REGULATORY UPDATE: FDA Bulletin Details Monkeypox Response; AABB Releases Monkeypox Resources

August 01, 2022

The Food and Drug Administration outlined its response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics, in a bulletin issued on Friday. The agency also recently launched a dedicated website that details the agency’s monkeypox preparedness and response and contains news items related to the agency’s role in addressing the outbreak.  

AABB also released a new toolkit, “Monkeypox Resources to Consider,” that includes member-exclusive resources. The toolkit contains the monkeypox virus fact sheet and member-exclusive outbreak summary, both updated last week by AABB’s Transfusion Transmitted Diseases (TTD) Committee. The toolkit also includes eligibility information for donors who have received a smallpox vaccine with a corresponding flow chart and information for blood centers considering the development of a local deferral.  

The TTD Committee continues to monitor developments related to the outbreak and will provide updates as they are available. AABB reminds members that monkeypox is not known to be transfusion-transmitted and that there have been no reports of transfusion-transmitted cases.

Members may contact regulatory@aabb.org with questions.