On August 23 2020, US President Donald Trump announced the emergency authorization of plasma treatment against Covid-19.
Blood Plasma treatment was given authorisation the US Food and Drug Administration (FDA) to treat COVID patients. The FDA said that the initial trials indicate it is safe as several experts have questioned the robustness of studies into its use.
While announcing the emergency authorization of blood plasma treatment against Covid-19, Trump said –
This is what I’ve been looking forward to doing for a long time,
I’m pleased to make a truly historic announcement in our battle against the China virus that will save countless lives.
FDA has also stated that
This product may be effective in treating COVID-19 and… the known and potential benefits of the product outweigh the known and potential risks of the product,
Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks said
It appeared that the product is safe and we’re comfortable with that and we continue to see no concerning safety signals,
Will plasma treatment work?
Early research suggests blood plasma treatment can decrease the mortality rate and also improve patient’s health if it is administered within the first 3 days of admittance into the hospital.
Till date, the treatment results have shown that plasma treatment can reduce the death rate by at least 35%. It is to be noted that the mortality rate in the US is the highest in the world.
However, though many countries like India are using the plasma treatment, the effectiveness has been not authenticated officially by the health departments of the respective countries at International levels.
WHO reaction about the US plasma treatment permission
World Health Organization (WHO) officials, on Monday, said that using convalescent plasma was “
still an experimental treatment.
Also, WHO chief scientist Soumya Swaminathan stated
There are a number of clinical trials going on around the world looking at convalescent plasma compared to the standard of care. Only a few of them have actually reported interim results… and at the moment, it’s still very low-quality evidence,
Previously, WHO stated that
Covid-19 convalescent plasma can be made available on an experimental basis through local production provided that ethical and safety criteria are met for its preparation and use.
FDA Recommendations for Investigational COVID-19 Convalescent Plasma
The guidance provides recommendations on the following:
- pathways for use of investigational COVID-19 convalescent plasma
- patient eligibility
- collection of COVID-19 convalescent plasma,
- Donor eligibility and his qualifications
- labelling, and
- requests should be made o between 8 p.m. ET and 8 a.m. ET from Monday to Sunday
Pathways for Use of Investigational COVID-19 Convalescent Plasma
- Clinical Trials
- Expanded Access
- Single Patient Emergency IND