FDA Champions Recovered COVID-19 Patients to Consider Donating Plasma for Development of Blood-based Therapies

FDA Champions Recovered COVID-19 Patients Consider Donating Plasma for Development of Blood-based Therapies

The U.S. Food and Drug Administration (FDA), embracing the All-of-America approach to fighting the COVID-19 pandemic, updates the country on a treatment called convalescent plasma, encouraging those who have recovered from COVID-19 to donate plasma to help others fight the disease. Convalescent plasma can be used to manufacture a biological product used to treat patients with COVID-19.

What is Convalescent plasma?

This is an antibody-rich product made from blood donated by people who have recovered from the disease caused by novel coronavirus.

Why is this product important?

Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity of shorten the length of illness caused by COVID-19.

Is the FDA imposing a controlled approach—involving clinical trials and/or careful emergency use?

Yes. The regulatory agency notes the importance that this potential therapy is evaluated in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients as appropriate.

What has the response been like to the FDA’s recently an...

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