FDA issues final guidance on investigational convalescent plasma

Nov. 18, 2020

The U.S. Food and Drug Administration (FDA) issued a final guidance for healthcare providers and researchers about the use of investigational COVID-19 convalescent plasma. The agency also extended its enforcement discretion through February 28, 2021.

The FDA issued an emergency use authorization for COVID-19 convalescent plasma on August 23. However, the EUA did not cover what the agency refers to investigational COVID-19 convalescent plasma. These are products that do not meet all of the conditions of EUA or which are used under an investigational new drug application during the public health emergency.

But in the interest of allowing hospitalized COVID-19 patients to have access to the investigational convalescent plasma, the FDA issued a proposed guidance on September 2, which it then finalized November 16.

The guidance allows providers to request permission for a single use of investigational convalescent plasma for patients with serious or life-threatening COVID-19. The agency also said it expects these situations to occur relatively infrequently since it has also issued EUA for convalescent plasma.

To meet the terms of the EUA, the FDA said the convalescent plasma should be collected only from donors who have had symptoms of COVID-19 and a positive result from a diagnostic test or if they did not have symptoms but have had positive results from two COVID-19 antibody tests. The agency said blood banks should not collect convalescent plasma from donors who have received an investigational vaccine because of uncertainty about the quality of the immune response produced from the vaccines.

By extending its enforcement discretion, the agency said it is granting blood banks additional time to “develop the necessary procedures to manufacture COVID-19 convalescent plasma under the conditions of the EUA, and if unable to develop such procedures, only administer investigational convalescent plasma under an IND.”

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