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  1. Safety & Availability (Biologics)

Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Ebola Disease and HCT/P Donation

Date: 07/16/26

FDA is issuing this communication to provide information regarding Ebola disease and considerations for donor eligibility determinations for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

In May 2026, CDC issued a Health Alert Network (HAN) Health Advisory to notify clinicians and public health authorities of a new outbreak of Ebola disease in the Democratic Republic of the Congo (DRC) and Uganda caused by the Bundibugyo virus (species Orthoebolavirus bundibugyoense). The risk of spread to the United States is considered low at this time. Federal agencies continue to monitor Ebola disease in U.S. travelers. 

Background:

On May 15, 2026, the DRC Ministry of Health confirmed an Ebola outbreak in Ituri Province, caused by the Bundibugyo virus (BVD). This is DRC's 17th recorded Ebola outbreak. Cases have been reported in the DRC and neighboring Uganda. No cases have been confirmed in the United States as of July 14. However, for the most current case counts and mortality data, please refer to the Ebola Outbreak: Current Situation | Ebola | CDC website, as figures are evolving rapidly.

Ebola disease is caused by a group of viruses known as orthoebolaviruses (formerly ebolavirus). Ebola disease most commonly affects humans and nonhuman primates, such as monkeys, chimpanzees, and gorillas. Four orthoebolaviruses cause illness in people, presenting as clinically similar disease:

  • Ebola virus (species Orthoebolavirus zairense) causes Ebola virus disease.
  • Sudan virus (species Orthoebolavirus sudanense) causes Sudan virus disease.
  • Taï Forest virus (species Orthoebolavirus taiense) causes Taï Forest virus disease.
  • Bundibugyo virus (species Orthoebolavirus bundibugyoense) causes Bundibugyo virus disease.

Symptoms include fever, generalized body pain, weakness, vomiting, and in some cases bleeding, with several patients deteriorating rapidly and subsequently dying. Regional insecurity, population displacement, and cross-border travel increase the risk of further spread.

The incubation period for BVD ranges from 2 to 21 days post-exposure, with infected individuals not considered contagious until after symptom onset. Early symptoms include fever, aches, pains, and fatigue ("dry" symptoms), progressing to diarrhea, vomiting, and unexplained bleeding ("wet" symptoms).

Transmission occurs via direct contact with bodily fluids (e.g., blood, urine, feces, saliva, semen) of infected or deceased individuals through broken skin or mucous membranes. Ebola disease may also be acquired through zoonotic exposure from infected animals or contact with contaminated objects, such as needles. Ebola disease is not spread through airborne transmission. The risk of spread to the United States is considered low at this time.

Transmission of Ebola disease through use of human cells, tissues, or cellular or tissue-based products (HCT/Ps) has not been described; therefore, the risk of infection transmitted by implantation, transplantation, infusion, or transfer of HCT/Ps remains theoretical.

A donor screening test for Ebola disease is not available.

Considerations:

Robust, routine screening measures, for the purposes of making a donor eligibility determination, are already in place for evaluating risk factors and conditions as well as clinical evidence and physical evidence of infection in HCT/P donors. For example, donor screening includes performing a donor medical history interview (21 CFR 1271.3(n)) and review of “relevant medical records” (21 CFR 1271.3(s)) to look for risk factors and conditions that may lead to a determination that the donor is ineligible.

These donor eligibility safeguards currently in place may identify individuals screened for potential donation who are diagnosed with Ebola disease or who are currently at greatest risk for infection with Ebola disease.

Based on information available at this time, establishments may also wish to consider whether, in the 21 days prior to HCT/P recovery, the donor:

  • was diagnosed with or suspected of having Ebola disease
  • had close contact with a person confirmed to have or suspected of having Ebola disease
  • resided in or travelled to a country with widespread transmission of Ebola disease (See Map of Impacted Areas: https://www.cdc.gov/ebola/situation-summary/index.html)
  • was notified by a federal, state, or local public health authority that he or she may have been exposed to a person with Ebola disease

FDA will continue to monitor cases of Ebola disease worldwide and available information about potential risks of Ebola disease transmission by HCT/Ps. We will communicate, as appropriate, as additional information becomes available.

Resources:

Ebola Outbreak: Current Situation | Ebola | CDC
Ebola Disease Outbreak in the Democratic Republic of the Congo and Uganda | HAN | CDC

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