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Trump will reportedly announce emergency approval for coronavirus plasma remedy

United States President Donald Trump speaks at the 2020 National Policy Council meeting in Arlington, Virginia on Friday, August 21, 2020.

Tasos Katopodis | UPI | Bloomberg | Getty Images

President Donald Trump will announce emergency convalescent plasma approval for Covid-19 on Sunday, according to the Washington Post and other reports.

The President will make the announcement at a press conference on Sunday evening. White House press secretary Kayleigh McEnany said the 5:30 pm briefing will include "a major therapeutic breakthrough in the China virus."

Convalescent plasma uses blood from Covid-19 patients who have raised and built antibodies to the virus and infuses it to people with Covid-19 to prevent serious illness, according to the Mayo Clinic, which is conducting studies on the treatment.

Several senior health officials, including White House coronavirus advisor Dr. Anthony Fauci, and Dr. Francis Collins, director of the National Institutes of Health, has raised concerns about the data on the country's largest blood plasma study. Concerns that the data were too weak led the Food and Drug Administration to stop granting emergency use for blood treatment.

Clinical studies have not proven whether plasma can help patients fight the coronavirus. Emergency approval doesn't require the same amount of evidence as FDA approval. There are currently no FDA-approved drugs or vaccines for the coronavirus.

Trump reacted angrily at the FDA's decision to keep the emergency clearance pending further data review, saying last week that the decision may be politically motivated.

"I hear great things about it … that's all I can tell you," Trump said during a White House press briefing about convalescent plasma therapy. "It could be a political decision because there are a lot of people over there who don't want to rush because they want to do it after November 3rd, and you've heard that before."

Trump has claimed without evidence that the convalescent plasma has helped more than 50% of the coronavirus patients who have received the treatment.

In a tweet on Saturday, the President accused the FDA for no reason of delaying the inclusion in clinical trials for Covid-19 vaccines or therapeutics for political reasons.

Trump's pressure on regulators has been criticized by academics and lawmakers who have warned the president is putting pressure on regulators to dispose of a vaccine before the November election, even if data from clinical trials do not support widespread use.

Peter Marks, director of the Food and Drug Administration's Center for Biologics Evaluation and Research, has vowed to step down if the Trump administration approves a vaccine before it is found safe and effective.

"The FDA must approve drugs or vaccines for their safety and effectiveness – NOT because of political pressure from the White House," House spokeswoman Nancy Pelosi wrote in a tweet on Saturday. "The President's dangerous attempt to intervene in the US FDA's scientific decisions is endangering the health and well-being of all Americans."

The former head of the Food and Drug Administration, Dr. Scott Gottlieb said Sunday the president's attack on the FDA was related to convalescent plasma and warned there were reasons officials are questioning it as a treatment.

"The study, on which 70,000 patients will be based, was not a very rigorous study. It was an open study in which everyone was treated. It is therefore difficult to draw conclusions," said Gottlieb in an interview with CBS Nation."

"I think plasma is likely to be beneficial. It is likely to be weakly beneficial for stopping this treatment. But I think some people wanted to see more rigorous data to justify this decision," continued Gottlieb. "And I think that's part of what's going on here regarding this tweet and FDA decision-making questions."

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