He said that the FDA (Food and Drug Administration) has issued an emergency use authorisation for a treatment known as convalescent plasma.
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“Today I am pleased to make a truly historic announcement, in our battle against China virus, that will save countless lives. The FDA (Food and Drug Administration) has issued an emergency use authorisation for a treatment known as convalescent plasma,” he said.
“It's only made possible because of Operation Warp Speed, i.e. everybody working together. We're yrs ahead of approvals. If we went by the speed levels of past administration would be 2-3 yrs behind where we're today. That includes vaccines you would be hearing about very soon,” he said.
"This is a powerful therapy that transfuses very-very strong anti-bodies from the blood of recovered patients to help treat patients battling a current infection," Trump said. He also appealed to Americans who have recovered from coronavirus to donate plasma.
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Trump informed that around 48 million dollars were provided to fund the Mayo clinic study that tested the efficacy of convalescent plasma for patients with the virus. "Through this study over 100,000 Americans have already enrolled to receive this treatment and it is proven to reduce mortality by 35 per cent. It is a tremendous number," he said while adding that the FDA MIT Harvard Hospital have also found convalescent plasma to be a very effective method of fighting this horrible disease.
"Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective. Recently, we provided up to 270 million dollars to the American Red Cross and America's Blood Centers to support the collection of up to 360,000 units of plasma," he said.
Patients who benefited the most from this treatment are those under 80 years old and who were not on a respirator, the FDA said. Such patients had a 35 percent better survival rate a month after receiving the treatment.
It appeared that the product is safe and we're comfortable with that and we continue to see no concerning safety signals," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, told reporters in a conference call.
What is convalescent plasma approach:
It is a century-old approach to fend off flu and measles before vaccine were developed. . It's a go-to tactic when new ddiseases come along, and history suggests it works against some, but not all, infections.
Many scientists and physicians believe that convalescent plasma might provide some benefit but it is far from a breakthrough. It is rich in antibodies that could be helpful in fighting the coronavirus, but the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.
What study revealed about plasma treatment:
The Mayo clinic researcher hinted that blood plasma for the survivors of Covid-19 helped other patients in recovery, but it was not considered proof.
More than 64,000 patients in the US have been given convalescent plasma.
The Mayo Clinic reported preliminary data from 35,000 coronavirus patients treated with plasma, and said there were fewer deaths among people given plasma within three days of diagnosis, and also among those given plasma containing the highest levels of virus-fighting antibodies.
Plasma therapy in India:
India has been using plasma therapy since last two months in the treatment of critical cases, but only on research basis. Though the health ministry has said that Plasma therapy is not an approved treatment for COVID-19 and is only one of the several therapies which is being explored currently. The ministry has said that the therapy is still at an experimental stage and the Indian Council for Medical Research (ICMR) is currently studying its efficacy.
Till the ICMR concludes its study and a robust scientific proof is available, plasma therapy should be used only for research or trial purpose, it has stated.
(with inputs from agencies)