.

Studies in the USA have shown that the treatment is effective, although United Kingdom scientists have questioned the robustness of the evidence.

The announcement by American authorities to use blood plasma from recovered coronavirus patients as a treatment against the disease came as President Donald Trump faced intense pressure to curb the contagion which has killed over 176,000 Americans. Thus, for any individual practitioner or group, nearly anything they do in caring for COVID-19 patients will be associated with a "good clinical outcome" as measured by avoidance of hospitalization and/or death.

A trial involving more than 35,000 patients showed that patients who received plasma within three days of diagnosis had a seven day death rate of 8.7 per cent, while those who received plasma treatment after four or more days had a mortality rate of 11.9 per cent.

As the COVID-19 pandemic has infected more than 24 million people and killed almost 1 million victims, the fever to identify effective preventive and therapeutic options has, at times, seemed chaotic.

Scientists have been discussing convalescent plasma since early in the pandemic.

In a letter describing the FDA's emergency action, the agency's chief scientist said the treatment "should not be considered a new standard of care" for coronavirus infections, and that more data from studies will be available in the coming months.

"Base on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective", Trump said, before urging all recovered COVID-19 patients in the U.S. to donate their blood plasma.

In a very on-brand response, Trump took to Twitter and accused the FDA of being run by "the deep state" and impeding the vaccine approval process, which is far from the first baseless conspiracy theory he's tweeted. "He had to make sure that they felt the heat".

Mr. Trump visited the American Red Cross headquarters in Washington last month to promote the treatment and cheer a COVID-19 survivor, Marty Sarsfield, as he donated his plasma in a basement room.

The president proudly made his announcement on the basis of weak data showing marginal improvement in a small segment of Covid-19 patients.

"I firmly reject the idea they would slow-walk anything or accelerate anything based on any political consideration or any consideration other than what is best for the public health and a real sense of mission to patients", Gottlieb said.

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