New Delhi: The US Food and Drug Administration (FDA) may authorise emergency use of blood plasma from recovered Covid-19 patients to treat other infected people, according to a Wall Street Journal report.
The report, citing sources, reveals that the FDA could approve plasma therapy for Covid-19 patients as soon as next week.
The therapy involves transfusing antibody-rich plasma from recovered Covid patients to those patients whose bodies have not produced adequate antibodies to fight off the infection.
Randomised controlled trials evaluating the efficacy of plasma therapy on Covid-19 patients are underway across the world, but results from such investigations are currently limited.
The US is the worst-affected country in the world by the Covid-19 pandemic with over 45 lakh cases and more than 1.5 lakh deaths.
What is ‘Emergency Use Authorization’ ?
FDA’s ‘Emergency Use Authorization’ (EUA) allows doctors in the US to use unapproved medical products or repurpose existing medical products during an emergency to diagnose, treat, or prevent life-threatening diseases that lack adequate, approved alternatives.
In May, hydroxychloroquine and remdesivir received emergency use authorisation by the FDA to treat Covid-19 patients, along with several testing kits and medical devices.
Later, on 15 June, FDA revoked the EUA for hydroxychloroquine, after it determined that it was unlikely to be effective in treating Covid-19.
The FDA had on 1 May issued guidelines for health care workers and researchers on the administration and study of Covid-19 convalescent plasma.
At present, only those who are involved in approved clinical trials can administer plasma therapy to their patients. However, there are also specific provisions for patients and doctors not participating in such trials to get approval for plasma therapy.
The EUA for this therapy will allow the US to further expand its use.
The FDA has also launched efforts to bring blood-related therapies for Covid-19 to the US market “as fast as possible”.
Existing research on convalescent plasma therapy
Patients who have recovered from Covid-19 have antibodies in their blood, which could help others fight off the infection.
Therefore, the idea behind plasma therapy is to leverage the antibodies in a recovered patient’s plasma to help others beat the disease.
In India, the therapy was first explored on a Covid-19 patient in April by Max Healthcare in Delhi. The patient recovered.
Several clinical trials are underway in India that are investigating whether the therapy can reduce death risk in patients. On 13 June, the Ministry of Health and Family Welfare sanctioned the use of plasma therapy by hospitals “off-label”, which means with unofficial approval, and as an “investigational therapy”.
It is not advised as a routine line of treatment and is only advised in patients with moderate symptoms.
While results of these trials are still awaited, several research groups from across the world have published papers based on their observations.
The most recent study, published in the Journal of the American Medical Association (JAMA) last month, showed that convalescent plasma therapy did not help patients recover any faster than those who received standard therapy.
The trial was conducted in 103 patients in China, and the authors acknowledged that the trial was terminated early (after 28 days) and may have missed out on important clinical differences in patients.
In a linked editorial to the study, researchers from the US suggested that the study shows that severely ill patients can benefit from blood plasma that has high levels of antibody against SARS-CoV-2.
The results suggested that future studies should focus on determining efficacy in less severely ill patients, they wrote.
A review of existing studies published in the Journal of Medical Virology in May suggested that convalescent plasma therapies are safe, clinically effective, and reduce mortality among Covid-19 patients.
However, the review noted that large multi-centre clinical trials still need to be conducted urgently to establish the efficacy of the therapy in Covid‐19 patients.
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