FDA Announces Smallpox Vaccine Guidance for Blood Industry

January 2, 2003
BioPharm International Editors

2 JANUARY - FDA has issued guidance for the blood industry regarding procedures for properly qualifying potential blood donors who have recently been inoculated with the smallpox vaccine (vaccinia virus) or those who may have had other direct exposure to smallpox vaccines.

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T02-58

Media Inquiries: 301-827-6242

December 30, 2002

Consumer Inquiries: 888-INFO-FDA

FDA has issued guidance for the blood industry regarding procedures for properly qualifying potential blood donors who have recently been inoculated with the smallpox vaccine (vaccinia virus) or those who may have had other direct exposure to smallpox vaccines.

These recommendations were developed in consultation with experts on the vaccine virus (smallpox vaccine) at the U.S. Centers for Disease Control and Prevention and the Department of Defense. They are preventive measures pertaining to non-emergency smallpox vaccination. In the event of widespread emergency vaccination due to an actual or impending smallpox outbreak, the procedures outlined in the guidance could be modified to adapt to changing risk/benefit assessments and other public health considerations.

The vaccine virus is closely related to smallpox (variola virus) and induces an immune response that is protective against smallpox. The vaccine virus has been used with great success for over 100 years to protect against smallpox.

FDA is issuing this guidance as a precautionary measure to reduce the very slight risk of blood borne exposure to the smallpox vaccine among certain small patient populations that may develop adverse reactions to the vaccine.

Those interested in the details of this guidance will find a copy of the full document at:

The What's New page at:
http://www.fda.gov/cber/whatsnew.htm

The Guidances page at:
http://www.fda.gov/cber/guidelines.htm#smpox

The Blood Guidances page at:
http://www.fda.gov/cber/blood/bldguid.htm

or directly at
http://www.fda.gov/cber/gdlns/smpoxdefquar.pdf (PDF)
http://www.fda.gov/cber/gdlns/smpoxdefquar.htm (Text)

####

Media Contacts   |   FDA News Page   |   FDA Home Page

Office of Public Affairs
Web page created by tg 2002-DEC-30.

Related Content:

News