FDA Gives Green Light to Convalescent Plasma for COVID-19 Treatment
Melissa Cruz, donates COVID-19 convalescent plasma at Bloodworks Northwest on April 17, 2020 in Seattle, Washington. The plasma would be used in a new experimental treatment in hopes that the antibodies would help others still battling the COVID-19 disease.
United States President Donald Trump has urged Americans who have recovered from COVID-19 to donate their blood plasma while announcing that the Food and Drug Administration has given an emergency use of authorization for convalescent plasma to treat COVID-19.
This new authorization means that people who had recovered from COVID-19 can already have their blood donated to be used to treat patients currently suffering from the infectious disease.
President Trump said, he was pleased to make "a truly historic announcement" yesterday, in the country's battle to save countless lives.
The president revealed that the said treatment has proven to lessen the chance of death from COVID-19 by more than one-third.
Alex Azar, Secretary of Health and Human Services, says "We dream in development of drug of around 35-percent reduction of mortality rate." Azar added that this is a major advance in treating COVID-19 patients.
ALSO READ: Analysis Shows Convalescent Plasma Could Reduce COVID-19 Deaths by 57%
Convalescent Plasma to Help Lessen the Severity of COVID-19
The announcement on the approval of use of convalescent plasma came after Trump publicly pressed the FDA to fast-track both the development of drugs and vaccines.
Even though Azar said that this latest announcement from the president is a major advance in COVID-19 treatment, FDA Commissioner Stephen Hahn says that plasma should not be considered as a new standard of care for the illness. But it may lessen the severity of the infection among patients confined at the hospital.
The commissioner also said that they are encouraged by early promising data that they have discovered about convalescent plasma.
Antibodies Against COVID-19
Initial findings suggest that the plasma, which has antibodies against COVID-19, could help enhance the chances of patients hospitalized with the illness to survive.
However, the said preliminary research indicated that the treatment has just been tried in small groups of people infected with COVID-19, and not in the large placebo-controlled clinical tests that could provide clearer answers.
The FDA noted that evidence backing the decision to approve plasma, was not a result of 'gold-standard' randomized clinical tests in its fact sheet on the said blood plasma for health care professionals and workers.
Facilitating patients' enrollment into any of the current randomized clinical tests, as stated in the agency's statement, is crucially essential for the absolute demonstration of convalescent plasma's safety and effectiveness for COVID-19.
DON'T MISS THIS: UK Might Roll Out Antibody Tests With at Least 98% Accuracy by the End of the Year
The FDA's Original Plan
According to the FDA, it originally planned to issue an emergency authorization for the convalescent plasma treatment at the start of this month, but such plan was put on hold following concerns raised by health officials that there was no sufficient strong data to support the treatment.
Data from an extensive research on plasma found that patients had reduced mortality rate if they were given plasma within three days of their diagnosis compared to receiving it later.
However, the said patients were not compared to a placebo group. Consequently, officials opted to examine the data more thoroughly.
IN CASE YOU MISSED THIS: Tricare Issues an Apology Statement After Telling 600k Beneficiaries They've Had COVID-19
Check out more news and information on COVID-19 and Convalescent Plasma on MD News Daily.
Aug 24, 2020 12:45 AM EDT
