The FDA has allowed the use of restorative plasma in an emergency

Among the many treatment options being considered as a way of ending the pandemic of coronavirus SARS-CoV-2, reparative plasma is one of the variables that came to the fore in the middle of last year. After encouraging and discouraging its use in an alternative way, international medical entities are rereading about its possibilities.

The United States Food and Drug Administration (FDA) has one authorization for emergency use (USA) for experimental restorative plasma as a treatment for COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to combat COVID-19. Based on the available scientific evidence, The FDA concluded, as detailed in its decision paper, that this product may be effective in the treatment of COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

The move is the result of the FDA’s extensive review of the science and data generated in recent months as a result of efforts to facilitate emergency access to recovering plasma for patients, while clinical trials continue to provide definitive proof of its safety and efficacy.

The US authorizes the distribution of COVID-19 restorative plasma in the US and its administration by healthcare professionals, if applicable, for the treatment of hospitalized patients with COVID-19 who are suspected or laboratory confirmed to have COVID-19.

Plasma rating

FDA Commissioner Dr. Stephen M. Hahn stated, “I am committed to providing access to safe and potentially useful treatments for COVID-19 as soon as possible to save lives. We are encouraged by the first promising data we have seen on restorative plasma. Data from studies conducted this year shows that Plasma from patients recovered from COVID-19 has the potential to help treat people suffering from the effects of this terrible virusSaid Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and efficacy of restorative plasma for the treatment of patients infected with the novel coronavirus.”

Based on the evaluation of the criteria for an AUS and all of the available scientific evidence, The FDA’s Biological Product Evaluation and Research Center has determined that the regulatory criteria for issuing an EUA are met.

The entity has determined that it is reasonable to believe that COVID-19 repair plasma may be effective in reducing the severity or duration of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product, and that no suitable alternative treatments have been approved and available.

The EUA is not intended to replace randomized clinical trials, and to facilitate the enrollment of patients in any of the ongoing randomized clinical trials is critical to definitively demonstrate the safety and efficacy of COVID-19 restorative plasma. The FDA continues to recommend that the ongoing designs of randomized clinical trials with COVID-19 recovery plasma remain unchanged, as COVID-19 recovery plasma does not yet represent a new standard of care based on the currently available evidence.

Plasma with approval

Emil Behring received the first Nobel Prize in medicine in history in 1901 precisely for his work demonstrating that plasma can be used to treat diphtheria. In Argentina, the serum was known for the hemorrhagic fever epidemic that hit the country 70 years ago, and was treated with restorative plasma after it managed to reduce the lethality of the disease thanks to the excellent work of Dr. Julio Maiztegui.

With the passage of time and scientific research that was proven the main component of plasma for the treatment of infections are antibodies. Antibodies are Y-shaped proteins that are highly specific for any infection a person has encountered before. They are produced in large quantities by the B cells of our immune system to bind to the invading virus and then attack it to destroy it.

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