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GUIDANCE DOCUMENT

Recommendations for Deferral of Donors and Quarantine and Retrieval of Blood and Blood Products in Recent Recipients of Smallpox Vaccine (Vaccinia Virus) and Certain Contacts of Smallpox Vaccine Recipients Guidance for Industry December 2002

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
02D-0362
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document provides the current recommendations of the Food and Drug Administration (FDA) for assessment of donor suitability and quarantine and retrieval of blood and blood products in cases of donors exposed to vaccinia virus, which is the virus used in smallpox vaccines. The presence of vaccinia virus in transfused blood or plasma could be harmful to some recipients. Although the presence of vaccinia virus in blood (viremia) has rarely been documented, this possibility has not been assessed using modern laboratory techniques. Therefore, the risk of transmission of vaccinia virus by blood and blood products is uncertain.

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Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 02D-0362.

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