FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data

The FDA is limiting the authorisation to the use of high-titre Covid-19 convalescent plasma only, for the treatment of hospitalised patients early in the disease course and to those who have impaired humoral immunity and cannot produce an adequate antibody response.

SPS commentary:

The use of Covid-19 convalescent plasma with low levels of antibodies is no longer authorised by the US FDA, as additional data from clinical trials have not shown any evidence of its effectiveness in the treatment of hospitalised patients with Covid-19.

Source:

Biospace Inc.

Resource links:

Revised letter of authorisation