U.S. Food and Drug Administration Publishes Updated Donor Eligibility Information Amid COVID-19
The U.S. Food and Drug Administration (FDA) continues to provide updates regarding donor eligibility determination amid the COVID-19 pandemic. In January, it posted an announcement with information about considerations for donor eligibility and vaccines.
The FDA does not recommend testing asymptomatic donors of human cells, tissues, and cell and tissue based products (HCT/Ps), but does offer considerations for donor screening based on information known at this time. HCT/P establishments may wish to consider whether the donor in the 28 days prior to collection:
- cared for, lived with, or otherwise had close contact with individuals diagnosed with or suspected of having COVID-19 infection; or
- had been diagnosed with or suspected of having COVID-19 infection; or
- had a positive diagnostic test (e.g., nasopharyngeal swab) for SARS-CoV-2 but never developed symptoms.
The FDA also states that, based on information available at this time, donors who have received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating HCT/Ps.