The Food and Drug Administration in the U.S. has just announced giving emergency authorization (EUA) to convalescent plasma as a form of COVID-19 treatment.
President Donald Trump made the announcement during a press conference on Sunday dubbing as a “historic breakthrough.” On the same day, the FDA made the official release of the announcement on its respective website for the “investigational convalescent plasma” as treatment.
The EUA allows the convalescent plasma to be administered to hospitalized patients affected by the COVID-19, as an added effort to fight the coronavirus pandemic.
An excerpt of the FDA’s announcement reads:
“Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.”
FDA on convalescent plasma distribution
Accordingly, the announcement covers the distribution of the COVID-19 convalescent plasma within the United States. Per Health and Human Services Secretary, Alex Azar, the agency, along with BARDA and private partners, has already started working on the convalescent plasma distribution to over 70,000 patients in the past months.
All the while, they have reportedly been evaluating the data gathered through clinical trials. However, supply is a concerning factor as the convalescent plasma must come from donors, per CNN.
As to its effectivity, the news outlet notes there are “promising signals from studies,” similar to those conducted by the Mayo Clinic—wherein plasma treatment was deemed safe after transfusion on 20,000 patients per STAT‘s report.
Trump has also encouraged COVID-19 recoveries to donate plasma, as a nationwide campaign will be collecting donations of such.
Political influence looms the EUA issuance
Before the FDA made the announcement, issues about the convalescent plasma treatment approval were reported, more of which was coming from the president himself. As The New York Times reports, Trump has been accusing the FDA of “deliberately holding up decision-making” until after November 3rd, which is the U.S. elections.
“That accusation exacerbated concerns among some government scientists, outside experts and Democrats that the president’s political needs could undermine the integrity of the regulatory process, hurt public confidence in safety and introduce a different kind of public health risk,” says the news outlet.
This was also the fear of a few experts when Vladimir Putin announced—also in a record-breaking way—about the approval of its Russian COVID-19 vaccine, the Sputnik-V. The fear is that the race for a cure might become a political race, which could deeply undermine the integrity of the vaccines to be produced.
More from FDA’s Hahn: “I’ve never been asked to make any decision at the FDA based on politics. The decisions the scientists at the FDA are making are done on data only.”
— Jim Acosta (@Acosta) August 24, 2020
Despite initially studies already conducted, more data are needed to assure the effectivity of convalescent plasma. CNN quotes Dr. Thomas File, president of the Infectious Diseases Society of America, saying:
“While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment.”
By politicizing the FDA, @realDonaldTrump has effectively tampered with the American people’s ability to have confidence in the agency that is supposed to tell us what is safe.
— Kurt Bardella (@kurtbardella) August 24, 2020
Meanwhile, Dr. Paul Offit of the Vaccine Education Center at Children’s Hospital of Philadelphia also told CNN that what the public is seeing is sort of bullying.
“I think what’s happening here is you’re seeing bullying, at least at the highest level of the FDA, and I’m sure that there are people at the FDA right now who are the workers there that are as upset about this as I am.”
The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives! @SteveFDA
— Donald J. Trump (@realDonaldTrump) August 22, 2020
President Trump’s tweet on Saturday of slamming unfounded claims against the FDA is found to be “very dangerous,” according to House Speaker Nancy Pelosi.
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