Re-entry Template for Donors Confirmed Positive for HBsAg Due to HBV Vaccination

This re-entry template is intended to be used by facilities to obtain permission from the Food and Drug Administration for re-entry of donors who recently confirmed positive for hepatitis B virus surface antigen following a prophylactic HBV vaccination (any of the three doses) under the provisions of 21 CFR 610.41(b). In the absence of other risk factors, the test results most likely are caused by the HBsAg contained in the vaccine, a scenario that has become increasingly common because of the use of screening tests with greater sensitivity. These donors are nonreactive for all other HBV markers, including antibody to hepatitis B core antigen and HBV DNA (if this test was performed). Once the vaccine-induced HBsAg has cleared a donor’s system, the donor should be eligible for re-entry provided he or she has not been exposed to the virus and does not have other specific HBV risk factors.

Re-entry Template (MS Word)