January 11, 2022
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 blood transfusion. There have been no reported cases of transfusion-transmitted coronavirus, including SARS-CoV-2, worldwide.
Routine measures used to determine blood donor eligibility prevent individuals with clinical respiratory infections from donating blood. For example, blood donors must be in good health and have a normal temperature on the day of donation (21 CFR 630.10).
It is imperative that healthy individuals continue to donate blood and blood components, including Source Plasma.
- FDA does not recommend using COVID-19 laboratory tests to screen routine blood donors.
- The blood establishment’s responsible physician must evaluate prospective donors and determine eligibility (21 CFR 630.5). The donor must be in good health and meet all donor eligibility criteria on the day of donation (21 CFR 630.10). The responsible physician may wish to consider the following:
- individuals diagnosed with COVID-19 or who are suspected of having COVID-19, and who had symptomatic disease, refrain from donating blood for at least 10 days after complete resolution of symptoms,
- individuals who had a positive diagnostic test for SARS-CoV-2 (e.g., nasopharyngeal swab), but never developed symptoms, refrain from donating at least 10 days after the date of the positive test result,
- individuals who are tested and found positive for SARS-CoV-2 antibodies, but who did not have prior diagnostic testing and never developed symptoms, can donate without a waiting period and without performing a diagnostic test (e.g., nasopharyngeal swab),
- individuals who received a nonreplicating, inactivated, or mRNA-based COVID-19 vaccine can donate blood without a waiting period,
- individuals who received a live-attenuated viral COVID-19 vaccine, refrain from donating blood for a short waiting period (e.g., 14 days) after receipt of the vaccine,
- individuals who are uncertain about which COVID-19 vaccine was administered, refrain from donating for a short waiting period (e.g., 14 days) if it is possible that the individual received a live-attenuated viral vaccine.
FDA will continue to monitor the situation and issue updated information as it becomes available.