Researchers from the United States Food and Drug Administration is considering convalescent plasma or a collected blood from patients who have already recovered from CoViD-19 — a potential source of cure against the disease.
According to the FDA press release, this strategy will take advantage to the fighting antibodies developed from the patients immune system after they recover from the illness.
FDA says that they would collect plasma – the liquid potion of the blood that does not include blood cells and platelets — from recovered patients and harvest the antibodies that would be use to cure COVID-19 patients.
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According to FDA, the use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2009-2010 H1N1 influenza virus pandemic, the 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic.
Although promising, convalescent plasma has not been shown to be effective in every disease studied, FDA clarified. It is therefore important to determine through clinical trials, that convalescent plasma is safe and effective before they are administered to patients with COVID-19.
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Currently, participation in clinical trials is only way for patients to obtain access to convalescent plasma. However FDA also stressed that these may not be readily available to all patients because of continuously increasing cases.
FDA also explains that, while clinical trials are being conducted, FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients under 21 CFR 312.310.
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This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization.
FDA also set some guidelines in collecting convalescent plasma from a previously recovered COVID-19 patient:
- COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood (21 CFR 630.10, 21 CFR 630.15). Required testing must be performed (21 CFR 610.40) and the donation must be found suitable (21 CFR 630.30).
- The donor must have a documented laboratory test for COVID-19.
- The donor must complete a resolution of symptoms at least 14 days prior to donation
- Donors must be negative for HLA (Human Leukocyte Antigen) antibodies
For more information read this FDA article on their website: Investigational COVID-19 Convalescent Plasma – Emergency INDs
or Contact FDA directly:
1-888-INFO-FDA (1-888-463-6332)
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
