The US Food and Drug Administration (FDA) has issued a safety alert
on the potential risk of transmitting SARS-CoV-2, the virus that causes coronavirus diseases 2019 (COVID-19), through fecal microbiota transplantation.
In the alert, published today, the FDA indicates that additional safety measures are needed after multiple studies reported that SARS-CoV-2 ribonucleic acid and/or SARS-CoV-2 virus was present in the stool of infected individuals.
Based on these studies, the virus may potentially be transmitted through fecal microbiota transplantation; however, the risk of transmission is unknown at this time.
Disruptions to health care activities due to the ongoing pandemic may result in decreased accessibility to nasopharyngeal specimen testing from stool donors. Additionally, little is known about the sensitivity and availability of direct testing of stool for SARS-CoV-2.
The FDA’s current recommendations for FMT include:
- Screening for donors should include questions that identify individuals who may currently be or recently were infected with SARS-CoV-2.
- Donors and/or donor stool should be tested for SARS-CoV-2, as feasible.
- Criteria should be developed for the exclusion of donors and donor stool based on screening and testing.
- Informed consent should include information about potential transmission of SARS-CoV-2 through fecal microbiota transplantation, including stool from donors who are asymptomatic for COVID-19.
The FDA indicates that more guidance will be provided as more information about this situation becomes available.
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