The United States Food and Drug Administration (FDA) has granted emergency clearance for the use of plasma to treat patients with coronavirus.
The technique uses antibody-rich blood plasma from people who have recovered from the disease and has already been used on more than 70,000 people in the United States.
President Donald Trump has said the treatment could reduce deaths by 35%.
It comes a day after accusing the FDA of hampering the deployment of vaccines and therapies for political reasons.
The announcement comes on the eve of the Republican National Convention, where Mr. Trump will launch his campaign to win a second term in the White House.
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“This is what I look forward to doing for a long time,” the president told reporters on Sunday. “I am happy to make a truly historic announcement in our battle against the Chinese virus that will save countless lives. ”
President Trump has described the procedure as powerful therapy and he called on Americans to come forward to donate plasma if they have recovered from Covid-19.
The FDA has given the treatment “emergency use authorization”, rather than full approval, saying early research suggests blood plasma may reduce mortality and improve patient health if administered in the first three days of their hospitalization. However, more trials are needed to prove its effectiveness.
The agency said it concluded it was safe after a thorough review of the data collected over the past few months. In a statement, he added that the benefits of the treatment outweighed the risks.
“It appeared that the product is safe and we are comfortable with that and we still don’t see any safety signals,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, according to the agency. Reuters press release.
But several experts, including Anthony Fauci, a member of the White House coronavirus task force, have expressed reservations about the robustness of the studies so far.
The FDA has already approved the use of plasma transfusions on coronavirus patients under certain conditions, such as those who are critically ill or are participating in clinical trials.
In a tweet on Saturday, President Trump said that “the deep state, or whoever, at the FDA makes it very difficult for drug companies to get people to test vaccines and therapeutics.
“Obviously, they hope to delay the response after [the US presidential election], ” he added.
Earlier this year, U.S. regulators granted emergency clearance to Gilead Science Inc.’s remdesivir as a therapeutic treatment for coronavirus.
Meanwhile, a Financial Times report suggests the White House is considering granting emergency clearance for a vaccine developed by the University of Oxford and pharmaceutical giant AstraZeneca, ahead of the US presidential election on November 3. The White House has not commented on the story, but a spokesperson for AstraZeneca told Reuters that the efficacy results of its trials were not expected until later this year.
More than 176,000 people have died from coronavirus since the outbreak began in the United States, according to a count from Johns Hopkins University. Almost 5.7 million cases have also been confirmed nationwide.