The FDA Authorizes the Emergency Use of Plasma Convalescence

Between the many treatment options that are barajan how to contain the pandemic of coronavirus SARS-CoV-2, the plasma convalescent is one of the variables which surgeon in the middle of the past year. As a result of slowing down and slowing down the use of alternative methods, international medical entities are making new readings of their possibilities.

The Food and Drug Administration of the EE.UU. (FDA, by its seal in English) issue a emergency use authorization (EUA, por sig siglas in English) for plasma convalescence in research with treatment for COVID-19 in hospitalized patients as part of the continuing efforts of the agency to combat the COVID-19. Based on the available scientific evidence, the FDA concludes, as described in its decision memorandum (in English), that this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

The study has been the subject of an extensive revision carried out by the FDA on the science and data generated during the last months of derivatives of the experiments to facilitate access to plasma convalescent for patients, while clinical trials continue until further notice. and efficacy.

The EUA authorizes the distribution of COVID-19 plasma convalescence in the EU and its administration by medical attenuation providers in accordance with to treat patients hospitalized with COVID-19 who are suspected of having been confirmed by a laboratory holding COVID-19.

Plasma revision

Dr. Stephen M. Hahn, FDA Commissioner, stated: Safe treatments and potentially useful for the COVID-19 as fast as possible for saving lives. We feel sorry for the first dates we have seen about plasma convalescence. The dates of the tests carried out this year will be shown by The plasma of patients recovered from COVID-19 has the potential to help treat those who are suffering from the effects of this terrible virus”, Dijo el Dr. Rooster. “At the same time, we will continue to work with investigators to continue the clinical clinical trials to study the safety and efficacy of plasma convalescence to treat new coronavirus-infected patients.”

Based on an evaluation of the criteria for an EUA and the totality of the available scientific evidence, the Center for the Evaluation and Investigation of Biological Products of the FDA has determined that it meets the statutory criteria for issuing an EUA.

The entity determines that it is reasonable to believe that The covalent plasma of COVID-19 can be effective in reducing the severity or reducing the duration of COVID-19 in some hospitalized patients. The agency also determines that the known and potential benefits of the product, which are used to treat the COVID-19, superimpose the known and potential risks of the product, and that there are no alternative treatment options that are available and available

The EUA does not object to the replacement of high-altitude clinical clinics, and facilitates the enrollment of patients in any of the high-altitude clinical clinics in the course is of critical importance in order to demonstrate definitively the safety and efficacy of COVID-19 plasma convalescence. The FDA continues to recommend that the designs of the clinical clinical trials in the course of COVID-19 plasma convalescence be permanent, and that the COVID-19 plasma convalescence should not represent a new state of mind based on current evidence.

Plasma Aval

Emil Behring received the first Nobel Prize in Medicine in 1901 precisely for his work in demonstrating that plasma can be used to treat diphtheria. In Argentina, the disease was well known to lead to the hemorrhagic fever epidemic that broke out in the country 70 years ago, and was treated with convalescence plasma, having recently reduced the death toll from breastfeeding from doctor Julio Maiztegui.

With the passage of time and the scientific investigation, it is evident that the plasma key component for the treatment of infections are the antidote. They anticipate their proteins in the form of Y which are very specific to any infection that a person may have encountered. Its large quantities are produced by cells B of our immune system to unite the invasive virus and attack to destroy it.

SEGUÍ LEYENDO:

United Kingdom launched a campaign to help COVID-19 recover donated plasma

The opinion of the investigators regarding the study which proves that the plasma convalescent does not serve in cases of serious neumonia

The results of the study of the study of plasma convalescence in Latin America led by Fernando Polack