New Crown Outbreak: 23.58 million! FDA grants emergency use authorization (EUA) for recovery plasma to treat hospitalized COVID-19 patients!

August 24, 2020 / / -- At present, the new crown pneumonia epidemic is still spreading rapidly around the world.
according to Baidu's Real-Time Big Data Report on the Outbreak of New Coronavirus Pneumonia, as of 12 p.m. on August 24, 2020, more than 23.58 million cases and more than 812,000 deaths had been confirmed worldwide.
recently, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for recovery plasma as a potentially promising COVID-19 therapy for COVID-19 inpatients.
is part of the agency's ongoing efforts to combat COVID-19 and another achievement of the U.S. government's fight against the COVID-19 pandemic.
Based on available scientific evidence, the FDA concludes that recovery plasma may be effective in treating COVID-19, as described in its decision memorandum, and that the known and potential benefits of the product outweigh the known and potential risks of the product.
The recovery phase plasma EUA follows an extensive FDA review of the science and data generated over the past few months, which stem from efforts to promote patients' urgent access to rehab plasma, as clinical trials are still ongoing to clearly demonstrate its safety and effectiveness.
this EUA authorizes the distribution of COVID-19 recovery plasma in the United States and, where appropriate, is managed by healthcare providers to treat suspected or laboratory-confirmed COVID-19 inpatients.
S. Department of Health and Human Services Secretary Alex Azar said: "The FDA's emergency authorization for recovery plasma is a landmark achievement in President Trump's efforts to save lives from COVID-19.
Trump administration has long recognized the potential of recovery plasma.
months ago, the FDA, BARDA and private partners began to roll out the product nationwide, while continuing to evaluate data through clinical trials.
so far, our research in recovering plasma has made the product more accessible to more than 70,000 U.S. patients.
we are deeply grateful to americans who have already donated and encourage individuals recovering from COVID-19 to consider donating recovery plasma.
Fda Commissioner Stephen M. Hahn, M.D., said, "To save lives, we are committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible."
we are encouraged by the early potential data for plasma recovery.
this year, patients recovering from COVID-19 may have plasma in their bodies that could help treat those affected by the terrible virus, according to research conducted this year.
, we will continue to work with researchers to advance randomized clinical trials to study the safety and effectiveness of recovery plasma therapy for COVID-19 patients.
" recovery plasma therapy process (Photo: pharmacologyupdate.com) The scientific evidence for recovery plasma is based on an assessment of the EUA standard and an overall assessment of the available scientific evidence, and the FDA Biological Products Assessment and Research Center (CBER) determines that the statutory criteria for publishing the EUA standard are met.
FDA believes there is reason to believe that COVID-19 recovery plasma can effectively reduce the severity or shorten the course of some hospitalized patients.
the agency also determined that when the product is used to treat COVID-19, its known and potential benefits outweigh the known and potential risks of the product and that there are insufficient, approved and available alternative treatments.
EUA is not a substitute for randomized clinical trials, promoting patients to join any ongoing randomized clinical trials, and is critical to clearly demonstrating the safety and importance of COVID-19 recovery plasma.
FDA continues to recommend that the design of randomized clinical trials of COVID-19 rehabilitation plasma and other therapeutic drugs remain unchanged, as the available evidence suggests that COVID-19 rehabilitation plasma does not yet represent a new standard of care.
EUA Clause EUA requires that healthcare providers and patients be provided with important information about the use of COVID-19 recovery plasma to treat COVID-19, including dose instructions and potential side effects.
side effects of plasma during COVID-19 recovery include allergic reactions, blood transfusion-related circulatory overload, blood transfusion-related lung damage, and the possibility of blood transfusion-borne infections.
Origin: FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Forward COVID-19 Treatment, Another Establish in Administration's Fight Against Pandemic.