FDA has emergency authorization for plasma for Covid-19, according to the New York Times

08/20/2020 Health, World


The hold came after a group of federal health officials – including National Institutes of Health Director Dr Francis Collins, NIAID Director Dr Anthony Fauci and Lane – stepped in to argue that emerging data on treatment were too weak, the Times reported Wednesday. two sources for senior administration.

“The three of us are pretty attuned to the importance of robust data through randomized counter-tests, and that a pandemic that does not change,” Lane told the Times.

CNN referred to the FDA and was told “per policy, we are unable to comment on whether or not we will take action regarding emergency use authorization for consuming plasma.”

The treatment was made from the blood of people recovering from Covid-19, and it has been shown to be successful in two other deadly coronaviruses, MERS and SARS. It is also used to treat the flu.

Authorization for emergency use by the FDA does not require the same level of evidence as full FDA approval. The agency previously issued an EUA on hydroxychloroquine and chloroquine for Covid-19 treatment, and did so back in June, after the antimalarial substances remained ineffective against coronavirus.

At the end of March, the FDA created a pathway for scientists to test convalescent plasma with patients and study its effects. Doctors have been using the treatment ever since. USCovidPlasma.org reports that nearly 67,000 people have completed the treatment and nearly 14,000 physicians use it as part of a Mayo Clinic-run program, but it is not yet clear if it works. Several studies are underway.

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President Donald Trump and U.S. health leaders, including Fauci and other White House Task Force members, and even celebrities like Dwayne “The Rock” Johnson, have encouraged people who have survived Covid-19 to donate plasma. Two weeks ago, on a tour of the Red Cross, Trump pleaded with people to donate plasma, saying, “We have a lot of people who would be healed, would get better. If you can, please.”

The US government has invested in experimental treatment. It awarded Plasma Technologies LLC a $ 750,000 defense contract to develop upscale Covid-19 plasma technologies, according to an announcement on the Department of Defense’s website Monday. It also has 200,000 units of convalescent plasma in stock and the DoD said it wants to collect more by September.

Early results from some small studies have looked promising.

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A very small study published in JAMA in March showed that four out of five patients received convalescent plasma improvement. A second very small study of 10 Chinese patients published in May in the procedures of the National Academy of Sciences saw improvement in patients treated with plasma recovery, without safety concerns. Another May study of 25 patients in Houston showed that patients got better without safety issues. In July, a larger study of 5,000 hospital patients showed that treatment was safe.
Not all tears have come to the same conclusions. One small study by Chinese researchers published in June showed no improvement in mortality among six critically ill patients, but the researchers did not completely reject the convalescent plasma. Instead, they suggested that it might work if patients were treated earlier.
Another randomized trial of 103 patients in China found no statistically significant improvement in patients, but it is difficult to draw conclusions from that trial because it had to be stopped early when the flow of patients slowed to a trickle and there were not sufficient for the therapy. Some other studies in the US have also had problems recruiting enough patients.
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One major study was released in August in which 35,000 patients have not yet been peer reviewed. It found that giving people early plasma treatment seems to reduce death more. People who received the transfusions within three days of diagnosis had a seven-day mortality rate of 8.7%, while patients treated four or more days in the course of illness had a mortality rate of 11.9%.

But there was no placebo group in the study. Without that comparison, it is still very difficult to know if the treatment made the difference.

“Convalescent plasma has not yet been proven to work with the trials we want to see, these randomized control tests,” said Dr. Ian Lipkin, the director of the Center for Infection and Immunity at Columbia University Mailman School of Public Health, in an interview on Monday. “While there is a lot of reason for optimism, it has not been shown and until that is done, there will always be a healthy skepticism in the community, despite all the background information that suggests it is likely to work. “

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