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  1. Safety & Availability (Biologics)

Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic

January 4, 2021

FDA continues to work closely with CDC and other federal and international agencies to monitor the coronavirus disease 2019 (COVID-19) pandemic caused by the virus, SARS-CoV-2. Respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps). To date, there have been no reported cases of transmission of COVID-19 via these products.

Routine screening measures are already in place for evaluating clinical evidence of infection in HCT/P donors.

Considerations

FDA does not recommend using laboratory tests to screen asymptomatic HCT/P donors.

FDA is aware that some HCT/P establishments in the U.S. are considering additional donor screening and testing measures in response to the COVID-19 pandemic.

The HCT/P establishment’s responsible person must determine and document the eligibility of a cell or tissue donor (21 CFR 1271.50). Based on information available at this time, establishments may wish to consider, whether, in the 28 days prior to HCT/P recovery, the donor

  • 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.

COVID-19 vaccines hold the promise to alter the course of this pandemic and are complex biological products intended to be administered to millions of individuals to prevent COVID-19. Recently, vaccines for the prevention of COVID-19 have become available under emergency use authorization (EUA) issued by the FDA.  Based on information available at this time, those who have received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating HCT/Ps.

FDA will continue to monitor the situation and will issue updates as information becomes available.

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