The Food and Drug Administration (FDA) has given an emergency approval to amplify the use of antibody-rich blood plasma in an effort to help the hospitalized COVID-19 patients, enabling President Donald Trump. He has been forcing the agency to move swiftly to tackle the pandemic, to insist the progress on the Republican convention eve.
President Trump praised the approval, which had been powered by specific concerns of the top government scientists related to the data. This has been considered as the welcome news in the battle against the deadly pandemic, which has taken 176,000 lives in the US alone, leaving the nation fall behind most other states in the potency of its response.
In the news briefing, President Trump described the treatment as ‘a powerful therapy’ made possible ‘by assembling the full potential of the federal government.’ This decision will extend the use of a treatment, which has already been regulated to 70,000+ patients. However, the FDA specified the benefits for only a few patients. Unlike a new drug, plasma can’t be made in millions of doses; it has limited availability with respect to the blood donations. President Trump has urged the patients who have recovered from the coronavirus to donate plasma, stating the\re is a nationwide campaign to collect it.
President Trump has represented his request to cut red tape and speed approval of vaccines and treatments as a mandatory response to a public health emergency.
The most recent announcement of plasma donation has come a day after he repeated his baseless claim that the FDA was intentionally holding on the decision-making until after the election, this time quoting it as a ‘deep state.’ This allegation aggravated concerns among some outside experts, government scientists, and Democrats that the president’s legislative requirements could erode the virtue of the regulatory process, disturb the public confidence in the safety, and initiate a different kind of public health risk.
No unarranged trials of the categorized researchers, which have been considered the most strong, have suggested a benefit from convalescent plasma. However, the FDA said that the data they have so far, which also includes over a dozen published studies, showing that ‘it is practical to believe’ that the treatment ‘may be potent in curbing the severity or reducing the length of COVID-19 illness in some hospitalized patients,’ to be specific to those who earlier received it.
According to the FDA’s center for biologics, evaluation, and research director, Dr. Peter Marks said that patients below 80 years who had received plasma with a high level of virus-fighting antibodies within 3 days of diagnosis are the same patients who were not on a ventilator ( around 35% ) were more possibly to be alive a month later when compared to those who received plasma of the low level of the antibodies.
President Trump denied the agency’s overtones language during his appearance before reporters at the White House stated that convalescent plasma has been ‘proven to curb the mortality by around 35%.’
The FDA is solely responsible for approving new medicines, has also lagged the authorization for about a week after top health officials, which included National Institutes of Health director Dr. Francis S. Collins, and the top infectious disease specialist, Dr. Anthony S. Fauci, questioned if the data available was enough.
In a recent tweet, President Trump complained claiming with no evidence that officials were predicting to postpone the answer until after November 3rd’ — Election Day — urging the FDA to ‘focus on speed, and saving lives.’
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