COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval.

ABSTRACT:

Introduction

COVID-19 convalescent plasma with high anti-SARS-CoV-2 antibody levels transfused within 6 months from donor collection was formally approved by the Food and Drug Administration in December 2024 for COVID-19 treatment in immunocompromised patients. Here we summarize the safety and efficacy data submitted for the Biologics License Application.

Areas covered

Safety evaluation in over 100,000 individuals in the expanded access program and 24,000 in randomized controlled trials, showed no serious adverse event increases. Robust randomized controlled trials established efficacy in four distinct disease stages: outpatient, inpatient, newly mechanically ventilated, and in those immunocompromised to prevent acute disease progression or eliminate persistent viral carriag

SUBMITTER: Sullivan DJ 

PROVIDER: S-EPMC12949555 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature