The US Food and Drug Administration (FDA) has granted emergency authorisation for the use of blood plasma treatments for COVID-19 patients.
Investigational convalescent blood plasma treatments utilise antibody-rich blood gathered from recovered COVID-19 patients, to treat those still suffering from the disease.
The emergency use authorisation (EUA) means that these treatments can now be administered to treat suspected or laboratory-confirmed COVID-19 in hospitalised patients in the US.
The decision was made after a review of the scientific evidence currently available on the use of blood plasma for the treatment of COVID-19, with the FDA concluding that the known and potential benefits outweigh the risks.
The FDA has determined that it is ‘reasonable’ to determine COVID-19 blood plasma treatments could be effective in lessening the severity or shortening the length of illness in some hospitalised patients.
“We’re encouraged by the early promising data that we’ve seen about convalescent plasma,” said Stephen Hahn, FDA Commissioner.
“The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” he added.
Despite the early encouraging data, further clinical trial data is needed to prove the robustness of efficacy for this type of treatment.
Earlier this month, top federal health officials in the US, including National Institute of Allergy and Infectious Disease director Antony Fauci and National Institutes of Health director Francis Collins, attempted to place a hold on the emergency use authorisation for blood plasma treatments, raising concerns about the strength of the initial data.
A study from the Mayo Clinic is the main cause of these worries, despite the programme having already published analysis from over 66,000 COVID-19 patients who have received the treatment so far.
Data from that study has shown that the use of convalescent blood plasma to treat COVID-19 is safe and could provide a benefit for some patients.
In particular, the results suggested that when plasma is administered within three days of a diagnosis, mortality rates dropped.
However, the study did not include a control group of patients given a placebo to compare to those who had received the plasma, making it hard to definitely determine efficacy.